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Acupuncture for chronic fatigue syndrome (Protocol)

Zhang W, Liu Z, Wu T, Peng W

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2009, Issue 2
http://www.thecochranelibrary.com

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .

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Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Protocol]

Acupuncture for chronic fatigue syndrome


Wei Zhang1 , Zhishun Liu1 , Taixiang Wu2 , Weina Peng1
1 Department of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine, Beijing, China. 2 Chinese Cochrane

Centre, Chinese EBM Centre, West China Hospital, Sichuan University, Chengdu, China
Contact address: Wei Zhang, Department of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine,
Guang An Men Hopital, No.5 Bei Xian Ge Street, Beijing, Xuanwu District, 100053, China. zhangwei_7108@hotmail.com. (Editorial
group: Cochrane Depression, Anxiety and Neurosis Group.)
Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD006010
This version first published online: 19 April 2006 in Issue 2, 2006. (Help document - Dates and Statuses explained)
This record should be cited as: Zhang W, Liu Z, Wu T, Peng W. Acupuncture for chronic fatigue syndrome. Cochrane Database of
Systematic Reviews 2006, Issue 2. Art. No.: CD006010. DOI: 10.1002/14651858.CD006010.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
Our objective is to conduct a systematic review and if possible, a quantitative meta-analysis, with any evidence collected from randomised
controlled trials and quasi-randomised trials of acupuncture for adults and children with chronic fatigue syndrome (CFS). In this way,
we can assess the efficacy and safety of acupuncture therapy for CFS and test the hypothesis that acupuncture is more effective than
other interventions.

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

BACKGROUND
Chronic fatigue syndrome (CFS) is a clinically defined condition characterised by severe, disabling fatigue and other symptoms, including self-reported musculoskeletal pain, sleep disturbance, headaches and impairments in concentration and shortterm memory. These symptoms, as opposed to a debilitating but
nonspecific condition shared by many diseases, are usually medically unexplained. A diagnosis of chronic fatigue syndrome can be
made only after all the physical and psychiatric causes of chronic
fatigue have been excluded. Because of the absence of objective
clinical signs, CFS patients are often annoyed by the lack of understanding from others, including medical professionals.
Historically, CFS has also been called Royal Free disease, Iceland
disease, neurasthenia, myalgic encephalomyelitis (ME), and postviral fatigue syndrome. Nowadays the term CFS is widely adopted
for research in the field, however sometimes ME is also seen in
articles and textbooks.
Epidemiological research in western countries has demonstrated
that the prevalence of CFS is 0.2-2.6%, depending on the criteria
used (Wessely 1997, Steele 1998). In China, it was reported in
2004 that among 2000 citizens interviewed in the cities of Beijing
and Baotou, 1.98% of them had symptoms that were consistent
with CDC criteria of CFS (Zhang 2004).
In 1987, the US Centers for Disease Control and Prevention
(CDC) developed a diagnostic criteria of CFS. These criteria were
updated in 1994 which widened their use (Fukuda 1994). The
Oxford criteria, also called the British criteria, is another operational criteria for research (Sharpe 1991). There are two important
differences between these definitions. The British criteria insist
on the presence of mental fatigue; the American criteria include
a requirement for several physical symptoms, reflecting the belief
that chronic fatigue syndrome has an underlying immunological
or infective pathology.
Etiologically, the cause of chronic fatigue syndrome is poorly understood. There has been some new work in virology, immunology, and imaging which also holds promise but still does not provide any diagnostic test or a mechanism for the production of
symptoms of CFS (Sabin 2003).
The treatment of CFS is attracting more and more attention. However, so far no single pharmacological treatment has been shown
to be effective for people with CFS. Two Cochrane systematic
reviews were published concerning cognitive behaviour therapy
for chronic fatigue syndrome in adults (Price 2003) and exercise
therapy for chronic fatigue syndrome (Edmonds 2004). They suggested that cognitive behaviour therapy appears to be an effective
and acceptable treatment for adult out-patients with chronic fatigue syndrome and encouraging evidence has demonstrated that
some patients may benefit from exercise therapy. In 2002, clinical
practice guidelines for chronic fatigue syndrome were conducted
by a working group convened under the auspices of the Royal Aus-

