J Neurol (2001) 248 : 558–563 © Steinkopff Verlag 2001
Jongbae Park Val Hopwood Adrian R. White Edzard Ernst
■ Abstract Background Acupuncture has been suggested as a treatment for stroke rehabilitation, but the question whether it is effective has not been answered satisfactorily. Purpose To summarise and critically review all randomised
Received: 20 September 2000 Received in revised form: 16 February 2001 Accepted: 13 February 2001
V. Hopwood Complementary Medicine Research Unit Medical Specialties University of Southampton, UK Jongbae Park KMD MKM () · A. R. White · E. Ernst Dept. of Complementary Medicine School of Postgraduate Medicine and Health Sciences University of Exeter 25 Victoria Park Road Exeter, EX2 4NT, UK Tel.: +44 (0) 13 92-43 90 35 Fax: +44 (0) 13 92-42 49 89 e-mail:J.
[email protected]
REVIEW
Effectiveness of acupuncture for stroke: A systematic review
controlled trials of the effectiveness of acupuncture as a treatment for stroke. Methods Four independent computerised literature searches (in MEDLINE, Cochrane Controlled Trials Register, Embase, and CISCOM data bases) were conducted in June 1999. All randomised-controlled trials that compared any form of needle insertion acupuncture to any form of non-acupuncture control intervention in the treatment of human stroke patients were included. Data were extracted independently by two authors and arbitrated by a third. The methodological quality of the included studies was assessed using the Jadad score. Results Nine randomised controlled trials with a total sample size of 538 patients were included. Two studies were assessor blind, one was subject blind, and one was assessor and subject blind. Two studies exclusively used manual acupuncture, five only electroacupuncture, and two used both.
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Introduction Stroke is a main cause of disability and dependence in the elderly. The overall prevalence of stroke is 17.5/1000 (95 % CI 17.0, 18.0) in the population aged 45 years and over. The prevalence of stroke associated dependence is 11.7/1000 (95 % CI 11.3, 12.1). Approximately 67 % of survivors become functionally dependent [22]. There is
Outcome measures used were Scandinavian Stroke Scale, Chinese Stroke Scale or Recovery Scale, Barthel index, Nottingham Health Profile, Motor function, balance, and days in hospital. Of the nine studies, six yielded a positive result suggesting that acupuncture is effective, and three produced a negative finding implying that acupuncture is not superior to control treatment. Only two studies obtained a Jadad score of more than 3. These methodologically best trials showed no significant effect of acupuncture. Conclusion Based on the evidence of rigorous randomised controlled trials, there is no compelling evidence to show that acupuncture is effective in stroke rehabilitation. Further, better-designed studies are warranted. ■ Key words Acupuncture · Electro-acupuncture · Stroke · Cerebro-vascular accident · Systematic review
no single rehabilitative intervention that has been demonstrated unequivocally to aid recovery. Acupuncture has been used for stroke in China and Korea for centuries, but scientific studies on this topic have only recently started to emerge. Some but not all of these trials have suggested a positive effect on recovery. Two reviews of acupuncture for stroke have been published [5, 10]. These reviews are open to criticism because the literature was not searched systematically [10]
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or inappropriate studies were not excluded [5]. Moreover, new data have been published since.We have therefore undertaken a fresh systematic review to summarise all randomized trials on the subject.
Methods Computerised literature searches were conducted of the following databases: Medline (1969–June 1999), Cochrane Controlled Trials Register (Issue 2, 1999), Embase (1988–1999), and the Centralised Information Service for Complementary Medicine (June 1999), which includes the British Library Alternative Medicine database, AMED, as well as some complementary medicine publications that are not included in the standard databases.Additionally, personal files of all reviewers were searched. The search terms (“acupuncture” or “electrotherapy”) and (“stroke” or “cerebrovascular disorders”) were used.
