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), 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

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Translator: Huang Guo-qi (黃國琪)

近10年中國針刺結(jié)合康復(fù)治療腦卒中后肢體痙攣隨機(jī)對照試驗(yàn)的CONSORT及STRICTA評價(jià)

目的：評價(jià)國內(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)對照試驗(yàn)的文獻(xiàn)質(zhì)量。方法：通過檢索中國期刊全文數(shù)據(jù)庫(China National Knowledge Internet, CNKI)、萬方學(xué)術(shù)期刊全文數(shù)據(jù)庫(Wanfang)、重慶維普數(shù)據(jù)庫(CQVIP)和中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(Chinese Biomedical Literature Database, CBM) 4個(gè)數(shù)據(jù)庫, 篩選針刺結(jié)合康復(fù)治療腦卒中后肢體痙攣隨機(jī)對照試驗(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)局限性的說明、輔助干預(yù)措施治療方案及治療師背景等問題。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.