Wu HM, Tang JL, Lin XP, Lau JTF, Leung PC, Woo J, Li Y
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2009, Issue 1
http://www.thecochranelibrary.com
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Acupuncture versus open control, Outcome 1 Improvement of global neurological deficit at
the end of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
1
2
2
3
3
5
7
8
9
9
13
22
22
22
23
23
24
24
24
24
[Intervention Review]
Contact address: Hong Mei Wu, Department of Geriatrics, West China Hospital, Sichuan University, 37 Guo Xue Xiang Street,
Chengdu, Sichuan, 610041, China. drwhm@163.com. drwhm@126.com.
Editorial group: Cochrane Stroke Group.
Publication status and date: Edited (no change to conclusions), published in Issue 1, 2009.
Review content assessed as up-to-date: 15 March 2006.
Citation: Wu HM, Tang JL, Lin XP, Lau JTF, Leung PC, Woo J, Li Y. Acupuncture for stroke rehabilitation. Cochrane Database of
Systematic Reviews 2006, Issue 3. Art. No.: CD004131. DOI: 10.1002/14651858.CD004131.pub2.
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
Background
Stroke is the third leading cause of death in Western society; in China it is the second most common cause of death in cities and
the third in rural areas. It is also a main cause of adult disability and dependency. Acupuncture for stroke has been used in China for
hundreds of years and is increasingly practiced in some Western countries.
Objectives
To assess the efficacy and safety of acupuncture for patients with stroke in the subacute or chronic stage.
Search strategy
We searched the Cochrane Stroke Group Trials Register (November 2005), the Cochrane Complementary Medicine Field Trials Register
(November 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to
November 2005), EMBASE (1980 to November 2005), CINAHL (1982 to November 2005), AMED (1985 to November 2005), the
Chinese Stroke Trials Register (November 2005), the Chinese Acupuncture Trials Register (November 2005), the Chinese Biological
Medicine Database (1977 to November 2005), the National Center for Complementary and Alternative Medicine Register (November
2005), and the National Institute of Health Clinical Trials Database (November 2005). We handsearched four Chinese journals and
checked reference lists of all papers identified for further trials.
Selection criteria
Truly randomised unconfounded clinical trials among patients with ischemic or hemorrhagic stroke, in the subacute or chronic stage,
comparing acupuncture involving needling with placebo acupuncture, sham acupuncture or no acupuncture.
Data collection and analysis
Two review authors independently selected trials for inclusion, assessed quality, extracted and cross-checked the data.
Acupuncture for stroke rehabilitation (Review)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Main results
Five trials (368 patients) met the inclusion criteria. Methodological quality was considered inadequate in all trials. Although the
overall estimate from four trials suggested the odds of improvement in global neurological deficit was higher in the acupuncture group
compared with the control group (odds ratio (OR) 6.55, 95% confidence interval (CI) 1.89 to 22.76), this estimate may not be reliable
since there was substantial heterogeneity (I2 = 68%). One trial showed no significant improvement of motor function between the real
acupuncture group and the sham acupuncture group (OR 9.00, 95% CI 0.40 to 203.30), but the confidence interval was wide and
included clinically significant effects in both directions. No data on death, dependency, institutional care, change of neurological deficit
score, quality of life or adverse events were available.
Authors conclusions
Currently there is no clear evidence on the effects of acupuncture on subacute or chronic stroke. Large, methodologically-sound trials
are required.
BACKGROUND
Stroke is the third leading cause of death in the world (Bonita
1990). In China, stroke is the second most common cause of death
in cities and the third most common cause of death in rural areas
(MOH PRC 1999). Stroke is also a major cause of disability and
dependency in the elderly in the world. The overall prevalence of
stroke is 17.5/1000 per year (95% confidence interval (CI) 17.0
to 18.0) in the population aged 45 years and over. The prevalence
of stroke-associated dependence is 11.7/1000 per year (95% CI
11.3 to 12.1). Approximately 67% of survivors become functionally dependent (OMahony 1999) and 10% require long-term institutional care (DPH 1994) thus imposing a great burden on the
family and community. Despite considerable research efforts on
multiple treatment modalities, there is still no single rehabilitation
intervention demonstrated unequivocally to aid recovery. This reality drives people to search for other modalities of treatment in an
attempt to further improve the outcome of stroke rehabilitation,
such as acupuncture and Chinese herb medicine.
