Cochrane Database of Systematic Reviews

Tongxinluo capsule for acute stroke (Review)

Zhuo Q, Yang X, Wu T, Liu G, Zhou L

Zhuo Q, Yang X, Wu T, Liu G, Zhou L.

Tongxinluo capsule for acute stroke.
Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD004584.
DOI: 10.1002/14651858.CD004584.pub2.

www.cochranelibrary.com

Tongxinluo capsule for acute stroke (Review)

Copyright © 2008 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Analysis 1.1. Comparison 1 Effects, Outcome 1 Improvement. . . . . . . . . . . . . . . . . . . . 14
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
WHAT’S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Tongxinluo capsule for acute stroke (Review) i

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]

Tongxinluo capsule for acute stroke

Qi Zhuo2 , Xunzhe Yang2 , Taixiang Wu1 , Guanjian Liu1 , Likun Zhou3

1 ChineseCochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, Chengdu, China. 2 West China Hospital,
Sichuan University, Chengdu, China. 3 Clinical Epidemiology, West China Hospital of Sichuan University, Chengdu, China

Contact address: Taixiang Wu, Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, No. 37,
Guo Xue Xiang, Chengdu, Sichuan, 610041, China. txwutx@hotmail.com. txwutx@public.cd.sc.cn.

Editorial group: Cochrane Stroke Group.

Publication status and date: New, published in Issue 4, 2008.
Review content assessed as up-to-date: 18 March 2008.

Citation: Zhuo Q, Yang X, Wu T, Liu G, Zhou L. Tongxinluo capsule for acute stroke. Cochrane Database of Systematic Reviews 2008,
Issue 4. Art. No.: CD004584. DOI: 10.1002/14651858.CD004584.pub2.

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

Background

Tongxinluo capsules are a compound of Chinese traditional medicine which contain substances that are thought to have vasodilatory,
antiplatelet, anticoagulant, thrombolytic and even lipid-lowering properties, and therefore may improve outcome after acute ischaemic
stroke. To date the evidence of its effect has not been systematically reviewed, making it difficult to derive robust conclusions about its
actual benefits, and indeed, possible harms.

Objectives
To assess the effectiveness and possible harms of tongxinluo capsule for acute cerebral infarction compared with control.

Search methods

We searched the Cochrane Stroke Group trials register (last searched on 24 January 2008) the Cochrane Central Register of Controlled
Trials (CENTRAL) (The Cochrane Library, Issue 4, 2007), MEDLINE (1995 to 2006), EMBASE (1995 to 2006), China National
Knowledge Infrastructure (CNKI, 1994 to 2006), CBM (Chinese Biomedical Database) (1995 to 2006), Current Controlled Trials
(www.controlled-trials.com), National Research Register (http://www.update-software.com/national/). We handsearched 30 journals
(1995 to 2006), and contacted drug companies and the principal of included trials.

Selection criteria

Randomised controlled trials comparing tongxinluo with placebo or open control (or tongxinluo plus standard therapy versus standard
therapy alone) in people with definite acute stroke. We excluded trials if they sought to recruit patients with transient ischaemic attacks
(TIA), intracerebral haemorrhage, heart failure, or renal failure.

Data collection and analysis

Two review authors extracted data and assessed trial quality.

Main results

Only two poor quality studies with a total of 232 participants were included in this review. Neither study reported any of our pre-
specified outcomes, so no reliable estimate of the effect of treatment on major clinical outcomes could be obtained.
Tongxinluo capsule for acute stroke (Review) 1
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Authors’ conclusions

It was not possible to reliably determine whether tongxinluo has a favourable or unfavourable effect in acute ischaemic stroke. High
quality trials are required to assess the efficacy and safety of tongxinluo capsule for acute ischaemic stroke.

PLAIN LANGUAGE SUMMARY

Tongxinluo capsule for acute stroke

Traditional Chinese medicine is often used to treat patients with acute ischaemic stroke. The authors undertook a systematic review
of the potential benefits and safety of tongxinluo capsule used for the treatment of patients with acute ischaemic stroke. Two relevant
studies with a total of 232 participants were identified, but they did not provide reliable evidence about the effects of this treatment.
Larger-scale high quality randomised controlled trials (RCTs) are needed to determine the effects of tongxinluo capsule in patients with
stroke.