No language restrictions were applied. In addition, a Chinese database was accessed through the China Academy of Traditional Chinese Medicine in Beijing by a local researcher, using the above search terms. Similarly, a Japanese researcher was asked to contribute any studies found in the library of Toyama Medical and Pharmaceutical University. A Korean researcher searched two leading Korean acupuncture journals (the Journal of Korean Acupuncture Society, and Kyung-Hee University Oriental Medicine Journal) for relevant studies. Copies of all original reports were obtained where possible, and reference lists of these papers were searched for further relevant trials. Articles were included in the review if they reported prospective, randomised, controlled trials (RCTs) in which any form of needle acupuncture was compared with any form of non-acupuncture control intervention for stroke rehabilitation. Decision on inclusion and exclusion of studies was made by discussion between the first 2 authors with arbitration by other 2 authors in one case [20]. Data were extracted using predefined criteria (Table 1, 2). The quality of the study was assessed by using the Jadad score [12]. This validated
Tab. 1 Key Data of Study Design of Randomised Controlled Trials on Effectiveness of Acupuncture for stroke First Author
Subjects (acupuncture)
Days Post Onset
Intervention (Sessions/weeks)
Control
Outcomes CSRM
Zou [31] 1990
63 (32)
> 14
MA(42/6)
Naeser [20] 1992 Johansson [14] 1993
16 (10) 78 (38)
60 10
EA (20/4), 1–2 Hz EA(20/10), 2–5 Hz
Routine care (vinpocetin) Sham EA Rehabilitation only
Hu [11] 1993
30 (15)
EA(12–14/4), 9.4 Hz
Rehabilitation only
Sallström [25] 1995
49 (24)
Zhang [30] 1996 Gosman-Hedström [7] 1998 Si [26] 1998 Duan [4] 1998
1.5 40
64 (31) 104 (37, 34) 42 (20)
8 14 7
92 (47)
Acute
MA + EA or Moxibustion Rehabilitation only (18–24/ 6), 2–4 Hz EA (12–14/2), 2 Hz Rehabilitation only Deep EA + MA (20), 2 Hz 2 (a) sham EA, b) Rehabilitation only) EA (25±10/ 5±2), Routine care 5–45 Hz MA (30/5) Routine care
Follow up, Statistics
None, Non-parametric test Range of movement None, Fisher’s test Walking, Motor function, 1 year, Mann-Whitney Balance, Barthel ADL, test NHP, Days in hospital SSS, Barthel ADL 3 months, Mann-Whitney test MAS, Sunnas ADL, NHP 1 year, Wilcoxon’s test None, χ2 test 1 year, Fisher’s test
CSRM SSS, Barthel ADL, Sunnas ADL, NHP CSS
None, not stated
CSRM
None, t-test
MAS: Motor Assessment Scale; SSS: Scandinavian Stroke Scale; NHP: Nottingham Health Profile; CSS: Chinese Stroke Scale; CSRM: Chinese Stroke Recovery Measure Tab. 2 Key Results of Randomised Controlled Trials on Effectiveness of Acupuncture for stroke First Author
Design1
Primary Outcomes
Main result compared with control
Jadad score
Adverse events (No. of events)
Comment Lesion related Subgroup
Zou [31] 1990 Naeser [20] 1992 Johansson [14] 1993
Open SB Open
No mention No mention No mention
Analysis showed significant improvement.
Open
Significant improvement (p < 0.001) No significant improvement(p > 0.05) Significant improvement (p < 0.01) except active movements score SSS-significant improvement (p=0.02 except Barthel ADL
1 3 2
Hu [11] 1993
CSRM Range of movement Motor function, Barthel ADL, NHP SSS, Barthel ADL
2
Dizziness (1)
Sallström [25] 1995
AB
No mention
Zhang [30] 1996 GosmanHedström [7] 1998 Si [26] 1998. Duan [4] 1998
Open SB, AB
MAS, Sunnas ADL, NHP Significant improvement (p < 0.001) 2 except Sunnas ADL CSRM No significant improvement (p=0.4372) 1 Barthel ADL No significant improvement (P > 0.05) 5
Subgroup analysis showed significant improvement in the poor initial neurological score.
No mention No mention
AB Open
CSS CSRM
No mention No mention
Significant improvement (p < 0.01) Significant improvement (p < 0.001)
1 1
Data more fully given in the follow-up study.