Many studies in animals and humans have demonstrated that
Types of participants
Trials involving patients of any age or sex with ischemic or hemorrhagic stroke in the subacute (one to three months since onset)
or chronic phases (over three months since onset) were eligible.
Stroke must be diagnosed according to the World Health Organization definition (rapidly developed clinical signs of focal (or
global) disturbances of cerebral function, lasting more than 24
hours or leading to death, with no other apparent cause than of
vascular origin (Asplund 1988)); or confirmed by computerised
tomography (CT) or magnetic resonance imaging (MRI). Trials of
patients with subarachnoid hemorrhage and subdural hematoma
were also to be included but were to be analysed separately. Trials
that included patients in the acute phase (within one month since
onset) were excluded.
OBJECTIVES
The objective of this systematic review was to determine the efficacy and safety of acupuncture therapy in patients with subacute
and chronic stroke. We intended to test the following hypotheses:
(1) acupuncture can reduce the risk of death or dependency in
patients with subacute and chronic stroke at the end of treatment
and at follow up;
(2) acupuncture can improve neurological deficit and quality of
life after treatment and at the end of follow up;
(3) acupuncture can reduce the numbers of patients requiring
institutional care;
(4) acupuncture is not associated with any intolerable adverse effects.
METHODS
Types of studies
Randomised controlled clinical trials (RCTs) comparing acupuncture with at least one control group that used placebo, sham treatment or conventional treatment in patients with subacute (one to
three months since onset ) or chronic stroke (over three months
since onset) were included in the review. We excluded trials using
quasi-randomisation or allocating patients using alternation, case
Types of interventions
Trials evaluating acupuncture therapy which involved needling after stroke onset at subacute or chronic phases were included in the
review, regardless of times of treatment and length of treatment
period. Either traditional acupuncture in which the needles were
inserted in classical meridian points or contemporary acupuncture in which the needles were inserted in non-meridian or trigger points were included regardless of the source of stimulation
(for example, hand or electrical stimulation). Trials in which the
acupuncture treatment did not involve needling, such as acupressure or laser acupuncture, were excluded.
The control interventions were placebo acupuncture, sham
acupuncture, or other conventional treatment. Placebo acupuncture refers to a needle attached to the skin surface (not penetrating the skin but at the same acupoints) (Van Tulder 2000). Sham
acupuncture refers to:
(1) a needle placed in an area close to but not in the acupuncture
points (Van Tulder 2000);
(2) subliminal skin electrostimulation via electrodes attached to
the skin (SCSSS 1999).
Comparisons investigated were:
(1) acupuncture only compared with placebo or sham treatment;
(2) acupuncture in addition to baseline medication or treatment
compared with placebo or sham treatment in addition to baseline
medication or treatment;
(3) acupuncture in addition to baseline medication or treatment
compared with baseline medication or treatment alone.
Trials that compared different forms of acupuncture only were
excluded.
(1) The proportion of people requiring institutional care or requiring extensive family support at the end of follow up (at three
months or longer after stroke onset). Family care is the main form
of care for severely dependent people in developing countries.
(2) Changes of neurological deficit after acupuncture treatment
and at the end of follow up (at three months or longer after stroke
onset). The measures could focus on specific impairment (for example, Motricity Index, or Motor Assessment Scale which assess
only motor function) or global neurological deficit (for example,
the National Institute of Health Stroke Scale, European Stroke
Scale, the Scandinavian Stroke Scale) or two kinds of Chinese
Stroke Recovery Scales which involve motor, sensory and other
impaired neurological functions. The Chinese Stroke Recovery
Scale (CSRS 1) refers to the Revised Diagnostic Criteria of Acute
Cerebral Infarction formulated by the second National Academic
Symposium on Cerebrovascular Diseases of the Chinese Medical
Association in 1986, which is similar to the Revised Scandinavian
Stroke Scale (RSSS). The Chinese Stroke Recovery Scale 2 (CSRS
2) refers to the Chinese Stroke Recovery Scale based on principles
of traditional Chinese medicine.
