Liu Ting (劉婷), Li Jin-bo (李金波)

1 Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

2 First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300000, China

CONSORT and STRICTA evaluation of randomized controlled trials of acupuncture and rehabilitation for post-stroke limb spasm in recent 10 years in China

Liu Ting (劉婷)1, Li Jin-bo (李金波)2

1 Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

2 First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300000, China

Objective:To evaluate the literature quality of randomized controlled trials of acupuncture plus rehabilitation for post-stroke limb spasm in the recent ten years in China.

Poststroke Syndrome; Hemiplegia; Myospasm; Acupuncture Therapy; Rehabilitation; Randomized Controlled Trial; Literature

Post-stroke limb spasm is frequently encountered during functional restoration after damage of the upper motor neurons, manifested by spasm in the flexor muscle of the upper limb and the extensor muscles of the lower limbs, forming an abnormal motor pattern, seriously affecting the motor functions of the limb and patients’ quality of life[1]. Therefore, how to effectively relieve spasm has become a key and difficult point for rehabilitation from cerebral stroke. In the recent years, the clinical reports about acupuncture plus rehabilitation for the treatment of post-stroke limbspasm had been published increasingly. Moreover, because of its remarkable therapeutic effects, this therapy has gradually become the major therapy for post-stroke limb spasm[2]. Randomized controlled trial (RCT) is a standardized design plan to verify the efficacy and safety of the intervention measures, termed‘golden standard’. Therefore, the document quality about the randomized controlled trials of acupuncture plus rehabilitation for post-stroke limb spasm directly affected the assessment of the clinical effects of the therapeutic plans. Now, the internationally acknowledged consolidated standards of reporting trials (CONSORT) and standards for reporting interventions in clinical trials of acupuncture (STRICTA) are used to evaluate the quality of the documents, in order to provide a foundation for improving the relevant clinical trial reports in the future.

1 Data and Methods

1 Document searching

Four databases of China National Knowledge Internet (CNKI), Wanfang Academic Journal Full-text Database (Wanfang), Chongqing VIP Database (CQVIP) and Chinese Biomedical Literature Database (CBM) were searched in computer. By cross searching in various databases, the manual searching was assisted to avoid omission.

Take the searching strategy for CNKI for example.

#1 Keywords: Cerebral apoplexy OR stroke.

#2 Keyword: Spasm.

#3 Keywords: Acupuncture-moxibustion OR acupuncture.

#4 Keyword: Rehabilitation.

#5 Full text: Random.

#6 Searching duration: January 1, 2005 to January 31, 2015.

Based upon the searching results of #1 AND #2 AND #3 AND #4 AND #5 AND #6, the documents were selected and included.

1.2 Inclusion and exclusion criteria of the documents

1.2.1 Inclusion criteria

Randomized controlled trials; including the subjects of the patients with post-stroke limb spasm; in any age, gender ratio and duration; with relevant diagnostic criteria; intervention measures by acupuncture plus rehabilitation in the trial groups, and any measures in the control groups; only in Chinese.

1.2.2 Exclusion criteria

Documents repeatedly published or in similar contents; document without full text.

1.3 Selection of document and data

Two evaluators respectively and independently selected and screened the documents primarily in accordance with the subjects, abstracts and quotations of the documents, and took out the unqualified ones. Then, they read the full texts and selected the qualified documents based upon the stipulated inclusion and exclusion criteria, and evaluated the quality of the inclusion documents item by item in accordance with 2010 edition of CONSORT and STRICTA, and made the answer of ‘yes’ or ‘no’ based upon the reports. Microsoft Excel 2007 was used to establish database for the selected data. If disagreement took place, it was solved by discussion with the third person.

2 Results

2.1 Situation of document searching

By searching the databases of CNKI、Wanfang、CQVIP and CBM, obtained 284 articles in total, but 234 articles were excluded and finally 50 articles were included. Please see the detailed process in Figure 1.

2.2 General situation of included documents

The publishing time of the included documents was 1 article in 2005[3], 1 article in 2006[4], 4 articles in 2007[5-8], 4 articles in 2008[9-12], 4 articles in 2009[13-16], 5 articles in 2010[17-21], 4 articles in 2011[22-25], 10 articles in 2012[26-35], 10 articles in 2013[36-45], and 7 articles in 2014[46-52]. Please see Figure 2 for the details.

