Bian Zhao-Xiang, Li You-Ping, Moher David, Dagenais Simon, Liu Liang, Wu Tai-Xiang, Miao Jiang-Xia, Kwan Andrew K L, Song Lisa
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Zhong Xi Yi Jie He Xue Bao. 2006 Mar;4(2):120-9. doi: 10.3736/jcim20060204.
To discuss the quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) with respect to design and methodology, and provide suggestions for further improvement in future clinical trials.
A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs).
The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6%) trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6%) trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8%) of trials were open-label, while only 13.2% used blinding. Almost half (45.5%) administered the CHM intervention as a tea or decoction. Only one trial (0.6%) reported a sample size calculation, and a single trial (0.6%) discussed quality control of the CHM intervention.
The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area.
(1) Investigator conducting RCTs should have formal training about clinical trial design; (2) A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3) Conducting pilot studies prior to RCTs may help improve their design; (4) Registration of clinical trials and publishing their protocols prior to enrollment may reduce publication bias and solicit peer reviews of the proposed design; (5) Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.
探讨中药随机对照试验（RCT）在设计和方法学方面的质量，并为未来临床试验的进一步改进提供建议。
于2005年7月检索考克兰图书馆，以查找在线的中药RCT。使用根据修订后的CONSORT声明修改的11项清单评估RCT的质量，其中有2项是针对中药的特定项目（即草药制剂形式和草药质量控制）。
检索获得167项RCT并入选评估。所有试验均包含有关干预措施、目标、主要结局设计、统计方法和草药制剂形式的说明。虽然163项（97.6%）试验报告了纳入标准，但只有26项（15.6%）试验报告了排除标准。明确说明随机分配序列产生方法的试验不到10%，仅2.4%提及分配隐藏。绝大多数试验（86.8%）为开放标签，而仅13.2%采用了盲法。几乎一半（45.5%）将中药干预作为茶剂或汤剂给药。只有1项试验（0.6%）报告了样本量计算，且仅有1项试验（0.6%）讨论了中药干预的质量控制。
中药RCT的总体方法学质量较差。改善该临床领域未来RCT的设计至关重要。
（1）开展RCT的研究者应接受关于临床试验设计的正规培训；（2）建议使用流程图以确保纳入临床试验设计的所有关键步骤。（3）在进行RCT之前开展预试验可能有助于改进其设计；（4）临床试验注册并在入组前公布方案可能会减少发表偏倚并征求对拟议设计的同行评审意见；（5）中药研究者与对中西医结合感兴趣的传统医学学术研究中心之间的合作可能会提高中药RCT的质量。
