Bian Zhao-xiang, Moher David, Li You-ping, Wu Tai-xiang, Dagenais Simon, Cheng Chung-wah, Li Jing, Li Ting-qian
Zhong Xi Yi Jie He Xue Bao. 2008 Jul;6(7):661-7. doi: 10.3736/jcim20080701.
Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.
在随机对照试验（RCT）中，应简洁准确地报告中医干预措施。根据国家食品药品监督管理总局的分类，我们建议按以下方式报告干预措施：（1）基于单味中药/方剂/提取物的干预措施包括：1）名称、剂型和注册情况；2）干预措施的组成和质量；3）制药工艺和质量控制；4）最终产品的稳定性和质量控制；5）功能和安全性描述；6）剂量和疗程；7）对照组。（2）基于活性成分的中药药物干预措施包括：1）活性成分名称；2）活性成分的原始来源；3）获得活性成分的简要过程；4）最终产品中活性成分的百分比；5）添加物质及其质量和数量控制。此外，干预措施的详细信息可作为在线补充内容在网站上发布。
