Chinese herbal medicine for primary dysmenorrhoea

(Review)

Zhu X, Proctor M, Bensoussan A, Wu E, Smith CA

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2010, Issue 11
http://www.thecochranelibrary.com

Chinese herbal medicine for primary dysmenorrhoea (Review)

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Analysis 1.1. Comparison 1 Chinese herbal medicine versus placebo, Outcome 1 Reduction of pain. . . . . . . 84
Analysis 1.2. Comparison 1 Chinese herbal medicine versus placebo, Outcome 2 Reduction of pain. . . . . . . 85
Analysis 1.3. Comparison 1 Chinese herbal medicine versus placebo, Outcome 3 Overall symptoms. . . . . . . 86
Analysis 1.4. Comparison 1 Chinese herbal medicine versus placebo, Outcome 4 Adverse effects. . . . . . . . 86
Analysis 1.5. Comparison 1 Chinese herbal medicine versus placebo, Outcome 5 Use of additional medication. . . 87
Analysis 2.1. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 1
Reduction of pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Analysis 2.2. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 2 Overall
symptoms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
Analysis 2.3. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 3 Adverse
effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Analysis 2.4. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP), Outcome 4 Use of
additional medication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Analysis 3.1. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 1
Reduction of pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Analysis 3.2. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 2 Overall
symptoms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Analysis 3.3. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 3 Adverse
effects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Analysis 3.4. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula, Outcome 4 Use of
additional medication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
Analysis 4.1. Comparison 4 Chinese herbal medicine versus acupuncture, Outcome 1 Reduction of pain. . . . . 97
Analysis 5.1. Comparison 5 Chinese versus heat compression, Outcome 1 Reduction of pain. . . . . . . . . 98
Analysis 5.2. Comparison 5 Chinese versus heat compression, Outcome 2 Adverse effects. . . . . . . . . . . 98
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Chinese herbal medicine for primary dysmenorrhoea (Review) i

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Chinese herbal medicine for primary dysmenorrhoea

Xiaoshu Zhu1 , Michelle Proctor2 , Alan Bensoussan3 , Emily Wu4 , Caroline A Smith5
1
Center for Complementary Medicine Research, School of Biomedical and Health Science, University of Western Sydney, Sydney,
Australia. 2 Psychological Service, Department of Corrections, Auckland, New Zealand. 3 Center for Complementary Medicine Research,
University of Western Sydney, Sydney, Australia. 4 Traditional Chinese Medicine, Emily Wu Traditional Chinese Medicine Clinic,
Lindfield, Australia. 5 Centre for Complementary Medicine Research, The University of Western Sydney, Penrith South DC, Australia

Contact address: Xiaoshu Zhu, Center for Complementary Medicine Research, School of Biomedical and Health Science, University
of Western Sydney, Building 24, Campbelltown Campus, Locked Bag 1797, Penrith South DC, Sydney, New South Wales, 1797,
Australia. x.zhu@uws.edu.au. mszhuxiaoshu@yahoo.com.

Editorial group: Cochrane Menstrual Disorders and Subfertility Group.

Publication status and date: Edited (no change to conclusions), published in Issue 11, 2010.
Review content assessed as up-to-date: 13 December 2007.

Citation: Zhu X, Proctor M, Bensoussan A, Wu E, Smith CA. Chinese herbal medicine for primary dysmenorrhoea. Cochrane Database
of Systematic Reviews 2008, Issue 2. Art. No.: CD005288. DOI: 10.1002/14651858.CD005288.pub3.

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by
some women. Chinese herbal medicine may be a suitable alternative.
Objectives
To determine the efficacy and safety of Chinese herbal medicine for primary dysmenorrhoea when compared with placebo, no treatment,
and other treatment.
Search methods
The Cochrane Menstrual Disorders and Subfertility Group Trials Register (to 2006), MEDLINE (1950 to January 2007), EMBASE
(1980 to January 2007), CINAHL (1982 to January 2007), AMED (1985 to January 2007), CENTRAL (The Cochrane Library issue
4, 2006), China National Knowledge Infrastructure (CNKI, 1990 to January 2007), Traditional Chinese Medicine Database System
(TCMDS, 1990 to December 2006), and the Chinese BioMedicine Database (CBM, 1990 to December 2006) were searched. Citation
lists of included trials were also reviewed.
Selection criteria
Any randomised controlled trials involving Chinese herbal medicine versus placebo, no treatment, conventional therapy, heat com-
pression, another type of Chinese herbal medicine, acupuncture or massage. Exclusion criteria were identifiable pelvic pathology and
dysmenorrhoea resulting from the use of an intra-uterine contraceptive device.
Data collection and analysis
Quality assessment, data extraction and data translation were performed independently by two review authors. Attempts were made
to contact study authors for additional information and data. Data were combined for meta-analysis using either Peto odds ratios or
relative risk (RR) for dichotomous data or weighted mean difference for continuous data. A fixed-effect statistical model was used,
where suitable. If data were not suitable for meta-analysis, any available data from the trial were extracted and presented as descriptive
data.
Chinese herbal medicine for primary dysmenorrhoea (Review) 1
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results

Thirty-nine randomised controlled trials involving a total of 3475 women were included in the review. A number of the trials were
of small sample size and poor methodological quality. Results for Chinese herbal medicine compared to placebo were unclear as data
could not be combined (3 RCTs). Chinese herbal medicine resulted in significant improvements in pain relief (14 RCTs; RR 1.99,
95% CI 1.52 to 2.60), overall symptoms (6 RCTs; RR 2.17, 95% CI 1.73 to 2.73) and use of additional medication (2 RCTs; RR 1.58,
95% CI 1.30 to 1.93) when compared to use of pharmaceutical drugs. Self-designed Chinese herbal formulae resulted in significant
improvements in pain relief (18 RCTs; RR 2.06, 95% CI 1.80 to 2.36), overall symptoms (14 RCTs; RR 1.99, 95% CI 1.65 to 2.40)
and use of additional medication (5 RCTs; RR 1.58, 95% CI 1.34 to 1.87) after up to three months of follow-up when compared to
commonly used Chinese herbal health products. Chinese herbal medicine also resulted in better pain relief than acupuncture (2 RCTs;
RR 1.75, 95% CI 1.09 to 2.82) and heat compression (1 RCT; RR 2.08, 95% CI 2.06 to 499.18).

Authors conclusions

The review found promising evidence supporting the use of Chinese herbal medicine for primary dysmenorrhoea; however, results are
limited by the poor methodological quality of the included trials.

PLAIN LANGUAGE SUMMARY

Chinese herbal medicine may help reduce menstrual pain.

Dysmenorrhoea is a very common complaint that refers to painful menstrual cramps in abdomen. Primary dysmenorrhoea refers to pain
of an unknown cause (i.e. no medical condition is identified). Nonsteroidal anti-inflammatory drugs or the contraceptive pill have been
used successfully for treatment but more women are looking for non-drug therapies. Chinese herbal medicine has been used for centuries
in China and it is currently used in public hospitals in China for the treatment of primary dysmenorrhoea. The review found promising
evidence for the use of Chinese herbal medicine in reducing menstrual pain in the treatment of primary dysmenorrhoea, compared
to conventional medicine such as NSAIDs and the oral contraceptive pill, acupuncture and heat compression. No significant adverse
effects were identified in this review. However the findings should be interpreted with caution due to the generally low methodological
quality of the included studies.

BACKGROUND
Dysmenorrhoea is a common gynaecological complaint among
adolescent girls and women of reproductive age and refers to the
occurrence of painful cramps in the lower abdominal region dur-
ing menstruation. It is usually classified into two subcategories:
primary dysmenorrhoea occurs in the absence of an identifiable
pathological condition (Lichten 1987); when the period pain is
associated with organic pathology such as endometriosis, it is de-
fined as secondary dysmenorrhoea (Dawood 2006).
Primary dysmenorrhoea characteristically begins at or shortly after
(six to 12 months) menarche, which coincides with the occurrence
of the regular ovulatory cycle. Pain usually develops within hours
of the start of menstrual bleeding and peaks as the flow becomes
heaviest during the first day or two of the cycle (Dawood 2006).
Period pain can have a significant impact on womens lives. Dys-
menorrhoea can affect as many as 50% of women of reproductive
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
age (Daniels 2002) although, using different measurement meth-
ods and study populations, prevalence estimates vary from 60% to
85% of adolescent girls (Banikarim 2000; Burnett 2005; Harlow
1996; Vicdan 1996). A survey undertaken by the University of
Western Australia has highlighted the high prevalence and impact
of primary dysmenorrhoea as a significant public health problem
that requires attention (Hillen 1999).
Period pain can lead to an absence from school or work (French
2005). In the US alone, it was estimated that in the mid 1980s
600 million hours were lost from work, which led to an economic
loss of two billion dollars; in todays dollars this figure would be
much higher (Dawood 1984).
The aetiology or cause of primary dysmenorrhoea has been the
source of some debate. Experimental and clinical research has
identified the over-production of uterine prostaglandins and va-
sopressin as contributing factors to the painful cramps (Dmitrovic
2
2003; Ekstrom 1992). Oestrogens can stimulate the release of va-
sopressin and this effect is counteracted by progesterones (Forsling
1985), which indicates that an imbalance in ovarian hormones
may be involved in dysmenorrhoea (Hauksson 1987).
Principal pharmacological therapies include drugs that inhibit
prostaglandins, such as non-steroidal anti-inflammatory drugs
(NSAIDs); or that regulate hormones, such as the oral contracep-
tive pills (OCPs). NSAIDs reduce myometrial activity (contrac-
tion of the uterus) by inhibiting prostaglandin F2 (PGF2) synthe-
sis and reducing vasopressin secretion. This may effectively reduce
menstrual pain. The OCPs suppresses ovulation and thins the en-
dometrial lining which in turn reduces menstrual fluid volume
along with the amount of prostaglandins produced, thus reducing
uterine contractions any associated pain (Creatsas 1990; Ekstrom
1992). These drugs provide no long-term relief as the treatment
relieves symptoms on an episode-by-episode basis only.
The failure rate of NSAIDs is often 20 to 25% (Dawood 1985)
and these drugs may be contraindicated or not tolerated by some
women (Taylor 2002). In addition, gastrointestinal side effects can
be particularly troublesome (Daniels 2002; Singh 1998; Strom
1996). Surgical interruption of the pelvic nerve pathways can be
used in women who do not respond to medical treatment but, as
yet, there is no strong evidence of long-term efficacy of this method
(Proctor 2005). Emerging documents suggest many women are
seeking for alternatives to conventional medicine including herbal
medicine (Proctor 2001).
Chinese herbal medicine (CHM) has been used for centuries in
China. Recently, the practice of CHM has significantly perme-
ated a broad cross-section of the Western community (Bensoussan
1996). A key primary requirement of traditional treatment with
CHM is that the treatment needs not only to be tailored at the
outset to the individual but should also be modified at different
stages of the patients recovery or illness. This is one of the un-
derpinning theoretical constructs of traditional Chinese medicine
(TCM) and a number of related complementary therapies. In this
way, a second and distinct diagnostic process is required, as illness
labelling (and therefore the treatment process) differs from con-
ventional medical approaches.
CHM is currently used in public hospitals in China for the treat-
ment of primary dysmenorrhoea. Case studies suggest that CHM
may be effective in treating primary dysmenorrhoea; herbs may
improve general well being and also reduce recurrence of the con-
dition over a three-month of follow-up period (Deng 2003). How-
ever, the evidence describing the safety and efficacy of CHM for
the treatment of primary dysmenorrhoea is important and there
is a need for a systematic review of the available literature.
This review aims to identify randomised controlled trials (RCTs)
of CHM as treatment for women with primary dysmenorrhoea in
order to establish the efficacy and safety of CHM.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
OBJECTIVES
To determine the efficacy and safety of CHM in the treatment of
primary dysmenorrhoea when compared with a placebo, no treat-
ment, conventional medical treatments (for example NSAIDs),
heat compression or other TCM therapy (such as acupuncture,
Chinese massage).
METHODS
Criteria for considering studies for this review
Types of studies
Any RCTs involving CHM for the treatment of primary dysmen-
orrhoea were considered for inclusion in the review. It was in-
tended to include only phase-one data from any cross-over trials
in meta-analysis but no such trials were found.
Types of participants
Women in the trials needed to meet the following inclusion criteria
for the trial to be included in the review:
* be of reproductive age;
* have primary dysmenorrhoea, i.e. individuals with no identifiable
pelvic pathology as indicated by pelvic examination, ultrasound
scans and laparoscopy; or women self reporting a diagnosis of
primary dysmenorrhoea;
* have primary dysmenorrhoea (self reported) during the majority
of the menstrual cycles or for three consecutive menstrual cycles;
* take hormones or NSAIDs for the management of primary dys-
menorrhoea.
Exclusion criteria:
* women with identifiable pelvic pathology as revealed by a phys-
ical or gynaecological examination;
* women with dysmenorrhoea resulting from intra-uterine device
(IUD) use.
Types of interventions
Any RCTs involving CHM as treatment for primary dysmenor-
rhoea. Interventions could include but were not limited to the
following:
* any Chinese herbal medicine versus placebo for primary dys-
menorrhoea;
* any Chinese herbal medicine versus no treatment for primary
dysmenorrhoea;
* any Chinese herbal medicine versus conventional therapy (e.g.
NSAIDs or OCPs) for primary dysmenorrhoea;
3
* one type of Chinese herbal medicine versus another type of CHM
for primary dysmenorrhoea;
* any Chinese herbal medicine versus acupuncture or massage for
primary dysmenorrhoea.
Change from protocol
Searches for trials identified a trial comparing CHM with heat
compression (Zhang 2000). The original protocol for this review
did not include this intervention. However, this trial was included
in the review to ensure that a full comparison of treatments could
be made.
Note
* Detailed interventions might include, but were not limited to,
a single Chinese herb or Chinese herbal formulae that were either
fixed formulae or tailored formulae.
* The routes of administration of interventions included, but were
not limited to, oral or external use.
* The forms of administration involved, but were not limited to,
herbal decoctions, herbal extract such as powders, herbal pills or
tablets or plasters containing herbs.
* Co-interventions included OCPs or NSAIDs.
Types of outcome measures
At least one of the following primary outcomes was measured for
a trial to be included. Data from each of the following outcomes
were recorded, where available.
Primary outcomes
1. Reduction in pain (i.e. menstrual pain) that occurred only dur-
ing the intervention or occurred during the intervention and was
maintained for more than two consecutive menstrual cycles - mea-
sured by a visual analogue scale (VAS), or other validated scales,
or measured as dichotomous outcomes.
2. Overall reduction in symptoms (other menstruation-related
symptoms) that occurred only during the intervention or occurred
during the intervention and was maintained for more than two
consecutive menstrual cycles - measured by changes in dysmenor-
rhoeic symptoms, treatment effectiveness that was either self re-
ported or observed or other similar measures.
3. Adverse effects - measured by any relevant incident and duration
of any side effects.
Secondary outcomes
1. Laboratory tests (where changes occurred only during the inter-
vention or occurred during the intervention and were maintained
for more than two consecutive menstrual cycles) - measured by
changes in a biomedical test (i.e. PGF2, oxytocin, vasopressin, oe-
strogen progesterone or another substance).
2. Use of additional medication - measured as the proportion of
women requiring no analgesics and continued routine activities.
3. Satisfaction of treatment as reported by patients - measured as
the proportion of women who reported improvements or satisfac-
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tion, or both, with their treatment.
4. Quality of life - measured by a validated scale, for example SF
36.
Change from protocol
The laboratory tests were removed at the review stage, as required
by the Cochrane Menstrual Disorders and Sub-fertility Group
(MDSG).
Search methods for identification of studies
The Cochrane MDSG search strategy was adopted. Reports which
described (or might describe) RCTs of CHM in the treatment of
primary dysmenorrhoea were obtained using the following search
strategy.
(1) The MDSG Specialised Register of controlled trials was
searched for any trials with primary dysmenorrhoea or dysmenor-
rhoea in the title, abstract or keyword sections.
(2) The following electronic databases were searched from their
inception to the date given:
Cochrane Central Register of Controlled Trials (CENTRAL)
(The Cochrane Library 2006, Issue 4), MEDLINE (1950 to Jan-
uary week 2 2007), EMBASE (1980 to January week 2 2007),
CINAHL (1982 to January week 1 2007), AMED (1985 to Jan-
uary week 1 2007).
The keywords used for MEDLINE and other English language
databases see Appendix 1. MeSH words were adapted as necessary
for other databases.
Search results
CENTRAL: eleven references found, four relevant (Deng 2003;
Kotani 1997; Song 2005; Sun2004).
MEDLINE: thirty-seven references found, six were RCTs (Deng
2003; Kennedy 2006; Kotani 1997; Song 2005; Sun2004; Tseng
2005).
EMBASE: seventy references found, two were RCTs (Kennedy
2006; Tseng 2005).
CINAHL: nineteen references found, none of them was relevant.
AMED: ten references found, one was a RCT (Kotani 1997).
The search of English language databases identified a number of
duplicated references from the search of the Chinese databases (see
below); however, three studies published in English were relevant
(Kennedy 2006; Kotani 1997; Tseng 2005).
(3) Three electronic Chinese databases were examined. These
were the China National Knowledge Infrastructure (CNKI)
(1990 to January week 1 2007), Traditional Chinese Medicine
Database System (TCMDS) (1990 to December 2006) and Chi-
nese BioMedicine Database (CBM) (1990 to December 2006).
The search identified a large number of trials on the use of CHM
in the treatment of primary dysmenorrhoea. However, search re-
sults from the individual databases overlapped significantly. Only
search results from CNKI were reported in this review given it is
regarded as having wide coverage with full paper access.
4
The keywords used for the Chinese language databases research Methodological quality assessment (Jadad 1996)
see Appendix 2. * Was the assigned treatment adequately concealed prior to allo-
The search of the CNKI identified five hundred and sixty-six ref- cation?
erences; thirty-six of these were RCTs. * Were the outcomes of patients who withdrew or were excluded
(4) The reference lists of all included studies or relevant review after allocation described and included in an intention-to-treat
articles were screened for further relevant papers. analysis?
(5) The authors of significant papers and other experts in the field * Were the withdrawals less than 15% of the study population?
were contacted to ask if they knew of other relevant published or * Were the inclusion and exclusion criteria for entry clearly de-
unpublished material for this review. fined?
* Were the treatment and control groups comparable at entry?
* Were the women blinded to assignment status following alloca-
Data collection and analysis tion (if trial design allowed it)?
* Were the treatment providers blinded to assignment status (if
Selection of studies
trial design allowed it)?
The selection of trials for inclusion in the review, or exclusion
* Were the care programmes, other than the trial options, identi-
from the review, was performed by two review authors (XZ and
cal?
MP), based on employing the search strategy described previously.
* Were there any checks to ensure compliance with treatment?
Since the majority of references were published in Chinese, two
* Were the outcome assessors blind to assignment status?
bilingual review authors (XZ and EW) translated the reports and
* Were the outcome measures used clearly defined?
extracted data onto hard copy data sheets independently.
* Were the accuracy, precision and observer variation of the out-
Quality assessment and data extraction
come measures adequate?
All assessments on the quality of trials and further data extraction
* Was the timing of the outcome measures appropriate?
were performed independently by two review authors (XZ and
* Were the outcome measures clearly reported?
MP). Any discrepancies were to have been resolved by a third re-
Furthermore, allocation concealment was scored according to the
view author (AB or CS) however this was not necessary due to the
categories used by the Cochrane Collaboration: allocation con-
lack of discrepancies. Additional information on the trial method-
cealment was adequate (A), unclear (B), inadequate (C) or alloca-
ology or actual original trial data were sought from the principal
tion concealment was not used (D). The reviewers followed the
author of those trials which appeared to meet the eligibility criteria
protocol for defining allocation concealment categories as set by
but where aspects of methodology were unclear or where the data
the Cochrane MDSG, that is allocation based on odd or even
were in a form unsuitable for meta-analysis.
hospital numbers, alternation, day of week and similar methods
Letters were sent to the authors of four included studies and sev-
were regarded as non-randomised. These studies were, therefore,
enteen excluded studies to request additional information on trial
excluded from the review rather than being classified as C. Other
methodology for clarification or original trial data if the data in the
aspects are reported in the Methodological quality of included
reports were in a form unsuitable for meta-analysis. The authors
studies section of the review, such as: use of blinding, use of inten-
would like to thank Dr Stephen Kennedy, Dr Hua Liu and Dr
tion-to-treatment analysis, numbers lost to follow up, trial design
Neirong Li for responding to the request for further information
and adherence to treatment protocols.
about their trials. Replies have not yet been received from the other
Analysis
studies. Letters were not sent to some contact authors of studies
Statistical analysis was performed in accordance with the guidelines
as recent addresses for the authors could not be located.
developed by the Cochrane MDSG. Where possible, intention-
When data were extracted for some included trials for the outcome
to-treat data were extracted from trials and used in the analysis.
of reduction of pain (measured as the number of women with
Statistical analysis was performed using the Review Manager soft-
reduced pain compared to the total number of women in the
ware (RevMan 2002). For dichotomous data, relative risk (RR)
treatment group), only women who reported a complete reduction
and associated 95% confidence interval (CI) were calculated using
in pain were counted as having reduced pain. For example, if a
a fixed-effect model. Weighted mean difference (WMD) and 95%
treatment group of 100 women were measured for intensity of
CI were calculated for continuous data using a fixed-effect model.
pain using either complete reduction (n = 50), moderate reduction
For two trials (Kotani 1997; Tseng 2005), data could not be ex-
(n = 30), minimal reduction (n = 10) or no reduction (n=10),
tracted for meta-analysis. The data from these trials were included
then only the number of women who reported complete reduction
as descriptive data and were still considered in the results of the
(n = 50) were included in meta-analysis as having experienced a
review (see Additional tables such as Table 1; Table 2).
reduction in pain (n = 50/100). The same approach was used for
Three of the included trials set up more than two comparisons.
the outcome of overall reduction in symptoms.
Two trials had two experimental groups versus one control group
All trials were assessed for methodological quality using the Jadad
(placebo or NSAIDs); the experimental groups were merged for
scale (as below).