(3) Death from any causes during the entire treatment and followup period.
(4) Quality of life (QOL) at the end of follow up (at three months
or longer after stroke onset). This could be measured by the Nottingham Health Profiles or Spiter Quality of Life Index.
(5) Possible adverse events including dizziness, difficulty in tolerating electrostimulation, infection, puncture of a lung, heart tamponades, spinal cord injury, disrupted pacemaker function; and
presumed to be caused by acupuncture or electrostimulation. The
number of patients developing at least one severe adverse event
listed above was evaluated.
Trials reporting only physiological or laboratory parameters were
excluded.
Acupuncture Research
Chinese Acupuncture and Moxibustion
Journal of Clinical Acupuncture and Moxibustion
Shanghai Journal of Acupuncture and Moxibustion
We checked reference lists of all relevant papers identified, including two systematic reviews (Park 2001; Sze 2002) for further published and unpublished trials.
Study selection
Two review authors (Wu HM, Lin XP) independently checked
the titles and abstracts of trials for inclusion based on selection
criteria outlined above. The full text of the article was retrieved
if there was any doubt whether the article should be excluded or
not. In cases of disagreement between the two review authors, a
third member of the stroke research group (Tang JL) reviewed the
information to decide on inclusion or exclusion of an abstract.
was next. Methods of allocation using date of birth, date of admission, hospital numbers, or alternation were not regarded as appropriate.
(2) Concealment of allocation: scored A (adequate), B (unclear),
or C (inadequate) following criteria adopted from the Cochrane
Handbook for Systematic Reviews of Interventions and Schulz et
al (Schulz 1995).
A: adequate measures to conceal allocations such as central randomisation; serially numbered, opaque, sealed envelopes; or other
description that contained convincing elements of concealment.
B: unclearly concealed trials in which the authors either did not
report an allocation concealment approach at all, or reported an
approach that did not fall into one of the categories in A.
C: inadequately concealed trials in which the method of allocation
was not concealed, such as alteration methods or use of case record
numbers.
(3) Blinding (both of participants and outcome assessors): a study
was regarded as double blind if the phrase double blind was used.
The method was regarded as appropriate if it was stated that neither
the person doing the assessments nor the study participant could
identify the intervention being assessed, or if in the absence of
such a statement the use of active placebos, identical placebos, or
dummies was mentioned.
(4) Intention-to-treat analysis: whether an intention-to-treat analysis was possible on all patients from the published data (that is,
whether there were any exclusions from the trial after randomisation) and the number of patients who were lost to follow up. If
there were no withdrawals, it should be stated in the article.
Quality assessment was performed by two independent review authors (Wu HM, Lin XP) and disagreement reported and resolved
by a third member (Tang JL). These criteria did not form exclusion criteria, and are described in the Characteristics of included
studies table.
Data analysis
The Cochrane Review Manager software, RevMan 4.2, was used
to calculate treatment effects across trials. Heterogeneity between
trial results was tested using a standard chi-squared test, with a
threshold value of p < 0.1, and with the I2 statistic. For dichotomous outcomes, the results were expressed as odds ratio (OR) with
95% confidence intervals (CI). Data were pooled using the random-effects model. If appropriate continuous data reporting the
same scale for each trial had been available we had planned to use
the weighted mean difference (WMD) or the standardised mean
difference (SMD) if different scales had been used.
Because poststroke neurological recovery is known to be obvious
within three months, especially poststroke motor recovery, and is
unlikely beyond six months, mixing patients with interval to stroke
onset of less than three months, three to six months, and more
than six months in one sample would make the assessment of the
efficacy of an intervention methodologically unsound. Therefore,
if appropriate data were available, we planned a subgroup analysis to compare patients with different times to start of treatment
(within three months, three to six months, and after six months)
using the method outlined by Deeks et al (Deeks 2001).
Similarly, if appropriate data were available, we planned a sensitivity analysis to assess the effects of including:
only those trials which were double blind;
only those trials with adequate concealment of
randomisation;
only those trials published in a language other than Chinese.
Finally, if sufficient RCTs were identified, we planned to examine
for potential publication bias (Vickers 1998) using a funnel plot (
Egger 1997).
