Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
BMJ Open. 2013 Jul 16;3(7). doi: 10.1136/bmjopen-2013-002968. Print 2013.
Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.
To describe the characteristics of TCM trials, estimate bias risk and outcome-reporting bias in clinical trials.
Fifteen trial registries were searched from their inception to July 2012 to identify randomised trials on TCM including Chinese herbs, acupuncture and/or moxibustion, cupping, tuina, qigong, etc.
We extracted data including TCM specialty and treated disease/conditions from the registries and searched for subsequent publications in PubMed and Chinese databases. We compared information in the registries of completed trials with any publications focusing on study design, sample size, randomisation, bias risk including reporting bias from the register protocol.
1096 registered randomised trials were identified evaluating TCM, of which 505 were completed studies (46.1%). The most frequent conditions were pain (13.3%), musculoskeletal (11.7%), nervous (8.7%), digestive (7.1%), circulatory (6.5%), respiratory (6.3%), mental and behavioural disorders (6.2%) and cancer (6.0%). The trial register data identified parallel, phase II/III randomised trials with sample size estimations and blinding, but limited information about randomisation (sequence generation and allocation concealment). Comparing trial registration data of 115 completed trials (22.8%) with their subsequent 136 publications, inconsistencies were identified in one or more of the following: sample size (11%), outcome assessor blinding (37.5%), primary outcomes (29%) and safety (28%) reporting.
Increasing numbers of clinical trials investigating a variety of TCM interventions have been registered in international trial registries. The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos. However, selective outcome reporting is widespread and similar to conventional medicine and therefore study conclusions should be interpreted with caution.
中药临床试验应在公开可获取的国际临床试验注册平台上进行注册，并报告所有结局。我们系统地评估和评价了注册平台中的中药试验，并对其随后的出版物进行了分析。
描述中药试验的特征，估计临床试验中的偏倚风险和结局报告偏倚。
从创建伊始至 2012 年 7 月，我们检索了 15 个临床试验注册平台，以确定关于中药（包括草药、针灸和/或艾灸、拔罐、推拿、气功等）的随机对照试验。
我们从注册平台中提取了包括中医药专科和治疗疾病/病症的信息，并在 PubMed 和中文数据库中检索了随后的出版物。我们比较了已完成试验的注册平台信息与任何出版物，重点关注研究设计、样本量、随机分组、偏倚风险（包括来自注册平台方案的报告偏倚）。
共确定了 1096 项评估中药的注册随机试验，其中 505 项为已完成的研究（46.1%）。最常见的病症为疼痛（13.3%）、肌肉骨骼（11.7%）、神经（8.7%）、消化（7.1%）、循环（6.5%）、呼吸（6.3%）、精神和行为障碍（6.2%）以及癌症（6.0%）。试验注册平台数据可识别平行、Ⅱ/Ⅲ期随机试验，具有样本量估计和盲法，但关于随机分组的信息有限（序列生成和分配隐藏）。将 115 项已完成试验（22.8%）的注册平台数据与随后的 136 项出版物进行比较，发现以下一个或多个方面存在不一致：样本量（11%）、结局评估者盲法（37.5%）、主要结局（29%）和安全性（28%）报告。
越来越多的中药干预临床试验已在国际临床试验注册平台上注册。注册中药试验的研究设计在估计样本量、使用盲法和安慰剂方面有所改进。然而，选择性结局报告仍很普遍，与常规药物相似，因此应谨慎解释研究结论。