Chinese herbal medicine for primary dysmenorrhoea (Review) 5

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
analysis of data accordingly in the graph (Sun2004; Zhao 2006).
The third trial had one experimental group against two control
groups, which was taken into account in the analysis (Wang 1996).
Statistical heterogeneity between trials was tested using a standard
chi-squared test. Inconsistency across trials included in meta-anal-
ysis was measured using I2 . This describes the percentage of the
variability in effect estimates that is due to heterogeneity rather
than sampling error. As a general rule, I2 values of up to 25%
provide evidence of low heterogeneity, a value of 50% is consid-
ered moderate heterogeneity and 75% or above is considered as
high heterogeneity. In the presence of significant heterogeneity,
the causes of heterogeneity were examined by pre-specified sub-
group analysis and also sensitivity analysis, if possible. Where sub-
group analysis failed to explain the heterogeneity, then data were
analysed using the random-effects model.
Sensitivity analysis was used to explore the influence of high quality
trials (defined as A category) versus moderate and low quality
trials (defined as B or C), as well as the effects of analysing by
intention-to-treat, on the effect size. If heterogeneity could not be
explained by these pre-specified analyses then meta-analysis was
to be performed using a random-effects model. The intention-to-
treat analysis was not used as appropriate data were not always
available.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
Using the search strategy described above, thirty-nine RCTs in-
volving treatment for primary dysmenorrhoea with CHM were
identified.
Trials excluded from the review
A total of twenty-six trials were excluded from the review, for the
following reasons:
Three trials included participants with either primary or
secondary dysmenorrhoea and separate data were not reported.
Four trials did not mention randomisation.
One trial involved a combined intervention of CHM with
acupuncture in the experimental group
Eighteen trials were not randomised (the numbers of
women in each treatment arm were very different, for example
56 women in the herbal group versus 32 women in the control
group, even though the word of randomisation was used in the
reports). Attempts were made to contact the authors to clarify
randomisation and allocation concealment, however no response
was received.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
See the Characteristics of excluded studies table for more infor-
mation.
Trials included in the review
The review included thirty-nine RCTs, all of which were of parallel
design seeTable 3 .
Most of the studies were conducted in mainland China, except
one was conducted in Taiwan, one in Japan and another one in
the Netherlands. Thirty-six of the included trials were published
in Chinese and three were published in English (Kennedy 2006;
Kotani 1997; Tseng 2005).
Participants
The inclusion and exclusion criteria for participation were quite
explicit for the majority of included studies. Thirty-six out of the
thirty-nine included trials were carried out in hospitals in main-
land China and as a result, the diagnosis of primary dysmenor-
rhoea was confirmed through one of three methods; pelvic exam-
ination, ultra sound scans or laparoscopy. The trial conducted in
Japan did not state the source of the participants. However, it in-
dicated that a confirmed diagnosis of primary dysmenorrhoea was
an inclusion criterion, although the method used for diagnosis was
unclear (Kotani 1997). The trial in Taiwan recruited students as
participants (Tseng 2005). It appeared that participants with a self
report of primary dysmenorrhoea were included but it is unclear
if this self report was medically confirmed (Tseng 2005).
Principle of herbal treatment
It is a common approach in the practice of CHM to use differ-
entiated pattern(s) that is clusters of related symptoms to deter-
mine appropriate treatment. Research suggests that there are five
or six different patterns in TCM diagnostics that may correspond
to primary dysmenorrhoea as defined in western medicine. These
decide the herbal formulation to be used in the trials or clinical
practice (Luo 1986; SATCM 1995; Xia 1994).
In this review, six of the included trials considered patterns of
symptoms in conjunction with other factors determined by con-
ventional western medicine in the inclusion criteria. There were
another thirteen trials only considered a specific TCM diagnostic
pattern (that pattern was only treated with a corresponding ex-
perimental herbal formula). In other words, nineteen of the in-
cluded trials considered the traditional approach by making indi-
vidualised treatment based on differentiated pattern(s) in TCM
diagnosis.
The criteria for differentiating the patterns of symptoms in most
included trials were referred to the Traditional Chinese Medicine
Professional Statute: Criteria of diagnosis and therapeutic effect of
diseases/syndromes, published by the State of Administration of
Traditional Chinese Medicine, China (SATCM 1995) A number
of other references such as textbooks were supplemented (Luo
1986; Maciocia 1998; Xia 2000; ZCTCM 1991 ).
In accordance with the fundamental TCM philosophy (Maciocia
1998), the tailored approach was defined in this review as the pre-
scription of an experimental formula or herb to a group of women
6
who were diagnosed with a corresponding pattern as defined in
TCM diagnostics; or when an experimental formula or herb was
used but modified according to individualised clinical presenta-
tion in addition to the principal pattern; or the prescription of a
series of experimental formulae was made that corresponded with
each individualised diagnostic pattern.
In contrast, if an experimental formula or herb was applied to
the eligible women regardless of TCM diagnostic patterns, and
it was maintained throughout an entire course of intervention
without alteration, treatment was then defined as the standardised
approach.
The measurement of different patterns was mainly based on de-
scriptive symptoms and signs. However, two trials used integrated
numeric scales as assessment tools (Kotani 1997; Shen 2001).
Comparison and control groups
Included trials incorporated the following comparisons.
* Chinese herbal medicine versus placebo: three trials.
* Chinese herbal medicine versus no treatment: one trial.
* Chinese herbal medicine versus conventional therapy (for exam-
ple NSAIDs or OCPs): fourteen trials.
* Chinese herbal medicine versus another type/formula of Chinese
herbal medicine: eighteen trials.
* Chinese herbal medicine versus acupuncture: two trials.
* Chinese herbal medicine versus massage: no trial.
* Chinese herbal medicine versus heat compression: one trial.
The majority of trials compared two interventions; a placebo was
seldom used as the control intervention.
Many included trials comparing herbal medicine with con-
ventional therapy used non-steroidal anti-inflammatory drugs
(NSAIDs) such as indomethacin or ibuprofen. Oral contraceptive
pills (OCPs) were also used in the control groups.
The most popular comparison agent was different composition,
or another form of administration but the same composition, of
herbal formula. In most cases, an over-the-counter, commonly
used, patented formula or a single herb, considered as a natural
health product in China, was compared with a self-designed for-
mula.
Acupuncture with limited numbers of acupuncture points was also
selected as a control therapy (Miao 2001; Wang 2003). Heat com-
pression using a hot water bottle was the comparison treatment in
one trial (Zhang 2000).
Herbal intervention in the experimental group
The majority of included trials used complicated formulae with
more than five or six herbs. However, two included trials tested a
single herb, either in the form of a decoction tea or as an herbal
extraction (Niu 1996; Tseng 2005).
Regardless of the variations in formulation, the herbs were mostly
chosen from the following categories that are set out in the Chinese
herbal pharmacopoeia and textbooks: herbs regulating the Qi and
Blood, warming the Interior, tonifying the Kidney and Liver
and reinforcing Qi and Blood (Bensky 2004; NUTCM 2006).
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
The most frequently evaluated herbs were: Danggui (Angelicae
sinensis Radix; Chinese angelica root), Chuanxiong (Chuanx-
iong Rhizoma; Szechuan lovage root), Chishao (Paeoniae Radix
rubra; red peony root), Baishao (Paeoniae Radix alba; white
peony root), Yimucao (Leonuri Herba; Chinese motherwort),
Puhuang (Typhae Pollen; cattail pollen), Wulingzhi (Trogopterori
Faeces, flying squirrel feces), Niuxi (Achyranthis bidentatae Radix;
achyranthes root), Danshen (Salviae miltiorrhizae Radix; salvia
root), Chaihu (Bupleuri Radix; Chinese thorowax root), Xiangfu
(Cyperi Rhizoma; nut-grass rhizome), Yanhusuo (Corydalis Rhi-
zoma; corydalis rhizome), Aiye (Artemisiae argy Folium; mug-
wort leaf ), Wuzhuyu (Evodiae Fructus; evodia fruit), Huixiang
(Foeniculi Fructus; fennel fruit), Rougui (Cinnamomi Cortex;
cinnamon bark), Dihuang (Rehmanniae Radix; rehmannia root),
Gouqizi (Lycii Fructus; lycium fruit), Dangshen (Codonopsis
Radix; codonopsis root), Baizhu (Atractylodis macrocephalae Rhi-
zoma; atractylodes rhizome) and Gancao (Glycyrrhizae Radix;
liquorice root).
The dosages varied but most were within the standard ranges de-
fined by the Chinese herbal pharmacopoeia (NUTCM 2006).
Traditional preparation of herbs, a cooked decoction, was used in
many included trials. To avoid the inconvenience of the traditional
cooking procedure, preparations of herbs in a form of pills, pow-
ders, or plasters (for external use) were also used in the included
trials.
Most trials considered timing of the clinical intervention based on
phase of menstrual cycle. Herbal interventions were usually intro-
duced from five to seven days prior to the onset of menstruation
and continued for a period of approximately 10 to 15 days, which
was until the first or second day of menstruation or throughout the
whole bleeding period. One trial specified that the herbs should
be given three days prior to bleeding and continued for a period
of five days (Yang 2005).
Outcome measures
Outcome measures of reduction in pain varied. Most included
studies measured the pain intensity rating on an ordinal scale (for
example, from poor to excellent) in combination with a dichoto-
mous measure (for example, complete relief or ongoing pain). Pain
relief was measured as the number of women with pain relief, re-
duced pain or no improvement compared with the total number
of women in the treatment or control group; whether or not there
was a relapse during the follow-up was also taken into consid-
eration. The majority of trials that were conducted in mainland
China fell into this group; which indicates such practice was com-
pliant with the statute enacted by the State Administration of Tra-
ditional Chinese Medicine, Peoples Republic of China, for mea-
suring therapeutic efficacy of herbs in the treatment of primary
dysmenorrhoea (SATCM 1995).
A continuous numerical scale such as a visual analogue scale was
7
rarely used in mainland China, but was used in three included
studies from other countries or regions (Kennedy 2006; Kotani
1997; Tseng 2005). Tseng and her colleagues used multiple scales
to rate the degree of pain, such as the Short-form McGill Pain
Questionnaire and the Menstrual Distress Questionnaire Short
Form.
Associated menstrual symptoms analysed as overall reduction in
symptoms in meta-analysis, were measured in a similar way as
for reduction in pain in many included trials. Psychophysiological
well being was assessed by two trials (Kotani 1997; Tseng 2005).
Only eight out of thirty-nine included trials reported adverse ef-
fects. Seven trials (Kennedy 2006; Kotani 1997; Liu 2000; Shen
2001; Sun2004; Wang 2006a; Zhang 2000) provided a thorough
report. For example, the number of incidents in both the experi-
mental and control groups, the nature of an adverse event and how
the adverse incident was dealt with, were reported in the trials.
However, one trial ( Deng 2003) had incomplete data as it reported
that there was no incident in the experimental group, but did not
provide information on the control groups. One trial (Kennedy
2006) mentioned that headache was the most frequently reported
side effect, with equal frequency in both experimental and control
groups. The adverse effects were usually self reported. Four out
of the thirty-nine included trials (Kennedy 2006; Li 2001; Shen
2001; Sun2004) reported that the measures used were occurrence
of signs or symptoms as self-report; laboratory tests such as blood
and urine routine tests; electrocardiogram (EKG); and liver and
renal function tests.
Five included trials gave detailed reports on the impact of herbs on
biomedical parameters such as hormone levels; microcirculation
morphology; and haemorheology (not reported in this review).
One trial mentioned that laboratory tests were evaluated but did
not provide any details (Kotani 1997).
Ten out of the thrifty-nine included trials assessed requirements
for additional medication in the way similar to the measurement
of reduction in pain. One trial (Kennedy 2006) mentioned that
rescue medication was recorded but no details were provided.
Only one trial assessed the outcome of satisfaction with treatment,
as reported by the participants; no details were provided for meta-
analysis (Kennedy 2006).
No trial assessed the outcome of self-reported quality of life.
Risk of bias in included studies
Allocation concealment and randomisation
Only two out of the included trials described adequate methods
of randomisation and allocation concealment, receiving an allo-
cation score of A (Kennedy 2006; Sun2004). All other included
trials received allocation scores of B or C as they did not either have
clear descriptions of their method of allocation or their randomi-
sation methods, or the methods they chose were inadequate. Poor
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
compliance during clinical intervention was also noted (Huang
2000).
Blinding
Four included trials were single blinded (Li 2001; Niu 1996; Song
2003; Wang 1996); three trials were double blinded (Kennedy
2006; Kotani 1997; Sun2004). The other included trials did not
mention blinding at all.
Two included trials reported that there was no difference in appear-
ance, taste, packaging, labelling nor coding between the placebo
and the experimental herbal formula, to ensure that blinding was
maintained (Kennedy 2006; Sun2004). The trial conducted in
Japen also used a placebo as a control but no details were given
in the report as to similarity to the intervention formula (Kotani
1997).
Power calculation
Only one included trial mentioned power calculation and stated
that no formal statistical sample size calculation was made because
this was a pilot study; it estimated a sample size for future study
(Kennedy 2006).
Baseline similarity of comparison groups
Thirty-four included trials compared the treatment and control
groups at baseline to ensure that they were comparable with re-
spect to known prognostic factors; thirty-one out of thirty-four
reported no statistically significant difference between the groups
at baseline.
Nineteen out of the thirty-four trials considered the patterns in
TCM in addition to age, duration of symptoms, history and sever-
ity as entry measures. Thirteen trials only considered one specific
clinical pattern of primary dysmenorrhoea in TCM diagnosis.
Five included trials did not report on the baseline similarity of
comparison groups.
Intention-to-treat (ITT) analysis and follow-up
Only two included trial clearly reported the number of drop-
outs and withdrawals (Kennedy 2006; Tseng 2005), although ITT
analysis was not implemented; nor was it used in the other in-
cluded trials. One trial reported that the exclusion of data from
analysis was due to poor compliance and incomplete data; never-
theless the information about drop-outs was unclear (Deng 2005).
Most included trials had two to three months of follow-up after
the cessation of clinical intervention; four out of the thirty-nine
included trials did not report on any further follow-up (Luo 2001;
Qin 2003; Tseng 2005; Wang 2006a).
Effects of interventions
Reduction of pain
1) Reduction in pain - Chinese herbal medicine versus placebo
8
Three trials (166 women) compared CHM against placebo.
One trial (90 women) that set up two experimental herbal groups
with slightly changed formulae (30 women in each group) was
included in meta-analysis. The dichotomous data showed a statis-
tically significant difference between the herbal intervention and
placebo on reduction in pain (RR 5.59, 95% CI 0.32 to 97.87)
(Sun2004).
One trial with a small sample size (36 women) ( Kennedy 2006)
reported no statistically significant difference between the herbs
and placebo in pain relief, although after the third cycle of inter-
vention, 53% of women in the herbal groups reported less pain
than usual compared with 26% in the placebo group. Results
from meta-analysis for two outcomes measuring the maximal pain
scores (Cmax) and total pain (area under the curve) (AUC) at the
follow-up cycle showed no statistically significant difference be-
tween herbs and placebo (RR 1.00, 95% CI -17.95 to 19.95 and
RR 12.00, 95% CI -54.76 to 78.76, respectively). More details
are listed in the Additional table (Table 4).
One trial reported data in a form which was unsuitable to be
included in meta-analysis (Kotani 1997). It found that CHM was
significantly more effective than placebo through two treatment
months and two months of follow-up (40 women; P < 0.05 for
the first treatment month, P < 0.005 for subsequent months, see
Additional table Table 2).
2) Reduction in pain - Chinese herbal medicine versus no treat-
ment
One trial (130 women) (Tseng 2005) compared the use of a single
herb Meiguihua (Rosae rugosae Flosin, rosebud) in a form of tea, to
no treatment. Multi-dimensional indicators including the Short-
form of the McGill Pain Questionnaire (SF-MPQ), the Menstrual
Distress Questionnaire Short Form (MDQ-SF), a Visual Analogue
Scale for Anxiety (VASA), and a Perceived Stress Scale (PSS) were
used. However, the results could not be included in meta-analy-
sis. The trial reported no significant difference between rose tea
and control for changes from baseline in any outcome measure
after six months of treatment (mean difference in the SF-MPQ
at six months was -1.76; VASA -0.04; perceived stress scale -1.58;
MDQ-SF -1.44). The P values were not reported. However, when
the adjustments for differences in age and the PSS scores at baseline
were made, it found that rose tea improved all scores significantly
more than control treatment for up to six months (P < 0.001 for
all scales). See Additional table Table 1.
3) Reduction in pain - Chinese herbal medicine versus conven-
tional therapy
Fourteen included trials (1441 women) with a methodological
quality score of B compared CHM against one of commonly used
conventional therapies such as NSAIDs or OCPs. Data from all
trials were suitable for meta-analysis, and the trials were divided
into sub-groups according to the use of standardised formulae or
tailored formulae.
Most trials assessed reduction in pain with the lasting effect during
two or three cycles of follow-up. One trial measured an immediate
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
efficacy of pain relief within 15 to 30 minutes of intervention,
without follow-up evaluation (Wang 2006a).
All these trials included at least one complex Chinese herbal for-
mula in experimental group.
The results for this outcome showed significant heterogeneity (I2
81.7) that could not be accounted for by the herbal formula, trial
quality or follow-up time. A random-effects model was used in
meta-analysis.
Five trials (652 women) used the standardised treatment approach,
which means a formula was given to participants regardless of diag-
nostic types of pattern in TCM. Overall results showed that stan-
dardised CHM provided significant improvement in pain relief
with long-term efficacy when compared to conventional therapies
(RR 2.28, 95% CI 0.88 to 5.94).
Nine trials (789 women) used the tailored approach where a for-
mula was prescribed according to a correlating pattern. Results
showed that the Chinese herbal formula tailored to individualised
clinical pattern also provided significant improvements in pain re-
lief for up to three months of follow-up (RR 2.13, 95% CI 1.70
to 2.66).
One trial (340 women) tested a herbal product which is com-
monly used sublingually for heart disorders such as angina pectoris,
against oral administration of indomethacin. The results showed
that the herbs were superior to indomethacin (RR 1.67, 95% CI
1.42 to 1.97) (Wang 2006a).
The overall outcome from meta-analysis of fourteen included trials
(1441 women) showed that the use of CHM resulted in a signif-
icant improvement in pain relief compared to conventional ther-
apies (RR 1.99, 95% CI 1.52 to 2.60); in most cases, the benefit
continued for up to three months of follow-up.
4) Reduction in pain - Chinese herbal medicine (experimental)
versus Chinese herbal medicine (OTC)
Eighteen included trials (1527 women) compared self-designed
Chinese herbal formulae or a single herb with one of the commonly
used OTC herbal health products. Data from all trials were suitable
for meta-analysis. Sub-groups were set up for statistical analysis
based on the type of formulation used (standard or tailored).
One trial had a methodological quality score of C; the other sev-
enteen trials were scored as B for quality.
Seventeen out of the eighteen (1474 women) included trials used
complex Chinese herbal formulae designed by the researchers, only
one trial (53 women) used a single herbal ingredient (Niu 1996).
Five out of the eighteen trials (380 women) used self-designed
formulae during an entire course of intervention, regardless of
the individual clinical patterns, that is defined as a standardised
approach in this review. The other fourteen included trials (1147
patients) also used self-designed formulae but the formulae were
tailored throughout the treatment period based on a principal
formula.
One out of the eighteen trials (60 patients), with a methodolog-
ical quality score of C, had one experimental group which was
9
used with herbal suppository in comparison with two different
control groups both in a form of capsule for oral administration
(one was a herbal health product , and the other was as the same
herbal formula as used in the experimental group). The results
from the comparison of experimental formula (same formula in
both forms of suppository and capsules) and the control formula
(capsules, different formula) showed no statistically significant dif-
ference (RR 0.92, 95% CI 0.43 to 1.99) (Wang 1996). In order to
evaluate the efficacy of experimental formula, although the group
used the same herbal formula in a form of capsule was defined as
one of the control groups, the data were merged with the exper-
imental group (in a form of suppository) for meta-analysis, since
the same experiemental formula was tested.
Five trials, with a methodological quality score of B, compared a
standard and self-designed formulae against an over-the-counter
herbal product. These trials showed a statistically significant dif-
ference in favour of the self-designed formulae (RR 2.09, 95% CI
1.62 to 2.70). Twelve trials, with a methodological quality score of
B, compared tailored formulae with an over-the-counter formula.
These trials showed a statistically significant difference in favour
of the tailored formulae (RR 2.13, 95% CI 1.80 to 2.51).
Overall, meta-analysis of eighteen trials (1527 women) showed
that CHM provided pain relief for primary dysmenorrhoea for up
to three months of follow-up (RR 2.06, 95% CI 1.80 to 2.36).
5) Reduction in pain - Chinese herbal medicine versus acupunc-
ture
Two trials (156 women) compared CHM against acupuncture.
One used a standardised formula (Miao 2001) and the other trial
used a tailored formula (Wang 2003). Overall results showed a
statistically significant difference between CHM and acupuncture
(RR 1.75, 95% CI 1.09 to 2.82).
6) Reduction in pain - Chinese herbal medicine versus massage
No data were available for this comparison
7) Reduction in pain - Chinese herbal medicine versus heat
compression
One trial (55 women) compared CHM to heat compression. Re-
sults showed that CHM was significantly more effective for re-
duction in pain at three months of follow-up than applying a
heat compress to the lower abdomen (RR 32.08, 95% CI 2.06 to
499.18).
Overall reduction in symptoms
1) Overall symptoms - Chinese herbal medicine versus placebo
Two trials (130 women) compared CHM against placebo. One
trial (90 women) with two experimental herbal groups (30 women
in each group with slightly changed formulae) was included in
meta-analysis and showed statistically significant difference be-
tween the herbal intervention and placebo (RR 5.59, 95% CI 0.32
to 97.87) (Sun2004).
Another trial did not report direct results on this outcome (see
Additional tables), but monitored depression associated with the
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
menstrual pain. The trial reported no significant difference be-
tween groups or within groups in depression associated with the
menstrual pain (Kotani 1997).
2) Overall reduction in symptoms - Chinese herbal medicine
versus no treatment
Only one trial had no treatment as a comparison (Tseng 2005).
The results could not be included in meta-analysis. There were no
direct results available on this outcome, but it stated that when
the adjustments for differences in age and the perceived stress scale
scores at baseline were made, rosebud tea improved psychophysio-
logic well being significantly compared to placebo in scores using
the Psychophysiologic Life Adaptation scale (PLAS) over time (P
<0.001 for all scales), see Additional table Table 1.
3) Overall reduction in symptoms - Chinese herbal medicine
versus conventional therapy
There were six trials (482 women) that compared CHM with one
of the commonly used conventional therapies such, as NSAIDs
or OCPs. The trials reported dichotomous data and they were
suitable for meta-analysis; although patients were split into sub-
groups according to whether standardised or tailored formulas
were used. In addition, the methodological quality score was taken
into account for setting up the sub-groups.
One trial compared two different experimental herbal groups
against a control group using pharmaceutical drugs including anal-
gesics, NSAID, or in combination of OCPs.
The six trials (482 women) reported significant improvements in
overall symptoms for CHM compared to conventional therapy for
up to three months of follow-up (RR 2.17, 95% CI 1.73 to 2.73).
This meta-analysis included one (58 women) of the eleven trials
that compared a standard formula CHM to conventional medicine
(RR 23.39, 95% CI 1.45 to 377.35); the other five trials (424
women) compared tailored formulae with conventional treatment
(RR 2.00, 95% CI 1.59 to 2.52).
4) Overall reduction in symptoms - Chinese herbal medicine
(experiment) versus Chinese herbal medicine (OTC)
Fourteen included trials (1167 women) evaluated one experimen-
tal Chinese herbal formulae or selected a single herb in compar-
ison with one of the commonly used herbal products. The data
were dichotomous and suitable for meta-analysis. The relevant
sub-groups were also set up for appropriate statistical analysis in
consideration of the type of formulation (standardised or tailored).
They were all in a score of B for the trial quality.
Thirteen out of fourteen included trials (1114 women) used com-
plex Chinese herbal formulae that were designed by the researchers;
only one trial (53 women) experimented a single herbal ingredient
(Niu 1996).
Four out of fourteen trials (320 women) used standardised formu-
lae in experimental groups throughout the whole period of inter-
vention, while the other ten included trials (847 women) tailored
treatment individually based on principle formulae in experimen-
10
tal groups.
All of the trials (1167 women) found significant improvement in
overall symptoms after up to three months of follow-up (RR 1.99,
95% CI 1.65 to 2.40).
5) Overall reduction in symptoms - Chinese herbal medicine
versus acupunctur e
No data were available for this comparison.
6) Overall reduction in symptoms - Chinese herbal medicine
versus massage
No data were available for this comparison
7) Overall reduction in symptoms - Chinese herbal medicine
versus heat compression
No data were available for this comparison
Adverse effects
1) Adverse effects - Chinese herbal medicine versus placebo
Three included trials (166 women) reported no serious adverse
events in either the experimental or control groups.
Trial data were extracted and suitable for meta-analysis (Kennedy
2006; Kotani 1997; Sun2004). One of the trials (36 women) re-
ported that headache was the most frequently reported side ef-
fect and that there was no difference between the groups. How-
ever, meta-analysis showed a small statistical difference between
the groups with more incidents occurring in the placebo group
than in the herbal group (RR 0.81, 95% CI 0.61 to 1.07). There
were no serious adverse events and no clinically relevant changes
in laboratory values (Kennedy 2006).
2) Adverse effects - Chinese herbal medicine versus no treat-
ment
No data were available for this comparison
3) Adverse effects - Chinese herbal medicine versus conventional
therapy
Only two included trials (418 women) mentioned that adverse
effects were monitored, with no incident reported in either the
experimental or the control groups.
4) Adverse effects - Chinese herbal medicine (experiment) versus
Chinese herbal medicine (OTC)
Two included trials (183 women) reported no adverse effects. Only
one of the trials (120 women) had data that could be extracted
(Shen 2001) for meta-analysis; the data were incomplete in the
other trial, since the information on the control group was not
provided (Deng 2003).
5) Adverse effects - Chinese herbal medicine versus acupuncture
No data were available for this comparison
6) Adverse effects - Chinese herbal medicine versus massage
No data were available for this comparison
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
7) Adverse effects - Chinese herbal medicine versus heat com-
pression
One trial (55 women) reported no adverse effects in either the
experimental or control groups; data could be extracted for meta-
analysis (Zhang 2000).
Use of additional medication
1) Use of additional medicines - Chinese herbal medicine versus
placebo
Three trials (166 women) compared CHM against placebo. One
trial (90 women) (Sun2004) that set up two experimental herbal
groups with slightly different formulae (30 women in each group)
was included in meta-analysis, the results showed a statistically
significant difference between the herbal intervention and placebo
(RR 12.00, 95% CI 1.70 to 84.49).
Another included trial (40 women) reported results on this out-
come in such a form that no numerical data could be extracted,
nor were the data suitable for meta-analysis (see Table 2). Signif-
icant reduction in the use of pain-relieving medication while on
the intervention and at follow-up was found in the herbal group
(P < 0.05; P < 0.01, respectively). Significant reduction in the use
of pain-relieving medication was found in the placebo group in
the first intervention cycle only (P < 0.01) (Kotani 1997).
One trial (36 women) reported that it had assessed the amount of
additional medication used; however, this trial did not report any
detail for undertaking meta-analysis (Kennedy 2006).
2) Use of additional medicine - Chinese herbal medicine versus
no treatment
No data were available for this comparison.
3) Use of additional medicine - Chinese herbal medicine versus
conventional therapy
Two trials (194 women) measured this outcome. One (132
women) used a tailored formula with up to three months of fol-
low-up, and the other trial (62 women) used a standard formula
with no follow-up. Overall results showed that the use of CHM
resulted in a reduction in the use of additional pain-relieving med-
ication (RR 1.58, 95% CI 1.30 to 1.93).
4) Use of additional medicine - Chinese herbal medicine (ex-
periment) versus Chinese herbal medicine (OTC)
Five trials (402 women) including two trials (116 women) with
standardised formulae, and three trials (286 women), used tailored
formulae, all were with three months of follow-up. The results
showed significant improvements - numbers of women did not
require analgesics after the herbal intervention (RR 1.58, 95% CI
1.34 to 1.87).
5) Use of additional medicine - Chinese herbal medicine versus
massage
No data were available for this comparison.
6) Use of additional medicine - Chinese herbal medicine versus
heat compress
11
No data were available for this comparison.
Laboratory tests
Omitted from this review
Satisfaction from patients
No data were available for this outcome. One trial assessed the
global assessment of treatment and reported the data were similar
in both groups. However, no details were provided for meta-anal-
ysis (Kennedy 2006).
Quality of life
No data were available for this outcome
DISCUSSION
The aim of this review was to assess the effectiveness of Chinese
herbal therapy and its safety for the treatment of primary dys-
menorrhoea. CHM has been used to treat womens conditions for
hundreds of years; however, data on the administration of CHM
in a rigorous scientific context is still lacking.
The review found promising evidence in the form of RCTs for
the use of CHM in reducing menstrual pain in the treatment of
primary dysmenorrhoea, with up to three months of effectiveness.
No significant adverse effects were identified from the included
studies in this review.
Impact of an individualised approach to the routine practice
of CHM
A key primary requirement of traditional treatment with CHM is
that treatment needs to be tailored according to different patterns;
these are of a description of selection of phenomena (symptoms
and signs) that have a mutual relation with each other. Moreover,
a pattern has individual variations and changes over time with
different stages of illness.
For example, primary dysmenorrhoea, is a clinical diagnosis in
Western medicine (WM) that can be classified into different pat-
terns in TCM. Although lower abdominal pain associated with
menstruation that occurs for more than three consecutive cycles is
also acknowledged as the main symptom in TCM practice, TCM
takes further interest in other associated complaints such as the
nature of the pain, feeling of coldness, and whether pain is re-
lieved by warmth, psychological status, and so on, all of which
impact on the final TCM diagnosis. These associated symptoms
form a syndrome with a distinct label, such as retention of Cold,
or stagnation of Qi and Blood. Treatment differs according to
the identified and diagnosed syndrome.
Nineteen out of thirty-nine included trials considered an inclu-
sion criterion in relation to the TCM diagnostic pattern(s), and
another twenty-three trials considered the influence of the pat-
tern(s) (for example, a pattern was only treated by one correlating
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
experimental herbal formula). In other words, the majority of in-
cluded trials paid a specific attention to the role of differentiated
patterns defined in TCM diagnosis for primary dysmenorrhoea,
because the patterns of primary dysmenorrhoea in TCM inform
selection of treatment formulation. The patterns of stagnation of
Qi & Blood, retention of Cold, deficiency of the Kidney and
Liver were the common diagnostic classifications of primary dys-
menorrhoea in TCM diagnosis. In addition, stagnation of Blood
was the fundamental aetiology and pathological condition for pri-
mary dysmenorrhoea in TCM. This was in agreement with the
majority of published diagnostic protocols in TCM (Luo 1986;
Maciocia 2004; SATCM 1995; Xia 1994).
The selection of treatment formulae used in the trials in this review
were mostly influenced by the TCM diagnostic process. Some trials
used tailored formulae in accordance with the individual patterns.
Because the nature of primary dysmenorrhoea is fairly straightfor-
ward in terms of the principal TCM diagnostic patterns, most tai-
lored formulae were actually designed based on a principal formu-
lation with limited modification throughout an entire course of
herbal intervention. Some trials used a standard formula (includ-
ing a single herb) across the whole period of clinical intervention,
either because one diagnostic pattern of primary dysmenorrhoea
was selected for this specific formula, or simply no consideration
was given to the possible variation of diagnostic patterns.
Overall, twenty-three trials used modified experimental Chinese
herbal formulae in order to fit the different TCM diagnostic pat-
terns, or selected a standard formula based on a defined specific
pattern, that is the individualised (tailored) treatment approach
was employed. The results demonstrated promising evidence of
effective pain relief for primary dysmenorrhoea. Whilst sixteen tri-
als did not consider a possible variation in patterns, the results still
demonstrated the effectiveness of CHM in pain reduction with
statistical significance.
Japanese researchers stated that a favourable outcome for pain
relief could only be achieved when TCM diagnostic patterns that
inform the decision of selection of formulae were considered, so a
tailored formula might be better than a standard formula (Kotani
1997). This may be becasue a complex formula designed for a
relevant diagnostic pattern could possibly address multiaspects of
imbalance in the body. This may also further explain why a single
herb could only achieve limited therapeutic scopes, in contrast
with a complicated formula, even the formula may be remained
unchanged throughout an entire period of clinical intervention.
However, this review was unable to provide an explicit answer as
to whether tailored treatment was more beneficial than standard
formulae in the treatment of primary dysmenorrhoea.
Types of control interventions
12
Apart from the use of conventional types of control interventions,
such as placebo, NSAIDs and OCPs, eighteen of the thirty-nine
included trials compared two different Chinese herbal formulae.
In general, both types of pharmaceutical and traditional Chinese
herbal agents are available as over-the-counter (OTC) products
in China, therefore a commonly used OTC herbal product was
chosen for the comparison group. However, in an experimental
group, it appeared that researchers and practitioners were reluc-
tant to further explore commonly used herbal products, instead,
exploring self-desgined formulae were of their interests.
Adverse effects
The attention to the safety of CHM in clinical practice was not
addressed adequately in the reviewed trials. The measurement and
report of adverse effects were poor; most trials neglected the fact
that herbs are not risk free. Only eight out of the thirty-nine
included trials mentioned some adverse effects in their reports.
Only seven trials detailed the number of incidents not only in the
experimental groups but also in the control groups. This allowed
suitable data to be extracted for meta-analysis.
Generally, the reviewed trials reported that CHM for primary
dysmenorrhoea were safe when compared with conventional
medicines. However, the data were limited and more trials that
monitor possible adverse effects are needed.
Herbal pharmacotherapeutic action
It is difficult to elucidate the pharmacotherapeutic action of CHM
because the herbal formulae contain many potentially active com-
pounds, many of which remain unknown. Nevertheless, some
studies explored the potential mechanisms of action of CHM fo-
cusing mainly on the potential aetiology of primary dysmenor-
rhoea. It was requested by the Menstrual Disorders and Subfertility
Group that the detailed laboratory results in relation to pharma-
cotherapeutic actions were removed from this Cochrane review.
Further effort for understanding aetiology of primary dysmen-
orrhoea
In China, CHM has been used to treat dysmenorrhoea for cen-
turies, with positive clinical responses. Clinical success is likely to
be related to one of the TCM fundamental theories - stagnation of
Blood is the main pathological condition in primary dysmenor-
rhoea. To draw relevant parallels between contemporary medical
sciences and TCM, four included trials attempted to reveal and
explore the aetiology of primary dysmenorrhoea in the fields of
endocrinology and neurology.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
General haemorheology and vascular microcirculation effects were
also investigated. Some studies stated that abnormalities were
found in women with primary dysmenorrhoea. Such abnormali-
ties included high levels of blood viscosity (BV), both at high and
low shear rates. CHM from the category removing Blood stagna-
tion was investigated and was found to improve the haemocyto-
logic parameters as well as to improve period pain (Sun2004).
Methodological weaknesses
The methodological quality of many trials included in this review
was poor calibre. Only three out of the thirty-nine trials clearly
described their methods of randomisation and allocation conceal-
ment. The rest either did not state the methods or the methods
were inadequate.
A consistent weakness of all the trials was their small sample size.
Only one trial had more than one hundred participants. The small
size reduces the likelihood of detecting any effect of an intervention
in a single study, but given the similarities between studies, it makes
meta-analysis of the data particularly valuable.
Placebo was seldom used in the trials (only three trials compared
CHM with placebo). The lack of placebo trials affects the results,
since typically a medicines efficacy is established with placebo trials
before comparisons are made with other drugs . With CHM this
has not been the case. In addition, the lack of blinding in some
trials had the potential to affect the results as it may give skewed
results, if participants were aware of their treatment.
The measurement outcomes were generally subjective. Most of the
trials collected the data by using descriptions of symptoms with
no quantitative standards. Only four trials used numerical scales.
A possible publication bias has not excluded for this review as the
majority of trials reported positive effects of CHM in the treatment
of primary dysmenorrhoea. Funnel plots were used to investigate
the possibility of publication bias, for the trials comparing CHM
with conventional medicine. For the outcomes of pain reduction
and overall symptom assessment (outcomes that are highly corre-
lated), the funnel plots appear to be asymmetrical, which suggests a
bias towards positive studies (see Figure 1 and Figure 2). However,
it remains unclear whether this bias is related solely to publication
bias or whether it is an effect of poor methodological quality of
the smaller trials. Conversely, funnel plots of the trials comparing
CHM (experimental) with other CHM (OTC) appeared roughly
symmetrical indicated less chance of publication bias in this group
of trials (Figure 3 and Figure 4). Therefore, the existence of pub-
lication bias in the reviewed trials remains unclear.
13
 Figure 1. Funnel plot of trials comparing CHM with conventional therapy for the outcome of reduction of
pain