The included documents involved 4 630 cases. The largest amount of test samples were 218 cases and the smallest amount of test samples was 36 cases. Among them, the subjects were divided into two groups of 41 articles. With acupuncture plus rehabilitation as the intervention measure, the rehabilitation groups were set up as control study in 20 articles. Different needling techniques plus rehabilitation were used for control study in 17 articles. Acupuncture plus rehabilitation was used with acupuncture as control study in 3 articles. Acupuncture plus rehabilitation was used with the routine control study in 1 article. Subjects were divided into three groups of 9 articles. Acupuncture plus rehabilitation was used together with control study by acupuncture or rehabilitation alone in 7 articles. Different needling techniques plus rehabilitation were used with the control study by simple rehabilitation in 2 articles.

The evaluated items of the results were mainly based upon modified Ashworth scale (MAS), Fugl-Meyer assessment scale (FMA), Barthel index (BI), and neurological functional deficit scale (NFDS).

Figure 1. Document searching process

Figure 2. Publishing year of the included documents

2.3 Evaluation results of 2010-edition CONSORT

As shown in Table 1, random was mentioned in the title only in 2 articles (4.0%), not convenient for document searching. The research background was mentioned in the introduction part in most articles. But, scientific foundation was included at the same time only in 29 articles (58.0%). No document was mentioned with calculation of sample size, leading to a too big or too small clinical sample size. These factors would affect the authenticity and reliability of the test results. Major issues existed in the random and blind methods in all documents. In some documents, only the word of ‘random’ was mentioned, but without detailed method. The blind method was used in 2 articles (4%), only single blind method for assessing the therapeutic effects and analyzing the data. This might be related to the specificity of acupuncture treatment, in which double blind method was not possible for both patients and therapists. Although the statistical methods were mentioned in 45 articles (90.0%), the detailed use was seldom described. As for the results of the trial reports, there was no procedure of the subjects in all documents, and no follow-up for the subjects. Some documents gave the explanation about it. The documents about the baseline information of the patients shown in the table were not more than half (36.0%), and the statistical contents were not complete. Adverse reaction was mentioned in 11 articles (22.0%) but did not take place. The explanation to the included cases was given only in 1 article (2.0%). There was no estimation for theconclusion in all documents. The theoretical foundation discussed in the documents was mostly about the therapeutic methods, indicating that the trial limitation existed only in 13 articles (26.0%). There were 12 articles (24.0%) belonging to funding projects.

Table 1. Evaluation results of 2010-edition CONSORT of the documents

2.4 Evaluation results of 2010-edition STRICTA

As shown in Table 2, there were only 8 articles mentioning the types of acupuncture methods (16.0%). Because the included documents were published in the domestic journals, in addition to warm needling moxibustion, electroacupuncture and fire-needle method, generally ‘Chinese acupuncture’ would not be explained in particular. In the details of acupuncture treatment, the names of the acupoints were indicated in all articles. But, some articles did not mention the acupoints in the affected side, healthy side or bilateral sides. The number of the used needles was not mentioned in any articles, which was relation to the selection of the acupoints based upon symptoms and signs and it was unable to be restricted. In terms of the needle types, no detailed explanation was given in more than half of the documents (52.0%). The qualification of the therapists was seldom mentioned and only was mentioned in 2 articles (4.0%). In other documents, the professional therapists were mostly expressed. In some documents, the auxiliary and intervention measures in the control study were not described in details. The therapeutic venues and relevant information were not further described in any documents.

Table 2. Evaluation results of 2010-edition STRICTA of the documents

3 Discussion

The quality of RCT documents is certainly influential to whether trial design and practice are correct, to the reliability of the trial results, to whether the patients could comprehensively understand the trials and to the clinical popularization of the intervention measures. Currently, there are many tools to evaluate the quality of the documents. Among them, CONSORT and STRICTA are most authoritative. CONSORT was promulgated in 1996 for the first time and is a standard for randomized controlled clinical study. It can be used to guide the researchers to design and practice the trials and write the reports, but also be regarded as the criteria for quality evaluation of the published documents about the randomized controlled trials. It can be downloaded from the internet free of charge[53]. STRICTA was formally published in 2002. It is especially set up for reporting the intervention measures of acupuncture clinical controlled trials and does not include the standard of all contents in clinical trials[54]. STRICTA is often used together with CONSORT, as a supplementation to CONSORT. The whole text of STRICTA can also be downloaded from the internet free of charge.