RESULTS
Data extraction
Information on patients, methods, interventions, outcomes, and
results was extracted independently by two review authors (Wu
HM, Lin XP) using a self-developed data extraction form. Disagreements were resolved by a third member (Tang JL) or through
discussion. For dichotomous outcomes (such as death or dependency, numbers experiencing adverse effects), the number of participants experiencing the event and the total number of participants in each arm of the trial were extracted. For continuous outcomes (impairment scales such as specific neurological disturbance
and QOL), mean change and standard deviation for the mean
change in each arm of the trial were extracted along with the total
number in each group. Data on the number of patients with each
outcome event and by allocated treatment group, irrespective of
compliance or follow up, was sought to allow an intention-to-treat
analysis.
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies.
Fifty potentially eligible trials were retrieved for further assessment. Of these, five trials including a total of 368 patients met
our inclusion criteria. Forty-five trials were excluded because:
(1) they compared two different kinds of acupuncture (22 trials)
(Che 2002; Ding 2000; Feng 1996a; Feng 1996b; Jiang 1998;
Jin 1993; Lai 1997a; Lai 1998; Lai 2004; Li 1994a; Li 1993; Li
1994b; Liang 1993; Qi 2000; Qu 1991; Sui 2001;Tong 1997;
Xiao 1996; Yu 2002; Zhang 2002a; Zheng 1996; Zhou 1995);
(2) of confounding with drug therapy or rehabilitation treatment
(14 trials) (Chen 2000; Cui 1992; Gao 2001; Guo 1999; Hou
1998; Huang 2002; Jiang 2000; Lai 1997b; Liu 2004a; Muo 2001;
Zhang 1988; Zhang 1997; Zhang 2002b; Zheng 2000);
(3) no usable data were available for analysis (four trials) (Fink
2004; Li 1997b; Liu 1998; Wu 1999);
(4) they included patients with acute stroke (five trials) (Kjendahl
1997; Liu 2004b; Sallstrom 1996; Wang 2004; Wei 2005).
For details of each included trial please see the Characteristics of
included studies table.
Of the five included trials, four were conducted in China and one
in the USA. The age of participants ranged from 24 to 86 years.
More men than women were included in three trials (between
56% and 75% men) (Dai 1997; Lun 1999; Wang 2001). Two
trials did not describe the gender characteristics of patients (Li
1997a; Naeser 1992). The range of time from stroke onset was
from one month to 8.5 years. There was one trial involving patients
with interval to stroke onset between one to three months (Naeser
1992), one trial more than three months (Dai 1997) and three
trials including patients with interval to stroke onset of either less
than three months or more than three months (Li 1997a; Lun
1999; Wang 2001). Two trials (Dai 1997; Naeser 1992) included
patients with ischemic stroke only. All other trials included patients
with ischemic and hemorrhagic stroke (Li 1997a; Lun 1999; Wang
2001). There was no trial involving patients with subarachnoid
hemorrhage or subdural hematoma. All of the included trials used
CT or MRI to confirm the diagnosis of stroke. The severity on
entry was mild to severe in two trials (Dai 1997; Naeser 1992),
without a definition of severity, and not stated in the remaining
three trials (Li 1997a; Lun 1999; Wang 2001).
Method of randomisation
Concealment of allocation
Allocation concealment was unclear in all included trials.
Blinding
Only one trial reported that participants were blinded but did not
describe the method in detail (Naeser 1992). No information on
blinding was available in the remaining four trials.
Intention-to-treat analysis
There was no statement on dropouts or withdrawals in any of the
included trials. For each trial the number of patients randomised
was the same as patients analysed, so it appears there were no
exclusions from the trials after randomisation. We conclude that
although the results appear to be analysed by intention to treat we
cannot be certain about this.
In general, the methodological quality of included trials was poor.
An insufficient number of trials prohibited us from performing
meaningful sensitivity analysis in relation to study quality.
Effects of interventions
Subgroup analysis
From the available information, it was not possible to conduct
subgroup analysis on interval to stroke onset of less than three
months, three to six months, and more than six months.