Chinese herbal medicine for primary dysmenorrhoea (Review) 14

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 2. Funnel plot of trials comparing CHM with conventional therapy for the outcome of overall
symptoms

Chinese herbal medicine for primary dysmenorrhoea (Review) 15

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 3. Funnel plot of trials comparing CHM (self-desogned) with CHM (over-the-counter) for the
outcome of reduction of pain

Chinese herbal medicine for primary dysmenorrhoea (Review) 16

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Figure 4. Funnel plot of trials comparing CHM (self-desogned) with CHM (over-the-counter) for the
outcome of overall symptoms

Overall the review has found that an attempt towards evidence-

based TCM practice has been made. However, more research trials
with high quality design are needed.
AUTHORS CONCLUSIONS
Implications for practice
The review found promising evidence from RCTs for the use of
CHM in reducing menstrual pain associated with primary dys-
menorrhoea, with up to three months of effectiveness. All avail-
able measures of effectiveness confirmed the overall superiority of
CHM to placebo, no treatment, NSAIDs, OCPs, acupuncture
and heat compression. No significant adverse effects were identi-
fied by this review. However, the small number and the low quality
of included studies did not allow for any definite conclusion for
their use in clinical practice.
In CHM practice, categories of herbs such as herbs regulating
the Qi and Blood, warming the Interior, tonifying the Kidney
and Liver and reinforcing Qi and Blood were most commonly
used. The herbs may influence primary dysmenorrhoea through
the effects on hormones and microcirculation haemorheology.
Implications for research
Overall, current weaknesses of trials included in this review such
as poor methodological quality, lack of the use of placebo as the
control comparison, no appropriate blinding and restricted lan-
guage publication, which all require rectification. Therefore, the
findings of this review should be interpreted with caution. In addi-
tion, more carefully designed, double-blinded, placebo-controlled
randomised trials with large numbers of participants that use of
CHM in the treatment of primary dysmenorrhoea are required.
Biomedical evidence is also needed. Any adverse effect that is ei-
ther symptomatic or biomedical needs to be investigated further.
ACKNOWLEDGEMENTS
To Professor Chunxiang Zhou (Nanjing University of Traditional
Chinese Medicine, China) and Professor Jin Yu (Fudan University,
China) who advised on data searches in the Chinese literature and
strategic planning at an early stage of the review.

Chinese herbal medicine for primary dysmenorrhoea (Review) 17

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 REFERENCES
References to studies included in this review
Deng 2003 {published data only}
Deng HX, Zhu NS, Wang CW, Qing HX, Xu YZ. Clinical
observation on the use of Jia Wei Muo Jie Pian in the
treatment of primary dysmenorrhoea. Zhong Guo Zhong Yi
Ji Chu Yi Xue Za Zhi [Chinese Journal of Basic Medicine in
Traditional Chinese Medicine] 2003;9(10):578.
Deng 2005 {published data only}
Deng DM. Observation on the use of Jiang Ji Jiu in the
treatment of dysmenorrhoea. Yi Xue Wen Xuan [Anthology
of Medicine] 2005;24(4):56970.
Fan 1999 {published data only}
Fan J. The use of modified Huo Xue Zhen Tong Tang in
the treatment of 50 cases of primary dysmenorrhoea. Shi
Yong Zhong Yi Yao Za Zhi [Journal of Practical Traditional
Chinese Medicine] 1999;15(3):156.
Guo 1997 {published data only}
Guo WP, Zhang XK. The use of Tong Jing San in the
treatment of 35 cases of primary dysmenorrhoea. Shi Yong
Zhong Xi Yi Jie He Za Zhi [Practical Journal of Integration of
Traditional Chinese Medicine with Western Medicine] 1997;
10(3):233.
Huang 2000 {published data only}
Huang, G, Xu YH. Analysis of the use of Si Wuo Tang
in the treatment of 58 cases of primary dysmenorrhoea.
Nei Meng Gu Zhong Yi Yao [Journal of Inner Mongolia
Traditional Chinese Medicine] 2000;4:14.
Jiang 2000 {published data only}
Jiang H. Clinical observation on the use of Li Qi Huo
Xue Tang in the treatment of severe cases of primary
dysmenorrhoea. He Bei Zhong Yi [Hebei Journal of
Traditional Chinese Medicine] 2000;22(8):587.
Kennedy 2006 {published data only}
Kennedy S, Jin X, Zhong S, Magill P, Vliet T.V, et
al.Randomised controlled trial assessing a traditional
Chinese medicine remedy in the treatment of primary
dysmenorrhoea. Fertility and Sterility 2006;86(3):7624.
Kotani 1997 {published data only}
Naoki K, Tsutomu O, Ichiro S, Hiroshi H, Masatoshi
M, Yasuhiro O, Akitomo M. Analgesic effect of a herbal
medicine for treatment of primary dysmenorrhoea - a
double-blind study. American Journal of Chinese Medicine
25;2:20512.
Li 1999 {published data only}
Li HB, Zhao GX, Wang LJ. Clinical research on the
use of Fu Ke Qian Jin Pian in the treatment of primary
dysmenorrhoea of a pattern of stagnation of Qi & Blood.
Hu Nan Zhong Yi Za Zhi [Hunan Journal of Traditional
Chinese Medicine] 1999;15(1):445.
Li 2001 {published data only}
Li NR, Jiang QH, Guo AX. The use of Tong Jing Wan in the
treatment of 50 cases of primary dysmenorrhoea of pattern
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
of retention of Cold and stagnation of Blood. Shang Dong
Zhong Yi Za Zhi [Shangdong Journal of Traditional Chinese
Medicine] 2001;20(10):5978.
Li 2004 {published data only}
Li ZP, Xu Y. The use of Nuan Gong Zhi Tong Tang in the
treatment of 40 cases of primary dysmenorrhoea. Xin Zhong
Yi [New Chinese Medicine] 2004;36(4):589.
Liu 2000 {published data only}
Liu XH. The use of combination of Chinese herbs
with western drug in the treatment of 40 cases primary
dysmenorrhoea. Shang Dong Yi Yao [Shangdong Journal of
Medicine] 2000;40(10):64.
Liu 2002 {published data only}
Liu SJ. Clinical observation on the use of Wen Tong Tang in
the treatment of 30 cases of primary dysmenorrhoea. Zhong
Yi Yao Xue Kan [Journal of Traditional Chinese Medicine &
Pharmacology] 2002;20(4):463.
Liu 2003 {published data only}
Liu H, Mao XL. The use of Wen Jing Tang in combination
of Xin Jie San in the treatment of 52 cases of primary
dysmenorrhoea of a pattern of stagnation of Blood. Guang
Zhou Yi Xue Yuan Xue Bao [Academic Journal of Guangzhou
Medical College] 2003;31(3):812.
Liu 2004 {published data only}
Liu WP. Clinical observation on the external use of Chinese
herbal medicine in the treatment of 45 cases of primary
dysmenorrhoea of the pattern of retention of Cold and
Blood stasis. Zhong Yi Wai Zhi Za ZHi [Journal of External
Therapy of Traditional Chinese Medicine] 2004;13(4):45.
Liu 2005 {published data only}
Liu HM, Wang XX, Han YH, Yao JP, Jin FR. Analysis on
the use of Wen Jing Zhi Tong Yin in the treatment of 60
cases of primary dysmenorrhoea of a patter of retention
of Coldness and stagnation of Blood. Shou Duo Yi Yao
[Capital Medicine] 2005;3:478.
Lu 2002 {published data only}
Lu YM. Observation on the use of Fu Kang Bao in the
treatment of primary dysmenorrhoea. Suzhou University
Journal of Medical Science 2002;22(3):328.
Luo 2001 {published data only}
Luo FP, Li BQ. Clinical observation on the use of Tong Jing
San in the treatment of primary dysmenorrhoea. Shang
Dong Zhong Yi Za Zhi [Shangdong Journal of Traditional
Chinese Medicine] Shang Dong Zhong Yi Za Zhi [Shangdong
Journal of Traditional Chinese Medicine] 2001;20(6):3389.
Miao 2001 {published data only}
Miao F. The use of Niu Xi San in the treatment of 36 cases
of primary dysmenorrhoea. Zhe Jiang Zhong Yi Xue Yuan
Xue Bao [Academic Journal of Zhejing College of Traditional
Chinese Medicine] 2001;25(1):2930.
Niu 1996 {published data only}
Niu Y, Hou LL, Wang SB, Yang LX. Observation on the
use of Tie Xin Gan Cao in the treatment of dysmenorrhoea.
18
 Zhong Guo Yi Yao Xue Bao [China Journal of Chinese
Medicine and Pharmacology] 1996;11(2):1820.
Qin 2003 {published data only}
Qin XL, Lu SP, ZHou YM. Clinical observation on the
use of Du Yi Wei Jiao Nang in the treatment of 60 cases
of dysmenorrhoea. Zhong Guo Zhong Yi Yao Xin Xi Zao
Zhi [China Journal of Information of Traditional Chinese
Medicine] 2003;10(6):60.
Shen 2001 {published data only}
Shen YH. Clinical observation on the use of Wen Jing Jian
Tong Jiao Nang in the treatment of 60 cases of primary
dysmenorrhoea of a pattern of retention of Cold and
Blood stasis. Hu Nan Zhong Yi Za Zhi [Hunan Journal of
Traditional Chinese Medicine] 2001;17(2):223.
Song 2003 {published data only}
Song RX, Yang YQ, Chen FH. The use of Tong Jing
Jiao Nang in the treatment of 50 cases of primary
dysmenorrhoea. Shang Dong Zhong Yi Za Zhi [Shangdong
Journal of Traditional Chinese Medicine] 2003;22(7):404.
Sun 2006 {published data only}
Sun, W.F, & Liu, Y. Tiao Jing Ding Tong Tang in the
treatment of 46 cases of primary dysmenorrhoea. Zhong
Guo Zhong Yi Ji Zheng [China Chinese Medicine Emergency
Treatment] 2006;15(12):13523.
Sun2004 {published data only}
Sun WH, Zhao L, Tian XP, Yang CQ, Li XH. Clinical
observation on the use of Gui Zhi Fu Ling Wan in the
treatment of 90 cases of primary dysmenorrhoea. Zhong
Guo Zhong Xi Yi Jie He Za Zhi [CJITWM] 2004;24(12):
11213.
Sun2004 -2 {published data only}
Sun WH, Zhao L, Tian XP, Yang CQ, Li XH. Clinical
observation on the use of Gui Zhi Fu Ling Wan in the
treatment of 90 cases of primary dysmenorrhoea. Zhong
Guo Zhong Xi Yi Jie He Za Zhi [CJITWM] 2004;24(12):
11213.
Tseng 2005 {published data only}
Tseng YF, Chen CH, Yang YH. Rose tea for relief of primary
dysmenorrhoea in adolescents: a randomised controlled
trial in Taiwan. Journal of Midwife & Womens Health 2005;
50:517.
Wang 1996 {published data only}
Wang SJ, Liu SQ, Luo SX, Guo RF. Laboratory research on
the use of Tong Jing Ling suppository in the treatment of
primary dysmenorrhoea of the pattern of retention of cold
and stagnation of Qi. Liao Ning Zhong Yi Za Zhi [Liaoning
Journal of Traditional Chinese Medicine] 1996;23(7):3323.
Wang 2000b {published data only}
Wong L. The use of Bu Shen Hua Yu Tang in the treatment
of 50 cases of primary dysmenorrhoea. Zhong Guo Min Jian
Liao Fa [China Folk Therapy] 2000;8(4):312.
Wang 2003 {published data only}
Wang X. The treatment of primary dysmenorrhoea in
accordance with the differentiation of syndrome in Chinese
medicine. Lin Chuang Lun Tan [China Medicine Bulletin]
2003;3(3):334.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2006a {published data only}
Wang X G. Clinical observation on use of Su Xiao
Jiu Xin Wan in the treatment of 340 cases of primary
dysmenorrhoea. Lin Chuang He Shi Yan Yi Xue Za Zhi
[Journal of Clinical and Laboratory Medicine] 2006;5(7):
969.
Wang 2006b {published data only}
Wang YH. Use of Tong Jing Ling in the treatment of 32
cases of primary dysmenorrhoea. Shan Xi Zhong Yi [Shan
Xi Journal of Traditional Chinese Medicien] 2006;22(6):20.
Wu 2006 {published data only}
Wu XM, Li H.J. Modified Dang Gui Shao Yao San in the
treatment of 45 cases of primary dysmenorrhoea. Liao Ning
Zhong Yi Yao Da Xue [Journal of Liao Ning University of
TCM] 2006;8:5.
Ye 2004 {published data only}
Ye LL. The use of Nv Jin Jiao Nang in the treatment of 30
cases of primary dysmenorrhoea. Shi Yong Zhong Yi Yao Za
Zhi [Journal of Practical Traditional Chinese Medicine] 2004;
20(3):148.
Yu 2003 {published data only}
Yu P, Li QC, Tan BL. Clinical observation of the use of Fu
Mei Tong Jing Fang in the treatment of 35 cases of primary
dysmenorrhoea of pattern of retention of Cold and Blood
stasis. Xin Zhong Yi [New Chinese Medicine] 2003;35(8):
278.
Zhang 2000 {published data only}
Zhang J. Observation on the use of modified Si Wu Tang in
the treatment of 35 cases of primary dysmenorrhoea. Yi Xue
Wen Xuan [Anthology of Medicine] 2000;19:100.
Zhang 2001 {published data only}
Zhang Q, Wan ZX. Clinical observation of the use of
Chinese herbal medicine in the treatment of 60 cases of
primary dysmenorrhoea. Shi Yong Zhong Yi Yao Za Zhi
[Journal of Practical Traditional Chinese Medicine] 2001;17
(5):11.
Zhu 2001 {published data only}
Zhu YL, Li X. The use of Dang Gui Ai Ye Tang in the
treatment of 78 cases of primary dysmenorrhoea. Jiang Su
Zhong Yi [Jiangsu Journal of Traditional Chinese Medicine]
2001;22(8):25.
Zhu 2002 {published data only}
Zhu LY. Observation on the use of Chines herbal medicine
in the treatment of 70 cases of primary dysmenorrhoea. Ye
Yu Jian Kang [Occupation and Health] 2002;18(8):1212.
Zhu 2003 {published data only}
Zhu Y, Wang J. The use of Chinese herbal medicine Hua
Yu Tong Mai Zhi Tong Tang in the treatment of 42 cases of
primary dysmenorrhoea. Zhong Guo Zhong Yi Yao Xin Xi
Za Zhi [Chinese Journal Information on Traditional Chinese
Medicine] 2003;10(9):27.
References to studies excluded from this review
Chen 1995 {published data only}
Chen ZL. The use of Tong Jing Yao Fang in the treatment
of 78 cases of primary dysmenorrhoea. Nan Jing Zhong Yi
19
 Yao Da Xue Xue Bao [Academic Journal of Nanjing University
of Traditional Chinese Medicine ] 1995;11(6):479.
Du 2000 {published data only}
Du CY. Clinical observation on the use of modified Jia
Wei Shi Xiao San in the treatment of 68 cases of primary
dysmenorrhoea. Zhong Guo Min Zu Min Jian Yi Yao Za Zhi
[China Journal of Folk Medicine] 2000;44:1356.
Huang 2005 {published data only}
Huang L. Observation on the use of self-designed formula
Tong Jing Zhi Tong Tang in the treatment of 56 cases of
primary dysmenorrhoea. Zhong Yi Yao Dao Bao [Guiding
Journal of Traditional Chinese Medicine] 2005;11(7):36, 44.
Ji 2001 {published data only}
Ji XM, Dong CM, Yuan LH, Xu XH. Clinical anaylsis on
the use of Dan Shen Tong/Tanshinone in the treatment of
203 cases of primary dysmenorrhoea. Journal of Chinese
Physician 2001;3(6):476.
Li 2005 {published data only}
Li PJ, Zhang YM. A clinical report on use of Yang Xue Tiao
Jing He Ji for 200 cases of dysmenorrhoea. Zhong Hua Shi
Yong Zhong Xi Yi Za Zhi [Chinese Journal of the Practical
Chinese and Modern Medicine] 2005;18(6):784.
Liao 2002 {published data only}
Liao W, Wang CW. Clinical observation on the use
of Jia Wei Muo Jie Pian in the treatment of primary
dysmenorrhoea. Shi Yong Zhong Yi Yao Za Zhi [Journal of
Practical Traditional Chinese Medicine] 2002;18(2):101.
Lin 2004 {published data only}
Lin H. Analysis on the clinical efficacy of the use of Gui
Zhi Fu Ling Jiao Nang in the treatment of gyneocological
conditions. Zhong Guo Ji Ceng Yi Yao [Chinese Journal of
Primary Medicine and Pharmacy] 2004;11(12):1509.
Liu 2006 {published data only}
Liu Y.Z. Tong Jing Tang in combination with Wu Ji
Bai Feng Wan in the treatment of 60 cases of primary
dysmensorrhoea. He Nan Zhong Yi [He Nan TCM] 2006;
26(8):523.
Miao 2006 {published data only}
Miao Q. Clinical observation on modified Tao Hong Si Wu
Tang in the treatment of primary dysmenorrhoea. Zhong
Yi Yao Xue Kan [Journal of Traditional Chinese Medicine &
Pharmacology] 2006;24(10):1926.
Ni 2004 {published data only}
Ni GL, Zhang QY, Sheng W, Shi MJ, Han M. Therapeutic
efficacy of An Gong Ding Tong Wan in the treatment
of primary dysmenorrhoea and its microcirculation
disturbance. He Bei Bei Fang Xue Yuan Xue Bao [Journal of
Hebei North University] 2004;21(5):713.
Pan 2003 {published data only}
Pan CP. The use of Tiao Jing Zhi Tong Fan in the treatment
of 76 cases of primary dysmenorrhoea. Guan Xi Zhong
Yi Yao [Guanxi Journal of Traditional Chinese Medicine &
Pharmacology] 2003;26(3):47.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Shi 2003 {published data only}
Shi JH, Yin JH, Jin QY, Xue LN, Wang XX, Hou XM,
Ji CH. Clinical research on use of Tong Jing Ling in the
treatment of primary dysmenorrhoea. Hebei Zhong Yi
[Hebei J TCM] 2003;25(4):25052.
Song 2005 {published data only}
Song ZM, Xin SM, Luo MY, Sun SZ, Ha XX, Zhu LP.
Clinical observation on the use of Tong Jing Lin Ke Li in
the treatment of primary dysmenorrhoea. Zhong Guo Zhong
Xi Yi Jie He Za Zhi [CJITWM] 2005;25(7):608.
Sun 2005 {published data only}
Sun H, Li YQ, Song HX. Clinical observation on the use
of Tao Hong Shi Xiao Zhi Tong Tang in the treatment of
30 cases of primary dysmenorrhoea. Si Chuan Zhong Yi
[Journal of Sichuan of Traditional Chinese Medicine] 2005;
23(4):612.
Wang 2000a {published data only}
Wang H, Bei HW, Chang H, Wu XZ, Sun G. Clinical
research on the use of series capsule Tiao Jing Mie Tong in
the treatment of primary dysmenorrhoea. He Bei Zhong
Yi Za Zhi [Hebei Journal of Traditional Chinese Medicine]
2000;22(2):99100.
Wang 2002 {published data only}
Wang CL. The use of Wen Jing Huo Xue San in the
treatment of 150 cases of primary dysmenorrhoea. Zhong
Guo Zhong Yi Ji Zheng [China Chinese Medicine Emergency
Treatment] 2002;11(4):311.
Wei 2000 {published data only}
Wei B, Wu J. Injection of Honghua in the treatment of 90
cases of primary dysmenorrhoea. Zhong Yao Cai [Chinese
Herbs] 2000;23(7):4301.
Wu 2002 {published data only}
Wu JF. The use of Tong Jing Fan in the treatment of 50
cases of primary dysmenorrhoea. Zhe Jiang Zhong Yi Xue
Yuan Xue Bao [ Academic Journal of Zhejiang College of
Traditional Chinese Medicine] 2002;26(4):40.
Wu 2005 {published data only}
Wu P. The use of modified self-designed formula in the
treatment of 60 cases of primary dysmenorrhoea. Bei Jing
Zhong Yi Za Zhi [Beijing Journal of Traditional Chinese
Medicine] 2005;24(4):2223.
Xu 2000 {published data only}
Xu JY, Yan XJ, Ma GX. Clinical observation on the use of
Gui Xin Xiang Cao Tang in the treatment of 60 cases of
primary dysmenorrhoea. Ning Xia Yi Yao [Ning Xia Medical
Journal] 2000;22(7):435.
Yang 2005 {published data only}
Yang CQ, Yuan J. The use of modified Tiao Gan Tang in
the treatment of 40 cases of primary dysmenorrhoea. He
Nan Zhong Yi [Henan Traditional Chinese Medicine] 2005;
25(2):52.
Zhang 2003 {published data only}
Zhang AL. Clinical observation on the use of Chinese herbs
with a principle of reinforcing body and warming meridians
for removing blood stasis in the treatment of 50 cases of
20
 primary dysmenorrhoea. Jiang Su Zhong Yi [Jiangsu Journal
of Traditional Chinese Medicine] 2003;24(1):256.
Zhang Y 2003 {published data only}
Zhang Y, Li ZP. The use of Wen Jing San Han Tang in the
treatment of 30 cases of dysmenorrhoea. Shang Xi Zhong Yi
[Shanxi Journal of Traditional Chinese Medicine] 2003;24
(5):4012.
Zhao 2006 {published data only}
Zhao C. Clinical observation on use of Hua Yu Tong
Jing Jiao Nang in the treatment of 318 cases of primary
dysmenorrhoea. Zhong Yi Yao Guan Li [Chinese Journal of
Management in Chinese Medicine] 2006;14(10):67.
Zhen 1996 {published data only}
Zhen C, Xu J, Xu HX, Wei Y. Clincial and laboratory
research on use of Tong Jing Ting Tea in the treatment of
primary dysmenorrhoea of the pattern of retention of cold
and blood stasis. Zhong Guo Zhong Yi Yao Ke Ji [China
Chinese Medicine Scientific Technology] 1996;3(1):104.
Zhen 2002 {published data only}
Zhen C, Xu J, Zhang ZH. The use of Tong Jing Ting in
the treatment of primary dysmenorrhoea of a pattern of
retention of cold and blood stasis. Hunan Guiding Journal
of TCMP 2002;8(5):269.
Additional references
Banikarim 2000
Banikarim C, Chacko M, Kelder S. Prevalence and impact
of dysmenorrhea on hispanic female adolescents. ARCH
Pediatra Adolesc Med 2000;154:12269.
Bensky 2004
Bensky D, Clavey S, Stoger E. Chinese herbal medicine:
materia medica. Seattle: Eastland Press, Inc., 2004.
Bensoussan 1996
Bensoussan A, Myers SP. Towards a safer choice: the practice of
traditional Chinese medicine in Australia. Sydney, University
of Western Sydney, 1996.
Burnett 2005
Burnett MA, Antao V, Feldman K, Grenville A, Lea, R,
et al.Prevalence of primary dysmenorrhoea in Canada. J
Obstet Gynaecol Can 2005;27(8):76570.
Creatsas 1990
Creatsas G, Delugeoroglou E, Zachari A, Loutradis D,
Papadimitriou, Miras K, et al.Prostaglandins: PGF2a,
PGF2, 6-keto-PGF1a and TXB2 serum levels in
dysmenorrheic adolescents before, during and after
treatment with oral contraceptives. European Journal of
Obstetrics, Gynaecology, and Reproductive Biology 1990;36
(3):2928.
Daniels 2002
Daniels SE, Talwalker S, Torri S, Snabes MC, Recher
DP, Verburg KM. Valdecoxib, a cyclooxygenase-2-specific
inhibitor, is effective in treating primary dysmenorrhoea.
The American College of Obetetricians and Gynaecologists
2002;100(2):3508.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Dawood 1984
Dawood M. Ibuprofen and dysmenorrhoea. American
Journal of Medicine 1984;77(1A):8794.
Dawood 1985
Dawood M. Dysmenorrhoea. Pain and Analgesia 1985;84:
239.
Dawood 2006
Dawood MY. Primary dysmenorrhoea. Obstetrics and
Gynecology 2006;108(2):428441.
Dmitrovic 2003
Dmitrovic R, Branimir P, Cvitkovic-Kuzmic A, Strelec M,
Kereshi T. Severity of symptoms in primary dysmenorrhoea
- a doppler study. European Journal of Obstetrics and
Gynaecology and Reproductive Biology 2003;107:1914.
Ekstrom 1992
Ekstrom P, Akerlund M, Forsling M, Kindahl H, Laudanski
T, Mrugacz G. Stimulation of vasopressin release in women
with primary dysmenorrhoea and after oral contraceptive
treatment: effect on uterine contractility. British Journal of
Obstetrics and Gynaecology 1992;99(8):6804.
Forsling 1985
Forsling M, Stromberg P, Akerland M. Effect of ovarain
steroids on vasopressin secretion. Journal of Endocrinology
1985;92(1):4751.
French 2005
French L. Dysmenorrhoea. American Family Physician
2005;71(2):28591.
Harlow 1996
Harlow SD, Park M. A longitudinal study of the risk factors
for the occurrence, duration and severity of menstrual
cramps in a cohort of college women. British Journal of
Obstetrics and Gynaecology 1996;103(11):113442.
Hauksson 1987
Hauksson A, Akerland M, Forsting M, Kingahl H. Plasma
concentration of vasopressin and a prostagalandin F2 alpha
metabolite in women with primary dysmenorrhoea before
and during treatment with combined oral contraceptive.
Journal of Endocrinology 1987;115:35561.
Hillen 1999
Hillen TIJ, Grbavac SL, Johnston PJ, Straton JA, Keogh
JM. Primary dysmenorrhoea in young western Australian
women: prevalence, impact and knowledge of treatment.
Journal of Adolescent Health 1999;25(1):405.
Jadad 1996
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds
DJ, Gavaghan DJ, et al.Assessing the quality of reports of
randomized clinical trials: is blinding necessary?. Controlled
Clinical Trials 1996;17(1):112.
Lichten 1987
Lichten EB. Surgical treatment of primary dysmenohrroea
with laparoscopic uterine nerve ablation. Reproductive
Medicine 1987;987(32):3741.
Luo 1986
Luo YK. Gynecology in Traditional Chinese Medicine.
Shanghai Science and Technology Press, 1986.
21
Maciocia 1998
Maciocia, G. The Foundations of Chinese Medicine: A
Comprehensive Text for Acupuncturists and Herbalists.
Edinburgh: Churchill Livingstone, 1998.
Maciocia 2004
Maciocia G. Diagnosis in Chinese Medicine: A Comprehensive
Guide. Churchill Livingstone: Elsevier Science, 2004.
NUTCM 2006
Nanjing University of Traditional Chinese Medicine.
Chinese Materia Medica Pharmacopoeia. Shanghai:
Shanghai Scientific and Technology Press, 2006.
Proctor 2001
Proctor ML, Murphy PA. Herbal and dietary therapies for
primary and secondary dysmenorrhoea (Cochrane Review).
Cochrane Database of Systematic Reviews 2001, Issue 2.
[DOI: 10.1002/14651858.CD002124]
Proctor 2005
Procotor ML, Farquhar CM, Sinclair OJ, Johnson NP.
Surgical interruption of pelvic nerve pathways for primary
dysmenorrhoea (Cochrane Review). Cochrane Database
of Systematic Reviews 2005, Issue 4. [DOI: 10.1002/
14651858.CD001896.pub2]
RevMan 2002
The Cochrane Collaboration. Review Manager (RevMan)
(Computer program) Version 4.2 for Windows. Oxford,
England: The Cochrane Collaboration, 2002.
SATCM 1995
State Administration of Traditional Chinese Medicine, P.R.
China. Traditional Chinese Medicine Professional Statute:
Criteria of diagnosis and therapeutic effect of diseases/
syndromes. Government document 1995:65.
Chinese herbal medicine for primary dysmenorrhoea (Review)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Singh 1998
Singh G, Ramey D. NSAID-induced gastrointestinal
complications: The ARAMIS perspective -1997. Arthritis,
Rheumatism, and Aging Medical Information Sydtem. Journal
of Pheumatol Suppl 1998;51:816.
Strom 1996
Strom BL, Berlin JA, Kinman JL, Sptiz PW, Hennessy S,
Feldman H. Parenteral ketorolac and risk of gastrointestinal
and operative site bleeding: A postmarking surveillance
study. Journal of American Medicine Association 1996;275:
37682.
Taylor 2002
Taylor D, Miaskowski C, Kohn J. A randomised clinical
trial of the effectiveness of an acupressure device (relief
brief ) for managing the symptoms of dysmenorrhoea. The
Journal of Alternative and Complementary Medicine 2002;8
(3):35770.
Vicdan 1996
Vicdan K, Kukner S, Darakoglu T, Ergin T, Keles G,
Gokmen O. Demographic and epidemiologic features of
female adolescents in Turkey. Journal of Adolescent Health
1996;18:548.
Xia 1994
Xia G. Clinical Gynecology in Traditional Chinese Medicine.
Beijing: Peoples Health Press, 1994.
Xia 2000
Xia G. Chinese medicine diagnosis and treatment in the
management of menstrual disorders. Beijing: Peoples Health
Press, 2000.
ZCTCM 1991
Zhejiang College of Traditional Chinese Medicine. A
Handbook of Traditional Chinese Gynecology. Boulder: Blue
Poppy Press, 1991.
Indicates the major publication for the study
22
CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Deng 2003