CONSORT and STRICTA will be renewed regularly in accordance with the actual application. 2010 editions are used in this study. In the evaluated documents, 14 articles were published before 2010. In the documents after 2010, none of the documents was reported completely based upon the standards of CONSORT and STRICTA, and the quality of the document is generally lower. The issues of titles, sample size estimation, randomization and application of blind methods, and explanation to the procedure of subjects, conclusion and estimated value, and trial limitation, therapeutic plans of adjunct intervention measures, and background of the therapists exist in most documents. We hope the researchers at home can offer standardized RCT reports based upon CONSORT and STRICTA, in order to enhance the document quality and provide a better basis for study of evidence-based medicine.

Conflict of Interest

The authors declared that there was no conflict of interest in this article.

Received: 23 May 2015/Accepted: 23 June 2015

[1] Qiu L, Liu YC. Observation on clinical effects of acupuncture plus rehabilitative training for post-stroke spasmodic hemiplegia. Henan Zhongyi, 2014, 34(9): 1827-1828.

[2] Cui HF, Gao GQ, Wang YL, Yu XH, Guo L, Ren S. Therapeutic efficacy analysis of balancing yin-yang manipulation for post-stroke upper limb spasticity. J Acupunct Tuina Sci, 2014, 12(6): 369-374.

[3] Zeng HH, Wu SL, Huang LR, Ma C, Jin DM. Clinical study on acupuncture plus rehabilitative training for post-stroke muscular spasm. Zhongguo Kangfu Yixue Zazhi, 2005, 20(11): 846-847.

[4] Zhu FL. Clinical study on acupuncture and low-frequency electroacupuncture plus rehabilitative training for poststroke spasmodic status. Liaoning Zhongyi Zazhi, 2006, 33(7): 875-876.

[5] Yang DF, Lin XD, Yu ZM, Wu ZB, Wu XF, Lin JF. Influence of acupuncture plus bobath therapy for apoplectic spasmodic status and motor functions. Liaoning Zhongyi Zazhi, 2007, 34(2): 215-216.

[6] Hai Y, Yu X. Observation on therapeutic effect of acupuncture on spastic dyskinesia due to stroke. Zhongguo Zhen Jiu, 2007, 27(10): 735-737.

[7] Hu JX. Clinical observation on acupuncture plus rehabilitative training for post-stroke muscular spasm. Zhongguo Zhongyiyao Xinxi Zazhi, 2007, 14(8): 64-65.

[8] Luo QP. Clinical observation of acupuncture plus modern rehabilitation for post-stroke spasmodic hemiplegia. CJGMCM, 2012, 27(3): 528-530.

[9] Ren YF. Clinical study on acupuncture plus rehabilitative therapy for post-stroke spasm. Zhongguo Yiyao Zhinan, 2008, 6(23): 426-428.

[10]Ao JB, Li XY, Peng L, Cheng JM, Zhou LZ, Wang J, Mu JP. Clinical observation of 80 cases of spastic hemiplegia of stroke treated by warm acupuncture-moxibustion. Zhongguo Zhongyiyao Xinxi Zazhi, 2008, 15(7): 10-11.

[11]Li Y, Li YF, Pan FQ, Chang YJ, Xu J, Xiao ZX, YangYL, Chen J, Zhao GL. Effect of acupuncture cooperating with bobath approach on spasticity after stroke. Zhongguo Kangfu Lilun Yu Shijian, 2008, 14(11): 1063-1064.

[12]Chen J, Zhang DM, Xu W, Chen L. Clinical observation on acupuncture plus rehabilitation for post-stroke spasmodic hemiplegia. The Proceedings of First Academic Conference of Acupuncture Rehabilitation Medicine of China Acupuncture Association and the Third Academic Conference on Rehabilitation Medicine of Fujian Acupuncture Association, 2008: 2.

[13]Wu P, Liang FR, Hu KM, Tian WW, Yuan XL, Huang YL. Clinical study on acupuncture composite facilitation for post-stroke hemiplegia and limb spasm: a report of 160 cases. Chengdu Zhongyiyao Daxue Xuebao, 2009, 32(1): 11-13.