BACKGROUND Scorpio, Hirudo, Eupolyphaga seu Steleophage, Scolopendra, Perios-

There are two main types of stroke: ischaemic (if an artery to the
brain is blocked), or haemorrhagic (if an artery to the brain bursts
and bleeding occurs) (Stanford 1999).
When the lining of a blood vessel (the endothelium) is damaged
blood platelets adhere to it and may provoke the local formation of
a clot (or thrombus) which blocks the vessel. This will occur more
readily if the blood shows an increased propensity for clotting.
Clot dissolving (or thrombolytic) drugs may restore blood supply
to the brain after a stroke, but may also cause serious bleeding in
the brain (Wardlaw 2003). Antiplatelet therapy, with drugs like
aspirin, has been shown to reduce the risk of recurrent stroke,
myocardial infarction and vascular death in patients with a history
of stroke or transient ischaemic attack by about 15% to 20% (Algra
1996; APT 1994).
There are over one million new strokes each year in the European
Union and the USA (Bamford 1990; Broderick 1989; Homer
1987), of which 85% are ischaemic (Bamford 1990). It is estimated
that there will be 8.5 million patients with acute ischaemic stroke
in these countries over the next decade and of these about one and a
half million will die within six months of stroke onset (Sandercock
1992). Of those who survive, about one third will depend on other
people for help with their activities of daily living (IST Pilot 1996).
Tongxinluo capsule has properties that might be effective in acute
stroke. It is a new drug (clinical study was started in 1995) for
cardio-cerebral vascular diseases on the national essential drug list
of China, and has the second-class award of the National Sci-
ence and Technology Development of China 2001 (Editor 2002).
The composition of Tongxinluo capsule includes Radi Ginseng,
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
tracum Cicadae, Radix Paeoniae Rubra, and Borneolum Syntheticum
(Editor 2002; Liu 1997; Wu 2001). These materials are powdered
and prepared as capsules which contain 0.38g of mixture (Wu
2001). Pharmacological studies showed that Radix Ginseng dilates
blood vessels, has anticoagulant effects, and inhibits platelet ad-
hesion reaction (Xu 1988a). Hirudo’s action includes anticoagula-
tion (Ou 1987), thrombolysis, it reduces viscosity of whole blood
(Xu 1988b), reduces blood cholesterol, and has atherosclerotic
actions (Wu 1994). Periostracum Cicadae acts as an anticonvul-
sant and slows heart rate down significantly (Pharmacology 1960).
Scolopendra extraction strengthens cardiac contractility, decreases
blood pressure, and increases blood vessel perfusion flow (Chen
1985). Radix Paeoniae Rubra has anticoagulant and antithrom-
botic effects (Deng 1991; Lu 1983). Eupolyphaga seu Steleophage
increases cardiac output and improves tolerance of hypoxia (Nong
1989; Yang 1989). The actions of Borneolum Syntheticum are anal-
gesia and sedation (Wu 2001). Scorpio is used in traditional Chi-
nese medicine mainly for hypertension, apoplexy, arteriosclero-
sis, some nervous system diseases, and various infections (Wang
1998). These components of tongxinluo and their pharmacolog-
ical actions are listed in Table 1 with their Latin and common
names.
Some completed research (Fan 2001; Xu 2001) suggested that the
capsule might have effects on acute cerebral infarction, but this
research has not been systematically reviewed.
In light of this incomplete evidence and the possibility of side ef-
fects, a systematic review of controlled trials of tongxinluo capsule
is needed.
2
OBJECTIVES
To assess the effect (harms and benefits) of tongxinluo capsule for
acute cerebral infarction compared with control.
METHODS
Criteria for considering studies for this review
Types of studies
We considered unconfounded randomised controlled trials com-
paring tongxinluo with placebo or open control (or tongxinluo
plus standard therapy versus standard therapy alone).
Types of participants
Participants were male or female of any age or ethnic origin with
acute cerebral infarction in any vascular territory confirmed by
computerised tomography (CT) or magnetic resonance imaging
(MRI) brain scan. We excluded trials that sought to recruit patients
with transient ischaemic attacks (TIA), intracerebral haemorrhage,
heart failure, or renal failure.
Types of interventions
Tongxinluo capsule compared with placebo or no intervention
(or tongxinluo plus standard treatment versus standard treatment
alone).
Types of outcome measures
Primary outcome measures
(1) Death from any cause during the scheduled follow-up period.
(2) The proportion of participants who were dead or dependent
on others for activities of daily living at the end of the scheduled
follow-up period.
Secondary outcome measures
(1) Neurological impairment at the end of follow up.
(2) Death during scheduled treatment period.
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Adverse events
(1) Bleeding, nausea, vomiting, abdominal pain, diarrhoea, allergic
action, or other serious adverse event caused by tongxinluo.
(2) Frequency of other complications such as pneumonia, coagu-
lopathy or other serious adverse events during treatment and fol-
low-up period.
Search methods for identification of studies
See: ’Specialized Register’ section in Cochrane Stroke Group
We conducted a comprehensive and exhaustive search in an at-
tempt to identify all relevant studies in all languages, published or
unpublished.
Electronic searches
We searched the Cochrane Stroke Group Trials Register, which was
last searched by the Review Group Co-ordinator on 24 January
2008. In addition, we searched the following electronic databases
and trials and research registers in an attempt to identify published,
unpublished and ongoing studies.
• Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library Issue 4, 2007)
• MEDLINE (1995 to 2006)
• EMBASE (1995 to 2006)
• China National Knowledge Infrastructure (CNKI) (1994
to 2006)
• Chinese Biomedical Database (CBM) (1995 to 2006)
• Current Controlled Trials (www.controlled-trials.com)
• National Research Register (http://www.update-