Sensitivity analysis
Changes of global neurological deficit after
acupuncture treatment and at the end of follow up
Four trials with a total of 352 patients (Dai 1997; Li 1997a; Lun
1999; Wang 2001) measured improvement of global neurological deficit after acupuncture treatment by using categorical approaches only (CSRS 1 and CSRS 2) rather than continuous scales,
for example changes of global neurological deficit score. There was
significant heterogeneity among the four trials (chi squared P =
0.04, I2 = 68%), which was possibly due to differences in outcome
measurements used, times of evaluation from stroke onset, and
types of stroke. This means that the overall estimate of treatment
effect is not reliable. Hence, the apparent improvement of global
neurological deficit in the acupuncture group compared with the
control group (OR for neurological improvement with acupuncture 6.55, 95% CI 1.89 to 22.76) should be interpreted with caution.
Publication bias
It was not possible to perform a funnel plot for checking publication bias in this systematic review because of limited number of
trials for each outcome.
DISCUSSION
Five trials with a total of 368 patients were included in this review.
Compared with three previous systematic reviews on acupuncture for stroke (Liu 2005; Park 2001; Sze 2002), the present review included only patients in the subacute or chronic stage of
stroke. However, there was still no clear evidence on the effects of
acupuncture on subacute or chronic stroke.
Although the overall estimate appeared to show there was a significant improvement of global neurological deficit after acupuncture
treatment, this result needs to be interpreted with caution. The
result was based on data from four trials with a limited number
of patients (total of 352 patients); the trials were of very poor
methodological quality with regard to method of randomisation,
allocation concealment and blinding of assessment. Methodologically less rigorous studies show larger differences between experimental and control groups than do those conducted with better
rigor (Kjaergard 1999; Moher 1998; Schulz 1995). Schulz et al (
Schulz 1995) found that odds reductions were exaggerated by up
to 30% for trials that did not have clear concealment, and by 41%
for inadequately concealed trials.
AUTHORS CONCLUSIONS
Implications for practice
This systematic review does not provide evidence to support the
routine use of acupuncture for patients with subacute or chronic
stroke.
ACKNOWLEDGEMENTS
We would like to thank Mrs Hazel Fraser for providing us with
relevant trials and systematic reviews from the Cochrane Stroke
Group Trials Register; Mrs Brenda Thomas for her help with developing the search strategy and helpful comments; Kelvin Tsoi
and Wilson Tam for providing us with statistical support; and
Yanling Zhang, Jun Li and Hongwei Zhang for copying trials. We
would also like to express our gratitude to Dr Livia Candelise, Dr
Andrew Vickers, Dr Steff Lewis and lead editor Prof Peter Sandercock for their very helpful comments.
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10
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12
CHARACTERISTICS OF STUDIES
RCT.
Method of randomisation: not stated.
Blinding: not stated.
ITT analysis: not stated.
Losses to FU: none.
Participants
Country: China.
Number of patients included: 136 (46/45/45).
Demographics: aged 48 to 86 yrs, 75% male.
Type of stroke: cerebral infarction only.
Diagnosis: WHO definition and all confirmed by CT.
Severity on entry: mild to severe.
Time from stroke onset: 3 to 14 months.
Setting: unclear.
Comparability: unclear.
Interventions
3 arms:
(1) acupuncture + WM;
(2) acupuncture only;
(3) WM only.
Comparison eligible:
acupuncture + WM versus WM.
Acupuncture treatment
(1) Acupuncture rationale: not stated.
(2) Needling details:
points used: both body and scalp (three temporal points) acupoints.
Numbers of points used: 5 - 11 points.
Depths of insertion: 1.5 - 2.0 inch.
Deqi elicited: Yes.
Needle stimulation: manual.
Needle retention time: 30 min.
Needle type: stainless steel, gauge 26 - 30# with length 2.0 - 2.6 inch.
(3) Treatment regimen:
Number of treatment sessions: 30 sessions.
Frequency of treatment: 1 session/day.
Total course: 30 days.
(4) Practitioner background: not stated.
(5) Co-intervention:
aspirin 25 mg qd orally.
Control interventions
WM: aspirin 25 mg qd orally.