tralasian College of Physicians (CFS workshop 2002). There, the


management of CFS was described in detail. Cognitive-behaviour
therapy and graded exercise were strongly supported (Level I and
Level II respectively) to be effective for some people with CFS.
Acupuncture is a very important constituent of Traditional Chinese Medicine (TCM) with a history of literature spanning over
2000 years. Acupuncture is a therapy implemented by inserting
needles into certain points on the human body, which are called
Xue Wei in Chinese. Generally, acupoints can be classified into
meridian points which are located on the pathway of a meridian
or so called Jing Luo in Chinese, and extra points which are discovered through practical experience. There are types of needling
methods other than the frequently used filiform needle, such as fire
needle, seven star needle, three-edged needle (mainly for bleeding)
and so on. With the development of technology, electricity was
introduced into the stimulation method of acupuncture and now
electro-acupuncture is a very important type of acupuncture apart
from the traditional hand manipulation. According to the location
where needling is carried out, acupuncture can also be classified
into body acupuncture, scalp acupuncture, auricular acupuncture
and ankle-wrist acupuncture etc. Acupuncture is not just a therapy
alone, many centuries ago acupuncture developed into a discipline
which has its own theory and practice system. It is believed in
TCM theory that acupuncture can strengthen the vital essence of
the human body, which is called Qi in Chinese, and remove the
blockage of channels. There are a wide range of diseases that are
thought to benefit from treatment with acupuncture.
According to our search of main medical and biological bibliography databases both inside and outside China, so far no study has
been done on acupuncture for CFS in any foreign institution. In
China, from a preliminary search, we found 15 clinical trials on
the topic of acupuncture for CFS. From a rough review of these
trials we can see that the quality of these were uneven, however
some could provide evidence for further analysis. All the Chinese
trials that had control groups got results of benefit in the acupuncture group, with success rates ranging from 88.90% (Ni 2002) to
94.29% (Liu 2004).
No research was done concerning the mechanism of acupuncture
for CFS with modern medical measures. Traditionally, it can be
explained as adjusting the balance of Yin-Yang and nourishing the
Qi and blood if a deficiency exists. This explanation is based on the
theory of traditional Chinese medicine, which stems from ancient
Chinese philosophy.
So far, the clinical application of acupuncture for CFS is mainly
based on experience and its effects have not been evaluated. In
past decades, acupuncture has gained more popularity both inside
and outside China because of its advantages of convenience, economy and reports of effectiveness. A precise evaluation of acupuncture is required. This review, will assess the efficacy and safety of
acupuncture therapy for CFS.

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

OBJECTIVES
Our objective is to conduct a systematic review and if possible, a
quantitative meta-analysis, with any evidence collected from randomised controlled trials and quasi-randomised trials of acupuncture for adults and children with chronic fatigue syndrome (CFS).
In this way, we can assess the efficacy and safety of acupuncture
therapy for CFS and test the hypothesis that acupuncture is more
effective than other interventions.

METHODS
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials and quasi-randomised trials.
Types of participants
Patients with CFS according to the criteria of Centre for Disease
Control, (CDC) (Fukuda 1994), Oxford (Sharpe 1991), ICD10 (WHO 1992) or any other validated criteria will be included
irrespective of gender, race, age and setting.
Types of interventions
Any type of acupuncture therapy, including body acupuncture,
auricular acupuncture, scalp acupuncture, or electroacupuncture
will be considered. The stimulation method can be hand manipulation or electricity pulse. Acupuncture methods without needle
insertion such as seed stimulation or seven-star needle will also be
included.
The control interventions will be
(1) No intervention, placebo acupuncture (using points very near
to normal acupuncture points but not the exact acupuncture
point) or sham acupuncture (using different acupuncture instruments which can cause a similar sensation to acupuncture but are
not inserted into the skin) (Streitberger 1998)
(2) Pharmacological treatments (herbal medicine or western
medicine such as antidepressant or combination of them)
(3) Cognitive behaviour therapy (CBT)
(4) Exercise therapy
(5) Any other interventions
Types of outcome measures
Primary outcome measure
Fatigue is the key characteristic of CFS, so we will take fatigue
symptoms as the main outcome of this review (eg Chalder Fatigue
Scale (Chalder 1993) or any type of instrument considered to scale
fatigue).
Secondary outcome measures
(1) Mood such as depression (eg Hamilton Depression Rating
Scale (Hamilton 1960)) and sleep disturbance using any instrument (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO), (Buscemi 2005)).

(2) Quality of life score (eg SF-36, (Garratt 2002)).


(3) Other symptoms such as pain, headache using any instrument
(eg Visual analog scale (VAS), (WSDLI 2002) or quality of life)
(4) Adverse effects (eg pain (VAS), bleeding, broken needles).