software.com/national/)
The following text word search was used for all databases:
Tongxinluo or Tong xin luo or Tong-xin-luo or TXLC or TXL
Handsearches
We have handsearched the following Chinese traditional medicine
journals (1995 to 2006):
• China Journal of Basic Medicine in Traditional Chinese
Medicine;
• Chinese Journal of Integrated Traditional and Western
Medicine in Intensive and Critical Care;
• Chinese Journal of Traditional & Western Medicine;
• Chinese Traditional Patent Medicine;
• Chinese Traditional Patent Medicine Research;
• Chinese Traditional and Herbal Drugs;
• Chinese Pharmaceutical Abstracts;
• Forum on Traditional Chinese Medicine;
• Fujian Journal of Traditional Chinese Medicine;
• Guang Ming Zhong Yi Journal of Traditional Chinese
Medicine;
3
 • Gansu Journal of Traditional Chinese Medicine;
• Guangxi Journal of Traditional Chinese Medicine;
• Guangdong Journal of Traditional Chinese Medicine;
• Hebei Integrated Traditional and Western Medicine;
• Hebei Journal of Traditional Chinese Medicine;
• Heilongjang Journal of Traditional Chinese Medicine;
• Henan Journal of Traditional Chinese Medicine and
Pharmacy;
• Henan Journal of Traditional Chinese Medicine;
• Information on Traditional Chinese Medicine;
• Jiangxi Journal of Traditional Chinese Medicine;
• Jilin Journal of Traditional Chinese Medicine;
• Journal of Chinese Medicinal Materials;
• Journal of Emergency in Traditional Chinese Medicine;
• Journal of HeNan College of Traditional Chinese Medicine;
• Journal of Practical Chinese Traditional Internal Medicine;
• Modern Traditional Chinese Medicine;
• Neimongol Journal of Traditional Chinese Medicine;
• Pharmacology and Clinics of Chinese Materia Medica;
• Shenzhen Journal of Integrated Traditional and Western
Medicine;
• Xinjiang Journal of Traditional Chinese Medicine.
Other search strategies
In an effort to identify further published and unpublished tri-
als, we contacted relevant organizations (including the World
Health Organization), companies manufacturing tongxinluo, and
researchers and colleagues working in the field. The reference lists
of all relevant publications have been examined.
Data collection and analysis
Trials selection
To determine the studies to be assessed further, we scanned the
titles, abstract sections and keywords of every record retrieved. We
retrieved the full article for further assessment if the information
given suggested that the study:
(1) included participants with acute cerebral infarction;
(2) compared tongxinluo with any control;
(3) assessed one or more relevant clinical outcome measure;
(4) used random allocation to the comparison groups.
There were no disagreements between review authors.
Quality assessment of trials
Assessment of risk of bias in included trials
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Two authors will independently assess risk of bias using the fol-
lowing criteria that are described in the Cochrane Handbook for
Systematic Reviews of Interventions 5.0.0 (Higgins 2008) and Wu
2007 . We will assess the following characteristics.
Randomisation process: assessment of selection bias
A - adequate sequence generation is reported using one of the fol-
lowing approaches: random number tables or computer-generated
random numbers. Coin tossing or shuffling used for generating
the allocation sequence before the trial started will be considered
eligible and with a low risk of selection bias.
B - does not specify one of the adequate methods outlined in A
but only mentioned ’random’ and will be considered at moderate
risk of selection bias.
C - other methods of allocation, for example, quasi-randomisation,
that appeared to be at high risk of bias and will be excluded.
Allocation concealment process: assessment of selection bias
A - adequate measures to conceal allocation defined as when the
person enrolling participants cannot forsee allocation assignment,
for example, central randomisation, sealed opaque envelopes, the
allocation sequence is held in a locked computer, or another de-
scription that describes good concealment will be considered at
low risk of selection bias.
B - unclear: concealed trials in which the author does not report
the method of allocation concealment at all will be considered at
moderate risk of selection bias.
C - inadequately-concealed allocation that does not fall into one
of the categories in A.
D - does not conceal allocation.
C and D will be considered at high risk of selection bias.
Level of blinding: assessment of performance bias and
detection bias
A - double blinding: participants and outcome assessors were
masked and will be considered at low risk of both performance
and detection bias.
B - single blinding for outcome assessors will be considered at
moderate risk of both performance and detection bias. If partici-
pants were single blinded but not the outcome assessors, it will be
considered at high risk of detection bias.
C - non-blinding will be considered as a high risk for both perfor-
mance and detection bias.
Drop out, withdrawal, loss to follow up: assessment of
potential attrition bias
A - low risk of attrition bias: trials where an intention-to-treat
analysis is possible and few drop outs or losses to follow up are
noted.
4
B - moderate risk of attrition bias: trials which reported the rate
of exclusions was about 10% whatever intention-to-treat analysis
was used.
C - high risk of attrition bias: the rate of exclusion was at least
15%, or wide differences in exclusions between groups whatever
the intention-to-treat analysis was used.
Based on these criteria, we broadly subdivided studies into the
following three categories:
A - all quality criteria met: low risk of bias;
B - one or more of the quality criteria only partly met: moderate
risk of bias;
C - one or more criteria not met: high risk of bias.
Data extraction
Two review authors (ZQ and WT) independently extracted data
using a piloted data extraction form. We extracted data on study
characteristics including methods, participants, interventions, and
outcomes. We resolved any disagreements by referring to the trial
report and through discussion.