13
Dai 1997
(Continued)
Outcomes
Number of patients with improvement in global neurological deficit (CSRS 1 score decrease > 18%) at
the end of treatment.
FU: 30 days.
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
Li 1997a
Methods
RCT.
Method of randomisation: not stated.
Blinding: not stated.
ITT analysis: not stated.
Losses to FU: none.
Participants
Country: China.
Number of patients included: 112 (42/20/50).
Demographics: aged 24 to 76 yrs.
Type of stroke: both ischemic and hemorrhagic strokes.
Diagnosis: WHO definition and all confirmed by CT or MRI.
Severity on entry: not stated.
Time from stroke onset: 1 month to 8.5 yrs.
Setting: inpatients.
Comparability: comorbidity and past history similar.
Interventions
3 arms:
(1) acupuncture + PT and OT
(2) acupuncture only
(3) PT and OT.
Comparison eligible: acupuncture + PT and OT versus PT and OT.
Acupuncture treatment
(1) Acupuncture rationale: not stated.
(2) Needling details
Points used: both body and scalp acupoints. Numbers of points used: 10 - 12 points.
Depths of insertion: not stated.
Deqi elicited: unclear.
Needle stimulation: manual.
Needle retention time: 30 min.
Needle type: not stated.
(3) Treatment regimen Number of treatment sessions: 72 sessions.
Frequency of treatment: 6 sessions/week.
Total course: 3 months.
(4) Practitioner background: not stated.
14
Li 1997a
(Continued)
(5) Co-intervention:
baseline medication, PT and OT.
Control interventions: baseline medication plus PT and OT.
Outcomes
Number of patients with improvement in global neurological deficit (CSRS 1 score) at the end of treatment.
FU: 3 months.
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
Lun 1999
Methods
RCT.
Method of randomisation: not stated.
Blinding: not stated.
ITT analysis: not stated.
Losses to FU: none.
Participants
Country: China.
Number of patients included: 109 (61/48).
Demographics: aged 35 to 75 yrs, 60% male.
Type of stroke: both ischemic and hemorrhagic strokes.
Diagnosis: WHO definition and all confirmed by CT before entry.
Severity on entry: not stated.
Time from stroke onset: 2 months to 5 years.
Setting: unclear
Comparability: unclear.
Interventions
Comparison: acupuncture
+ TCM versus TCM.
Acupuncture treatment
(1) Acupuncture rationale: not stated.
(2) Needling details
Points used: scalp acupoints. Numbers of points used: 5 points.
Depths of insertion: 2 - 2.6 inch.
Deqi elicited: yes.
Needle stimulation: manual.
Needle retention time: 30 min.
Needle type: stainless steel needle with gauge 28 - 30# and length 2.6 inch.
(3) Treatment regimen
Number of treatment sessions: 30 sessions.
Frequency of treatment: 1/day.
15
Lun 1999
(Continued)
Number of patients with improvement in global neurological deficit (CSRS 2) at the end of treatment.
FU: 45 days.
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
Naeser 1992
Methods
RCT.
Method of randomisation: not stated.
Blinding: patients blinded.
ITT analysis: not stated.
Losses to FU: none.
Participants
Country: USA.
Number of patients included: 16 (10/6).
Demographics: aged 44 to 74 yrs.
Type of stroke: cerebral infarction only.
Diagnosis: all confirmed by CT.
Severity on entry: moderate.
Time from stroke onset: 1 - 3 months.
Setting: inpatients.
Comparability: no significant difference in age or time post onset.
Interventions
16
Naeser 1992
(Continued)
Number of patients with improvement in motor function (BMIT) within 5 days after completing treatment.
FU: 35 days.
Notes
Conclusion of authors:
negative.
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
Wang 2001
Methods
RCT.
Method of randomisation: not stated.
Blinding: not stated.
ITT analysis: not stated.
Losses to FU: none.
Participants
Country: China.
Number of patients included: 90 (34/30/26).
Demographics: aged 39 to 75 yrs, 56% male.
Type of stroke: both ischemic and hemorrhagic strokes.
Diagnosis: WHO definition and all confirmed by CT.
Severity on entry: not stated.
Time from stroke onset: 2 months to 5 years.
Setting: unclear.