Methods Allocation concealment and randomisation: randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number
Experimental: 33 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 16-33,
Control: 15-33
History: stated
TCM Pattern: unstated

Interventions Self-designed formula (Jia Wei Muo Jie Pian) vs OTC (Yue Yue Shu)
Jia Wei Muo Jie Pian: Xue Jie (Sanguis Draconis), Mo Yao (Myrrha), Pu Huang (Pollen Typhae), Wu
Ling Zhi (Excrementum Trogopteri Seu Pteromi), San Leng (Rhizoma Sparganii Stoloniferi), Er Zhu
(Rhizoma Curcumae Ezhu) etc. 4 tablets, tid. 2 weeks prior to bleeding till 1st day of cycle
Yue Yue Shu: 1 sachet (10g), bid. 1 week prior to bleeding till 1st day of cycle

Outcomes 1. Pain
Experimentalerimental :
Casess of cure: 19/33
Casess of improvement: 7/33
Casess of response: 5/33
Casess of no response: 2/33
Total effectiveness: 93.94%
Controlrol
Cases of cure: 7/30
Cases of improvement: 8/30
Cases of response: 9/30
Cases of no response: 6/30
Total effectiveness: 80.00%
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 19/33
Cases of improvement: 7/33
Cases of response: 5/33
Cases of no response: 2/33
Total effectiveness: 93.94%
Control:
Cases of cure: 7/30

Chinese herbal medicine for primary dysmenorrhoea (Review) 23

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Deng 2003 (Continued)

Cases of improvement: 8/30

Cases of response: 9/30
Cases of no response: 6/30
Total effectiveness: 80.00%
Significant difference between the two groups in the rate of cure P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, pain scores reduced to 0, no relapse during 3
cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, no need to
take pain relieving medication, the pain scores after intervention reduced less than 1/2 of the scores before
intervention
Response: abdominal pain reduced, other symptoms improved, pain relieving medication needed, the
pain scores after intervention reduced between 1/2 to 4/3 of the scores before intervention
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: stated, but no statement for the Controlrol group
4. Lab tests:
unstated
5. Use of additional medication: stated.
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Deng 2005

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration:3-5 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 70 women
Control: 70 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-37 ys.
History: stated
TCM Pattern: both groups were diagnosed as retention of cold, stagnation of Qi and blood, deficiency
of liver and kidney, retention of dampness and heat

Interventions Folker formula (Jiang Ji Jiu) vs OTC ( Tian Qi Tong Jing Jiao Nang)
Jiang Ji Jiu: rice wine 200ml, Sheng Jiang (Rhizoma Zingiberis Officinalis Recens) 200 g, Ai Ye (Folium

Chinese herbal medicine for primary dysmenorrhoea (Review) 24

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Deng 2005 (Continued)

Artemisiae Argyri) 200 g, Yi Mu Cao (Herba Leonuri Herterophylli) 50 g, Hen 1000 g, modification of
formula may be required. Stewing all ingredients, taking the soup and the chicken meat, one dose for 3
days. 3 days prior to bleeding, no chicken soup during menstruation, then started it again on day 2 of
cycle for 6 days
Tian Qi Tong Jing Jiao Nang: 6 pills, tid. 2 days prior to bleeding for 6 days

Outcomes 1. Pain:
Experimental:
Rate & Casess of cure: 44.3%, 31/70
Rate & Casess of improvement: 51.4%, 36/70
Rate & Casess of no response: 4.3%, 3/70
Cont:
Rate & Cases of cure: 21.4%, 15/70
Rate & Cases of improvement: 67.1%, 47/70
Rate & Cases of no response: 11.4%, 8/70
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapse during 3 cycles of follow up
No response: abdominal pain and other symptoms not changed at all
2. Overall symptoms:
unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Fan 1999

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles + 3 cycles of follow up

Participants Number:
Experimental: 50 women
Control: 48 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-26 y
History: stated
Chinese herbal medicine for primary dysmenorrhoea (Review) 25
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Fan 1999 (Continued)

TCM Pattern: specified, stagnation of blood Qi and blood, ,retention of cold, deficiency of kidney
deficiency

Interventions Self-designed formula (Huo Xue Zhen Tong Tang) vs indomethacin + Atropome
Huo Xue Zhen Tong Tang:
Pu Huang (Pollen Typhae) 15 g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 15 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 30 g, Dan Shen (Radix Salviae Miltrorrhizae) 12 g,
Hong Hua (Flos Carthami Tinctorii) 12 g, Bai Shao (Radix Paeoniae Latiflorae) 30-45 g,
Chai Hu (Radix Bupleuri) 12 g.
Modification might be required. Herbal decoction, one dose/day, 5 days prior to bleeding for a period of
7 days
Indomethacin: 25mg, tid. Atropome: 0.3 mg, tid. 20 th days of cycle for a period of 7 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 58.00%, 29/50
Rate and Cases of improvement: 42.00%, 21/50
Rate and Cases of no response: 0%, 0/50
Total effectiveness: 100%
Control:
Rate and Cases of cure: 35.42%, 17/48
Rate and Cases of improvement: 43.75%, 21/48
Rate and Cases of no response:0%, 0/48
Total effectiveness: 79.17%
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 58.00%, 29/50
Rate and Cases of improvement: 42.00%, 21/50
Rate and Cases of no response: 0%, 0/50
Total effectiveness: 100%
Control:
Rate and Cases of cure: 35.42%, 17/48
Rate and Cases of improvement: 43.75%, 21/48
Rate and Cases of no response:0%, 0/48
Total effectiveness: 79.17%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapse during 3 cycles of follow up
No response: abdominal pain and and other symptoms changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Chinese herbal medicine for primary dysmenorrhoea (Review) 26

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Fan 1999 (Continued)

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Guo 1997

Methods Allocation concealment and randomisation: Randomised - method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles + 3 cycles of follow up

Participants Number:
Experimental: 35 women
Control: 31 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-26 years
History: stated
TCM Pattern: unspecified, but mentioned the common reasons as stagnation of blood Qi and blood,
retention of cold etc

Interventions Self-designed formula (Tong Jing San) vs OTC formula (Yue Yue Shu)
Tong Jing San: Xue Jie (Sanguis Draconis), Rou Gui (Cortex Cinnamomi Cassiae), in a ratio of 3:1 and
a form of powder, 3 g, bid. Mixed and dissolve with warm water. starting 24 hours prior to bleeding till
3rd day of cycle
Yue Yue Shu (powder): 10g, bid. 1 week prior to bleeding till day 3 of cycle

Outcomes 1. Pain:
Experimental:
Cases of cure: 24/35
Cases of improvement: 7/35
Cases of response: 3/35
Cases of no response: 1/35
Total effectiveness: 97.14%
Control:
Cases of cure: 9/31
Cases of improvement: 9/31
Cases of response: 11/31
Cases of no response: 1/31
Total effectiveness: 93.55%
Significant difference between the two groups in the total efficacy P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 24/35
Cases of improvement: 7/35
Cases of response: 3/35
Cases of no response: 1/35
Total effectiveness: 97.14%

Chinese herbal medicine for primary dysmenorrhoea (Review) 27

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Guo 1997 (Continued)

Control:
Cases of cure: 9/31
Cases of improvement: 9/31
Cases of response: 11/31
Cases of no response: 1/31
Total effectiveness: 93.55%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced, capable
of working without pain relieving medication
Response: abdominal pain reduced, and other symptoms improved, capable of working with pain relieving
medication
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Huang 2000

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Parallel performance: No
Duration: 2 cycle of intervention + 2 cycles of follow up

Participants Number:
Experimental: 33 women
Control: 25 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-33 ys
History: unstated
TCM Pattern: unspecified, only common patters were stagnation of Qi and blood in the channels and
retention of cold in the channels

Interventions Self -designed formula (modified Si Wuo Tang) vs Indomethacin

Modified Si Wu Tang based on patterns.
Stagnation of Qi and Blood:
Dang Gui (Radix Angelicae Sinensis) 15 g,

Chinese herbal medicine for primary dysmenorrhoea (Review) 28

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Huang 2000 (Continued)

Chuan Xiong (Radix Ligustici Chuanxiong) 10 g,

Bai Shao (Radix Paeoniae Latiflorae) 10 g,
Shu Di (Radix Rehmanntae Glutinosae Conquitae) 10 g,
Xiang Fu (Rhizoma Cypri Rotundi) 10 g,
Tao Ren (Semen Persicae) 15 g,
Hong Hua (Flos Carthami Tinctorii) 10 g
Retention of Cold and Blood Stasis:
Dang Gui (Radix Angelicae Sinensis) 15 g, Chuan Xiong (Radix Ligustici Chuanxiong) 10 g,
Bai Shao (Radix Paeoniae Latiflorae) 10 g,
Shu Di (Radix Rehmanntae Glutinosae Conquitae) 10 g,
Tao Ren (Semen Persicae) 15 g,
Hong Hua (Flos Carthami Tinctorii) 10 g
Gui Zhi (Ramulus Cinnamomi Cassiae) 6 g,
Wu Zhu Yu (Fructus Evodiae Rutaecorpae) 6 g
Herbal decoction, one dose/day, as soon as bleeding started, for a period of 3 days
Indomethacin: 25mg, as soon as bleeding started, for a period of 3 days

Outcomes 1. Pain:
Experimental:
Cases of cure: 10/33
Cases of improvement: 18/33
Cases of no response: 5/33
Total effectiveness: 92.4%
Control:
Cases of cure: 2/25
Cases of improvement: 17/25
Cases of no response: 6/25
Total effectiveness: 76%
Criteria
Cure: abdominal pain disappeared. no relapse during 2 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 2 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms:
unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 29

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Jiang 2000

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 40 women
Control: 36 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-25 years
History: stated
TCM Pattern: unspecified, but the common pattern was stagnation of Qi and blood with retention of
cold

Interventions Self designed formula (Li Qi Huo Xue Tang) vs Indomethacin

Li Qi Huo Xue Tang:
Di Huang (Radix Rehmanniae Glutinosae) 12 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 12 g, Ge Gen (Radix Puerariae) 12 g,
Dang Gui (Radix Angelicae Sinensis) 10 g, Chi Shao (Radix Paeoniae Rubrae) 10 g, Ze Lan (Herba Lycopi
Lucidi) 10 g,
Xiang Fu (Rhizoma Cypri Rotundi) 10 g,
Hu Lu Ba (Semen Trigonellae Foeni-graeci) 10 g, Dan Shen (Radix Salviae Miltrorrhizae) 15 g,
Wu Yao (Radix Linderae Strychnifoliae) 6 g, Sha Ren (Fructus Amomi) 6 g,
Wu Zhu Yu (Fructus Evodiae Rutaecorpae) 5 g
Herbal decoction, one dose daily, starting from 3 days prior to bleeding till bleeding ended, plus OCT
(Wu Ji Bai Feng Wan) started as soon as bleeding stopped for a period of 10 days
Indomethacin: 25mg, bid. 3 days before bleeding till bleeding ended

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 37.5%, 15/40
Rate and Cases of improvement: 52.5%, 21/40
Rate and Cases of no response: 10%, 4/40
Total effectiveness: 90.0%
Control:
Rate and Cases of cure: 30.5%, 11/36
Rate and Cases of improvement: 41.7%, 15/36
Rate and Cases of no response: 27.8%, 10/36
Total effectiveness: 72.2%%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 37.5%, 15/40
Rate and Cases of improvement: 52.5%, 21/40
Rate and Cases of no response: 10%, 4/40
Total effectiveness: 90.0%
Control:
Rate and Cases of cure: 30.5%, 11/36

Chinese herbal medicine for primary dysmenorrhoea (Review) 30

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Jiang 2000 (Continued)

Rate and Cases of improvement: 41.7%, 15/36

Rate and Cases of no response: 27.8%, 10/36
Total effectiveness: 72.2%%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
Criteria:
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapse during 3 cycles of follow up
No response: abdominal pain and other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Kennedy 2006

Methods Allocation concealment and randomisation: Randomised - method stated (computer-generated opaque
sealed envelope)
Blinding: double blinded
Trial design: parallel
Duration: 3 cycles of intervention + 1 cycles of follow up

Participants Number:
Experimental: 17 women
Control: 19 women
Drop-outs/withdrawals: stated 3 dropped out before randomisation, 2 dropped out after randomisation
due to either irregular menstruation or personal reasons. Their data were excluded (no intention-to-
treatment performed)
Diagnosis of dysmenorrhoea: stated
Age: 18-45 years
History: unstated
TCM Pattern: unspecified

Interventions Self-designed formula vs Placebo

Self-designed formula: Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix Paeoniae Latiflorae), Chi
Shao (Radix Paeoniae Rubrae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), in a ration of approximately
1:1.5:1
Placebo: sugar beet fiber and maltodextrin indistinguishable in appearance
Both groups took 3 tablets, bid, 2 days prior to bleeding for a period of 7 days
Rescue medication: Ibuprofen, 200 mg, 6 tablets/day maximum

Chinese herbal medicine for primary dysmenorrhoea (Review) 31

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Kennedy 2006 (Continued)

Outcomes 1. Pain:
VAS, more details in the additional table
2. Overall symptoms: unstated
3. Adverse effect: stated, measured by hematological and biochemical tests. No details provided
4. Lab tests: unstated
5. Use of additional medication: stated, no details provided
6. Satisfaction from patients: stated, no details provided.
7. Quality of life: unstated

Notes Additional results in the additional table.

Sample size calculation was mentioned but no formal statistic estimation was performed

Risk of bias

Item Authors judgement Description

Allocation concealment? Yes A - Adequate

Kotani 1997

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: double blind
Trial design: parallel
Duration: 2 cycles of observation + 2 cycles of intervention + 2 cycles of follow up

Participants Number:
Experimental: 20 women
Control: 20 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: unstated
Age: 14-45
History: unstated
TCM Pattern: stated, only included stagnation blood, deficiency, yin, and cold

Interventions Classic Chinese formula (Tao Hong Si Wuo San) vs placebo

Tao Hong Si Wuo San:
Dang Gui (Angelicae sinensis radix)
Chi Shao (Paeoniae rubrae radix)
Fu Ling (Sclerotium poriae cocos)
Cang Zhu (Atractylodis lanceae rhizoma)
Ze Xie (Alismatis rhizoma)
Chuan Xiong (Chuanxiong rhizoma)
(in a ratio of 3:4:4:4:4:3)
Placebo: no details
Both groups took study materials 7.5g, daily, for two cycles
Rescue medication: Diclofenac sodium 25 mg, 4 tablets/day maximum

Chinese herbal medicine for primary dysmenorrhoea (Review) 32

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Kotani 1997 (Continued)

Outcomes Reduction in pain

Visual analogue scale (VAS)
Reduction in depression
Zung self-rating depression scale
Reduced consumption of pain relieving medication
Improved biomedical parameters (FSH, LH, Prolactin, Estradiol, Blood count, Hepatic and renal function
tests at each cycle). No data assessed
Adverse Effects
Self report from subjects: None Experimentalerienced adverse effects

Notes Results listed in the additional table

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Li 1999

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Parallel performance: yes
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 44 women
Control: 36 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-45
History: stated
TCM Pattern: stated, stagnation of Qi and Blood

Interventions Self designed formula (Fu Ke Qian Jin Pian) vs OTC Chinese herbal formula (Tian Qi Jiao Nang)
Fu Ke Qian Jin Pian: no details stated
Tian Qi Jiao Nang: no details stated
Both group took 5 tablets of each study material, tid. 4-5 days prior to bleeding till day 2 of cycle

Outcomes 1. Pain:
Experimental:
Cases of cure: 13/44
Cases of improvement: 23/44
Cases of response: 5/44
Cases of no response: 3/44
Total effectiveness: 93.2%
Control:

Chinese herbal medicine for primary dysmenorrhoea (Review) 33

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 1999 (Continued)

Cases of cure: 10/36

Cases of improvement: 17/36
Cases of response: 5/36
Cases of no response: 4/36
Total effectiveness: 88.9%
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 13/44
Cases of improvement: 23/44
Cases of response: 5/44
Cases of no response: 3/44
Total effectiveness: 93.2%
Control:
Cases of cure: 10/36
Cases of improvement: 17/36
Cases of response: 5/36
Cases of no response: 4/36
Total effectiveness: 88.9%
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
Significant difference between the two groups in the rate of cure P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced
Response: abdominal pain reduced, and other symptoms improved
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests:
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes Unclear how women assigned to different groups

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 34

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 2001

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: single blinded
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 50 women
Control: 50 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental:15-35,
Control: 15-33
History: stated
TCM Pattern: unstated

Interventions Self designed formula (Tong Jing Wan) vs OTC Chinese herbal formula (Yuan Hu Zhi Tong Pian)
Tong Jing Wan: Xiao Hui Xiang (Fructus Foeniculi Vulgaris), Rou Gui (Cortex Cinnamomi Cassiae),
San Qi (Radix Notoginseng), Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi), Pu Huang (Pollen
Typhae), Chen Xiang (Lignum Aquitariae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Mu Xiang (Radix
Aucklandiae Lappae), Bai Zhu (Rhizoma Atractylodis Macrocephalae), made as a form of pills in certain
ratio. 2g, tid
Yuan Hu Zhi Tong Pian: 5 tablets, tid
Both groups started from 5 days prior to bleeding till day 2 of cycle

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 68.0%, 34/50
Rate and Cases of improvement: 10%, 5/50
Rate and Cases of response: 12%, 6/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 90%
Control:
Rate and Cases of cure: 20%, 10/50
Rate and Cases of improvement: 30%, 15/50
Rate and Cases of response: 22%, 11/50
Rate and Cases of no response: 28%, 14/50
Total effectiveness: 72%
Significant difference between the two groups in the rate of cure P<0.001
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 68.0%, 34/50
Rate and Cases of improvement: 10%, 5/50
Rate and Cases of response: 12%, 6/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 90%
Control:
Rate and Cases of cure: 20%, 10/50
Rate and Cases of improvement: 30%, 15/50