[14]Liu Y, Peng XH, Zhao Y, Liu J, Yao XQ. Clinical research ofYigan Zhijingacupuncture therapy on spastic limbs after stroke. Sichuan Zhongyi, 2009, 28(4): 114-116.

[15]Wu XM, Yu YM. Clinical study on treatment of post-stroke spasmodic hemiplegia by puncturing Back-Shu points and Jiaji (EX-B 2) points. Beijing Zhongyiyao, 2009, 28(7): 494-496.

[16]Zan DQ. Observation on clinical effects of Jin’s three needles plus occupational therapy for post-stroke spastic hemiplegia. Master Thesis of Guangzhou University of Chinese Medicine, 2009.

[17]Chen X, Chen YF, Mao M, Mou X, Rao P, Bai Y. Acupuncture therapy combined with contemporary rehabilitation techniques for treatment of hemiplegia and spasticity cause by apoplexy. Chengdu Zhongyiyao Daxue Xuebao, 2010, 33(1): 27-29.

[18]Lu JY, Tu WZ, Zhang DY, Xie WX, Li JM, Jiang SH. Effects of acupuncture on different acupoints in combination with rehabilitation on hemiplegic muscle spasticity in hemiplegia patients. Zhongguo Zhen Jiu, 2010, 30(7): 542-546.

[19]Shen W, Sun M, Zhuang LX. Effect ofJinsanzhentherapy combined with rehabilitation training for treatment of post-stroke spasticity. Liaoning Zhongyi Zazhi, 2010, 37(11): 2228-2230.

[20]Dai Z. The clinical effect of acupuncture reinforcement and reduction and rehabilitation in treating muscular spasm caused by apoplexy. Shiyong Zhongyi Neike Zazhi, 2010, 24(9): 97-98.

[21]Chen YY. Clinical observation of acupuncture plus rehabilitative therapy for apoplectic limb spasm. Master Thesis of Guangzhou University of Chinese Medicine, 2010.

[22]Li L. Study on influence of electroacupuncture to serum Glu, GABA contents of apoplectic spastic hemiplegia. Master Thesis of Hunan University of Chinese Medicine, 2011.

[23]Du GQ. Clinical study on acupuncture of antagonistic muscle plus rehabilitative training for post-stroke spastic hemiplegia. Master Thesis of Guangzhou University of Chinese Medicine, 2011.

[24]Li HX, Luo LM, Liu DP, Zhou HF. Clinical observation ontreatment by puncturing acupoints on side of antagonistic muscle for post-stroke limb spasm. Shanghai Zhenjiu Zazhi, 2011, 30(4): 252-253.

[25]Sheng GB, Lu FJ, Liu CY, Wang W. Treatment of post-stroke spastic hemiplegia by puncturing muscular regions plus rehabilitation therapy. JCAM, 2011, 27(5): 25-26.

[26]Fan YH, Li LQ, Yi HL, Li JM, Wang XG, Tao YL. Observation on therapeutic effects of acupuncture plus modern rehabilitation for post-stroke spasm at side of hemiplegia. Xiandai Zhongxiyi Jiehe Zazhi, 2012, 21(33): 3715-3716.

[27]Cao QN, Qiao HF. Influence of acupuncture on antagonistic muscle plus rehabilitative therapy to acute apoplectic hemiplegia and spasm. Shaanxi Zhongyi, 2012, 33(11): 1530-1532.

[28]Feng XG, Zhao SY, Yu L. Clinical observation of acupuncture plus rehabilitation training for apoplectic spastic hemiplegia. Dangdai Yixue, 2012, 18(27): 83-84.

[29]Chen HY. Clinical observation on all-meridian acupuncture therapy plus rehabilitation training for apoplectic spastic hemiplagia in the recovery phase. Master Thesis of Hunan Zhongyiyao Daxue, 2012.

[30]Hu KM, Li N, Lu Y, Yang L, Liu Y, Jin SG, Zeng JP, Yu Q. Clinical study on limb spasticity after stroke treated withYigan Zhijingneedling. Henan Zhongyi, 2012, 32(1): 49-51.

[31]Jin X. Observation on clinical effects of acupuncture plus modern rehabilitative training for post-stroke limb spasm. Zhongguo Yiyao Zhinan, 2012, 10(10): 263-264.

