Challenges of Chinese Medicine Clinical Trials: How to Interpret the Data from “Negative” RCTs?

摘要

In spite of many efforts have been made to evaluate the efficacy of Chinese herbal medicines by using evidence- basedapproaches such as golden standard randomized clinical trial, positive studies are still rarely reported. What can we learnfrom those negative studies? Is it because we used wrong research methodology? By using two RCTs in Chinese medicines asexamples, Prof. Lao will discuss the challenges and possible strategies for future clinical trials. The first study is to examinethe efficacy and safety of Huo-Luo-Xiao-Ling (HLXL)-Dan, a traditional Chinese medicine, in patients with knee osteoarthritis (OA). In this trial, a placebo herbal control was adapted to mimic the real herbs. It was a multi-site, randomized,double-blind, placebo-controlled phase II dose-escalation clinical trial. The results showed that although safe to use, an 8-week treatment of HLXL-Dan was not superior to placebo for reduction in pain or functional improvement in patients withknee OA. The second trial was conducted in the University of Hong Kong. The purposed of the study was to determinewhether a standard dosage of an herbal formula, Tumor-shrinking Decoction (TSD) was more effective than same TSDformula with lower dosage, one third dosage of the standard dosage, in treating patients with uterine fibroids. This was adouble-blind, randomized clinical trial. The results showed that the herbal formula TSD was safe in treating patients withuterine fibroids and both low-dose and high-dose TSD significantly ameliorated UF-related symptoms and fibroid size.