Comparability: unclear.
Interventions
3 arms:
(1) acupuncture + TCM
(2) acupuncture only
(3) TCM only.
Comparison eligible:
acupuncture + TCM versus TCM only.
Acupuncture treatment
(1) Acupuncture rationale: not stated.
17
Wang 2001
(Continued)
Number of patients with improvement in global neurological deficit (CSRS 2) at the end of treatment.
FU: 78 days.
Notes
Risk of bias
Item
Authors judgement
Description
Allocation concealment?
Unclear
B - Unclear
18
Che 2002
The trial aimed to assess effects of two methods of acupuncture on subacute or chronic stroke. Acupoints were
different between the two groups.
Chen 2000
Confounded; the trial aimed to assess effects of acupuncture only compared with drug therapy (such as WM or
TCM).
Cui 1992
It was not possible to include data from this trial in the analysis (see reason for exclusion for Chen 2000).
Ding 2000
It was not possible to include data from this trial in the analysis (see reason for exclusion for Che 2002).
Feng 1996a
It was not possible to include data from this trial in the analysis (see reason for exclusion for Che 2002).
Feng 1996b
It was not possible to include data from this trial in the analysis (see reason for exclusion for Che 2002).
Fink 2004
It was not possible to include data from this trial in the analysis. MAS scores (as a clinical measure of spasticity)were
assessed before and after the treatment period but mean change of neurological score after the treatment period was
not available.
Gao 2001
It was not possible to include data from this trial in the analysis (see reason for exclusion for Chen 2000).
Guo 1999
The trial aimed to assess effects of acupuncture only compared with PT and OT.
Hou 1998
The trial aimed to assess the effects of the combination of acupuncture, oxygen and herbs compared with acupuncture
or oxygen respectively.
Huang 2002
It was not possible to include data from this trial in the analysis (see reason for exclusion of Chen 2000).
Jiang 1998
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Jiang 2000
It was not possible to include data from this trial in the analysis (see reason for exclusion of Chen 2000).
Jin 1993
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Kjendahl 1997
The trial included patients with stroke less than one month since onset although the median time to post-stroke
was more than one month.
Lai 1997a
The trial aimed to assess the effects of electrical acupuncture compared with manual acupuncture. Acupoints were
the same between the two groups.
Lai 1997b
It was not possible to include data from this trial in the analysis (see reason for exclusion of Chen 2000).
Lai 1998
The trial aimed to assess the effects of electrical acupuncture compared with manual acupuncture. Acupoints were
the same between two groups.
19
(Continued)
Lai 2004
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Li 1993
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Li 1994a
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Li 1994b
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Li 1997b
No outcome measures of interest were available in the trial, which aimed to assess the effects of acupuncture on the
change of intellectual disturbance in patients with vascular dementia caused by cerebrovascular disease.
Liang 1993
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Liu 1998
It was not possible to include data from this trial in the analysis. ADL was assessed before and after the treatment
period but the number of patients being independent after the treatment period was not available. The trial primarily
aimed to assess the effects of acupuncture on the intellectual disturbance in patients with vascular dementia due to
stroke.
Liu 2004a
Confounded (acupuncture plus one kind of Chinese herbs versus another kind of Chinese herbs).
Liu 2004b
The trial included patients with stroke less than one month since onset (that is, acute stroke).
Muo 2001
It was not possible to include data from this trial in the analysis (see reason for exclusion of Chen 2000).
Qi 2000
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Qu 1991
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Sallstrom 1996
The median time to post-stroke was more than one month, but the trial included patients with acute stroke (that
is, less than one month).
Sui 2001
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Tong 1997
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
Wang 2004
Randomisation was not stated; the trial included patients with acute stroke (less than one month since onset).
Wei 2005
The trial included patients with ischemic stroke less than one month since onset (that is, acute stroke). Data for
patients with hemorraghic stroke more than 150 days were not separated from data for patients with ischemic
stroke.
Wu 1999
Data on pre-planned outcome measures of interest were not available from the trial, which aimed to assess the
effects of acupuncture on urinary incontinence in stroke patients.
Xiao 1996
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
20
(Continued)
Yu 2002
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002 and Chen
2000).