[32]Zhang Y, Liu GC, Wang JY, Sun YG, Yang LJ. Therapeutic observation on contralateral needling plus rehabilitation training for post-stroke spastic hemiplegia. Shanghai Zhenjiu Zazhi, 2012, 31(9): 631-633.

[33]Li FL. Observations on the efficacy of antagonistic muscle acupuncture plus rehabilitation training in treatingpost-stroke spastic hemiplegia. Shanghai Zhenjiu Zazhi, 2012, 31(11): 794-796.

[34]Song JJ. Limb spasm after apoplexy treatment technology research. Master Thesis of Changchun University of Chinese Medicine, 2012.

[35]Xu F, Jiang X. Influence of acupuncture plus rehabilitation training to post-stroke spastic hemiplegia. Zhongguo Baojian Yingyang, 2012, 22(10): 3662.

[36]Huang JB, Chen Q, Wang Z, Zhuo LJ. Effect of warm needling therapy combined with facilitation techniques on patients with spasticity after stroke. Zhongguo Zhongyi Jizhen, 2013, 22(1): 42-44.

[37]Li XJ, Guo QD, Hu CH, Wang XY. Observation on therapeutic effects of scalp acupuncture and synchronous movement therapy for post-stroke spastic hemiplegia. Zhongguo Zhongyiyao Keji, 2013, 20(1): 75-76.

[38]Lang JY, Zhuang LX, He J, Jia C, Zhou ZH, Ke LP. Randomized controlled study on Jin’s three needle therapy on spastic hemiplesia after ischemic stroke. Shanghai Zhenjiu Zazhi, 2013, 32(6): 440-443.

[39]Li D. Randomized and parallel controlled study on acupuncture plus electric stimulation for post-stroke spastic hemiplegia. Shiyong Zhongyi Neike Zazhi, 2013, 28(5): 145-146,162.

[40]Yan WL. Efficacy research on treating limb spasm with three-reinforcing and three-reducing needling combined with rehabilitation training therapy. CJCM, 2013, 5(2): 51, 53.

[41]Tong S, Su L, Lü HB, Liu JQ. Observation on the efficacy of acupuncture at key acupoints combined with rehabilitation therapy for spasmodic hemiplegia after cerebral infarction. Zhongguo Zhen Jiu, 2013, 33(5): 399-402.

[42]Liao FR, Fu CW. Clinical study of yin-yang harmonizing acupuncture plus rehabilitation training for the treatment of post-stroke spastic paralysis. Shanghai Zhenjiu Zazhi, 2013, 32(4): 250-252.

[43]Lu YQ, Yang HT, Zhuang LX, Liu Y. A clinical observation on Jin’s three-needle therapy combined with rehabilitation for 40 cases of post-stroke hemiplegia. Zhongyi Zazhi, 2013, 63(12): 1034-1037.

[44]Zhou CY, Pu R, Zheng WZ, He XH. The rehabilitation effects of acupuncture therapy used for spastic hemiplegia induced by stroke. Zhongguo Xiandai Yaowu Yingyong, 2013, 7(14): 44-45.

[45]Yang HT, Zhuang LX, Liu Y. Efficacy observation on post-stroke spastic hemiplegia treated with temporal three-needle and spastic three-needle therapy. Zhongguo Zhen Jiu, 2013, 33(10): 889-892.

[46]Wu BL. The study of clinical observation of fire acupuncture combined with rehabilitation therapy for stroke spastic paralysis. Master Thesis of Guangzhou University of Chinese Medicine, 2014.

[47]Wang J. Observation on therapeutic effects of fire needle plus theory of muscular region for post-stroke spastic hemiplegia. Master Thesis of Guangzhou University of Chinese Medicine, 2014.

[48] Jia XY. Clinical study on sparse acupuncture on cutaneous regions of yang meridians of sick side by fire needle for post-stroke limb spasm. Master Thesis of Guangzhou University of Chinese Medicine, 2014.

[49]Wang LJ, Wang YL, Wang CY, Wang JK. Clinical observation of combination of opposing needling and jiaji acupuncture in the treatment of spastic state of stroke hemiplegia. Zhongyiyao Xinxi, 2014, 24(2): 88-90.

[50]Zhang Y, Chen WP, Wang CY, Xie T, Wang M, Xia YJ, Wang YL. Modified acupuncture combined with rehabilitation therapy in treatment of limb spasticity in stroke patients. Zhejiang Zhongxiyi Jiehe Zazhi, 2014, 24(4): 290-292.