Chinese herbal medicine for primary dysmenorrhoea (Review) 35

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 2001 (Continued)

Rate and Cases of response: 22%, 11/50

Rate and Cases of no response: 28%, 14/50
Total effectiveness: 72%
Significant difference between the two groups in the rate of cure P<0.001
Criteria
Cure: abdominal pain and other symptoms disappeared, pain scores reduced to 0, no relapse during 3
cycles of follow up
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced, the scores
reduced to as low as more than 1/2 of the scores before, capable of working without pain relieving
medication
Response: abdominal pain reduced, and other symptoms improved, the scores reduced to as low as more
than 1/3 of the scores before, capable of working with pain relieving medication
No response: abdominal pain not changed at all.
3. Adverse effect: unstated.
4. Lab tests: stated. But no investigation nor data on the Controlrol group as a comparison
5. Use of additional medication: stated.
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Li 2004

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 40 women
Control: 40 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 12-33 y
Control: 13-32 y
History: unstated
TCM Pattern: stated, only the pattern of retention of cold and blood stasis

Interventions Self-designed formula (Nuan Gong ZHi Tong Tang) vs OTC (Yue Yue Shu)
Nuan Gong ZHi Tong Tang:
Rou Gui (Cortex Cinnamomi Cassiae) 5 g,
Zhi Fu Zi (Radix Lateralis Aconiti Carmichaeli Praeparata) 3 g,
Chinese herbal medicine for primary dysmenorrhoea (Review) 36
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 2004 (Continued)

Zi Shi Ying (Fluoritum) 10 g,

San Leng (Rhizoma Sparganii Stoloniferi) 10 g,
Er Zhu (Rhizoma Curcumae Ezhu) 10 g, Dang Gui (Radix Angelicae Sinensis) 10 g, Xiang Fu (Rhizoma
Cypri Rotundi) 10 g, Chuan Xiong (Radix Ligustici Chuanxiong) 6 g,
Chi Shao (Radix Paeoniae Rubrae) 12 g, Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 12 g.
300ml of herbal decoction as daily dosage, 150ml, bid
Yue Yue Shu: 1 sachet (10g), bid
Both groups started from 5 days prior to bleeding for a period of 7 days

Outcomes 1. Pain:
Experimental:
Casess of cure: 21/40
Casess of improvement: 11/40
Casess of response: 5/40
Casess of no response: 3/40
Total effectiveness: 92.5%
Control:
Casess of cure: 14/40
Casess of improvement: 10/40
Casess of response: 7/40
Casess of no response: 9/40
Total effectiveness: 77.5%
Significant difference between the two groups in the rate of cure P<0.05
2. Overall symptoms:
Experimental:
Casess of cure: 21/40
Casess of improvement: 11/40
Casess of response: 5/40
Casess of no response: 3/40
Total effectiveness: 92.5%
Control:
Casess of cure: 14/40
Casess of improvement: 10/40
Casess of response: 7/40
Casess of no response: 9/40
Total effectiveness: 77.5%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapsed during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced, remained
the efficacy during 3 cycles of follow up
Response: abdominal pain reduced, and other symptoms improved, relapsed but less severe
No response: abdominal pain, other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Chinese herbal medicine for primary dysmenorrhoea (Review) 37

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Li 2004 (Continued)

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Liu 2000

Methods Allocation concealment and randomisation: Randomised - method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 40 women
Control: 38 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-31
History: stated
TCM Pattern: unspecified

Interventions OCT Chinese herbal formula (Xiao Yao Wan) + Piroxicam vs Prioxicam
Xiao Yao Wan: Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix Paeoniae Latiflorae), Chai Hu
(Radix Bupleuri), Fu Ling (Sclerotium Poriae Cocos), Bai Zhu (Rhizoma Atractylodis Macrocephalae)
, Gan Cao (Radix Glycyrrhizae Uralensis), Wei Jiang (Rhizoma Phragmitis Communis), Bo He (Herba
Menthae Haplocalcis), 9g, bid. in combination with Piroxicam: 20mg, once daily
Piroxicam: 20 mg, once daily
Both groups started from 2 days prior to bleed for a period of 3 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 70%, 28/40
Rate and Cases of improvement: 22.5%, 9/40
Rate and Cases of no response: 7.5%, 3/40
Total effectiveness: 92.5%
Control:
Rate and Cases of cure: 31.6%, 12/38
Rate and Cases of improvement: 52.6%, 20/38
Rate and Cases of no response: 15.8%, 6/38
Total effectiveness:84.2%
No significant difference between the Experimentalerimental and Controlrol groups in total efficacy P>0.
05. but different in rate of cure P<0.001
Criteria
Cure: abdominal pain disappeared, no relapse during 10 cycles of follow up
Improvement: abdominal pain reduced or disappeared, no relapse during 3 cycles of follow up

Chinese herbal medicine for primary dysmenorrhoea (Review) 38

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2000 (Continued)

No response: relapsed as soon as cease of intervention.

2. Overall symptoms: unstated
3. Adverse effect: stated. no incidence in neither of groups
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Liu 2002

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 12-36
History: stated
TCM Pattern: unspecified

Interventions Self designed formula (Wen Tong Tang) vs OTC Chinese herbal formula (Gu Zhi Wan)
Wen Tong Tang:
Dang Gui (Radix Angelicae Sinensis) 10 g,
Chuan Xiong (Radix Ligustici Chuanxiong) 10 g,
Chi Shao (Radix Paeoniae Rubrae) 10 g,
Chuan Niu Xi (Radix Cyathulae Officinalis) 15 g,
Pu Huang (Pollen Typhae) 10g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 10 g,
Rou Gui (Cortex Cinnamomi Cassiae) 5 g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 5 g,
Pao Jiang (Quick-Fried Rhizoma Zingiberis Officinalis) 5 g,
Lu Jiao Shuang (Cornu Cerri Degelatinatium) 10 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10 g, Xiang Fu (Rhizoma Cypri Rotundi) 10 g.
Herbal decoction, one dose, bid
Gu Zhi Wan: 9g, bid
Both group started study material from the first day of cycle (bleeding) to the end of bleeding

Chinese herbal medicine for primary dysmenorrhoea (Review) 39

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2002 (Continued)

Outcomes 1. Pain:
Experimental:
Cases of cure: 22/30
Cases of improvement: 6/30
Cases of no response: 2/30
Total effectiveness: 93.3%
Control:
Cases of cure: 12/30
Cases of improvement: 10/30
Cases of no response: 8/30
Total effectiveness: 73.3%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced or disappeared, but relapse during 3 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: stated but doesnt fit the criteria of outcomes
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Liu 2003

Methods Allocation concealment and randomisation: Randomised - method unstated

Blinding: unstated
Trial design: parallel
Parallel performance: yes
Duration:
2-3 days prior to bleeding or 1st day of bleeding for 7 days x 3 cycles of intervention + 3 cycles of follow
up

Participants Number:
Experimental: 52 women
Control: 38 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-30
History: stated

Chinese herbal medicine for primary dysmenorrhoea (Review) 40

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2003 (Continued)

TCM Pattern: specified, pattern of stagnation of blood only

Interventions Self designed formula (Wen Jing Tang -> oral administration +
Xin Jie San -> external administration ) vs Indomethacin + Vit B6 + Hot water bottle
Wen Jing Tang:
Rou Gui (Cortex Cinnamomi Cassiae) 3 g,
Chuan Xiong (Radix Ligustici Chuanxiong) 8 g,
Dangshen (Codonopsis Radix) 20 g,
Dang Gui (Radix Angelicae Sinensis) 10 g, Er Zhu (Rhizoma Curcumae Ezhu) 10 g, Dan Shen (Radix
Salviae Miltrorrhizae) 15 g, Chuan Niu Xi (Radix Cyathulae Officinalis) 10 g,
Bai Shao (Radix Paeoniae Latiflorae) 10 g, Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10 g,
Gan Cao (Radix Glycyrrhizae Uralensis) 6 g. Herbal decoction, one dose daily
Xin Jie San: Xi Xin (Asari Herba) 30 g,
Bai Jie Zi (Sinapis Semen) 30 g,
Mang Xiao (Natrii Sulfas) 30g. All ingredients were mixed, ground into powder and packed into a bag
sized as 20x30cm, then sealed. Warmed up in microwave oven before applied on the lower abdominal
region
Indomethacin: 25 mg, tid. Vit B6 20 mg, tid. Hot water bottle in the lower abdominal region
Both groups started from 2-3 days prior to bleeding or 1st day of bleeding for a period of 7 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure:90.4%, 47/52
Rate and Cases of improvement: 7.7%, 4/52
Rate and Cases of no response: 1.9%, 1/52
Total effectiveness: 98.1%
Control:
Rate and Cases of cure: 44.7%, 17/38
Rate and Cases of improvement: 31.6%, 12/38
Rate and Cases of no response: 23.7%, 9/38
Total effectiveness: 76.3%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced.
No response: abdominal pain not changed at all.
2. Improved other symptoms: unstated
3. Adverse effect: unstated
4. Improvement in lab tests: unstated
5. Reduced additional medication: unstated
6. Satisfaction from patients: unstated
7. improvement in quality of life: unstated

Notes Unclear how women assigned to different groups

Risk of bias

Item Authors judgement Description

Chinese herbal medicine for primary dysmenorrhoea (Review) 41

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2003 (Continued)

Allocation concealment? Unclear B - Unclear

Liu 2004

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 45 women
Control: 40 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-18
History: stated
TCM Pattern: retention of coldness and stagnation of blood

Interventions Self-designed formula administrated externally vs classic formula (Wen Jing Tang) administrated orally
Zi Ni Wai Fu Tong Jing Zhi Tong Fan:
Rou Gui (Cortex Cinnamomi Cassiae) 30 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 30 g, Ru Xiang (Gummi Olibanum) 30 g,
Mo Yao (Myrrha) 30 g,
Di Bie Chong (Eupolyphaga Seu Opisthaplatia) 30 g,
Wu Yao (Radix Linderae Strychnifoliae) 30 g.
All ingredients were dried and granted into powder, 20g each time, mixed with rice wine as paste for
external use on navel. Change once daily
Wen Jing Tang: no details. One dose daily.
Both groups started from 3 days prior to bleeding for a period of 5 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 88.89%, 40/45
Rate and Cases of improvement: 6.67%, 3/45
Rate and Cases of response: 2.22%, 1/45
Rate and Cases of response: 2.22%, 1/45
Total effectiveness: 97.78%
Control:
Rate and Cases of cure: 47.50%, 19/40
Rate and Cases of improvement: 10.00%, 4/40
Rate and Cases of response: 15.00%, 6/40
Rate and Cases of no response: 27.50%, 11/40
Total effectiveness: 72.50%
Significant difference between the two groups in the rate of cure P<0.05
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 88.89%, 40/45
Rate and Cases of improvement: 6.67%, 3/45

Chinese herbal medicine for primary dysmenorrhoea (Review) 42

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2004 (Continued)

Rate and Cases of response: 2.22%, 1/45

Rate and Cases of response: 2.22%, 1/45
Total effectiveness: 97.78%
Control:
Rate and Cases of cure: 47.50%, 19/40
Rate and Cases of improvement: 10.00%, 4/40
Rate and Cases of response: 15.00%, 6/40
Rate and Cases of no response: 27.50%, 11/40
Total effectiveness: 72.50%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain and other symptoms disappeared, scores reduced to 0, no relapse during 3 cycles
of follow up
Improvement: abdominal pain and other symptoms significantly reduced, after intervention, scores re-
duced as 1/2 below as before
Response: abdominal pain and reduced, after intervention, scores reduced as 1/2 below as before
No response: abdominal pain, other symptoms.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Liu 2005

Methods Allocation concealment and randomisation: Randomised - method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-30
History: stated
TCM Pattern: stated, retention of coldness and stagnation of blood

Chinese herbal medicine for primary dysmenorrhoea (Review) 43

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2005 (Continued)

Interventions Self-designed formula (Wen Jing Zhi Tong Yin) vs OTC Chinese herbal formula (Ai Fu Nuan Gong
Tang)
Wen Jing Zhi Tong Yin: Pao Jiang (Quick-Fried Rhizoma Zingiberis Officinalis), Rou Gui (Cortex
Cinnamomi Cassiae), Dang Gui (Radix Angelicae Sinensis), Chuan Xiong (Radix Ligustici Chuanxiong)
, Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi), Pu Huang (Pollen Typhae), Bai Shao (Radix
Paeoniae Latiflorae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Huai Niu Xi (Radix Achyranthis
Bidentatae), Xiao Hui Xiang (Fructus Foeniculi Vulgaris), Xiang Fu (Rhizoma Cypri Rotundi), Gan Cao
(Radix Glycyrrhizae Uralensis) etc. No dosage in detail stated. Herbal decoction. 5 days prior to bleeding
for a period of 7 days
Ai Fu Nuan Gong Tang: No dosage in detail stated. 3 days prior to bleeding for a period of 6 days

Outcomes 1. Pain:
Experimental:
Casess of cure: 7/30
Casess of improvement: 15/30
Casess of response: 6/30
Casess of no response: 2/30
Total effectiveness: 93.33%
Control:
Casess of cure: 6/30
Casess of improvement: 6/30
Casess of response: 11/30
Casess of no response: 7/30
Total effectiveness: 76.67%
Significant difference between the two groups in the rate of cure P<0.05
2. Overall symptoms: Experimental:
Casess of cure: 7/30
Casess of improvement: 15/30
Casess of response: 6/30
Casess of no response: 2/30
Total effectiveness: 93.33%
Control:
Casess of cure: 6/30
Casess of improvement: 6/30
Casess of response: 11/30
Casess of no response: 7/30
Total effectiveness: 76.67%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, the pain scores
after intervention reduced as low as 1/2 of the scores before intervention
Response: abdominal pain reduced, other symptoms improved, the pain scores after intervention reduced
as low as between 1/2 to 3/4 of the scores before intervention
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated

Chinese herbal medicine for primary dysmenorrhoea (Review) 44

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Liu 2005 (Continued)

6. Satisfaction from patients: unstated

7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Lu 2002

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 45 women
Control: 41 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-32
History: stated
TCM Pattern: unspecified

Interventions Self designed formula (Fu Kang Bao) vs Ibuprofen

Fu Kang Bao: Dang Gui (Radix Angelicae Sinensis), E Jiao (Gelatinum Corii Asini), Chuan Xiong (Radix
Ligustici Chuanxiong), Shao Yao (Radix Paeoniae Latiflorae), Shu Di (Radix Rehmanntae Glutinosae
Conquitae) etc. No dosage, nor form of herbal preparation in detail stated. 10ml, bid, before meals
Ibuprofen: 300mg, bid
Both groups started from 5 days prior to bleeding to the end of bleeding

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 66.7%, 30/45
Rate and Cases of improvement: 28.8%, 13/45
Rate and Cases of no response: 4.4%, 2/45
Total effectiveness: 95.6%
Control:
Rate and Cases of cure: 42.5%, 20/41
Rate and Cases of improvement: 26.8%, 11/41
Rate and Cases of no response: 24.3%, 10/41
Total effectiveness: 75.6%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up

Chinese herbal medicine for primary dysmenorrhoea (Review) 45

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Lu 2002 (Continued)

Improvement: abdominal pain reduced.

No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Luo 2001

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 31 women
Control: 31 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 13-40
History: stated
TCM Pattern: Stagnation of Qi and Blood

Interventions Self designed formula (Tong Jing San) vs Indomethacin

Tong Jing San:
Pu Huang (Pollen Typhae) 15 g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 12 g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 15 g, Xiang Fu (Rhizoma Cypri Rotundi) 10 g,
Chuan Niu Xi (Radix Cyathulae Officinalis) 10 g, Pao Jiang (Quick-Fried Rhizoma Zingiberis Officinalis)
6 g,
Xi Xin (Herba cum Radice Asari) 3 g. Herbs were soaked for one hour, cooked for one hour, extracted
into 200ml decoction, 100ml, bid. Started from 7 days prior to bleeding till 1st day of cycle
Indomethacin: 25 mg, tid. 3 days prior to bleeding till 1st day of cycle

Outcomes 1. Pain:
Experimental:
Cases of improvement: 26/31
Cases of response: 5/31
Cases of no response: 0/31
Chinese herbal medicine for primary dysmenorrhoea (Review) 46
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Luo 2001 (Continued)

Total effectiveness: 83.87%

Control:
Cases of improvement: 15/31
Cases of response: 11/31
Cases of no response: 4/31
Total effectiveness: 48.39%
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Casess of improvement: 26/31
Casess of response: 5/31
Casess of no response: 0/31
Total effectiveness: 83.87%
Control:
Casess of improvement: 15/31
Casess of response: 11/31
Casess of no response: 4/31
Total effectiveness: 48.39%
Criteria:
Improvement: abdominal pain reduced obviously, and other symptoms disappeared or reduced, pain
scores reduced as low as more then 1/2 of the scores before the intervention, capable of working without
pain relieving medication
Response: abdominal pain reduced, and other symptoms improved, pain scores reduced as low as between
1/2 to 3/4 of the scores before the intervention, capable of working with pain relieving medication
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication:
Experimental: 26/31
Control: 15/31
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 47

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Miao 2001

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design:
parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 36 women
Control: 27 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 12-20 y
History: stated
TCM Pattern: believed all clinical patterns related to deficiency of kidney and liver

Interventions Self designed formula (Niu Xi San) vs Acupuncture (LI 4, and SP 6 only)
Niu Xi San: Niu Xi (Chuan Niu Xi (Radix Cyathulae Officinalis) or Huai Niu Xi (Radix Achyranthis
Bidentatae) (not clear), Rou Gui (Cortex Cinnamomi Cassiae), Chi Shao (Radix Paeoniae Rubrae), Tao
Ren (Semen Persicae), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Dang Gui (Radix Angelicae Sinensis)
, Mu Xiang (Radix Aucklandiae Lappae), Dan Pi (Cortex Mouten Radicis) in a ration of 3:1:1:1:1:1:1:1:
1, in a form of powder, 9g, mixed with warm water or wine, for a period of 5 days (unclear when started
the intervention)
Acupuncture: needles remained for 30 minutes of each point, for a period of 5 days (unclear when started
the intervention)

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 47.3%, 17/36
Rate and Cases of improvement: 41.3%, 15/36
Rate and Cases of no response: 11.4%, 4/36
Total effectiveness: 88.6%
Control:
Rate and Cases of cure: 17.1%, 3/17
Rate and Cases of improvement: 47.1%, 8/17
Rate and Cases of no response: 34.8%, 6/17
Total effectiveness: 65.2%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
Criteria:
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced or disappeared, but relapse during 3 cycle of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Chinese herbal medicine for primary dysmenorrhoea (Review) 48

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Miao 2001 (Continued)

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Niu 1996

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: single blinded
Trial design: parallel
Parallel performance: may not
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 32 women
Control: 21 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 17-47 ys
Control: 18-42yrs
History: stated
TCM Pattern: unstated

Interventions Single herb (Glycyrrhiza uralensis Fisch) vs OTC (Yuan Hu Zhi Tong Pian)
Glycyrrhiza uralensis Fisch: no dosage of details stated
Yuan Hu Zhi Tong Pian: 6 tablets, tid
Both group took herb as soon as pain started for 3 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 28.1%, 9/32
Rate and Cases of improvement: 40.6%, 13/32
Rate and Cases of response: 25.0%, 8/32
Rate and Cases of no response: 6.3%, 2/32
Total effectiveness: 93.8%
Control:
Rate and Cases of cure: 9.5%, 2/21
Rate and Cases of improvement: 23.8%, 5/21
Rate and Cases of response: 23.8%, 5/21
Rate and Cases of no response: 42.9%, 9/21
Total effectiveness: 57.1%
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 28.1%, 9/32
Rate and Cases of improvement: 40.6%, 13/32
Rate and Cases of response: 25.0%, 8/32

Chinese herbal medicine for primary dysmenorrhoea (Review) 49

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Niu 1996 (Continued)

Rate and Cases of no response: 6.3%, 2/32

Total effectiveness: 93.8%
Control:
Rate and Cases of cure: 9.5%, 2/21
Rate and Cases of improvement: 23.8%, 5/21
Rate and Cases of response: 23.8%, 5/21
Rate and Cases of no response: 42.9%, 9/21
Total effectiveness: 57.1%
Criteria
Cure: abdominal pain and other symptoms disappeared, scores reduced to 0, no relapse during 3 cycles
of follow up
Improvement: abdominal pain and other symptoms significantly reduced, after intervention, scores re-
duced as 1/2 below as before, maintain daily activities with pain relieving medication.
Response: abdominal pain and reduced, after intervention, scores reduced as 1/2 to 3/4 below as before,
pain relieving medication needed.
No response: abdominal pain, other symptoms.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Qin 2003

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 60 women
Control: 60 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
average 14-40 y
History: unstated
TCM Pattern: unstated

Chinese herbal medicine for primary dysmenorrhoea (Review) 50

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Qin 2003 (Continued)

Interventions Self designed formula (Du Yi Wei Jiao Nang) vs OTC Formua (Yuan Hu Zhi Tong Jiao Nang) or added
pain relieving medication if required
Du Yi Wei Jiao Nang: no details given. 3 pills, tid.
Yuan Hu Zhi Tong Jiao Nang: no details given.
Both group started herb from 1st day of cycle/bleeding for 7 days

Outcomes 1. Pain:
Experimental:
Rate of cure: 81.67%, 49/60
Rate of improvement: 15.00%, 9/60
Rate of no response: 3.33%, 2/60
Total effectiveness: 96.66%
Control:
Rate of cure: 35.00%, 21/60
Rate of improvement: 48.33%, 29/60
Rate of no response: 16.66%, 10/60
Total effectiveness: 83.33%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, but relapsed during 3 cycle of follow up
No response: abdominal pain and other symptoms not changed at all
2. Overall symptoms:
Experimental:
Rate of cure: 81.67%, 49/60
Rate of improvement: 15.00%, 9/60
Rate of no response: 3.33%, 2/60
Total effectiveness: 96.66%
Control:
Rate of cure: 35.00%, 21/60
Rate of improvement: 48.33%, 29/60
Rate of no response: 16.66%, 10/60
Total effectiveness: 83.33%
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 51

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Shen 2001

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 60 women
Control: 60 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 26.63 y
Control: 25.1 y
History: stated
TCM Pattern: stated, the retention of cold and stagnation of blood

Interventions Self designed formula (Wen Jing Jian Tong Jiao Nang) vs OCT Formua (Jiu Qi Jian Tong Wan)
Wen Jing Jian Tong Jiao Nang: Rou Gui (Cortex Cinnamomi Cassiae), Jiu Xiang Chong (Aspongopus)
, Xiao Hui Xiang (Fructus Foeniculi Vulgaris), Dang Gui (Radix Angelicae Sinensis), Wu Ling Zhi
(Excrementum Trogopteri Seu Pteromi), Xiang Fu (Rhizoma Cypri Rotundi), Yan Hu Suo (Rhizoma
Corydalis Yanhusuo), Bing Pian (Borneol), dosage of herbal ingredients unstated. 4 pills, bid
Jiu Qi Jian Tong Wan: no detail of dosage of herbal ingredient stated. 9g, bid
Both groups started herbs 7 days prior to period for a period of 5 days

Outcomes 1. Pain:
Experimental:
Cases of cure: 14/60
Cases of improvement: 27/60
Cases of response: 16/60
Cases of no response: 3/60
Total effectiveness: 57 (95.00%)
Control:
Cases of cure: 8/60
Cases of improvement: 19/60
Cases of response: 28/60
Cases of no response: 5/60
Total effectiveness: 55 (91.67%)
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Cases of cure: 14/60
Cases of improvement: 27/60
Cases of response: 16/60
Cases of no response: 3/60
Total effectiveness: 57 (95.00%)
Control:
Cases of cure: 8/60
Cases of improvement: 19/60
Cases of response: 28/60

Chinese herbal medicine for primary dysmenorrhoea (Review) 52

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Shen 2001 (Continued)

Cases of no response: 5/60

Total effectiveness: 55 (91.67%)
Significant difference between the two groups in the rate of cure P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, pain scores reduced to 0, no relapse during 3
cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, no need to
take pain relieving medication, the pain scores after intervention reduced was less than 1/2 of the scores
before intervention
Response: abdominal pain reduced, other symptoms improved, pain relieving medication needed, the
pain scores after intervention reduced was between 1/2 to 4/3 of the scores before intervention
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: stated, confirmed with lab tests such as blood and urine, excrement routine tests, ECG,
ALT, BUN, Cr
4. Lab tests: unreported
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Song 2003

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: single blinding
Trial design: parallel
Parallel performance: no
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 50 women
Control: 50 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 15-35,
Control: 14-36
History: stated
TCM Pattern: stated, only the pattern of stagnation of Qi and Blood was included

Interventions Self designed formula (Tong Jing Jiao Nang) vs Indomethacin

Tong Jing Jiao Nang: Xue Jie (Sanguis Draconis), Pu Huang (Pollen Typhae), Wu Ling Zhi (Excrementum

Chinese herbal medicine for primary dysmenorrhoea (Review) 53

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Song 2003 (Continued)

Trogopteri Seu Pteromi), Chuan Niu Xi (Radix Cyathulae Officinalis), Xiang Fu (Rhizoma Cypri Rotundi)
, Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix
Paeoniae Latiflorae), Xi Xin (Herba cum Radice Asari), etc. in a form of capsule (no detailed dosage), 4
capsules, tid. 5 days prior to period for a period of 7 days
Indomethacin: 25 mg, tid. 3 days prior to period for a period of 6 days

Outcomes 1. Pain:
Experimental:
Rate of cure: 70%, 35/50
Rate of improvement: 20%, 10/50
Rate of no response: 10%, 5/50
Total effectiveness: 90%
Control:
Rate of cure: 20%, 10/50
Rate of improvement: 52%, 26/50
Rate of no response: 28%, 14/50
Total effectiveness: 72%
significant difference between the Experimentalerimental and Controlrol groups P<0.005
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapsed during 3 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Sun 2006

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 46 women
Control: 45 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Chinese herbal medicine for primary dysmenorrhoea (Review) 54
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun 2006 (Continued)

Age:
Experimental: 13-35
Control: 12-35
History: stated
TCM Pattern: specified, only the pattern of stagnation of blood and retention of cold