Data analysis
We analysed the data using the Review Manager software RevMan
5. We summarised dichotomous data as relative risk (RR). There
were no continuous data; in future, we would expressed such
data as mean difference (MD). We used 95% confidence inter-
vals throughout. We have listed non-randomised controlled stud-
ies but these have not been discussed further. We did not perform
subgroup analyses because of clinical heterogeneity of the only two
studies included.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
See Characteristics of included studies
Studies identified
After reading titles and abstracts, we retained 29 studies for ad-
vanced assessment. Of these, we excluded six studies because they
were confounded studies without proper control (Liu 2001; Liu
2001b; Liu 2001c; Lu 2001; Wang 2006b; Zhang 2001). We ex-
cluded four other studies because they were retrospective trials
with no research protocol (Ding 2003; Sun 2000; Xu 2003; Zhang
2002), another six because they were quasi-randomised trials with
no blinding (Gu 2004; Han 2006; Hu 2002; Yang 2001; Zhou
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
2005; Zhou 2004), and another four because they were non-RCTs
(Jia 2001; Lu 2002; Xu 2001; Xu 2001b). The reasons for the
other exclusions can be seen in Characteristics of excluded studies.
Finally, we consider that only two trials (Ding 2004; Wang 2006),
with a total of 120 and 112 participants respectively, fulfilled the
defined inclusion criteria; however we were unable to contact the
authors for more information.
Design of included studies
Details of the characteristics of the included studies are shown in
Characteristics of included studies. The two included studies were
of single centre, parallel design and had a control group. Both of
them mentioned randomisation, but the specific randomisation
procedure was unclear. For both of the two studies, individual
participants formed the unit for allocation, and whether allocation
concealment was used was unknown. Trial duration was two and
four weeks respectively. Both the trials were conducted in China.
Participants in included studies
The number of participants in the studies was 120 (Ding 2004)
and 112 (Wang 2006), and all were diagnosed as cerebral infarction
based on head MRI or CT, and in accordance with the diagnosis
criteria formulated at the 4th Chinese National Symposium on
Cerebrovascular Diseases. The age of participants ranged from 35
to 83 years with mean age about 62 years old. Baseline neurological
impairment was mentioned as similar between the two groups
although detailed data were unavailable.
Interventions in included studies
One study (Ding 2004) compared routine treatment plus tongxin-
luo capsule to routine treatment (detailed data unavailable), the
other study (Wang 2006) compared routine treatment (low molec-
ular heparin, mannitol, citicoline, etc) plus tongxinluo capsule to
routine treatment (low molecular heparin, mannitol, citicoline,
etc).
Tongxinluo was given in the form of capsules and taken orally
three times a day. Doses and duration of treatment however varied
between the two studies: Ding 2004 administered four capsules
at a time for four weeks, while Wang 2006 administered three
capsules for two weeks.
Outcome measures of included studies
Both of the two studies reported neurological impairment and
daily living capability improvement based on Chinese national
therapeutic effect evaluation criteria and the Modified Edinberg-
Scandinavian stroke scale. No primary outcome measures were
reported. Neither were adverse effects.
5
Risk of bias in included studies
Both of the two included trials were of low quality (C). An overview
of study quality can be found in Characteristics of included studies.
Randomisation
Both of the included studies mentioned randomisation, but nei-
ther of them described the method of randomisation in detail.
Allocation concealment
Neither of the included studies mentioned allocation concealment.
We tried to interview the authors of the studies by telephone for
more detailed information but without success.
Blinding
Neither of the two studies mentioned blinding.
Description of withdrawals and losses to follow up
and intention-to-treat analysis
Neither study mentioned withdrawals and losses to follow up, or
performed intention-to-treat analysis.
Similarity of comparison groups at baseline
Both studies considered age and gender to be important factors and
appeared to be balanced across the treatment and control groups,
but no details were available. Wang 2006 reported the duration of
acute stroke.
Effects of interventions
Primary outcome measures
Neither study reported any primary outcome measures as defined.
Secondary outcome measures
Both studies reported neurological impairment and daily living
capability improvement at the end of follow up based on Chinese
National Therapeutic Effect Evaluation Criteria and the Modified
Edinburgh-Scandinavian Stroke Scale.
Ding 2004 showed no significant difference between the two
groups, and that tongxinluo was no better or worse at improving
neurological impairment and daily living capability when com-
paring routine treatment plus tongxinluo capsule to routine treat-
ment (RR 1.24, 95% CI 0.98 to1.56).
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2006 showed that routine treatment (low molecular hep-
arin, mannitol, citicoline, etc) plus tongxinluo capsule was better
at improving neurological impairment and daily living capability
than routine treatment (low molecular heparin, mannitol, citico-
line, etc) alone (RR 1.79, 95% CI 1.35 to 2.36).
Subgroup analysis
The duration of follow up for the two studies was different; we
were therefore unable to analyse the studies according to short or
long-term follow up. It was the same for the subgroup analysis
based on dosage.
DISCUSSION
Limitations of included studies and the review
This systematic review aimed to examine and compare the effec-
tiveness of the traditional Chinese preparation tongxinluo alone
and in combination with placebo or other routine treatment. How-
ever, only two studies which compared tongxinluo plus routine
