国内外针刺治疗慢性颈痛随机对照试验的文献质量分析

Literature quality analysis of RCTs regarding acupuncture for chronic neck pain

采用国际公认的试验报告统一标准CONSORT (Consolidated Standards for Reporting of Trials,CONSORT)声明和报告针刺临床试验中干预措施的国际标准STRICTA(Standards for Reporting Interventions in Controlled Trials of Acupuncture,STRICTA)评价近10年国内外针刺治疗慢性颈痛的随机对照试验(randomized controlled trial,RCT)的报告质量。计算机检索针刺治疗慢性颈痛的RCT,英文文献通过PubMed和EMbase,中文文献通过中国知网、万方数据知识服务平台、维普中文期刊服务平台、中国生物医学文献数据库,检索时限为2008年1月至2018年1月。最终纳入29篇中文文献和10篇英文文献。根据CONSORT条目,中文文献有28篇(96.6%)描述了基线资料,23篇(79.3%)描述了随机说明,0篇描述了分配隐藏,3篇(10.3%)提及盲法;英文文献有6篇(60.0%)描述了基线资料,8篇(80.0%)描述了随机说明,8篇(80.0%)描述了分配隐藏,7篇(70.0%)描述了盲法。根据STRICTA条目,中文文献有8篇(27.6%)描述了针具类型,18篇(62.1%)描述了针刺深度,24篇(82.8%)描述了针刺反应,0篇描述了治疗师资历;英文文献有5篇(50.0%)描述了针具类型,8篇(80.0%)描述了针刺深度,3篇(30.0%)描述了针刺反应,4篇(40.0%)描述了治疗师资历。中文文献在针刺细节的报告方面优于英文文献,英文文献在试验设计的报告方面略优于中文文献,而两者均有很多不足,需按照CONSORT声明和STRICTA标准进一步完善临床试验设计以提高临床证据的报告质量。

The internationally-accepted Consolidated Standards for Reporting of Trials(CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture(STRICTA) were applied to evaluate the literature quality of randomized controlled trials(RCTs) regarding acupuncture for chronic neck pain in past 10 years. The literature of RCTs regarding acupuncture for chronic neck pain was searched by computer;the English literature was searched in PubMed and EMbase, while the Chinese literature was searched in CNKI, Wanfang database, VIP database and China Biomedical Literature Database. The literature published from January 2008 to January 2018 was searched. As a result, 29 Chinese articles and 10 English articles were included. According to CONSORT, among Chinese articles, 28 articles(96.6%) described baseline data, 23 articles(79.3%) described randomization, 0 articles(0.0%) described allocation concealment, 3 articles(10.3%) described blind method;among English articles, 6 articles(60.0%) described baseline data, 8 articles(80.0%) described randomization, 8 articles(80.0%) described allocation concealment, and 7 articles(70.0%) described blind method. According to STRICTA, among Chinese articles, 8 articles(27.6%) described needle instrument selection, 18 articles(62.1%) described needle depth, 24 articles(82.8%) described needling sensation, and 0 articles(0.0%) described acupuncturist’ qualifications;among English articles, 5 articles(50.0%) described needle instrument selection, 8 articles(80.0%) described needle depth, 3 articles(30.0%) described needling sensation, and 4 articles(40.0%) described acupuncturist’ qualifications. In conclusion, the reporting of acupuncture details in Chinese literature is superior to that in English literature, while the reporting of trial design in English literature is slightly superior to that in Chinese literature. Moreover, both Chinese and English literature need to further improve clinical trial design to improve the reporting quality of clinical evidence based on CONSORT and STRICTA.