Search methods for identification of studies


1/ Electronic searches
We will search the following electronic databases irrespective of
language and publication status:
a) The Cochrane Collaboration Depression, Anxiety & Neurosis
Controlled Trials Register (CCDANCTR-Studies).
b) The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 4, 2004).
c) MEDLINE (1966-2004).
d) EMBASE (1998-2004).
e) Chinese Biomedical Database (1979-2004).
CCDANCTR-Studies will be searched using the following strategy
Diagnosis = Chronic Fatigue
and
Intervention = Acupuncture
In the Cochrane Reviewers Handbook 4.2.2 [updated December
2003] a highly sensitive search strategy for identifying reports of
randomized controlled trials in MEDLINE is provided for reviewers. We will put its 5b.2 Format for MEDLINE on Ovid web version (#1-#29) into usage in order to locate randomized controlled
trials.
Below is the further search strategy for MEDLINE:
#30 chronic fatigue syndrome or CFS/
#31 myalgic encephalomyelitis or ME/
#32 or/30-31
#33 acupuncture/
#34 acupuncture points/
#35 (electroacupuncture or electro- acupuncture).tw.
#36 electroacupuncture.tw.
#37 acupuncture$.tw.
#38 acupoints.tw.
#39 meridians/
#40 or /33-39
#41 29 and 32 and 40
2/ Reference Lists
The reference lists of all identified papers will be searched for
further information.
3/ Personal Communication
We will contact authors for unpublished studies.

Data collection and analysis


Eligibility

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Two reviewers, Zhang and Peng, will independently decide on


eligibility.
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng). The following data will be extracted from each included
study:
a) patients demographic characteristics including maximum; minimum and mean age
b) inclusion and exclusion criteria
c) type, frequency, treatment course of acupuncture therapy and
outcomes
d) type, severity and number of adverse effects
e) number and reasons for dropouts; withdrawals and lost to follow-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone. Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu).
Quality assesment
Quality assessment will be carried out by two independent reviewers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence.
In line with the empirical evidence (Schulz 1995; Jadad 1996;
Juni 2001; Kjaergard 2001), we intend to assess the methodological quality as described by Kjaergard et al, (Kjaergard 2001) and
Cochrane Reviewers Handbook 4.2.2:
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next. We will assess the
quality of the method of randomisation as follows:
a) Adequate: random number table, computer randomization,
tossing of a coin, will be considered adequate.
b) Inadequate: methods of allocation using odd-even numbers,
patient social security numbers, days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random processes instead of real randomization, and will be considered inadequate.
c) Unclear: those who only used randomization as a decoration
of article and no explanation available in articles will be regarded
as unclear on randomization procedure.
2) Allocation concealment
a) Adequate: allocation concealment such as a central randomisation scheme by telephone or controlled by pharmacy; numbered
or coded identical containers administered sequentially; sequentially numbered opaque sealed envelopes; on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant.
b) Unclear: authors did not report conditions of allocation concealment or approach did not fall into one of the adequate mea-

sures. Also, sealed envelopes were not sequentially numbered or


opaque, open list enrollment.
c) Inadequate: Alternation, odd-even, date of birth or week or case
record numbers.
3) Blinding
Since blinding is not possible for treatment providers, trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate.
4) Follow-ups:
Number and reason for dropouts; withdrawals and fail to fulfill
follow ups should be described in articles.
a) Good: A rate of dropouts, withdrawals and lost to follow ups
10%
b) Acceptable: A rate of dropouts, withdrawals and lost to follow
ups 20%
c) Unacceptable: A rate of dropouts, withdrawals and lost to follow
ups >20%.
Trials which meet the criteria of good or acceptable rate of
dropouts, withdrawals and lost to follow ups will be included for
analysis.
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined.
A meta-analysis will be implemented with the Cochrane Collaboration Review Manager (RevMan 4.3) software. All the primary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(P>0.1) using a random effects model. Results will be expressed as
relative risks (RR, ratio of risk of treatment group vs that of control group) with their 95% confidence intervals for dichotomous
data. For continuous variables measured with the same scale, the
weighted mean differences ((WMD), the difference between treatment and control pooled means at endpoint) along with their 95%
confidence intervals will be calculated and standardised mean difference (SMD) will be calculated in case different scales are used.
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size:
(i) Repeating the analysis, taking into account quality, only trials
with adequate randomisation, allocation concealment and blinding will be included.
(ii) Repeating the analysis, excluding any trials with long duration
or large studies to establish how much they dominate the results.
(iii) Repeat the analysis excluding trials using the following filters:
diagnostic criteria (criterias except CDC, ICD-10 and Oxford will
be excluded considering the prevalence), language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation), Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia, especially China).

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Subgroup Analyses
Here we will compare the effects between subgroups below:
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot. We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR).