treatment with routine treatment have been included, both of
which are of low quality. There was weak evidence from one trial of
benefit on the non-standardised outcome improvement in impair-
ment and daily living capability, but no overall estimate of effect
could be obtained because of the marked clinical and statistical
heterogeneity. Overall, studies of tongxinluo for acute ischaemic
stroke lack sufficient power to provide reliable estimates of the
effects.
(1) Both included studies focused on neurological impairment
and daily living capability improvement only in a short treatment
duration, but not on mortality. It has been pointed out that few
trials of traditional Chinese medicine for stroke assess mortality
as the primary outcome, and that reducing the rate of death from
stroke should be the main objective of treatment (Wu 2007). Thus
the follow-up duration should be much longer than the included
studies.
(2) Both the neurological impairment and daily living capability
improvement are highly subjective outcomes rating the partici-
pants current state to their pre-treatment state. Particularly, they
were not tested blindly, so there is a high risk of detection bias.
(3) Neither study found adverse effects in the use of tongxinluo.
Due to the small sample size, safety is yet to be assessed.
(4) Publication bias may exist because only Chinese language pub-
lications were found and included.
6
(5) Among the papers that we retrieved for further details, the
fact that the great majority were small sample clinical trials (less
than 100 people) may limit the applicability of the systematic
review. But due to various reasons, it is a fact that most if not all
studies of traditional Chinese medicines were of a small sample
size. There was no study that reported on the defined primary
outcomes measures.
(6) Most of the trials claimed to be RCTs, but most of them failed
to give adequate and convincing information about the method-
ological quality, and when we telephoned the trial authors about
the method of randomisation they used, we found that many of
them described the concept of randomisation incorrectly.
Meanwhile, both the included studies were of poor methodological
quality and neither randomisation procedure nor blinding and
allocation concealment were mentioned in the studies. This could
lead to a high risk of both selection bias and detection bias. We were
unable to contact the two authors at present. We will make further
attempts to contact relevant authors for detailed information of
allocation concealment and randomisation for an update of this
review in the future.
(7) The administration of tongxinluo capsule lacks a standard reg-
imen, therefore different studies used varying trial durations and
dosage. This may have resulted in some clinical heterogeneity be-
tween studies, making it hard to perform any pooled analysis. Fur-
thermore, the comparator treatment in some trials was probably
sub-optimal. For example, Wang 2006 only used low molecular
heparin, mannitol, and citicoline in the control group. Conse-
quently, tongxinluo may have shown a more beneficial effect in
this particular trial.
(8) Neither of the included studies mentioned ethical issues or
REFERENCES
References to studies included in this review
Ding 2004 {published data only}
Ding L, Du W. Therapeutic effect observation of
Tongxinluo capsule for 68 cases of acute cerebral infarction.
Journal of Traditional Chinese Medicine and Pharmacology
2004;32(2):31–2.
Wang 2006 {published data only}
Wang X. Therapeutic effect observation of Tongxinluo
capsule for 56 cases of acute cerebral infarction. Chinese
Journal of Practical Nervous Diseases 2006;9:72.
References to studies excluded from this review
Cai 2001 {published data only}
Cai DF, Ruan QW, Chen XQ, Shen SJ, Zhao G, Liu J.
Research of tongxinluo capsule for acute stroke. In: Wu YL
editor(s). Luobing theory of Chinese medicine and cardio-
cerebral angiopathy. 1st Edition. Beijing: Chinese Science
and Technical Publish House, 2001:290–1.
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
whether the participants gave informed consent.
AUTHORS’ CONCLUSIONS
Implications for practice
We found insufficient evidence to support the routine use of
tongxinluo for the treatment of acute stroke.
Implications for research
More high quality randomised controlled trials, following the
CONSORT criteria, are required for assessing the effects of
tongxinluo, alone or in combination with placebo or routine stan-
dard treatment for acute ischaemic stroke. Relevant clinical events
such as death and the proportion of participants who were dead
or dependent on others for activities of daily living at the end of
the scheduled follow-up period should be included in outcomes
assessed in these studies, and adverse effects should be investigated
to assess safety.
ACKNOWLEDGEMENTS
We thank Hazel Fraser, Review Group Co-ordinator of the
Cochrane Stroke Group, and Graeme Hankey, Steff Lewis, Brenda
Thomas, Lawrence Wong, Peter Sandercock and Richard Kay for
their advice on writing the review.
Chen 2001 {published data only}
Chen ZH. The effect of Tongxinluo capsule for acute stroke.
In: Wu YL editor(s). Luobing theory of Chinese medicine and
cardio-cerebral angiopathy. 1st Edition. Beijing: Chinese
Science and Technical Publish House, 2001:315.
Ding 2003 {published data only}
Ding XJ, Xu YM, Liu L, Jiang XF, Liu XL, Luo ZM.
Observation of the result of Tongxinluo capsule for the
treatment acute cerebral infarction and analysis of its
mechanism. West China Medical Journal 2003;18(4):494–5.
Fan 2001 {published data only}
Fan WH, Zhang B. Clinical research of Tongxinluo capsule
for acute stroke. In: Wu YL editor(s). Luobing theory of
Chinese medicine and cardio-cerebral angiopathy. 1st Edition.
Beijing: Chinese Science and Technical Publish House,
2001:273–6.
Gu 2004 {published data only}
Gu YM, Zhu Y. Therapeutic effect observation of
Tongxinluo capsule for cerebral infarction. Modern Journal
7
 of Integrated Traditional Chinese and Western Medicine 2004;
13(2):178–9.
Han 2006 {published data only}