Interventions Self-designed formula (Tao Jing Ding Tong Tang) vs OTC Chinese herbal formula (Tian Qi Tong Jing
Jiao Nang)
Tao Jing Ding Tong Tang:
Gui Zhi (Ramulus Cinnamomi Cassiae) 15 g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 10 g, Dang Gui (Radix Angelicae Sinensis) 10 g, Chuan
Xiong (Radix Ligustici Chuanxiong) 15 g, Xiang Fu (Rhizoma Cypri Rotundi) 15 g,
Chai Hu (Radix Bupleuri) 10 g,
Yi Mu Cao (Herba Leonuri Herterophylli) 15 g,
Ze Lan (Herba Lycopi Lucidi) 15 g,
Wang Bu Liu Xing (Semen Vaccariae Segetalis) 20 g,
Lu Lu Tong (Fructus Liquidambaris Taiwanianae) 15 g,
Bai Shao (Radix Paeoniae Latiflorae) 15 g,
Gan Cao (Radix Glycyrrhizae Uralensis) 5 g. Herbal decoction, bid
Tian Qi Tong Jing Jiao Nang: 4 pills, tid, a half hour before meals
Both groups took herbs from 5 days prior to period for a period of 6 days

Outcomes 1. Pain:
Experimental:
Cases of cure: 27/46
Cases of improvement: 12/46
Cases of response: 5/46
Cases of no response: 2/46
Total effectiveness: 95.65%
Control:
Cases of cure: 7/45
Cases of improvement: 18/45
Cases of response: 8/45
Cases of no response: 12/45
Total effectiveness: 73.33%
Significant difference in rate of cure between the two groups: P<0.05
2. Overall symptoms:
Experimental:
Cases of cure: 27/46
Cases of improvement: 12/46
Cases of response: 5/46
Cases of no response: 2/46
Total effectiveness: 95.65%
Control:
Cases of cure: 7/45
Cases of improvement: 18/45
Cases of response: 8/45
Cases of no response: 12/45
Total effectiveness: 73.33%

Chinese herbal medicine for primary dysmenorrhoea (Review) 55

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun 2006 (Continued)

Significant difference in rate of cure between the two groups: P<0.05

Criteria
Cure: abdominal pain and other symptoms disappeared, scores reduced to 0, no relapse during 3 cycles
of follow up
Improvement: abdominal pain and other symptoms significantly reduced, after intervention, scores re-
duced as 1/2 below as before
Response: abdominal pain and reduced, after intervention, scores reduced as 1/2 to 3/4 below as before
No response: abdominal pain, other symptoms, lab tests not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication:
unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Sun2004

Methods Allocation concealment and randomisation: randomised based on a random number table
Blinding: double-blinding
Trial design: parallel
Parallel performance: may not
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-23
History: stated
TCM Pattern: unstated

Interventions OTC formula (Gui Zhi Fu Ling Wan No1) vs Placebo

Gui Zhi Fu Ling Wan No1: Gui Zhi (Ramulus Cinnamomi Cassiae), Fu Ling (Sclerotium Poriae Cocos)
, Chi Shao (Radix Paeoniae Rubrae), Dan Pi (Cortex Mouten Radicis), Tao Ren (Semen Persicae). 3 pills,
tid
Placebo: 3 pills, tid. no further details
Both groups started herbs/placebo from 3 days prior to period for a period of 7 days

Chinese herbal medicine for primary dysmenorrhoea (Review) 56

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun2004 (Continued)

Outcomes 1. Pain:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:
Rate and Cases of cure: 6.7%, 2/30
Rate and Cases of improvement: 30.0%, 9/30
Rate and Cases of response: 50.0%, 15/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Control:
Rate and Cases of cure: 0%, 0/30
Rate and Cases of improvement: 3.3%, 1/30
Rate and Cases of response: 36.7%, 11/30
Rate and Cases of no response: 60%, 18/30
Total effectiveness: 60.0%
2. Overall symptoms:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:
Rate and Cases of cure: 6.7%, 2/30
Rate and Cases of improvement: 30.0%, 9/30
Rate and Cases of response: 50.0%, 15/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Control:
Rate and Cases of cure: 0%, 0/30
Rate and Cases of improvement: 3.3%, 1/30
Rate and Cases of response: 36.7%, 11/30
Rate and Cases of no response: 60%, 18/30
Total effectiveness: 60.0%
Criteria
Cure: abdominal pain and other symptoms disappeared, scores reduced to 0, no relapse during 3 cycles
of follow up, lab tests within normal range
Improvement: abdominal pain and other symptoms significantly reduced, after intervention, scores re-
duced as 1/2 below as before, maintain daily activities with pain relieving medication, lab tests significantly
improved, closed to normal range
Response: abdominal pain and reduced, after intervention, scores reduced as 1/2 to 3/4 below as before,
pain relieving medication needed, lab tests improved
No response: abdominal pain, other symptoms, lab tests not changed at all

Chinese herbal medicine for primary dysmenorrhoea (Review) 57

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun2004 (Continued)

3. Adverse effect: stated

4. Lab tests: stated, including blood viscosity 200s/L, 30s/L and 1s/L; plasma viscosity (PV), blood viscosity
at high and low shear rate, PGE2a in menstrual blood
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes This trial had two Experimental groups,which is tabled separately, however the numbers of women in
placebo group was only entered into analysis once

Risk of bias

Item Authors judgement Description

Allocation concealment? Yes A - Adequate

Sun2004 -2

Methods Allocation concealment and randomisation: randomised based on a random number table
Blinding: double-blinding
Trial design: parallel
Parallel performance: may not
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 30 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 15-23
History: stated
TCM Pattern: unstated

Interventions OTC formula (Gui Zhi Fu Ling Wan No2) vs Placebo

Gui Zhi Fu Ling Wan No2: Gui Zhi (Ramulus Cinnamomi Cassiae), Fu Ling (Sclerotium Poriae Cocos)
, Bai Shao (Radix Paeoniae Latiflorae), Dan Pi (Cortex Mouten Radicis), Tao Ren (Semen Persicae). 3
pills, tid
Placebo: 3 pills, tid. no further details
Both groups started herbs/placebo from 3 days prior to period for a period of 7 days

Outcomes 1. Pain:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:

Chinese herbal medicine for primary dysmenorrhoea (Review) 58

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun2004 -2 (Continued)

Rate and Cases of cure: 6.7%, 2/30

Rate and Cases of improvement: 30.0%, 9/30
Rate and Cases of response: 50.0%, 15/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Control:
Rate and Cases of cure: 0%, 0/30
Rate and Cases of improvement: 3.3%, 1/30
Rate and Cases of response: 36.7%, 11/30
Rate and Cases of no response: 60%, 18/30
Total effectiveness: 60.0%
2. Overall symptoms:
Experimental 1:
Rate and Cases of cure: 10%, 3/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 46.7%, 14/30
Rate and Cases of no response: 10%, 3/30
Total effectiveness: 90.0%
Experimental 2:
Rate and Cases of cure: 6.7%, 2/30
Rate and Cases of improvement: 30.0%, 9/30
Rate and Cases of response: 50.0%, 15/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Control:
Rate and Cases of cure: 0%, 0/30
Rate and Cases of improvement: 3.3%, 1/30
Rate and Cases of response: 36.7%, 11/30
Rate and Cases of no response: 60%, 18/30
Total effectiveness: 60.0%
Criteria
Cure: abdominal pain and other symptoms disappeared, scores reduced to 0, no relapse during 3 cycles
of follow up, lab tests within normal range
Improvement: abdominal pain and other symptoms significantly reduced, after intervention, scores re-
duced as 1/2 below as before, maintain daily activities with pain relieving medication, lab tests significantly
improved, closed to normal range
Response: abdominal pain and reduced, after intervention, scores reduced as 1/2 to 3/4 below as before,
pain relieving medication needed, lab tests improved
No response: abdominal pain, other symptoms, lab tests not changed at all
3. Adverse effect: stated
4. Lab tests: stated, including blood viscosity 200s/L, 30s/L and 1s/L; plasma viscosity (PV), blood viscosity
at high and low shear rate, PGE2a in menstrual blood
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Chinese herbal medicine for primary dysmenorrhoea (Review) 59

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Sun2004 -2 (Continued)

Item Authors judgement Description

Allocation concealment? Yes A - Adequate

Tseng 2005

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: open trial
Trial design: parallel
Parallel performance: stated
Age: significant different in mean age and PSS scores (variable) between two groups, but adjusted
Duration: 6 cycles of intervention + 0 cycles of follow up

Participants Number:
Experimental: 70 adolescents
Control: 60 adolescents
Drop-outs/withdrawals: stated
21 out of 130 dropped out because of irregular course of menstruation, failure of compliance, withdrawal
of school. 59 Experimental and 50 Control subjects completed the assessment
Diagnosis of dysmenorrhoea: unstated
Age: adolescents/boarding school girls, age unspecified
History: stated
TCM Pattern: unstated, only mentioned stagnation Qi and blood as general condition

Interventions Rose tea vs no treatment

Rose tea: 2 teacups per day made from 6 dry rosebuds steeped in 300mL of hot water, taken for 12 days
from one week prior to their menstrual period to the fifth menstrual day

Outcomes Reduction in pain

The short-Form McGill Pain Questionnaire (SF-MPQ)
The Menstrual Distress Questionnaire Short Form (MDQ-SF)
Received Stress Scale (PSS)
Reduction in anxiety and psychophysiologic stress
Visual Analogue Scale for Anxiety (VASA)
The Psychophysiologic Life Adaptation Scale (PLAS)
Adverse Effects
Self report from subjects: two had mild diarrhoea after 1st course of rose tea, one quit the study, the other
Controlinued and Experimentalerienced no further diarrhoea

Notes The results listed in a separate table

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 60

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 1996

Methods Allocation concealment and randomisation: randomised based on random number table
Blinding: stated, single blinded
Trial design: parallel
Duration: 3 cycles + 3 cycles of follow up

Participants Number:
Experimental: 23 women
Control 1: 21 women
Control 2: 16 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
high school girls
History: stated
TCM Pattern: specified, retention of cold and stagnation of Qi

Interventions Self-designed formula (Tong Jing Ling) rectal administration vs 1 OCT Chinese herbal formula (Tian Qi
Tong Jing Jiao Nang) oral administration vs 2 Self-designed formula (Tong Jing Ling) oral administration
Tong Jing Ling: Gui Zhi (Ramulus Cinnamomi Cassiae), Wu Yao (Radix Linderae Strychnifoliae), Xiang
Fu (Rhizoma Cypri Rotundi), Yan Hu Suo (Rhizoma Corydalis Yanhusuo), Mu Xiang (Radix Aucklandiae
Lappae), Kun Cao, Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi), Chuan Xiong (Radix Ligustici
Chuanxiong), etc. Either in suppository administration, 1 piece, rectal administration, bid. or in oral
administration in capsule form, 5 pills, tid
Tian Qi Tong Jing Jiao Nang: 5 pills, tid
All groups started from 4-5 days prior to bleeding till day 2 of cycle (appx 7 days)

Outcomes 1. Pain:
Experimental:
Cases of cure: 8/23
Cases of improvement: 11/23
Cases of response: 2/23
Cases of no response: 2/23
Total effectiveness: 91.3%
Control 1:
Cases of cure: 7/21
Cases of improvement: 8/21
Cases of response: 2/21
Cases of no response: 4/21
Total effectiveness: 81.0%
Control 2:
Cases of cure: 4/16
Cases of improvement: 6/16
Cases of response: 3/16
Cases of no response: 3/16
Total effectiveness: 81.3%
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
2. Overall symptoms:
unstated
Criteria:

Chinese herbal medicine for primary dysmenorrhoea (Review) 61

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 1996 (Continued)

Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up

Improvement: abdominal pain reduced, capable of working, no relapse during 3 cycles
Response: abdominal pain reduced, capable of working, but relapsed
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: stated including PGF2a in menstrual blood, Lr(cp), Hr(cp), RE, ET(s), Hct(%), EsR (mm/
h), VK, VP(cp) and Fbg(mg%) of 14 samples of each Experimentalerimental and Controlrol 1groups
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? No C - Inadequate

Wang 2000b

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number: Experimental: 50 women Control: 50 women

Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental 14-35 years
Control 15-32 years
History: stated
TCM Pattern: unspecified

Interventions Self designed formula (Bu Shen Hua Yu Tang) vs OCT formula (Yue Yue Shu)
Bu Shen Hua Yu Tang:
Ba Jie Tian (Radix Morindae Officinalis) 15g,
Gou Qi Zi (Fructus Lycii) 15g,
Xian Ling Pi (Herba Epimedii) 15g,
Shu Di (Radix Rehmanntae Glutinosae Conquitae) 15g,
Bai Shao (Radix Paeoniae Latiflorae) 20g,
Dang Gui (Radix Angelicae Sinensis) 12g,
Hong Hua (Flos Carthami Tinctorii) 12g,
Pu Huang (Pollen Typhae) 12g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 12g,
Chuan Xiong (Radix Ligustici Chuanxiong) 6g, Xiang Fu (Rhizoma Cypri Rotundi) 9g,
Zhi Qiao (Fructus Aurantii) 9g,

Chinese herbal medicine for primary dysmenorrhoea (Review) 62

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2000b (Continued)

Gan Cao (Radix Glycyrrhizae Uralensis)6g. Modification of formulation might be required. Herbal de-
coction, one dose daily, starting from 5 days prior to bleeding for a period of 7 days
Yue Yue Shu: no details of formula stated. 10g, bid, started from 7 days prior to bleeding for a period of
10 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 38%, 19/50
Rate and Cases of improvement: 50%, 25/50
Rate and Cases of response: 8%, 4/50
Rate and Cases of no response: 4%, 2/50
Total effectiveness: 48/50
Control:
Rate and Cases of cure: 16%, 8/50
Rate and Cases of improvement: 24%, 12/50
Rate and Cases of response: 50%, 25/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 45/50
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 38%, 19/50
Rate and Cases of improvement: 50%, 25/50
Rate and Cases of response: 8%, 4/50
Rate and Cases of no response: 4%, 2/50
Total effectiveness: 48/50
Control:
Rate and Cases of cure: 16%, 8/50
Rate and Cases of improvement: 24%, 12/50
Rate and Cases of response: 50%, 25/50
Rate and Cases of no response: 10%, 5/50
Total effectiveness: 45/50
No significant difference between the Experimentalerimental and Controlrol groups P>0.05
Significant difference between the two groups in the rate of cure P<0.01
Criteria:
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, capable of working, no relapse during 3 cycles
Response: abdominal pain reduced, capable of working, but relapse
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Chinese herbal medicine for primary dysmenorrhoea (Review) 63

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2000b (Continued)

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Wang 2003

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: open labelled comparison
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 52 women
Control: 51 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental 14-35 y
Control 15-32 y
History: stated
TCM Pattern: specified

Interventions Tailored formulae based on clinical manifestation vs Acupuncture

Stagnation of Qi and Blood:
Chai Hu (Radix Bupleuri) 12g,
Bai Shao (Radix Paeoniae Latiflorae) 10g,
Qing Pi (Pericarpium Citri Reticulatae Viride) 12g, Zhi Shi (Fructis Immaturus Citri Aurantii) 10g,
Chuan Lian Zi (Fructus Meliae Toosendan) 10g, Tao Ren (Semen Persicae) 10g,
Yu Jing (Tuber Curcumae) 10g,
Dang Gui (Radix Angelicae Sinensis) 10g,
Fu Ling (Sclerotium Poriae Cocos) 10g,
Bai Zhu (Rhizoma Atractylodis Macrocephalae) 10g,
Dan Pi (Cortex Mouten Radicis) 10g,
Xiang Fu (Rhizoma Cypri Rotundi) 10g,
Yi Mu Cao (Herba Leonuri Herterophylli) 30g,
Nu Zhen Zi (Fructus Ligustri Lucidi) 10g,
Gan Cao (Radix Glycyrrhizae Uralensis) 10g
Retention of Cold and Blood Stasis:
Gui Zhi (Ramulus Cinnamomi Cassiae) 12g, Pao Jiang (Quick-Fried Rhizoma Zingiberis Officinalis)
10g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 10g, Chuan Xiong (Radix Ligustici Chuanxiong) 10g, Dang
Gui (Radix Angelicae Sinensis) 20g,
Mo Yao (Myrrha) 10g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10g, Xiang Fu (Rhizoma Cypri Rotundi) 12g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 10g,
Chi Shao (Radix Paeoniae Rubrae) 10g,
Hong Hua (Flos Carthami Tinctorii) 10g,

Chinese herbal medicine for primary dysmenorrhoea (Review) 64

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2003 (Continued)

Gan Cao (Radix Glycyrrhizae Uralensis) 6g.

Deficiency of Qi and Blood:
Huang Qi (Radix Astraguli Membranacei) 30g, Ren Shen (Radix Ginseng) 6g,
Bai Zhu (Rhizoma Atractylodis Macrocephalae) 10g,
Huang Jing (Rhizoma Polygonati) 15g,
Fu Ling (Sclerotium Poriae Cocos) 10g,
Dang Gui (Radix Angelicae Sinensis) 20g,
Chi Shao (Radix Paeoniae Rubrae) 10g,
Xiang Fu (Rhizoma Cypri Rotundi) 12g,
Chai Hu (Radix Bupleuri) 10g,
Zhi Qiao (Fructus Aurantii) 10g,
Chuan Xiong (Radix Ligustici Chuanxiong) 10g,
Gan Cao (Radix Glycyrrhizae Uralensis) 6g.
Deficiency of Kidney and Liver:
Shu Di (Radix Rehmanntae Glutinosae Conquitae) 20g,
Shan Yu Rou (Fructus Corni Officinalis) 15g,
Bai Shao (Radix Paeoniae Latiflorae) 10g,
Chi Shao (Radix Paeoniae Rubrae) 10g,
Gou Qi Zhi 10g,
Nu Zhen Zi (Fructus Ligustri Lucidi) 10g,
Han Lian Cao (Herba Ecliptue Prostratae) 10g,
Yi Mo Cao (Herba Leonuri Heterophylii) 15g, Xiang Fu (Rhizoma Cypri Rotundi) 15g,
Dang Gui (Radix Angelicae Sinensis) 20g,
Rou Gui (Cortex Cinnamomi Cassiae) 12g,
Gan Cao (Radix Glycyrrhizae Uralensis) 10g
Herbal decoction, 1 dose daily, 3 days prior to bleeding for a period of 7 days
Acupuncture: L4 (Lie Que), bilateral, needles remaining for 30 minutes after achievement of sensation
of arrival of Qi; meanwhile, needling manipulation every 5 minutes; moxibustion on the same point for
10 minutes of each side. Once a day for 3 days (beginning of intervention was unstated)

Outcomes 1. Pain:
Experimental:
Cases of cure: 23/52
Cases of improvement: 25/52
Cases of no response: 4/52
Control:
Cases of cure: 15/51
Cases of improvement: 21/51
Cases of no response: 14/51
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 3 cycle of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Chinese herbal medicine for primary dysmenorrhoea (Review) 65

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2003 (Continued)

Notes Author stated the selected point might not be suitable for two of four patterns based on Chinese medicine
diagnostic approach which might influence the outcome for women diagnosed with these two patterns

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Wang 2006a

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 172 women
Control: 168 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-23 y
History: stated
TCM Pattern: unspecified

Interventions OCT Chinese herbal formula (Su Xiao Jiu Xin Wan) vs Indomethacin
Su Xiao Jiu Xin Wan: sublingual adminstration, 2-5 pills, tid, as soon as pain started for 4 days
Indomethacin: 25mg, tid, as soon as pain started for 4 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 83.7%, 144/172
Rate and Cases of improvement: 14.0%, 24/172
Total effectiveness: 97.7%
Control:
Rate and Cases of cure: 50.0%, 84/168
Rate and Cases of improvement: 42.9%, 72/168
Total effectiveness: 92.7%
Criteria
Cure: abdominal pain disappeared within 15-30 mins
Improvement: abdominal pain reduced within 15-30 mins
No response: abdominal pain not changed at all.
2. Overall symptoms:
unstated
3. Adverse effect: stated
4. Lab tests: unstated
5. Use of additional medication: unstated

Chinese herbal medicine for primary dysmenorrhoea (Review) 66

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2006a (Continued)

6. Satisfaction from patients: unstated

7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Wang 2006b

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 32 women
Control: 24 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 14-29 y
Control: 15-30 y
History: stated
TCM Pattern: unspecified

Interventions Modified self-designed formula (Tong Jing Ling) vs Indomethacin

Tong Jing Ling:
Dang Gui (Radix Angelicae Sinensis) 15g,
Bai Shao (Radix Paeoniae Latiflorae) 15g,
Sheng Di (Radix Rennanniae Glutinosae) 15g, Dan Shen (Radix Salviate Miltiorrhizae)15g, Chuan Xiong
(Radix Ligustici Chuanxiong) 12g, Hong Hua (Flos Carthami Tinctorii) 12g,
Tao Ren (Semen Persicae) 9g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 9g, Guang Mu Xiang (Radix Aucklandiae Lappae) 6g.
Modification of formulation might be required. Herbal decoction, 1 dose daily, 3 days prior to bleeding
for a period of 6 days
Indomethacin: 50mg, bid, as soon as pain started for a period of 6 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 62.50%, 20/32
Rate and Cases of improvement: 31.25%, 10/32
Rate and Cases of no response: 6.25%, 2/32
Total effectiveness: 93.75%
Control:

Chinese herbal medicine for primary dysmenorrhoea (Review) 67

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2006b (Continued)

Rate and Cases of cure: 8.33%, 2/24

Rate and Cases of improvement: 62.50%, 15/24
Rate and Cases of no response: 29.17%, 7/24
Total effectiveness: 70.83%
Significant difference between the two groups in the rate of cure P<0.01
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 62.50%, 20/32
Rate and Cases of improvement: 31.25%, 10/32
Rate and Cases of no response: 6.25%, 2/32
Total effectiveness: 93.75%
Control:
Rate and Cases of cure: 8.33%, 2/24
Rate and Cases of improvement: 62.50%, 15/24
Rate and Cases of no response: 29.17%, 7/24
Total effectiveness: 70.83%
Significant difference between the two groups in the rate of cure P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, relapse during 3 months follow-up
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication:
unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Wu 2006

Methods Allocation concealment and randomisation: Randomised method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 45 women
Control: 45 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:

Chinese herbal medicine for primary dysmenorrhoea (Review) 68

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wu 2006 (Continued)

Experimental: 13-27 ys
Control: 14-29 ys
History: stated
TCM Pattern: no specific statement

Interventions Self-designed formula (Jia Wei Dang Gui Shao Yao San) vs Ibuprofen
Jia Wei Dang Gui Shao Yao San:
Dang Gui (Radix Angelicae Sinensis) 10-20g,
Chuan Xiong (Radix Ligustici Chuanxiong) 30g, Bai Shao (Radix Paeoniae Latiflorae) 15-30g,
Chi Shao (Radix Paeoniae Rubrae) 10-20g,
Fu Ling (Sclerotium Poriae Cocos) 10-20g,
Ze Xie (Rhizoma Alismatis Orientalis) 10-20g, Bai Zhu (Rhizoma Atractylodis Macrocephalae) 10-20g,
Wu Yao (Radix Linderae Strychnifoliae) 10-20g, Xiang Fu (Rhizoma Cypri Rotundi) 10-20g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 10-20g,
Gan Cao (Radix Glycyrrhizae Uralensis) 5-10g. Herbal decoction, 300ml daily, 150ml bid
Ibuprofen: 200mg, tid
Both groups started from 3 days prior to bleeding for a period of 5 days

Outcomes 1. Pain:
Experimental:
Cases of cure: 14/45
Cases of improvement: 27/45
Cases of no response: 4/45
Total effectiveness: 91.1%
Control:
Cases of cure: 1/45
Cases of improvement: 27/45
Cases of no response: 17/45
Total effectiveness: 60.2%
Significant difference between the two groups in the rate of cure P<0.05
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain almost disappeared or reduced.
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 69

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Ye 2004

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 30 women
Control: 28 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 15-27 ys
Control: 14-28y
History: unstated
TCM Pattern: unstated

Interventions Self designed formula (Nv Jin Jiao Nang) vs Indomethacin

Nv Jin Jiao Nang: Dang Gui (Radix Angelicae Sinensis), Bai Shao (Radix Paeoniae Latiflorae), Chuan
Xiong (Radix Ligustici Chuanxiong), Shu Di (Radix Rehmanniae Glutinosae Conquitae), Rou Gui (Cor-
tex Cinnamomi Cassiae), etc. 23 herbs in total, in a form of pills. 3pills, bid, 7 days prior to bleeding until
the end of bleeding
Indomethacin: 50 mg, tid, 1 days prior to bleeding until the end of bleeding

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 40%, 12/30
Rate and Cases of improvement: 56.67%, 17/30
Rate and Cases of no response: 3.33%, 1/30
Total effectiveness: 96.67%
Control:
Rate and Cases of cure: 0%, 0/28
Rate and Cases of improvement: 57.14%, 16/28
Rate and Cases of no response: 42.86%, 12/28
Total effectiveness: 57.14%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 40%, 12/30
Rate and Cases of improvement: 56.67%, 17/30
Rate and Cases of no response: 3.33%, 1/30
Total effectiveness: 96.67%
Control:
Rate and Cases of cure: 0%, 0/28
Rate and Cases of improvement: 57.14%, 16/28
Rate and Cases of no response: 42.86%, 12/28
Total effectiveness: 57.14%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up

Chinese herbal medicine for primary dysmenorrhoea (Review) 70

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Ye 2004 (Continued)

Improvement: abdominal pain and other symptoms reduced.