[51]Qu CY. Clinical observation on treating stroke spastic hemiplegia by acupuncture. Zhongyi Linchuang Yanjiu, 2014, 6(17): 18-19.

[52]Qiu L, Liu YC. Observation on therapeutic effects of acupuncture plus rehabilitative training for post-stroke spastic hemiplegia. Henan Zhongyi, 2014, 34(9): 1827-1828.

[53]Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, G?tzsche PC, Lang T, CONSORT Group (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med, 2001, 134(8): 663-694.

[54]MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med, 2001, 9(4): 246-249.

Translator: Huang Guo-qi (黃國(guó)琪)

近10年中國(guó)針刺結(jié)合康復(fù)治療腦卒中后肢體痙攣隨機(jī)對(duì)照試驗(yàn)的CONSORT及STRICTA評(píng)價(jià)

目的：評(píng)價(jià)國(guó)內(nèi)近十年針刺結(jié)合康復(fù)治療腦卒中后肢體痙攣隨機(jī)對(duì)照試驗(yàn)的文獻(xiàn)質(zhì)量。方法：通過(guò)檢索中國(guó)期刊全文數(shù)據(jù)庫(kù)(China National Knowledge Internet, CNKI)、萬(wàn)方學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)(Wanfang)、重慶維普數(shù)據(jù)庫(kù)(CQVIP)和中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(Chinese Biomedical Literature Database, CBM) 4個(gè)數(shù)據(jù)庫(kù), 篩選針刺結(jié)合康復(fù)治療腦卒中后肢體痙攣隨機(jī)對(duì)照試驗(yàn)(randomized controlled trial, RCT)的文獻(xiàn)。依據(jù)2010版的臨床試驗(yàn)報(bào)告統(tǒng)一標(biāo)準(zhǔn)(consolidated standards of reporting trials, CONSORT)和針刺臨床對(duì)照試驗(yàn)中干預(yù)措施報(bào)告標(biāo)準(zhǔn)(standards for reporting interventions in clinical trials of acupuncture, STRICTA)進(jìn)行RCT文獻(xiàn)的質(zhì)量評(píng)價(jià)。結(jié)果：最終共納入50篇文獻(xiàn), 大部分文獻(xiàn)都存在文題、樣本量估算、隨機(jī)化及盲法的使用、受試者流程、結(jié)局和估計(jì)值、試驗(yàn)局限性的說(shuō)明、輔助干預(yù)措施治療方案及治療師背景等問(wèn)題。結(jié)論：目前針刺結(jié)合康復(fù)治療腦卒中后肢體痙攣的RCT文獻(xiàn)質(zhì)量普遍偏低。今后應(yīng)參照CONSORT和STRICTA進(jìn)行規(guī)范臨床試驗(yàn)報(bào)告, 以提高文獻(xiàn)的質(zhì)量。

中風(fēng)后遺癥; 偏癱; 肌痙攣; 針刺療法; 康復(fù); 隨機(jī)對(duì)照試驗(yàn); 文獻(xiàn)

R246.6 【

】A

Author: Liu Ting, master degree candidate.

E-mail: 6_yuxin@sina.com

Methods:By searching four databases of China National Knowledge Internet (CNKI), Wanfang Academic Journal Full-text Database (Wanfang), Chongqing VIP Database (CQVIP) and Chinese Biomedical Literature Database (CBM), randomized controlled trial (RCT) of acupuncture plus rehabilitation for the treatment of post-stroke limb spasm were screened and selected. In accordance with 2010 edition of the consolidated standards of reporting trials (CONSORT) and standards for reporting interventions in clinical trials of acupuncture (STRICTA), the quality evaluation was processed for RCT documents.

Results:Finally, 50 documents were selected. The issues of titles, sample size calculation, application of randomization and blind method, subject’s procedure, conclusion and estimated value, explanation of trial limitation, auxiliary intervention measures and therapeutic plans, and background of therapists exist in most documents.

Conclusion:Currently, RCT documents about acupuncture plus rehabilitation for the treatment of post-stroke limb spasm are generally of low quality. In the future, it is necessary to standardize the reports of the clinical trials based upon CONSORT and STRICTA, in order to enhance the document quality.