Zhang 1988
It was not possible to include data from this trial in the analysis (see reason for exclusion of Chen 2000).
Zhang 1997
It was not possible to include data from this trial in the analysis (see reason for exclusion of Chen 2000).
Zhang 2002a
The trial aimed to assess the effects of magnetic acupuncture compared with routine acupuncture. Acupoints were
similar between the two groups.
Zhang 2002b
The duration of stroke since onset was not stated in the trial; it was not possible to include data from this trial in
the analysis (see reason for exclusion of Chen 2000).
Zheng 1996
The trial aimed to assess the effects of combination of body and scalp acupuncture compared with body acupuncture
only or scalp acupuncture only.
Zheng 2000
Zhou 1995
It was not possible to include data from this trial in the analysis (see reason for exclusion of Che 2002).
21
No. of
studies
No. of
participants
352
1 Improvement of global
neurological deficit at the end
of treatment
Statistical method
Effect size
Analysis 1.1. Comparison 1 Acupuncture versus open control, Outcome 1 Improvement of global
neurological deficit at the end of treatment.
Review:
Study or subgroup
Treatment
Control
n/N
n/N
Dai 1997
44/46
30/45
24.6 %
Li 1997a
38/42
42/50
28.0 %
Lun 1999
59/61
25/48
24.9 %
Wang 2001
32/34
21/26
22.5 %
183
169
100.0 %
Odds Ratio
Weight
M-H,Random,95% CI
Odds Ratio
M-H,Random,95% CI
0.1 0.2
0.5
Favours control
10
Favours treatment
22
APPENDICES
Appendix 1. MEDLINE search strategy
The following search strategy, using a combination of controlled vocabulary and text word terms, was used for MEDLINE and was
modified to suit other databases.
MEDLINE (Ovid)
1 exp cerebrovascular disorders/
2 (stroke$ or poststroke$ or cva$).tw.
3 (cerebrovascular$ or cerebral vascular).tw.
4 (cerebral or cerebellar or brainstem or vertebrobasilar).tw.
5 (infarct$ or isch?emi$ or thrombo$ or apoplexy or emboli$).tw.
6 4 and 5
7 (cerebral or intracerebral or intracranial or parenchymal).tw.
8 (brain or intraventricular or brainstem or cerebellar).tw.
9 (infratentorial or supratentorial).tw.
10 7 or 8 or 9
11 (haemorrhage or hemorrhage or haematoma or hematoma).tw.
12 (bleeding or aneurysm).tw.
13 11 or 12
14 10 and 13
15 1 or 2 or 3 or 6 or 14
16 acupuncture/
17 exp acupuncture therapy/
18 electroacupuncture/
19 meridians/
20 acupuncture points/
21 acupuncture$.tw.
22 (electroacupuncture or electro- acupuncture).tw.
23 acupoints.tw.
24 ((meridian or non-meridian or trigger) adj10 point$).tw.
25 or/16-24
26 15 and 25
27 limit 26 to human
WHATS NEW
Last assessed as up-to-date: 15 March 2006.
20 October 2008
Amended
23
HISTORY
Protocol first published: Issue 2, 2003
Review first published: Issue 3, 2006
15 July 2008
Amended
CONTRIBUTIONS OF AUTHORS
Wu HM: developing search strategy, assessment of studies, data extraction, data analysis, data entry, writing of protocol and review.
Lin XP: assessment of studies, data extraction, data entry.
Tang JL: developing search strategy, assessment of studies, data analysis, resolution of disagreements, writing protocol and review.
Lau J: expertise, suggestions and corrections.
Leung PC: expertise, suggestions and corrections.
Woo J: expertise, suggestions and corrections.
Li YP: expertise, suggestions and corrections.
DECLARATIONS OF INTEREST
None known
SOURCES OF SUPPORT
Internal sources
Hong Kong Branch of Chinese Cochrane Center, China.
Department of Community & Family Medicine, Chinese University of Hong Kong, China.
Chinese Cochrane Center, West China Hospital, Si Chuan University, China.
External sources
Hong Kong Croucher Foundation, China.
24
INDEX TERMS
Medical Subject Headings (MeSH)
Acupuncture
25