Wu Jing
Department of Gastroenterology, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210029, Jiangsu Province, China.
Zhong Xi Yi Jie He Xue Bao. 2010 Oct;8(10):906-10. doi: 10.3736/jcim20101001.
World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.
世界卫生组织旨在研发安全、有效且实用的传统医学。如今，中医药及其他补充和替代医学在全球范围内正得到认可。然而，中药的确切疗效仍需科学研究证明。在中药临床试验中，安慰剂对照与阳性对照和空白对照同等重要。本文简要回顾了安慰剂对照的重要性，并对其在中药临床试验中的现状进行了评述。本文还提出了安慰剂在中药临床试验中应用的初步建议。我们应强调科学制备安慰剂以及精心设计安慰剂对照试验，这应以《人用药品注册技术要求国际协调会》为指导。一个良好的临床试验项目将避免不必要的浪费，并为人们提供安全有效的治疗。