SB: Subject Blind; AB: Evaluator Blind; MAS: Motor Assessment Scale; SSS: Scandinavian Stroke Scale; NHP: Nottingham Health Profile; SS: Chinese Stroke Scale; CSRM: Chinese Stroke Recovery Measure; ADL: Activity of Daily Living 1 All studies were prospective randomised trials with 2 or more parallel arms
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method of assessing quality initially awards 1 point in each category of randomisation, blinding, and description of withdrawals and dropouts. A second point is awarded for randomisation if the method was appropriate, and a point is deducted if the method was inappropriate. Similarly, a second point is awarded if the method of doubleblinding was appropriate, but a point is deducted if the method of blinding was inappropriate. The maximum possible score then is 5 points and the minimum is zero [12]. Assuming that double-blinding means subject and therapist blinding as in pharmaceutical trial, the maximum for an acupuncture study is usually 3 since therapist blinding is impossible. In this review, double blinding was pragmatically interpreted as either subject-therapist, or subject-assessor blinding. Guidelines and checklists for appraising medical articles were adhered to [2, 6]. Study selection and data extraction were performed independently by two authors (JP, VH) except for two studies written in Chinese. These were extracted by one of the authors (JP), and assessed by the same criteria. There was no disagreement, so arbitration was not required. Initially, it was intended to perform a meta-analysis, but this proved impossible because of the heterogeneity of outcome measures used, and the absence of methodological details in several studies.
Results Twenty-two articles were initially located and obtained. Four of them were excluded for using historical controls [19], including disorders other than stroke [29], not relating to a controlled trial [3], or reporting a clinical case series [9]. Five trials were excluded for using another form of acupuncture as a control intervention [8, 13, 16, 17, 23], two further studies used laser acupuncture [21] or transcutaneous electrical nerve stimulation [28]. Two articles were follow-up reports of the included studies [15, 18], which did not present significant new outcome results. None of the articles located by Korean, Chinese, and Japanese researchers met our inclusion criteria. Eventually, nine studies were included in the review [4, 7, 11, 14, 20, 25, 26, 30, 31]. Their key data are summarized in Tables 1 and 2. The total number of subjects enrolled in the trials was 538, of whom 288 received acupuncture. One study used assessor and subject blinding [7], two studies blinded the assessor only [25, 26], and one blinded the subjects only [20]. Two studies used only manual acupuncture [4, 31], five only electro-acupuncture [11, 14, 20, 26, 30], and two used both techniques [7, 25]. Standard medical and rehabilitative treatments or sham electro-acupuncture were used as control intervention. Acupuncture point prescriptions were not consistent except that some points (e. g. LI4, LI11, GB34, TE5, LR3) were used in most studies.A range of outcome measures was used: the Scandinavian Stroke Scale, Chinese Stroke Scale or Recovery measure, Barthel Activities of Daily Living (ADL) index, Nottingham Health Profile (NHP), Motor function, balance, and number of days in hospital. Only two studies obtained a Jadad score of 3 or more. The included studies will be discussed in detail in the following paragraphs. One of the nine trials provided information on adverse event, which was not severe [11].
Zou et al. investigated 63 patients with cerebral infarction confirmed by CT after admission to a Chinese hospital from 2 weeks to more than 6 months after stroke [31]. The intervention group received daily sessions of manual acupuncture for 6 weeks. The control group received vinpocetin 5 mg four times a day as a standard medication. Evaluation was done by using Chinese Stroke Recovery Measure (CSRM), which grades therapeutic effects according to the improvement of function (the higher the points, the more improved) and the state of general viability (the lower the grade, the less disabled) as follows: basically cured, obvious improvement, improvement and no-change. The result showed that, on average, the acupuncture group improved significantly (p < 0.001) compared with controls. However, the quality of study was far below the usual acceptable score for quality obtaining a Jadad score of 1 for randomisation. Naeser et al. studied 16 in-patients in the US, one to three months after left hemisphere infarct [20]. They had to have great reduction in arm and leg power with reduced or no voluntary isolated finger movement. Patients were randomised to receive either electroacupuncture or sham acupuncture, which was similar to real needling but without an electrical current. Range of movement was assessed before and after treatment. The results showed no significantly (p > 0.05) greater improvement in the acupuncture group. However, in an exploratory analysis the authors described significant improvement according to density of lesion (p=0.013), which was used as a secondary endpoint. It should be noted that the required sample size was not calculated, the small sample risks a type II error, and the outcome (i. e. good response or poor response) was not objective. Johansson et al. included 78 patients (median age was 76 years) with severe hemiparesis due to stroke of either side, hospitalised in Sweden [14]. Infarction was confirmed by CT in 53 cases, and not fully excluded in the remainder. Patients had to be able to co-operate during the examination and tests, but unable to walk without support or eat and dress without help. Patients were excluded if they could not independently manage daily activities before stroke onset or if they were wearing pacemakers, because of potential risk of interaction with electro-acupuncture. Acupuncture started within 10 days of stroke onset. All patients received daily standard rehabilitation treatment comprising physiotherapy and occupational therapy, and 38 also received electroacupuncture twice a week for 10 weeks. Motor function, balance, and Barthel ADL were assessed before the start of treatment and at 1 and 3 months after the acute stroke; ADL was also assessed after 12 months. The authors also measured the quality of life (QoL) using the NHP 3, 6, and 12 months after stroke onset. Patients given acupuncture recovered faster and to a greater extent than the controls, with a significant difference for