No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Yu 2003

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 35 women
Control: 30 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 12-32 ys
Control: 13-30 ys
History: stated
TCM Pattern: both groups were diagnosed as retention of cold with blood stasis

Interventions Self designed formula (Fu Mei Tong Jing Fang) vs OTC formula (Tian Qi Tong Jing Jiao Nang)
Fu Mei Tong Jing Fang:
Zhi Fu Zi (Radix Lateralis Aconiti Carmichaeli Praeparata) 6g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 12g, Dang Gui (Radix Angelicae Sinensis) 12g,
Mo Yao (Myrrha) 9g,
E Zhu (Rhizoma Curcumae Ezhu) 9g,
Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 9g,
Pu Huang (Pollen Typhae) 9g,
Rou Gui (Cortex Cinnamomi Cassiae) 5g. Herbal decoction, extracted as 400 ml daily, 200 ml, bid
Tian Qi Tong Jing Jiao Nang: no details of formulation provided, 4 pills, tid
Both groups started from 3 days prior to bleeding for a period of 5 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 51.4%, 18/35
Chinese herbal medicine for primary dysmenorrhoea (Review) 71
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Yu 2003 (Continued)

Rate and Cases of improvement: 28.6%, 10/35

Rate and Cases of response: 11.4%, 4/35
Rate and Cases of no response: 8.6%, 3/35
Total effectiveness: 91.4%
Control:
Rate and Cases of cure: 36.7%, 11/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 16.7%, 5/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Significant difference between the two groups in the rate of cure P<0.001
2. Overall symptoms:
Experimental:
Rate and Cases of cure: 51.4%, 18/35
Rate and Cases of improvement: 28.6%, 10/35
Rate and Cases of response: 11.4%, 4/35
Rate and Cases of no response: 8.6%, 3/35
Total effectiveness: 91.4%
Control:
Rate and Cases of cure: 36.7%, 11/30
Rate and Cases of improvement: 33.3%, 10/30
Rate and Cases of response: 16.7%, 5/30
Rate and Cases of no response: 13.3%, 4/30
Total effectiveness: 86.7%
Significant difference between the two groups in the rate of cure P<0.001
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain and other symptoms reduced, after intervention, the scores reduced as
below as more than 1/2 of the scores before
Response: abdominal pain and reduced, after intervention, the scores reduced as below as more than 1/3
of the scores before
No response: abdominal pain not changed at all.
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 72

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhang 2000

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 35 women
Control: 20 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 16-22 ys
Control: 15-23
History: stated
TCM Pattern: unspecified, common patterns mentioned were deficiency of blood, blood stasis

Interventions Self designed formula (modified Si Wu Tang) vs heat compression

Modified Si Wu Tang: Dang Gui (Radix Angelicae Sinensis), Chi Shao (Radix Paeoniae Rubrae), Shen
Di, Chuan Xiong (Radix Ligustici Chuanxiong), etc. 2-3 days prior to bleeding for a period of 10 days
Heat compression: as soon as pain started till pain disappeared

Outcomes 1. Pain:
Experimental:
Rate of cure: 77.14%, 27/35
Rate of improvement: 11.43, 4/35
Rate of response: 8.57%, 3/35
Rate of no response: 2.86%, 1/35
Total effectiveness: 97.14%
Control:
Rate of cure: 0%, 0/20
Rate of improvement: 0%, 0/20
Rate of response: 10%, 2/20
Rate of no response: 90%, 18/20
Total effectiveness: 10%
Significant difference between the two groups in the rate of cure P<0.001
2. Overall symptoms: unstated
Criteria:
Cure: abdominal pain symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain symptoms reduced obviously, but relapsed
Response: abdominal pain reduced.
No response: abdominal pain not changed at all.
3. Adverse effect: stated. no incidence
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Chinese herbal medicine for primary dysmenorrhoea (Review) 73

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhang 2000 (Continued)

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Zhang 2001

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: paralleled
Duration: 3 - 5 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 60 women
Control: 40 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-26 y
History: stated
TCM Pattern: unstated

Interventions Self-designed formula (oral administration) + self-designed formula (external administration) vs 2 different
OTC formulae (Yuan Hu Zhi Tong Pian and Tong Jing Wan, oral administration)
Self-designed formula (oral administration):
Gui Zhi (Ramulus Cinnamomi Cassiae) 9g,
Ru Xiang (Gummi Olibanum) 9g,
Chi Shao (Radix Paeoniae Rubrae) 9g,
Ze Lan (Herba Lycopi Lucidi) 9g,
Gan Cao (Radix Glycyrrhizae Uralensis) 9g,
Xi Xin (Herba cum Radice Asari) 6g,
Xiao Hui Xiang (Fructus Foeniculi Vulgaris) 6g, Chuan Xiong (Radix Ligustici Chuanxiong) 6g, Yan Hu
Suo (Rhizoma Corydalis Yanhusuo) 6g, Yi Mu Cao (Herba Leonuri Herterophylli) 15g, Dang Gui (Radix
Angelicae Sinensis) 15g,
Xiang Fu (Rhizoma Cypri Rotundi) 15g. Herbal decoction, one dose daily, 7 days prior to period till
postal menstruation
Self-designed formula (external administration): Bai Zhi (Radix Angelicae) 6g,
Dang Gui (Radix Angelicae Sinensis) 6g,
Chi Shao (Radix Paeoniae Rubrae) 6g,
Da Huang (Radix et Rhizoma Rhei) 6g,
Huang Dan (Minium) mixed with sesame oil, in a form of paste, applied on Guan Yuan outpoint during
menstruation
Yuan Hu Zhi Tong Pian: 4 tablets, bid, 1st OCT herbs started from 7 days prior to period for 7 days
Tong Jing Wan: 10 pills, bid, 2nd OCT herbs in menstruation period for 3-5 days

Outcomes 1. Pain:
Experimental:
Rate and Cases of cure: 85%, 51/60

Chinese herbal medicine for primary dysmenorrhoea (Review) 74

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhang 2001 (Continued)

Rate and Cases of improvement: 11.67%, 7/60

Rate and Cases of no response: 3.33%, 2/60
Total effectiveness: 96.67%
Control:
Rate and Cases of cure: 25%, 10/40
Rate and Cases of improvement: 35%, 14/40
Rate and Cases of no response: 40%, 16/40
Total effectiveness: 60%
significant difference between the Experimentalerimental and Controlrol groups P<0.05
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 3 cycles of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Zhu 2001

Methods Allocation concealment and randomisation: Randomised, methods unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 78 women
Control: 39 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age:
Experimental: 12-30,
Control: 12.5-28
History: stated
TCM Pattern: stated,
stagnation of Qi and Blood, retention of cold, deficiency of Qi and Blood, deficiency of Liver and Kindey

Chinese herbal medicine for primary dysmenorrhoea (Review) 75

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhu 2001 (Continued)

Interventions Self-designed formula (Dong Gui Ai Ye Tang) vs Indomethacin and Vitamin B6

Dong Gui Ai Ye Tang:
Dang Gui (Radix Angelicae Sinensis) 30g,
Ai Ye (Folium Artemisiae Argyri) 15g,
Hong Tang (Caulis Sargentodoxae Cuneatae) 60g
600 ml herbal decoction daily, 3 days prior to bleeding for a period of 6 days
Indomethacin: 25 mg, tid, Vitamin B6 20 mg, tid, 3 days prior to bleeding till bleeding stopped

Outcomes 1. Pain:
Experimental:
Rate of cure: 71/78
Rate of improvement: 5/78
Rate of no response: 2/78
Total effectiveness: 97.4%
Control:
Rate of cure: 15/39
Rate of improvement: 16/39
Rate of no response: 8/39
Total effectiveness: 79.5%
significant difference between the Experimentalerimental and Controlrol groups P<0.01
Criteria
Cure: abdominal pain disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced, but relapse during 3 cycle of follow up
No response: abdominal pain not changed at all.
2. Overall symptoms: unstated
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Chinese herbal medicine for primary dysmenorrhoea (Review) 76

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhu 2002

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: paralleled
Parallel performance: no
Duration: 3 cycles of intervention + 3 cycles of follow up

Participants Number:
Experimental: 70 women
Control: 62 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 16-32,
History: stated
TCM Pattern: unstated

Interventions Self-designed formula vs Indomethacin

Self-designed formula:
Dan Shen (Radix Salviate Miltiorrhizae)30g,
Xiang Fu (Rhizoma Cypri Rotundi) 10-15g,
Sheng Jiang (fresh Rhizoma Zingiberis Officinalis) 6g,
Herbs were cooked and extracted into 300 ml decoction, mixed with brown sugar (no dose provided),
bid, 1 day prior to bleeding until 3rd day of cycle
Indomethacin: 50 mg, tid, 3 days prior to bleeding until 3rd day of cycle

Outcomes 1. Pain:
Experimental:
Cases of cure: 48/70
Cases of improvement: 14/70
Cases of response: 6/70
Cases of no response: 2/70
Total effectiveness: 97.14%
Control:
Cases of cure: 18/62
Cases of improvement: 18/62
Cases of response: 2/62
Cases of no response: 2/62
Total effectiveness: 93.55
Significant difference in rate of cure between the two groups: P<0.01
2. Overall symptoms:
Cases of cure: 48/70
Cases of improvement: 14/70
Cases of response: 6/70
Cases of no response: 2/70
Total effectiveness: 97.14%
Control:
Cases of cure: 18/62
Cases of improvement: 18/62
Cases of response: 2/62
Cases of no response: 2/62

Chinese herbal medicine for primary dysmenorrhoea (Review) 77

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhu 2002 (Continued)

Total effectiveness: 93.55

Significant difference in rate of cure between the two groups: P<0.01
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, no need to
take pain relieving medication
Response: Response: abdominal pain reduced, other symptoms improved, pain relieving medication
needed
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication: stated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Zhu 2003

Methods Allocation concealment and randomisation: Randomised, method unstated

Blinding: unstated
Trial design: parallel
Duration: 3 cycles of intervention or 6 cycles or 9 cycles + 3 cycles of follow up

Participants Number:
Experimental: 42 women
Control: 42 women
Drop-outs/withdrawals: unstated
Diagnosis of dysmenorrhoea: stated
Age: 14-32,
History: stated
TCM Pattern: unspecific, but mentioned stagnation of blood in the medians was most common pattern

Interventions Self-designed formula (Hua Yu Tong Mai Zhi Tong Tang) vs OCT (Yuan Hu Zhi Tong Jiao Nang)
Hua Yu Tong Mai Zhi Tong Tang:
Dang Gui (Radix Angelicae Sinensis) 10g,
Shi Shao 12g, Bai Shao (Radix Paeoniae Latiflorae) 12g,
Tao Ren (Semen Persicae) 10g,
Chuan Xiong (Radix Ligustici Chuanxiong) 10g, Hong Hua (Flos Carthami Tinctorii) 10g,
Xiang Fu (Rhizoma Cypri Rotundi) 12g,
Yan Hu Suo (Rhizoma Corydalis Yanhusuo) 15g, Yi Mu Cao (Herba Leonuri Herterophylli) 20g,
Ze Lan (Herba Lycopi Lucidi) 15g,

Chinese herbal medicine for primary dysmenorrhoea (Review) 78

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhu 2003 (Continued)

Xue Jie (Sanguis Draconis) 3g,

Wu Ling Zhi (Excrementum Trogopteri Seu Pteromi) 15g,
Gan Cao (Radix Glycyrrhizae Uralensis) 6g. Herbal decoction, one dose daily
Yuan Hu Zhi Tong Jiao Nang: 3 pills, tid
Both groups started from 4 days prior to bleeding for a period of 7 days

Outcomes 1. Pain:
Experimental:
Cases and rate of cure: 12/42, 28.6%
Casess and rate of improvement: 23/42, 54.8%
Cases and rate of response: 4/42, 9.5%
Cases and rate of no response: 3/42, 7.1%
Total effectiveness: 92.9%
Control:
Cases and rate of cure: 9/42, 21.4%
Cases and rate of improvement: 18/42, 42.9%
Cases and rate of response: 8/42, 19.0%
Cases and rate of no response: 7/42, 16.7%
Total effectiveness: 83.3%
2. Overall symptoms:
Experimental:
Cases and rate of cure: 12/42, 28.6%
Cases and rate of improvement: 23/42, 54.8%
Cases and rate of response: 4/42, 9.5%
Cases and rate of no response: 3/42, 7.1%
Total effectiveness: 92.9%
Control:
Cases and rate of cure: 9/42, 21.4%
Cases and rate of improvement: 18/42, 42.9%
Cases and rate of response: 8/42, 19.0%
Casess and rate of no response: 7/42, 16.7%
Total effectiveness: 83.3%
Criteria
Cure: abdominal pain and other symptoms disappeared, no relapse during 3 cycles of follow up
Improvement: abdominal pain reduced obviously, other symptoms disappeared or reduced, relapse during
3 cycles of follow up
Response: Response: abdominal pain reduced, other symptoms improved
No response: abdominal pain, or other symptoms not changed at all
3. Adverse effect: unstated
4. Lab tests: unstated
5. Use of additional medication:
unstated
6. Satisfaction from patients: unstated
7. Quality of life: unstated

Notes

Risk of bias

Chinese herbal medicine for primary dysmenorrhoea (Review) 79

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Zhu 2003 (Continued)

Item Authors judgement Description

Allocation concealment? Unclear B - Unclear

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Chen 1995 Trial not randomised.

Du 2000 Trial not randomised.

Huang 2005 Trial not randomised (the numbers of women in each treatment arm were very different, 56 women in herbal group
vs 32 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Ji 2001 Trial not randomised (the numbers of women in each treatment arm are very different, 273 women in herbal group
vs 70 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Li 2005 Mixed cases of primary and secondary dysmenorrhoea in the trial, review is limited to primary dysmenorrhoea only

Liao 2002 Trial not randomised (the numbers of women in each treatment arm were very different, 79 women in herbal group
vs 24 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was receieved

Lin 2004 Mixed cases of primary and secondary dysmenorrhoea in data, Review is limited to primary dysmenorrhoea only

Liu 2006 Trial not randomised (the numbers of women in each treatment arm were very different, 60 women in herbal group
vs 30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was receieved

Miao 2006 Trial not randomised (the numbers of women in each treatment arm were very different, 58 women in herbal group
vs 40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment

Ni 2004 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Pan 2003 Trial not randomised (the numbers of women in each group were very different, 76 women in herbal group vs
50 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Chinese herbal medicine for primary dysmenorrhoea (Review) 80

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Shi 2003 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Song 2005 Trial not randomised (the numbers of women in each group were very different, 120 women in herbal group vs
40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Sun 2005 Trial not randomised (randomisation based on hospital number allocation)

Wang 2000a Trial not randomised (the numbers of women in each group were very different, 150 women in herbal group vs
50 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Wang 2002 Trial not randomised (the numbers of women in each group were very different, 150 women in herbal group vs
50 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Wei 2000 No 3 month of follow up, contaminated data.

Wu 2002 Trial not randomised (randomisation based on sequence hospital number)

Wu 2005 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Xu 2000 Trial not randomised (the numbers of women in each group were very different, 60 women in herbal group vs
40 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Yang 2005 Trial not randomised (randomisation based on odd and even day)

Zhang 2003 Trial not randomised (the numbers of women in each group were very different, 50 women in herbal group vs
30 women in control group). Attempts were made to contact the authors to clarify randomisation and allocation
concealment however no response was received

Zhang Y 2003 The experimental group was mixed herbs and acupuncture - contaminated data, which is not one of the interventions
considered by this review

Zhao 2006 Trial not randomised (the numbers of women in each group were very different, 318 women in herbal group vs
132 women in control group 1 vs 116 women in control group 2). Attempts were made to contact the authors to
clarify randomisation and allocation concealment however no response was recieved

Zhen 1996 Trial not randomised.

Zhen 2002 Mixed cases of primary and secondary dysmenorrhoea in the trial, review is limited to primary dysmenorrhoea only

Chinese herbal medicine for primary dysmenorrhoea (Review) 81

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES

Comparison 1. Chinese herbal medicine versus placebo

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Reduction of pain 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
1.1 Methodological quality A 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
- standard formula - up to 3
month follow up
2 Reduction of pain 1 Mean Difference (IV, Fixed, 95% CI) Subtotals only
2.1 Intensity of pain Cmax 1 36 Mean Difference (IV, Fixed, 95% CI) 1.0 [-17.95, 19.95]
2.2 Intensity of pain AUCt 1 36 Mean Difference (IV, Fixed, 95% CI) 12.0 [-54.76, 78.76]
3 Overall symptoms 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
3.1 Methodology quality A 1 90 Risk Ratio (M-H, Fixed, 95% CI) 5.59 [0.32, 97.87]
- standard formula - up to 3
month follow up
4 Adverse effects 3 166 Risk Ratio (M-H, Fixed, 95% CI) 0.81 [0.61, 1.07]
4.1 Methodology quality A - 3 166 Risk Ratio (M-H, Fixed, 95% CI) 0.81 [0.61, 1.07]
standard formua
5 Use of additional medication 1 90 Risk Ratio (M-H, Fixed, 95% CI) 12.0 [1.70, 84.49]
5.1 Methodology quality A 1 90 Risk Ratio (M-H, Fixed, 95% CI) 12.0 [1.70, 84.49]
-standard formula

Comparison 2. Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Reduction of pain 14 1441 Risk Ratio (M-H, Random, 95% CI) 1.99 [1.52, 2.60]
1.1 Methodological quality B 4 312 Risk Ratio (M-H, Random, 95% CI) 2.28 [0.88, 5.94]
- standard formula - up to 3
months follow-up
1.2 Methodological quality B 9 789 Risk Ratio (M-H, Random, 95% CI) 2.13 [1.70, 2.66]
- tailored formula - up to 3
month follow up
1.3 Methodological quality B 1 340 Risk Ratio (M-H, Random, 95% CI) 1.67 [1.42, 1.97]
- standard formula - immediate
efficacy
2 Overall symptoms 6 482 Risk Ratio (M-H, Fixed, 95% CI) 2.17 [1.73, 2.73]
2.1 Methodological quality 1 58 Risk Ratio (M-H, Fixed, 95% CI) 23.39 [1.45, 377.35]
B - standard formula - up to
3month follow up
2.2 Methodology quality 5 424 Risk Ratio (M-H, Fixed, 95% CI) 2.00 [1.59, 2.52]
B - tailored formula - up to
3month follow up
Chinese herbal medicine for primary dysmenorrhoea (Review) 82
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3 Adverse effects 2 418 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
3.1 Methodology quality B 2 418 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
4 Use of additional medication 2 194 Risk Ratio (M-H, Fixed, 95% CI) 1.58 [1.30, 1.93]
4.1 Methodological quality 1 62 Risk Ratio (M-H, Fixed, 95% CI) 1.73 [1.17, 2.57]
B - standard formula - up to
3-month follow up
4.2 Methodological quality B 1 132 Risk Ratio (M-H, Fixed, 95% CI) 1.53 [1.21, 1.92]
- tailored followup - up to 3
month follow up

Comparison 3. Experimental Chinese herbal formula versus OTC Chinese herbal formula

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Reduction of pain 18 1527 Risk Ratio (M-H, Fixed, 95% CI) 2.06 [1.80, 2.36]
1.1 Methodological quality B 5 380 Risk Ratio (M-H, Fixed, 95% CI) 2.09 [1.62, 2.70]
- standard formula - up to 3
month follow up
1.2 Methodological quality B 12 1087 Risk Ratio (M-H, Fixed, 95% CI) 2.13 [1.80, 2.51]
- tailored formula - up to 3
month follow up
1.3 Methodological quality C 1 60 Risk Ratio (M-H, Fixed, 95% CI) 0.92 [0.43, 1.99]
- tailored formula - up to 3
month follow up
2 Overall symptoms 14 1167 Risk Ratio (M-H, Fixed, 95% CI) 2.04 [1.74, 2.39]
2.1 Methodological quality B 4 320 Risk Ratio (M-H, Fixed, 95% CI) 2.17 [1.61, 2.92]
- standard formula - up to 3
month follow up
2.2 Methodological quality B 10 847 Risk Ratio (M-H, Fixed, 95% CI) 1.99 [1.65, 2.40]
- tailored formula - up to 3
month follow up
3 Adverse effects 1 120 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
3.1 Completed data 1 120 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
4 Use of additional medication 5 402 Risk Ratio (M-H, Fixed, 95% CI) 1.58 [1.34, 1.87]
4.1 Methodological quality B 2 116 Risk Ratio (M-H, Fixed, 95% CI) 1.71 [1.21, 2.43]
- standard formula - up to 3
month follow up
4.2 Methodological quality 3 286 Risk Ratio (M-H, Fixed, 95% CI) 1.53 [1.27, 1.85]
B - tailored formula - up to
3month follow up

Chinese herbal medicine for primary dysmenorrhoea (Review) 83

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Comparison 4. Chinese herbal medicine versus acupuncture

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Reduction of pain 2 156 Risk Ratio (M-H, Fixed, 95% CI) 1.75 [1.09, 2.82]
1.1 Methodological quality 1 53 Risk Ratio (M-H, Fixed, 95% CI) 2.68 [0.91, 7.91]
B - standard formula with 3
month follow up
1.2 Methodological quality B 1 103 Risk Ratio (M-H, Fixed, 95% CI) 1.50 [0.89, 2.54]
- tailored formula - up to 3
month follow up

Comparison 5. Chinese versus heat compression

No. of No. of
Outcome or subgroup title studies participants Statistical method Effect size

1 Reduction of pain 1 55 Risk Ratio (M-H, Fixed, 95% CI) 32.08 [2.06, 499.18]
1.1 Methodological quality B 1 55 Risk Ratio (M-H, Fixed, 95% CI) 32.08 [2.06, 499.18]
- standard formula - up to 3
month follow up
2 Adverse effects 1 55 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
2.1 Methodology quality B - 1 55 Risk Ratio (M-H, Fixed, 95% CI) Not estimable
standard formula

Analysis 1.1. Comparison 1 Chinese herbal medicine versus placebo, Outcome 1 Reduction of pain.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 1 Chinese herbal medicine versus placebo

Outcome: 1 Reduction of pain

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality A - standard formula - up to 3 month follow up

Sun2004 5/60 0/30 100.0 % 5.59 [ 0.32, 97.87 ]

Total (95% CI) 60 30 100.0 % 5.59 [ 0.32, 97.87 ]

Total events: 5 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 1.18 (P = 0.24)

0.01 0.1 1 10 100

Favours placebo Favours Chinese herb

Chinese herbal medicine for primary dysmenorrhoea (Review) 84

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.2. Comparison 1 Chinese herbal medicine versus placebo, Outcome 2 Reduction of pain.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 1 Chinese herbal medicine versus placebo

Outcome: 2 Reduction of pain

Mean Mean
Study or subgroup Treatment Control Difference Weight Difference
N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI

1 Intensity of pain Cmax

Kennedy 2006 17 61 (28) 19 60 (30) 100.0 % 1.00 [ -17.95, 19.95 ]

Subtotal (95% CI) 17 19 100.0 % 1.00 [ -17.95, 19.95 ]

Heterogeneity: not applicable
Test for overall effect: Z = 0.10 (P = 0.92)
2 Intensity of pain AUCt
Kennedy 2006 17 150 (84) 19 138 (119) 100.0 % 12.00 [ -54.76, 78.76 ]

Subtotal (95% CI) 17 19 100.0 % 12.00 [ -54.76, 78.76 ]

Heterogeneity: not applicable
Test for overall effect: Z = 0.35 (P = 0.72)
Test for subgroup differences: Chi2 = 0.10, df = 1 (P = 0.76), I2 =0.0%

-100 -50 0 50 100

Favours placebo Favours CHM

Chinese herbal medicine for primary dysmenorrhoea (Review) 85

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.3. Comparison 1 Chinese herbal medicine versus placebo, Outcome 3 Overall symptoms.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 1 Chinese herbal medicine versus placebo

Outcome: 3 Overall symptoms

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodology quality A - standard formula - up to 3 month follow up

Sun2004 5/60 0/30 100.0 % 5.59 [ 0.32, 97.87 ]

Total (95% CI) 60 30 100.0 % 5.59 [ 0.32, 97.87 ]

Total events: 5 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 1.18 (P = 0.24)

0.01 0.1 1 10 100

Favours placebo Favours Chinese herb

Analysis 1.4. Comparison 1 Chinese herbal medicine versus placebo, Outcome 4 Adverse effects.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 1 Chinese herbal medicine versus placebo

Outcome: 4 Adverse effects

Study or subgroup Treatment Control Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodology quality A - standard formua

Kennedy 2006 13/17 18/19 0.81 [ 0.61, 1.07 ]

Kotani 1997 0/20 0/20 0.0 [ 0.0, 0.0 ]

Sun2004 0/60 0/30 0.0 [ 0.0, 0.0 ]

Total (95% CI) 97 69 0.81 [ 0.61, 1.07 ]

Total events: 13 (Treatment), 18 (Control)
Heterogeneity: Chi2 = 0.0, df = 0 (P = 1.00); I2 =0.0%
Test for overall effect: Z = 1.48 (P = 0.14)

0.1 0.2 0.5 1 2 5 10

More incidents in CT More incidents in CH

Chinese herbal medicine for primary dysmenorrhoea (Review) 86

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 1.5. Comparison 1 Chinese herbal medicine versus placebo, Outcome 5 Use of additional
medication.
Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 1 Chinese herbal medicine versus placebo

Outcome: 5 Use of additional medication

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodology quality A -standard formula

Sun2004 24/60 1/30 100.0 % 12.00 [ 1.70, 84.49 ]

Total (95% CI) 60 30 100.0 % 12.00 [ 1.70, 84.49 ]

Total events: 24 (Treatment), 1 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 2.50 (P = 0.013)

0.01 0.1 1 10 100

Favours placebo Favours Chinese herb

Chinese herbal medicine for primary dysmenorrhoea (Review) 87

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 2.1. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP),
Outcome 1 Reduction of pain.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

Outcome: 1 Reduction of pain

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
1 Methodological quality B - standard formula - up to 3 months follow-up
Liu 2000 37/40 32/38 11.1 % 1.10 [ 0.93, 1.29 ]

Lu 2002 30/45 20/41 9.4 % 1.37 [ 0.94, 1.99 ]

Wu 2006 14/45 1/45 1.6 % 14.00 [ 1.92, 102.03 ]

Ye 2004 12/30 0/28 0.9 % 23.39 [ 1.45, 377.35 ]

Subtotal (95% CI) 160 152 23.0 % 2.28 [ 0.88, 5.94 ]

Total events: 93 (Treatment), 53 (Control)
Heterogeneity: Tau2 = 0.60; Chi2 = 32.10, df = 3 (P<0.00001); I2 =91%
Test for overall effect: Z = 1.69 (P = 0.091)
2 Methodological quality B - tailored formula - up to 3 month follow up
Fan 1999 29/50 17/48 8.7 % 1.64 [ 1.05, 2.57 ]

Huang 2000 10/33 2/25 2.7 % 3.79 [ 0.91, 15.77 ]

Jiang 2000 15/40 11/36 7.0 % 1.23 [ 0.65, 2.31 ]

Liu 2003 47/52 17/38 9.5 % 2.02 [ 1.40, 2.91 ]

Luo 2001 26/31 15/31 9.3 % 1.73 [ 1.17, 2.57 ]

Song 2003 35/50 10/50 7.5 % 3.50 [ 1.95, 6.27 ]

Wang 2006b 20/32 2/24 2.9 % 7.50 [ 1.94, 29.04 ]

Zhu 2001 71/78 15/39 9.2 % 2.37 [ 1.58, 3.54 ]