REFERENCES

Additional references
Buscemi 2005
Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina
M, et al.Manifestations and management of chronic insomnia in adults.
Evidence Report/Technology. Assessment no 125. Vol. AHRQ Publication No. 05-E021-2, Rockville, MD: Prepared by University of Alberta Evidence-based Practice Centre, under contract C400000021,
June 2005.
CFS workshop 2002
CFS workshop. Clinical Practice Guidelines-Chronic fatigue syndrome Clinical practice guidelines - 2002. MJA 2002;9 Suppl:S17
S55.
Chalder 1993
Chalder T, Berelowitz G, Pawlikowska T. Development of a fatigue
scale. Journal of Psychosomatic Research 1993;37(6):14753.
Edmonds 2004
Edmonds M, McGuire H, Price J. Exercise therapy for chronic fatigue syndrome. The Cochrane Library 2004, Issue 3.[Art. No.:
CD003200. DOI: 10.1002/14651858.CD003200.pub2]
Fukuda 1994
Fukuda K, Straus SE, Hickie I. The chronic fatigue syndrome: a
comprehensive approach to its definition and study. Annals of Internal Medicine 1994;121:9539.
Garratt 2002
Garratt A, Schmidt L, Mackintosh A, et al.Quality of life measurement: bibliographic study of patient assessed health outcome measures. British Medical Journal 2002;June 15;324(7351):1417.
Hamilton 1960
Hamilton M. A rating scale for depression. Journal of Neurology and
Neurosurgery 1960;23:5662.
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:
112.
Juni 2001
Juni Peter, Altman DG, Egger M. Assessing the quality of controlled
clinical trials. BMJ 2001;323(7303):426.

Kjaergard 2001
Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality
and discrepancies between large and small randomized trials in metaanalyses. Annals of Internal Medicine 2001;135(11):9829.
Liu 2004
Liu J. Acupuncture with herbs for CFS. Journal of Chinese Clinical
medicine 2004;5(3):1134.
Ni 2002
Ni K. Acupuncture with herbs for 35 cases of CFS. Journal of Fujian
College of TCM 2002;12(4):223.
Price 2003
Price JR, Couper J. Cognitive behaviour therapy for chronic fatigue
syndrome in adults. The Cochrane Library 2003, Issue 4.[Art. No.:
CD001027. DOI: 10.1002/14651858.CD001027.pub2]
Reid 2000
Reid S, Chalder T. Extracts from Clinical Evidence. BMJ 2000;
320:2926.
Sabin 2003
Sabin TD. An approach to chronic fatigue syndrome in adults. Neurologist 2003;9(1):2834.
Schulz 1995
Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of
bias: dimensions of methodological quality associated with estimates
of treatment effects in controlled trials. JAMA 1995;273:40812.
Sharpe 1991
Sharpe M, Archard L, Banatvala J, Borysiewicz LK, Clare AW, David
A. Chronic fatigue syndrome: guidelines for research. Journal of the
Royal Society of Medicine 1991;84(2):11821.
Steele 1998
Steele L, Dobbins JG, Fukuda K, Reyes M, Randall B, Koppelman
M. The epidemiology of chronic fatigue in San Francisco. American
Journal of Medecine 1998;105(suppl 3A):8390S.
Streitberger 1998
Streitberger K, Kleinhenz J. Introducing a placebo needle into
acupuncture research. The Lancet 1998;352:364365.
Wessely 1997
Wessely S, Chalder T, Hirsch S, Wallace P, Wright D. The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome: a
prospective primary care study. American Journal of Public Health
1997;87(Not known):144955.

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

WHO 1992
World Health Organisation. The ICD-10 Classification of Mental and
Behavioural Disorders. Geneva: World Health Organisation, 1992.
WSDLI 2002
Washington State Department of Labor and Industries. Guidelines for
outpatient prescription of oral opioids for injured workers with chronic,
non-cancer pain. Olympia, Washington: Washington State Department of Labor and Industries, 2002.
Zhang 2004
Zhang R. Epidemiological study on CFS. Chinese journal of rehabilitation medicine 2004;19(4):2967.

Indicates the major publication for the study

WHATS NEW

31 October 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 2, 2006

CONTRIBUTIONS OF AUTHORS
Wei Zhang designed and wrote the protocol. Zhang will participate in the whole review procedure including data extraction, contacting
editors, statistical analysis, quality assessment and completion of the review. Zhishun Liu checked the protocol and gave comments.
Weina Peng and Wei Zhang will extract data and assess quality. In case of disagreement between the two data extractors, Wu will advise
on methodology and Liu will work as arbitrator.

DECLARATIONS OF INTEREST
Not known

SOURCES OF SUPPORT
Internal sources
Department of Acupuncture and Moxibustion, Guang An Men Hospital, Chinese Academy of TCM, China.

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

External sources
No sources of support supplied

Acupuncture for chronic fatigue syndrome (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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