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balance, walking,ADL, QoL in terms of energy, mobility, emotional reaction and sociality, and days spent at hospitals/nursing homes (p < 0.05). However, motor function was not significantly improved by acupuncture. The 1-year follow-up study was published by Magnusson et al. [18]. Hu et al. conducted a rigorous pilot study (limited by resources) in Taiwan with patients aged 46–74 years within 36 hours of their first ever ischaemic stroke causing limb weakness, but in whom anticoagulant therapy was not indicated at entry [11]. All patients were randomly assigned to rehabilitation therapy with or without electro-acupuncture 3 times per week for 4 weeks. The Scandinavian Stroke Scale (SSS) and Barthel index were adopted as primary outcome measures. A significantly better improvement in neurological score was observed in the acupuncture group on day 28 and day 90 (p < 0.05) but there was no significant difference in Barthel index. The improvement in neurological status was greatest in the patients with a poor neurological score at baseline. This study was the only one that mentioned adverse events, in which one patient complained of dizziness at the beginning of acupuncture but tolerated and completed the study. Sallström et al. investigated whether acupuncture treatment, if given to stroke patients in the subacute phase in addition to routine rehabilitation, would influence motor function, ADL and QoL [25]. Forty-nine patients (median age 57 years) in Norway with hemiparesis following a first ever stroke were included, but those with subarachnoid haemorrhage or other significant diseases were excluded. Patients with global aphasia were included provided they had a sufficient understanding. Median time from onset of stroke to inclusion in the study was 40 days. All patients underwent an individually adapted rehabilitation program. The test group also received electro-acupuncture sessions lasting 20–30 minutes, three to four times a week for six weeks. The Motor Assessment Scale (MAS), Sunnas ADL and NHP were assessed by the blinded assessor at inclusion and six weeks point. The improvement was significantly greater in the acupuncture group compared to the control group in terms of MAS and NHP, but not ADL. Additional data were given in the 1-year follow-up study published by Kjendahl et al. [15]. Zhang et al. tested the effects of electro-acupuncture on CSRM together with vasoactive intestinal peptide, somatostatin, and pancreatic polypeptide in blood and CSF. Patients in a Chinese hospital were included when an acute infarct was confirmed by CT. Results showed no significantly greater improvement of stroke recovery in the acupuncture group. The quality of the study was poor, scoring 1 on the Jadad scale. Gosman-Hëdstrom et al. investigated whether electro-acupuncture treatment favourably affects stroke patients’ ability to perform daily life activities, their health-
related quality of life, and their use of health care and social services [7]. Patients admitted to a Swedish hospital with acute focal nonhaemorrhagic ischaemic stroke were included within 1 week of onset if their paresis was so severe that they could not walk without support, and could not eat and/or dress without assistance. They had to be over 40 years of age and to be able to cooperate mentally. Patients with other severe disease necessitating care in hospital or nursing home, severe aphasia or unconsciousness, an earlier cerebral lesion with a documented need of care, or cardiac pacemaker were excluded. Consecutive patients were randomised to 3 groups: deep acupuncture, superficial acupuncture, and no acupuncture treatment. The acupuncture treatment, started 4 to 10 days after randomisation, was given twice a week by 4 physiotherapists. Electrical stimulation was given to the needles on the paretic side only. All patients underwent conventional stroke rehabilitation as well. Two blinded occupational therapists evaluated the effects 4 times during the first year after. The Scandinavian Stroke Scale, Barthel ADL, Sunnas ADL, NHP were assessed. The result showed no significant differences between experimental and the control group. The methodological quality was superior to all other included studies achieving a Jadad score of 5. Si et al. studied the effects of electro-acupuncture (EA) on Chinese patients with hemiplegia due to acute ischaemic stroke confirmed by CT [26]. Muscle strength had to be limited on the limb on the affected side; patients in coma were excluded. Subjects either received standard treatment or adjunctive electro-acupuncture. Neurological deficit was evaluated before and after treatment using the Chinese Stroke Scale, which ranges from 0 (normal) to maximum 43. The results showed that the functional recovery in the EA group was significantly better (P < 0.01) than in those who received standard treatment alone. However, the poor quality of the study design and report diminish the value of this finding. Duan et al. included 92 acute stroke patients in a Chinese hospital suffering from cerebral infarction confirmed by CT [4]. The subjects were randomised into acupuncture and control groups after stratification according to the location of infarction, i. e. deep (n= acupuncture/ control: 31/ 30) or surface (n= 16/15). All patients also received standard medical treatment. Manual acupuncture was performed once a day for 30 days. The therapeutic effect was assessed by using CSRM. The result suggested a significant (p < 0.001) improvement in the acupuncture group compared with the control group, but the quality of the study was poor since an open study design was used.
