Leung Kelvin S Y, Bian Zhao-Xiang, Moher David, Dagenais Simon, Li You-Ping, Liu Liang, Wu Tai-Xiang, Miao Jiang-Xia
School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Zhong Xi Yi Jie He Xue Bao. 2006 May;4(3):225-32. doi: 10.3736/jcim20060302.
To discuss quality control of Chinese herbal medicine (CHM) in randomized controlled trials (RCTs), and to provide suggestions for improving this aspect in future clinical study in this therapeutic area.
A search of the Cochrane Library was conducted to identify RCTs of CHM. Quality control information reported in those RCTs was then assessed independently.
The search yielded a total of 167 RCTs of CHM for a variety of conditions. A total of 11 CHM preparations were used in those RCTs. Only one trial discussed quality control of the CHM interventions used. Issues affecting the safety and efficacy of CHM products used in RCTs were discussed including standardization of raw herbal materials, processing methods, screening for product contamination, and effects of combination products.
The overall quality of reporting of RCTs of CHM was poor, reflecting the need for improvements in reporting future clinical trials in this area.
To improve quality control of CHM used in RCTs in future, we recommend developing and implementing guidelines such as Good Agricultural Practice (GAP) for Chinese crude drugs, and current Good Manufacturing Practice (GMP) specific to CHM products. Chemical analyses of individual herbs of CHM and combination products are also recommended to provide reference standards for quality control.
探讨随机对照试验（RCT）中中药的质量控制，并为该治疗领域未来的临床研究在这方面的改进提供建议。
检索考克兰图书馆以识别中药的随机对照试验。然后对这些随机对照试验中报告的质量控制信息进行独立评估。
检索共获得167项针对各种病症的中药随机对照试验。这些随机对照试验中共使用了11种中药制剂。只有一项试验讨论了所使用的中药干预措施的质量控制。讨论了影响随机对照试验中使用的中药产品安全性和有效性的问题，包括生药材的标准化、加工方法、产品污染筛查以及复方产品的影响。
中药随机对照试验的报告总体质量较差，这反映出该领域未来临床试验报告需要改进。
为了在未来改进随机对照试验中使用的中药的质量控制，我们建议制定并实施指南，如中药材的良好农业规范（GAP）以及针对中药产品的现行药品生产质量管理规范（GMP）。还建议对中药单味药和复方产品进行化学分析，以提供质量控制的参考标准。
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