Han JL, Wang HC, Yao XH. Therapeutic effect observation
of Tongxinluo capsule for 30 cases of cerebral infarction.
Clinical Journal of Difficult and Complicated Cases 2006;5
(5):363.
Hu 2002 {published data only}
Hu H, Cao ZQ. 80 cases of Tongxinluo capsule for stroke.
Chinese Folk Therapy 2002;10(1):40.
Jia 2001 {published data only}
Jia W, Zhang M. Effect of tongxinluo capsule for stroke. In:
Wu YL editor(s). Luobing theory of Chinese medicine and
cardio-cerebral angiopathy. 1st Edition. Beijing: Chinese
Science and Technical Publish House, 2001:286–7.
Li 2001 {published data only}
Li YH, Chen J, Han X. Clinical observation of Tongxinluo
capsule for acute stroke. In: Wu YL editor(s). Luobing
theory of Chinese medicine and cardio-cerebral angiopathy. 1st
Edition. Beijing: Chinese Science and Technical Publish
House, 2001:306–8.
Liu 2001 {published data only}
Liu L, Zhou HY. Clinical observation of Tongxinluo capsule
for acute stroke. In: Wu YL editor(s). Luobing theory of
Chinese medicine and cardio-cerebral angiopathy. 1st Edition.
Beiing: Chinese Science and Technical Publish House,
2001:302–3.
Liu 2001b {published data only}
Liu WZ, Zheng MY, Gu YL, Hu JW. 30 cases of Tongxinluo
capsule for acute stroke. In: Wu YL editor(s). Luobing
theory of Chinese medicine and cardio-cerebral angiopathy. 1st
Edition. Beijing: Chinese Science and Technical Publish
House, 2001:309–11.
Liu 2001c {published data only}
Liu RM. Observation of tongxinluo capsule for acute stroke.
In: Wu YL editor(s). Luobing theory of Chinese medicine and
cardio-cerebral angiopathy. 1st Edition. Beijing: Chinese
Science and Technical Publish House, 2001:303–4.
Lu 2001 {published data only}
Lu B, Han L. Clinical research of Tongxinluo capsule
for acute stroke. In: Wu YL editor(s). Luobing theory of
Chinese medicine and cardio-cerebral angiopathy. 1st Edition.
Beijing: Chinese Science and Technical Publish House,
2001:313.
Lu 2002 {published data only}
Lu K. Therapeutic effect observation of Tongxinluo capsule
for 62 cases of acute cerebral infarction. Medical Journal of
CASC 2002;4(1):50.
Sun 2000 {published data only}
Sun YS, Lin MS, Zhao L. Therapeutic effect evaluation of
Tongxinluo capsule for ischaemic cerebrovascular diseases.
Chinese Journal of Basic Medicine 2000;6(1):50–1.
Wang 2001 {published data only}
Wang SQ. Observation of ninety cases about Tongxinluo
capsule for acute stroke. In: Wu YL editor(s). Luobing
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
theory of Chinese medicine and cardio-cerebral angiopathy. 1st
Edition. Beijing: Chinese Science and Technical Publish
House, 2001:294–5.
Wang 2006b {published data only}
Wang YL. Clinical observation of tongxiluo in the treatment
of stroke with “qixu xueyu luozhu” signs. Hubei Journal of
Traditional Chinese Medicine 2006;28(4):34–5.
Wu 2001 {published data only}
Wu YM. Observation of Tongxinluo capsule for stroke. In:
Wu YL editor(s). Luobing theory of Chinese medicine and
cardio-cerebral angiopathy. 1st Edition. Beijing: Chinese
Science and Technical Publish House, 2001:314.
Xu 2001 {published data only}
Xu YM, Han F. Observation and analysis of Tongxinluo
capsule for acute stroke. In: Wu YL editor(s). Luobing
theory of Chinese medicine and cardio-cerebral angiopathy. 1st
Edition. Beijing: Chinese Science and Technical Publish
House, 2001:270–3.
Xu 2001b {published data only}
Xu ZQ, Jiang XJ, Li JT. The effect of Tongxinluo capsule
for stroke. In: Wu YL editor(s). Luobing theory of Chinese
medicine and cardio-cerebral angiopathy. 1st Edition.
Beijing: Chinese Science and Technical Publish House,
2001:315.
Xu 2003 {published data only}
Xu YM, Ruan SC, Liu L, Zheng HB, Luo ZM. Effects of
Tongxinluo capsule on neurological impairment and activity
of daily life in acute cerebral infarction. Chinese Journal of
Clinical Rehabilitation 2003;7(19):2709–10.
Yang 2001 {published data only}
Yang ZY, Qian YL. Observation of Tongxinluo capsule for
stroke. In: Wu YL editor(s). Luobing theory of Chinese
medicine and cardio-cerebral angiopathy. 1st Edition.
Beijing: Chinese Science and Technical Publish House,
2001:291–3.
Zhang 2001 {published data only}
Zhang JC. 30 cases about Tongxinluo capsule for acute
stroke. In: Wu YL editor(s). Luobing theory of Chinese
medicine and cardio-cerebral angiopathy. 1st Edition.
Beijing: Chinese Science and Technical Publish House,
2001:278–9.
Zhang 2001b {published data only}
Zhang JX, Zhu JG, Yuan DC, Li ZM, Wu Y, Wang HY.
Observation of Tongxinluo capsule for acute stroke. In: Wu
YL editor(s). Luobing theory of Chinese medicine and cardio-
cerebral angiopathy. 1st Edition. Beijing: Chinese Science
and Technical Publish House, 2001:317.
Zhang 2002 {published data only}
Zhang WY, Yang HP. 25 cases of Tongxinluo capsule for
stroke. Journal of practical traditional Chinese medicine
2002;18(9):10–11.
Zhou 2004 {published data only}
Zhou SN, Zhou GY, Liu LQ. Therapeutic effects of
tongxinluo capsule on patients with acute small cerebral
infarction and its influence on SPECT brain perfusion
8
 image. Chinese Journal of Integrative Medicine 2004;10(2):
107–11.
Zhou 2005 {published data only}
Zhou SN, Zhou GY, Liu LQ. Therapeutic effects of
tongxinluo capsule on patients with acute small cerebral
infarction and its influence on SPECT brain perfusion
image. Journal of the Neurological Sciences 2005;Suppl 1:
238.
References to studies awaiting assessment
Wang 2001b {published data only}
Wang DH, Xi MH, Shi Y. Observation of tongxinluo
capsule for acute stroke. In: Wu YL editor(s). Luobing
theory of Chinese medicine and cardio-cerebral angiopathy. 1st
Edition. Beijing: Chinese Science and Technical Publish
House, 2001:281–2.
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February 2008]. The Cochrane Collaboration, 2008.
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Zhou 2004
Zhou L, Wu T, Duan X, Liu G, Qiao J. Tongxinluo capsule
for acute stroke (Protocol). Cochrane Database of Systematic
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10.1002/14651858.CD004584]
∗
Indicates the major publication for the study
10
CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]