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Discussion Perhaps the most remarkable findings of this systematic review are the paucity and the poor average quality of the trials. Of the nine studies included in this review, seven trials obtained 2 or less points on the Jadad scale. In most of the trials, the quality of reporting was poor. For instance, in seven trials a simple description of the method of randomisation and the dropouts was missing. Stroke is a condition for which many confounding variables exist, e. g. aetiology, size and location of the lesion, dominance of the affected side, degree of damage and disability, age, previous medical history. Sufficient sample size is therefore an essential precondition. It is disappointing that in only one study a sample size calculation had been reported [7]. Ideally, non-specific effects, such as expectation, suggestion, therapeutic relationship, etc. should be controlled through subject blinding and sham /placebo controls in trials of acupuncture. However, only two trials used sham acupuncture techniques [7, 20]. Since two different types of sham needles have been developed for use in acupuncture trials [24, 27], subject blinding is now a more realistic option for future research in this area. The interventions used in the studies are not homogeneous, and this constitutes a serious problem for our systematic review. Seven studies used electrical stimulation with variable frequency [20, 26], two of which used combined techniques, manual stimulation with electrical current [7, 25]. Only two trials relied entirely on manual stimulation of acupuncture needles [4, 31]. The difference between the effects of manual and electro-acupuncture could not be explored. It is unclear from any of these trials whether an effect was due to the insertion of needles, or the application of an electric current. Needle sensation (“deqi”) was reported in two studies [7, 26] to indicate that the acupuncture was given correctly. However, this is not very meaningful since there is no consensus for the definition of deqi. Further exploration of the objective criteria of acupuncture should be conducted. Regarding point prescription, there is far less agreement and in fact no point was used in all the studies. Future research should define treatment schedules, and specify the theoretical framework. Another difficulty in comparing these studies is the lack of agreement regarding the outcome measures cho-
sen. The outcomes used can be polarised into two categories: western scales e. g. Scandinavian Stroke Scale, Barthel index, and NHP; and eastern scales e. g. Chinese Stroke Scale or Recovery Measure. It is interesting to note that three of four studies that used Chinese measures reported significant improvement [4, 26, 30, 31], and three of the four that adopted ADL showed no significance [7, 11, 14, 25]. One subject and assessor blind study showed no significant difference between acupuncture and control [7], one subject blind [20] and two assessor blind trials supported the effectiveness of acupuncture [25, 26]. Four of the five remaining open studies were in favour of the effect of acupuncture [4, 11, 14, 31] and one was not [30]. Despite the above-mentioned difficulty in comparing the results, having weighed the quality and results of the study, the overall evidence does not support the effectiveness of acupuncture for stroke rehabilitation, yet it is sufficiently promising to warrant further study. Such trials should incorporate the following features: sample size estimated by statistical calculation; clear definition of modality of acupuncture; acupuncture technique based on evidence, or on a consensus of experts; randomised, subject and assessor blind, and sham-controlled design; relatively homogeneous patient sample; usage of standard validated outcome measures; about 12 sessions of acupuncture over 2–4 weeks; and minimum 6 month follow-up. Finally, the trial should be reported according to the CONSORT statement [1].
Conclusion The evidence from rigorous randomised controlled trials is insufficient to conclude that acupuncture is an effective treatment for stroke rehabilitation. Further research on this topic seems to be warranted but should be conducted according to the highest methodological standards. ■ Acknowledgement Jongbae Park acknowledges with gratitude the support of The British Chevening Scholarship and Youngkwon Kim. Val Hopwood acknowledges the financial support of United Kingdom South West Region NHS Executive. Both authors acknowledge the help of Prof. S. Kagamimori PhD and Prof. P. Guijuan PhD in searching literature in Japan and China.
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