Zhu 2002 48/70 18/62 9.0 % 2.36 [ 1.55, 3.60 ]

Subtotal (95% CI) 436 353 65.9 % 2.13 [ 1.70, 2.66 ]

Total events: 301 (Treatment), 107 (Control)
Heterogeneity: Tau2 = 0.04; Chi2 = 13.13, df = 8 (P = 0.11); I2 =39%
Test for overall effect: Z = 6.62 (P < 0.00001)
3 Methodological quality B - standard formula - immediate efficacy
Wang 2006a 144/172 84/168 11.1 % 1.67 [ 1.42, 1.97 ]

Subtotal (95% CI) 172 168 11.1 % 1.67 [ 1.42, 1.97 ]

Total events: 144 (Treatment), 84 (Control)
Heterogeneity: not applicable

0.01 0.1 1 10 100

Favours Conventional Favours CHM
(Continued . . . )

Chinese herbal medicine for primary dysmenorrhoea (Review) 88

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 (. . .Continued)
Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio
M- M-
H,Random,95% H,Random,95%
n/N n/N CI CI
Test for overall effect: Z = 6.12 (P < 0.00001)
Total (95% CI) 768 673 100.0 % 1.99 [ 1.52, 2.60 ]
Total events: 538 (Treatment), 244 (Control)
Heterogeneity: Tau2 = 0.16; Chi2 = 71.13, df = 13 (P<0.00001); I2 =82%
Test for overall effect: Z = 5.02 (P < 0.00001)

0.01 0.1 1 10 100

Favours Conventional Favours CHM

Analysis 2.2. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP),
Outcome 2 Overall symptoms.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

Outcome: 2 Overall symptoms

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
1 Methodological quality B - standard formula - up to 3month follow up
Ye 2004 12/30 0/28 0.8 % 23.39 [ 1.45, 377.35 ]

Subtotal (95% CI) 30 28 0.8 % 23.39 [ 1.45, 377.35 ]

Total events: 12 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 2.22 (P = 0.026)
2 Methodology quality B - tailored formula - up to 3month follow up
Fan 1999 29/50 17/48 26.4 % 1.64 [ 1.05, 2.57 ]

Jiang 2000 15/40 11/36 17.6 % 1.23 [ 0.65, 2.31 ]

Luo 2001 26/31 15/31 22.8 % 1.73 [ 1.17, 2.57 ]

Wang 2006b 20/32 2/24 3.5 % 7.50 [ 1.94, 29.04 ]

Zhu 2002 48/70 18/62 29.0 % 2.36 [ 1.55, 3.60 ]

Subtotal (95% CI) 223 201 99.2 % 2.00 [ 1.59, 2.52 ]

0.01 0.1 1 10 100

Favours Conventional Favours CHM
(Continued . . . )

Chinese herbal medicine for primary dysmenorrhoea (Review) 89

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 (. . . Continued)
Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Total events: 138 (Treatment), 63 (Control)
Heterogeneity: Chi2 = 7.83, df = 4 (P = 0.10); I2 =49%
Test for overall effect: Z = 5.93 (P < 0.00001)
Total (95% CI) 253 229 100.0 % 2.17 [ 1.73, 2.73 ]
Total events: 150 (Treatment), 63 (Control)
Heterogeneity: Chi2 = 12.06, df = 5 (P = 0.03); I2 =59%
Test for overall effect: Z = 6.60 (P < 0.00001)

0.01 0.1 1 10 100

Favours Conventional Favours CHM

Analysis 2.3. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP),
Outcome 3 Adverse effects.
Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

Outcome: 3 Adverse effects

Study or subgroup Treatment Control Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodology quality B
Liu 2000 0/40 0/38 0.0 [ 0.0, 0.0 ]

Wang 2006a 0/172 52/168 0.01 [ 0.00, 0.15 ]

Total (95% CI) 212 206 0.01 [ 0.00, 0.15 ]

Total events: 0 (Treatment), 52 (Control)
Heterogeneity: Chi2 = 0.0, df = 0 (P = 1.00); I2 =0.0%
Test for overall effect: Z = 3.30 (P = 0.00096)

0.001 0.01 0.1 1 10 100 1000

More incidents in CM More incidents in CH

Chinese herbal medicine for primary dysmenorrhoea (Review) 90

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 2.4. Comparison 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP),
Outcome 4 Use of additional medication.
Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 2 Chinese herbal medicine versus conventional therapy (NSAIDs or OCP)

Outcome: 4 Use of additional medication

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality B - standard formula - up to 3-month follow up

Luo 2001 26/31 15/31 28.2 % 1.73 [ 1.17, 2.57 ]

Subtotal (95% CI) 31 31 28.2 % 1.73 [ 1.17, 2.57 ]

Total events: 26 (Treatment), 15 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 2.73 (P = 0.0063)
2 Methodological quality B - tailored followup - up to 3 month follow up
Zhu 2002 62/70 36/62 71.8 % 1.53 [ 1.21, 1.92 ]

Subtotal (95% CI) 70 62 71.8 % 1.53 [ 1.21, 1.92 ]

Total events: 62 (Treatment), 36 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 3.64 (P = 0.00028)
Total (95% CI) 101 93 100.0 % 1.58 [ 1.30, 1.93 ]
Total events: 88 (Treatment), 51 (Control)
Heterogeneity: Chi2 = 0.31, df = 1 (P = 0.58); I2 =0.0%
Test for overall effect: Z = 4.55 (P < 0.00001)

0.1 0.2 0.5 1 2 5 10

Favours conventional Favours CHM

Chinese herbal medicine for primary dysmenorrhoea (Review) 91

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 3.1. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula,
Outcome 1 Reduction of pain.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula

Outcome: 1 Reduction of pain

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality B - standard formula - up to 3 month follow up

Deng 2003 19/33 7/30 3.8 % 2.47 [ 1.21, 5.03 ]

Liu 2002 22/30 12/30 6.2 % 1.83 [ 1.12, 2.99 ]

Niu 1996 9/32 2/21 1.2 % 2.95 [ 0.71, 12.34 ]

Qin 2003 49/60 21/60 10.9 % 2.33 [ 1.62, 3.36 ]

Zhu 2003 12/42 9/42 4.7 % 1.33 [ 0.63, 2.83 ]

Subtotal (95% CI) 197 183 26.8 % 2.09 [ 1.62, 2.70 ]

Total events: 111 (Treatment), 51 (Control)
Heterogeneity: Chi2 = 2.44, df = 4 (P = 0.66); I2 =0.0%
Test for overall effect: Z = 5.68 (P < 0.00001)
2 Methodological quality B - tailored formula - up to 3 month follow up
Deng 2005 31/70 15/70 7.8 % 2.07 [ 1.23, 3.48 ]

Guo 1997 24/35 9/31 4.9 % 2.36 [ 1.30, 4.28 ]

Li 1999 13/44 10/36 5.7 % 1.06 [ 0.53, 2.14 ]

Li 2001 34/50 10/50 5.2 % 3.40 [ 1.89, 6.11 ]

Li 2004 21/40 14/40 7.2 % 1.50 [ 0.90, 2.51 ]

Liu 2004 40/45 19/40 10.4 % 1.87 [ 1.33, 2.63 ]

Liu 2005 7/30 6/30 3.1 % 1.17 [ 0.44, 3.06 ]

Shen 2001 14/60 8/60 4.1 % 1.75 [ 0.79, 3.86 ]

Sun 2006 27/46 7/45 3.7 % 3.77 [ 1.83, 7.77 ]

Wang 2000b 19/50 8/50 4.1 % 2.38 [ 1.15, 4.91 ]

Yu 2003 18/35 11/30 6.1 % 1.40 [ 0.79, 2.48 ]

Zhang 2001 51/60 10/40 6.2 % 3.40 [ 1.97, 5.88 ]

Subtotal (95% CI) 565 522 68.5 % 2.13 [ 1.80, 2.51 ]

Total events: 299 (Treatment), 127 (Control)
Heterogeneity: Chi2 = 17.79, df = 11 (P = 0.09); I2 =38%
Test for overall effect: Z = 8.84 (P < 0.00001)
3 Methodological quality C - tailored formula - up to 3 month follow up

0.1 0.2 0.5 1 2 5 10

Favours OTC formula Favours CHM
(Continued . . . )

Chinese herbal medicine for primary dysmenorrhoea (Review) 92

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 (. . . Continued)
Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Wang 1996 12/39 7/21 4.7 % 0.92 [ 0.43, 1.99 ]

Subtotal (95% CI) 39 21 4.7 % 0.92 [ 0.43, 1.99 ]

Total events: 12 (Treatment), 7 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 0.20 (P = 0.84)
Total (95% CI) 801 726 100.0 % 2.06 [ 1.80, 2.36 ]
Total events: 422 (Treatment), 185 (Control)
Heterogeneity: Chi2 = 24.20, df = 17 (P = 0.11); I2 =30%
Test for overall effect: Z = 10.32 (P < 0.00001)

0.1 0.2 0.5 1 2 5 10

Favours OTC formula Favours CHM

Analysis 3.2. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula,
Outcome 2 Overall symptoms.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula

Outcome: 2 Overall symptoms

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality B - standard formula - up to 3 month follow up

Deng 2003 19/33 7/30 5.0 % 2.47 [ 1.21, 5.03 ]

Niu 1996 9/32 2/21 1.7 % 2.95 [ 0.71, 12.34 ]

Qin 2003 49/60 21/60 14.4 % 2.33 [ 1.62, 3.36 ]

Zhu 2003 12/42 9/42 6.2 % 1.33 [ 0.63, 2.83 ]

Subtotal (95% CI) 167 153 27.3 % 2.17 [ 1.61, 2.92 ]

Total events: 89 (Treatment), 39 (Control)
Heterogeneity: Chi2 = 2.07, df = 3 (P = 0.56); I2 =0.0%
Test for overall effect: Z = 5.13 (P < 0.00001)
2 Methodological quality B - tailored formula - up to 3 month follow up
Guo 1997 24/35 9/31 6.6 % 2.36 [ 1.30, 4.28 ]

0.1 0.2 0.5 1 2 5 10

Favours OTC formula Favours CHM
(Continued . . . )

Chinese herbal medicine for primary dysmenorrhoea (Review) 93

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 (. . . Continued)
Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio
n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI
Li 1999 13/44 10/36 7.6 % 1.06 [ 0.53, 2.14 ]

Li 2001 34/50 10/50 6.9 % 3.40 [ 1.89, 6.11 ]

Li 2004 21/40 14/40 9.6 % 1.50 [ 0.90, 2.51 ]

Liu 2004 40/45 19/40 13.8 % 1.87 [ 1.33, 2.63 ]

Liu 2005 7/30 6/30 4.1 % 1.17 [ 0.44, 3.06 ]

Shen 2001 14/60 8/60 5.5 % 1.75 [ 0.79, 3.86 ]

Sun 2006 27/46 7/45 4.9 % 3.77 [ 1.83, 7.77 ]

Wang 2000b 19/50 8/50 5.5 % 2.38 [ 1.15, 4.91 ]

Yu 2003 18/35 11/30 8.2 % 1.40 [ 0.79, 2.48 ]

Subtotal (95% CI) 435 412 72.7 % 1.99 [ 1.65, 2.40 ]

Total events: 217 (Treatment), 102 (Control)
Heterogeneity: Chi2 = 13.88, df = 9 (P = 0.13); I2 =35%
Test for overall effect: Z = 7.23 (P < 0.00001)
Total (95% CI) 602 565 100.0 % 2.04 [ 1.74, 2.39 ]
Total events: 306 (Treatment), 141 (Control)
Heterogeneity: Chi2 = 16.44, df = 13 (P = 0.23); I2 =21%
Test for overall effect: Z = 8.85 (P < 0.00001)

0.1 0.2 0.5 1 2 5 10

Favours OTC formula Favours CHM

Chinese herbal medicine for primary dysmenorrhoea (Review) 94

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 3.3. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula,
Outcome 3 Adverse effects.
Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula

Outcome: 3 Adverse effects

Study or subgroup Treatment Control Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Completed data
Shen 2001 0/60 0/60 0.0 [ 0.0, 0.0 ]

Total (95% CI) 60 60 0.0 [ 0.0, 0.0 ]

Total events: 0 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 0.0 (P < 0.00001)

0.1 0.2 0.5 1 2 5 10

More incidents in CT More incidents in CH

Chinese herbal medicine for primary dysmenorrhoea (Review) 95

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 3.4. Comparison 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula,
Outcome 4 Use of additional medication.
Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 3 Experimental Chinese herbal formula versus OTC Chinese herbal formula

Outcome: 4 Use of additional medication

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality B - standard formula - up to 3 month follow up

Deng 2003 26/33 15/30 16.5 % 1.58 [ 1.06, 2.35 ]

Niu 1996 21/32 7/21 8.9 % 1.97 [ 1.02, 3.79 ]

Subtotal (95% CI) 65 51 25.4 % 1.71 [ 1.21, 2.43 ]

Total events: 47 (Treatment), 22 (Control)
Heterogeneity: Chi2 = 0.34, df = 1 (P = 0.56); I2 =0.0%
Test for overall effect: Z = 3.02 (P = 0.0025)
2 Methodological quality B - tailored formula - up to 3month follow up
Guo 1997 31/35 18/31 20.0 % 1.53 [ 1.11, 2.10 ]

Li 2001 39/50 25/50 26.2 % 1.56 [ 1.14, 2.14 ]

Shen 2001 41/60 27/60 28.3 % 1.52 [ 1.09, 2.11 ]

Subtotal (95% CI) 145 141 74.6 % 1.53 [ 1.27, 1.85 ]

Total events: 111 (Treatment), 70 (Control)
Heterogeneity: Chi2 = 0.02, df = 2 (P = 0.99); I2 =0.0%
Test for overall effect: Z = 4.48 (P < 0.00001)
Total (95% CI) 210 192 100.0 % 1.58 [ 1.34, 1.87 ]
Total events: 158 (Treatment), 92 (Control)
Heterogeneity: Chi2 = 0.54, df = 4 (P = 0.97); I2 =0.0%
Test for overall effect: Z = 5.40 (P < 0.00001)

0.1 0.2 0.5 1 2 5 10

Favours control Favours CHM

Chinese herbal medicine for primary dysmenorrhoea (Review) 96

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 4.1. Comparison 4 Chinese herbal medicine versus acupuncture, Outcome 1 Reduction of pain.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 4 Chinese herbal medicine versus acupuncture

Outcome: 1 Reduction of pain

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality B - standard formula with 3 month follow up

Miao 2001 17/36 3/17 21.2 % 2.68 [ 0.91, 7.91 ]

Subtotal (95% CI) 36 17 21.2 % 2.68 [ 0.91, 7.91 ]

Total events: 17 (Treatment), 3 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 1.78 (P = 0.075)
2 Methodological quality B - tailored formula - up to 3 month follow up
Wang 2003 23/52 15/51 78.8 % 1.50 [ 0.89, 2.54 ]

Subtotal (95% CI) 52 51 78.8 % 1.50 [ 0.89, 2.54 ]

Total events: 23 (Treatment), 15 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 1.53 (P = 0.13)
Total (95% CI) 88 68 100.0 % 1.75 [ 1.09, 2.82 ]
Total events: 40 (Treatment), 18 (Control)
Heterogeneity: Chi2 = 0.91, df = 1 (P = 0.34); I2 =0.0%
Test for overall effect: Z = 2.31 (P = 0.021)

0.1 0.2 0.5 1 2 5 10

Favours acupuncture Favours CHM

Chinese herbal medicine for primary dysmenorrhoea (Review) 97

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 Analysis 5.1. Comparison 5 Chinese versus heat compression, Outcome 1 Reduction of pain.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 5 Chinese versus heat compression

Outcome: 1 Reduction of pain

Study or subgroup Treatment Control Risk Ratio Weight Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodological quality B - standard formula - up to 3 month follow up

Zhang 2000 27/35 0/20 100.0 % 32.08 [ 2.06, 499.18 ]

Total (95% CI) 35 20 100.0 % 32.08 [ 2.06, 499.18 ]

Total events: 27 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 2.48 (P = 0.013)

0.1 0.2 0.5 1 2 5 10

Favours control Favours CHM

Analysis 5.2. Comparison 5 Chinese versus heat compression, Outcome 2 Adverse effects.

Review: Chinese herbal medicine for primary dysmenorrhoea

Comparison: 5 Chinese versus heat compression

Outcome: 2 Adverse effects

Study or subgroup Treatment Control Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 Methodology quality B - standard formula

Zhang 2000 0/35 0/20 0.0 [ 0.0, 0.0 ]

Total (95% CI) 35 20 0.0 [ 0.0, 0.0 ]

Total events: 0 (Treatment), 0 (Control)
Heterogeneity: not applicable
Test for overall effect: Z = 0.0 (P < 0.00001)

0.1 0.2 0.5 1 2 5 10

More incidents in CT More incidents in CH

Chinese herbal medicine for primary dysmenorrhoea (Review) 98

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ADDITIONAL TABLES
Table 1. Rose tea for relief of primary dysmenorrhoea

Study ID Outcome measures Exp group (SD) Control group (SD) P value

Tseng 2005 The Sort-form McGill Pain 1 month - 8.64 (8.35) 1 month - 11.86 (8.34) P = 0.0443
Questionnaire (SF-MPQ) - 3 months - 7.02 (6.24) 3 months - 11.41 (7.72) P = 0.0010
means (SD) 6 months - 6.82 (7.07) 6 months - 9.52 (7.76) P = 0.0629

The Menstrual Distress 1 month - 24.23 (5.42) 1 month - 26.86 (5.78) P = 0.0191
Questionnaire Short Form, 3 months - 23.44 (5.78) 3 months - 26.02 (5.21) P = 0.0144
mean (sd) 6 months - 22.75 (5.25) 6 months - 25.94 (6.26) P = 0.0040

Visual analogue scale for 1 month - 3.64 (1.74) 1 month - 4.04 (2.15) P = 0.2546
Anxiety (VASA), mean (sd) 3 months - 3.14 (1.84) 3 months - 4.16 (1.82) P = 0.0037
6 months - 3.09 (1.88) 6 months - 3.65 (2.20) P = 0.1537

Received Stress scale (PSS), 1 month - 20.83 (5.69) 1 month - 17.76 (5.82) P = 0.0063
mean (sd) 3 months - 20.81 (5.22) 3 months - 18.51 (5.12) P = 0.0195
6 months - 20.84 (4.61) 6 months - 19.12 (5.59) P = 0.0817

The Psychophysiologic Life 3 months - 94.08 (15.00) 3 months - 94.76 (13.13) P = 0.7972
Adaptation scale (PLAS), 6 months - 95.25 (13.43) 6 months - 95.64 (13.20) P = 0.8789
means (sd)

Table 2. Analgesic effect of a herbal medicine for treatment of primary dysmenorrhoea

Study ID Outcome measures Experimental group Control group Conclusion

Naoki 1997 Visual analogue scale (VAS) Data not available Data not available Compared to placebo, herbs significantly
reduced pain through 2 intervention cy-
cles and 2 follow-up cycles (P<0.05 for the
1st intervention cycle, P<0.005 for subse-
quence cycles)

Pain relieving medication
Data not available Data not available Significant reduction in pain relieving
medication through intervention and fol-
low-up in herbal group (P<0.05, P<0.01)
. Significant reduction in pain relieving
medication only in 1st cycle of interven-
tion in placebo group (P<0.01), then faded
out

Zung self-rating depression Data not available Data not available No significant difference between groups,
Scale nor within groups in Zung self-rating de-
pression scale

Chinese herbal medicine for primary dysmenorrhoea (Review) 99

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 2. Analgesic effect of a herbal medicine for treatment of primary dysmenorrhoea (Continued)

Improved biomed- Data not available Data not available Plasma levels of various hormones and
ical parameters (FSH, LH, chemical mediators changed during and
Prolactin, Esrtadiol, Blood after treatment
count, Hepatic and renal
function tests at each cycle)

Table 3. Quality features of included studies

Study Allocation Randomisation Blinding ITT Follow-up

concealme

Deng 2003a Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Deng 2003a Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Fan 1999 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Guo 1997 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Huang 2000 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 2 cycles

Jiang 2000 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Kotani 1997 Unclear/Not stated Unclear/Not stated Double blinded Unclear/Not stated 2 cycles

Li 1999 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Li 2001 Unclear/Not stated Unclear/Not stated Single blinded Unclear/Not stated 3 cycles

Li 2004 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Liu 2000 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Liu 2002 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Liu 2003 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Liu 2004 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Liu 2005 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Lu 2002 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Luo 2001 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Chinese herbal medicine for primary dysmenorrhoea (Review) 100

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 3. Quality features of included studies (Continued)

Miao 2001 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Niu 1996 Unclear/Not stated Unclear/Not stated Single blinded Unclear/Not stated 3 cycles

Qin 2003 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Shen 2001 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Song 2003 Unclear/Not stated Unclear/Not stated Single blinded Unclear/Not stated 3 cycles

Sun 2006 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Sun 2004 Unclear/Not stated Random number ta- Double blinded Unclear/Not stated 3 cycles
ble

Sun 2004-2 Unclear/Not stated Random number ta- Double blinded Unclear/Not stated 3 cycles
ble

Tseng 2005 Unclear/Not stated Unclear/Not stated Open trial Unclear/Not stated None

Wang 1996 Unclear/Not stated Random number ta- Single blinded Unclear/Not stated 3 cycles
ble

Wang 2000b Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Wang 2003 Unclear/Not stated Unclear/Not stated Open labelled Unclear/Not stated 3 cycles

Wang 2006a Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated None

Wang 2006b Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Wu 2006 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Ye 2004 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Yu 2003 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Zhang 2000 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Zhang 2001 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Zhu 2001 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Zhu 2002 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Zhu 2003 Unclear/Not stated Unclear/Not stated Unclear/Not stated Unclear/Not stated 3 cycles

Chinese herbal medicine for primary dysmenorrhoea (Review) 101

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 3. Quality features of included studies (Continued)

Table 4. RCT assessing a traditional Chinese medicine remedy in primay dysmenorrhoea

Study ID Outcome Group Observation Treatment cy- Treatment cy- Treatment cy- Follow-up cy-
cycle SD cle 1 SD cle 2 SD cle 3 SD cle SD

Kennedy The Placebo 76 (14) 67 (27) 57 (28) 61(31) 60 (30)

2006 maximal pain
scores (Cmax)

Chinese herbal medicine for primary dysmenorrhoea (Review) 102

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 4. RCT assessing a traditional Chinese medicine remedy in primay dysmenorrhoea (Continued)

Herbs 77 (19) 59 (28) 58 (36) 51 (36) 61 (28)

Total pain Placebo 186 (73) 123 (69) 115 (84) 134 (102) 138 (119)
area under the
curve (AUC)

Herbs 207 (84) 128 (83) 130 (97) 112 (88) 150 (84)

Duration of
pain (data not
shown)

Total
amount of res-
cure medica-
tion used (data
not shown)

Global assess-
ment of treat-
ment (data not
shown)

Safety Placebo (18

adverse
events)

Herbs (13 ad-

verse events)

APPENDICES
Appendix 1. MEDLINE search
1. randomised controlled trial.pt.
2. controlled clinical trial.pt.
3. randomised controlled trials/
4. random allocation/
5. double-blind method/
6. single-blind method/
7. or/1-6
8. clinical trial.pt.
9. exp clinical trials/
10. (clin$ adj25 trial$).tw.
11. ((singl$ or doubl$ or treb$ or tripl$) adj25 (blind$ or mask$)).tw.
Chinese herbal medicine for primary dysmenorrhoea (Review) 103
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
12. placebos/
13. placebo$.tw.
14. random$.tw.
15. research design/
16. or/8-15
17. animal/ not (human/ and animal/)
18. 7 or 16
19. 18 not 17
20 exp Menstruation disturbances/
21 Pelvic pain/
22 (pelvic adj5 pain).tw.
23 Dysmenorrhoea/
24 dysmenorrh$.tw.
25 (painful adj5 menstrua$).tw.
26 (painful adj5 period$).tw.
27 menstrual disorder.tw.
28 or/20-27
29 19 and 28
30 complementary medicine.mp
21 Alternative Medicine/
32 alternative medicine.mp.
33 herbal medicine.mp.
34 Medicine, Herbal/
35 Chinese adj 5 herbal.mp.
36 Medicine, Chinese Traditional/
37 Drugs, Chinese Herbal/
38 Medicine, Oriental Traditional/
39 or/30-38
40 29 and 39

Appendix 2. Chinese database search

1. Tong Jing (period pain).
2. Yuan Fa Xing Tong Jing (primary dysmenorrhoea).
3. 1 or 2.
4. Lin Chuang (clinical).
5. Lin Chuang Yun Yong (clinical application).
6. Lin Chuang Zhi Liao (clinical treatment).
7. Lin Chuang Yan Jiu (clinical research).
8. Lin Chuang Guan Cha (clinical observation).
9. Lin Chuang Dui Zhao (clinical comparison).
10. 4 or 5 or 6 or 7 or 8 or 9.
11. 3 and 10.

Chinese herbal medicine for primary dysmenorrhoea (Review) 104

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
WHATS NEW
Last assessed as up-to-date: 13 December 2007.

Date Event Description

20 September 2010 Amended Contact details updated.

HISTORY
Protocol first published: Issue 2, 2005
Review first published: Issue 4, 2007

Date Event Description

12 May 2008 Amended Minor edits made outcomes unchanged

5 May 2008 Amended Converted to new review format.

14 December 2007 New citation required and conclusions have changed Substantive amendment

CONTRIBUTIONS OF AUTHORS
Xiaoshu Zhu: conceptualised and wrote the protocol and review.
Michelle Proctor: commented on and assisted with structure and development of the review.
Alan Bensoussan: commented on and assisted with development of the protocol and review.
Emily Wu: assisted with data translation and extraction for the review.
Caroline Smith: commented on and assisted with development of the protocol.

DECLARATIONS OF INTEREST
Xiaoshu Zhu recently completed a randomised controlled trial of CHM for primary dysmenorrhoea. There are no other known
potential conflicts of interest.

Chinese herbal medicine for primary dysmenorrhoea (Review) 105

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
SOURCES OF SUPPORT
Internal sources
Cochrane Menstrual Disorders and Subfertility Group, New Zealand.

External sources
University of Western Sydney, Australia.

INDEX TERMS

Medical Subject Headings (MeSH)

Drugs, Chinese Herbal [ therapeutic use]; Dysmenorrhea [ drug therapy]; Phytotherapy [ methods]

MeSH check words

Adolescent; Adult; Female; Humans

Chinese herbal medicine for primary dysmenorrhoea (Review) 106

Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.