- 作者：Bin Hua ; Peter Ryan ; Dinesh Varma ; Regina Belski ; Lisa Nelson ; Alan Hayes ; Kylie O鈥橞rien
- 关键词：Osteoarthritis ; Knee ; Chinese herbal medicine ; Double blind ; Placebo controlled ; Randomised clinical trial
- 刊名：European Journal of Integrative Medicine
- 出版年：December, 2013
- 年：2013
- 卷：5
- 期：6
- 页码：553-560
- 全文大小：292 K
Introduction
Chinese herbal medicine (CHM) is a popular alternative therapy for osteoarthritis (OA), however the majority of CHM efficacy studies have been methodologically inadequate. This study was the first randomised, double-blind, and placebo-controlled clinical trial of a CHM formula in an Australian OA population.Methods
Eligible participants were randomised to receive either CHM or placebo over 12 weeks, with a one month follow-up. Each subject attended a total of six clinic visits. Study participants and investigators were both blinded to the block randomisation number code until the statistical analyses were completed. The Western Ontario and McMaster Universities Arthritis (WOMAC) Index was used as the primary outcome variable. Safety monitoring was conducted throughout the study.
Results
47 participants were recruited into the study. The study had a 62% power to detect a significant difference in the primary outcome variable. Within-group analyses indicated significant improvements (p < 0.05) in terms of change of the WOMAC indices of pain, physical activity and total score in both groups, but there was no significant difference (p > 0.05) between the groups. The effectiveness of the CHM formula was maintained in the follow-up period but not in the placebo group. Safety data indicated the CHM was safe and well tolerated.
Conclusions
There is some limited indication of a therapeutic effect for the CHM. Larger scale studies over a longer time period are required.
This article belongs to the Special Issue: 鈥業G000020鈥?