Ding 2004

Methods Design: randomised allocation was mentioned

Randomisation procedure: unclear
Blinding: not mentioned
Duration: 4 weeks

Participants 120 participants all diagnosed as cerebral infarction based on head MRI or CT, and in accordance with the diagnosis
criteria formulated at the 4th Chinese National Symposium on Cerebrovascular Diseases
Tongxinluo group: 62 participants (male/female: 40/22, age: 35 to 76 years, mean age: 64.12 years)
Control group: 58 participants (male/female: 38/20, age: 38 to 75 years, mean age 61.28 years)
Baseline neurological impairment similar between two groups (data unavailable)

Interventions Tongxinluo group: 4 tongxinluo capsules, tid for 4 weeks, and other basic treatment (unavailable)
Control group: the same basic treatment as tongxinluo group (unavailable)

Outcomes Neurological impairment and daily living capability improvement based on Chinese national therapeutic effect
evaluation criteria:
(1) cure
(2) marked improvement
(3) general improvement
(4) no improvement
(5) exacerbation

Notes The quality of this study is rated as C category

Wang 2006

Methods Design: randomised allocation was mentioned

Randomisation procedure: unclear.
Blinding: not mentioned
Duration: 2 weeks

Participants 112 participants all diagnosed as cerebral infarction based on head MRI or CT, and in accordance with the diagnosis
criteria formulated at the 4th Chinese National Symposium on Cerebrovascular Diseases. The onset is within 30
minutes and 48 hours before admission into hospital
Tongxinluo group: 56 participants (male/female: 34/22, age: 42 to 83 years, mean age 62.31 +/- 10.05 years)
Control group: 56 participants (male/female: 32/24, age: 41 to 80 years, mean age 61.64 +/- 9.87 years)
Baseline neurological impairment similar between two groups (data unavailable)

Interventions Tongxinluo group: 3 tongxinluo capsules, tid for two weeks, low-molecular heparin, mannitol, citicoline
Control group: low-molecular heparin, mannitol, citicoline

Tongxinluo capsule for acute stroke (Review) 11

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Wang 2006 (Continued)

Outcomes Neurological impairment and daily living capability improvement based on Chinese national therapeutic effect
evaluation criteria and the Modified Edinburgh-Scandinavian Stroke Scale:
(1) cure
(2) marked improvement
(3) general improvement
(4) no improvement
(5) exacerbation

Notes The quality of this study is rated as C category

CT: computerised tomography

MRI: magnetic resonance imaging
tid: three times per day

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Cai 2001 Randomisation was not mentioned in the study

Chen 2001 Randomisation was not mentioned in the study

Ding 2003 We contacted and interviewed the original author only to find that the trial was actually a retrospective trial with no
research protocol

Fan 2001 Confounded trial as control group used so-called positive effect drugs

Gu 2004 We contacted and interviewed the original author only to find that the trial was actually a quasi-randomised trial
with no blinding

Han 2006 We contacted and interviewed the original author only to find that the trial was actually a quasi-randomised trial
with no blinding

Hu 2002 We contacted and interviewed the original author only to find that the trial was actually a quasi-randomised trial
with no blinding

Jia 2001 Non-randomised controlled trial

Li 2001 Confounded trial as control group used so-called positive effect drugs

Liu 2001 Confounded trial as control group used so-called positive effect drugs

Liu 2001b Confounded trial as control group used so-called positive effect drugs

Tongxinluo capsule for acute stroke (Review) 12

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)

Liu 2001c Randomisation was not mentioned in the study

Lu 2001 Confounded trial as control group used so-called positive effect drugs

Lu 2002 We contacted and interviewed the original author only to find that the trial was actually a non-randomised trial with
no blinding

Sun 2000 We contacted and interviewed the original author only to find that the trial was actually a retrospective trial with no
research protocol

Wang 2001 Confounded trial as control group used so-called positive effect drugs

Wang 2006b This study aims to compare the effect of tongxinluo capsule versus danshen

Wu 2001 The whole study was not available

Xu 2001 Non-randomised controlled trial

Xu 2001b Non-randomised controlled trial

Xu 2003 We contacted and interviewed the original author only to find that the trial was actually a retrospective trial with no
research protocol

Yang 2001 Quasi-randomised controlled trial

Zhang 2001 Confounded trial as control group used so-called positive effect drugs

Zhang 2001b The whole study was not available

Zhang 2002 We contacted and interviewed the original author only to find that the trial was actually a retrospective trial with no
research protocol

Zhou 2004 Quasi-randomised trial

Zhou 2005 Quasi-randomised trial

Tongxinluo capsule for acute stroke (Review) 13

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DATA AND ANALYSES

Comparison 1. Effects

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

1 Improvement 2 Risk Ratio (M-H, Random, 95% CI) Totals not selected
1.1 Tongxinluo capsule and 2 Risk Ratio (M-H, Random, 95% CI) Not estimable
other treatment vs other
treatment

Analysis 1.1. Comparison 1 Effects, Outcome 1 Improvement.

Review: Tongxinluo capsule for acute stroke

Comparison: 1 Effects

Outcome: 1 Improvement

Study or subgroup Tongxinluo Control Risk Ratio Risk Ratio

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

1 Tongxinluo capsule and other treatment vs other treatment

Ding 2004 49/62 37/58 1.24 [ 0.98, 1.56 ]

Wang 2006 50/56 28/56 1.79 [ 1.35, 2.36 ]

0.001 0.01 0.1 1 10 100 1000

Favours control Favours tongxinluo

ADDITIONAL TABLES
Table 1. Composition of tongxinluo

Latin name Common name Pharmacological actions Dosage proportion

Radix Ginseng Ren shen Strengthens cardiac contractil- 10% to 20%

ity, increasing cardiac output,
and has cardiokinetic function,

Tongxinluo capsule for acute stroke (Review) 14

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. Composition of tongxinluo
Scorpio
Hirudo
Eupolyphaga seu Steleophage
Scolopendra
Periostracum Cicadae
Radix Paeoniae Rubra
Borneolum Syntheticum
Tongxinluo capsule for acute stroke (Review)
Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
slows heart rate down, dilates
blood vessel, anticoagulation,
inhibits platelet adhesion reac-
tion
Scorpion Treatment of hypertension, 10% to 20%
apoplexy, arteriosclerosis, some
nervous system diseases, various
tumefaction and infections
Leech Anticoagulation, thrombolysis, 20% to 30%
reduces viscos-
ity of whole blood, anti-myocar-
dial ischaemia, induces choles-
terol and anti-atherosclerosis
Eupolyphaga sinensis walk, Increases cardiac output, im- 10% to 20%
Ground beetle proves tolerance of hypoxia
Centipede Strengthens cardiac contractil- 6% to 15%
ity, decreases blood pressure,
and increases blood vessel per-
fusion flow
Cicada slough Anticonvulsive and slows heart 10% to 20%
rate down
The root of common peony Anticoagulation and prevents 5% to 15%
thrombosis functions, and in-
hibits formation of platelet and
fibrin thrombus, dilates coro-
nary artery directly, has a strong
anti-myocardial ischaemia func-
tion, and changes the content
of lipoprotein, deduces calcium
ion sediments on the arterious
parietes, anti-atherosclerosis
Borneol Analgesia and sedation 2% to 10%
15
WHAT’S NEW
Last assessed as up-to-date: 18 March 2008.

Date Event Description

28 March 2008 Amended Converted to new review format.

HISTORY
Protocol first published: Issue 1, 2004
Review first published: Issue 4, 2008

CONTRIBUTIONS OF AUTHORS
Qi Zhuo and Xunzhe Yang: trials searching, quality assessment of trials, data extraction, data analysis, review development.
Taixiang Wu: protocol development, searching for data, data extraction, data analysis, review development.
Likun Zhou: protocol development.
Guanjian Liu: data analysis.

DECLARATIONS OF INTEREST
None known

SOURCES OF SUPPORT

Internal sources
• Chinese Cochrane Centre, West China Hospital of Sichuan University, China.

External sources
• Chinese Medical Board of New York, USA.

Tongxinluo capsule for acute stroke (Review) 16

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
INDEX TERMS

Medical Subject Headings (MeSH)

Brain Infarction [drug therapy]; Capsules; Drugs, Chinese Herbal [adverse effects; ∗ therapeutic use]; Fibrinolytic Agents [adverse
effects; ∗ therapeutic use]; Randomized Controlled Trials as Topic; Stroke [∗ drug therapy]

MeSH check words

Humans

Tongxinluo capsule for acute stroke (Review) 17

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.