Rixin Chen1, Mingren Chen1, Tongsheng Su2, Meiqi Zhou3, Jianhua Sun4, Jun Xiong1, Zhenhai Chi1, Dingyi Xie1, Bo Zhang1. 1. The Affiliated Hospital with Jiangxi University of TCM, Nanchang, People's Republic of China. 2. Shanxi TCM Hospital, Xian, People's Republic of China. 3. The first Affiliated Hospital with Anhui University of TCM, Hefei, People's Republic of China. 4. Jiangsu TCM Hospital, Nanjing, People's Republic of China.
Abstract
BACKGROUND: In China, heat-sensitive moxibustion (HSM) is used for knee osteoarthritis (KOA) to reduce pain and improve physical activity. However, there is little high-quality evidence of its effectiveness. OBJECTIVE: To evaluate the effectiveness of HSM in the treatment of KOA compared with usual care. METHODS: We performed a multicentre, randomised controlled trial. In total, 432 patients with KOA were randomly assigned to one of three groups (HSM, conventional moxibustion, or conventional injection with sodium hyaluronate). The primary end point was the guiding principle of clinical research on new drugs in the treatment of KOA (GPCRND-KOA). Measurements were obtained at baseline and after 1 and 6 months (month 7) of study. RESULT: For GPCRND-KOA, there were significant differences among the three groups after treatment at months 1 and 7. Pairwise comparisons showed that HSM was more effective than the conventional drug. There was no difference in any measures between conventional moxibustion and the conventional drug. Compared with conventional moxibustion, HSM resulted in greater improvement in all outcomes. CONCLUSIONS: This trial provided some evidence of the superiority of HSM in patients with KOA, suggesting that the observed differences might be due to superiority effects of a heat-sensitive point, although the effect of expectation cannot be ruled out. TRIAL REGISTRATION NUMBER: The trial was registered at Controlled Clinical Trials: ChiCTR-TRC-09000600. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
BACKGROUND: In China, heat-sensitive moxibustion (HSM) is used for knee osteoarthritis (KOA) to reduce pain and improve physical activity. However, there is little high-quality evidence of its effectiveness. OBJECTIVE: To evaluate the effectiveness of HSM in the treatment of KOA compared with usual care. METHODS: We performed a multicentre, randomised controlled trial. In total, 432 patients with KOA were randomly assigned to one of three groups (HSM, conventional moxibustion, or conventional injection with sodium hyaluronate). The primary end point was the guiding principle of clinical research on new drugs in the treatment of KOA (GPCRND-KOA). Measurements were obtained at baseline and after 1 and 6 months (month 7) of study. RESULT: For GPCRND-KOA, there were significant differences among the three groups after treatment at months 1 and 7. Pairwise comparisons showed that HSM was more effective than the conventional drug. There was no difference in any measures between conventional moxibustion and the conventional drug. Compared with conventional moxibustion, HSM resulted in greater improvement in all outcomes. CONCLUSIONS: This trial provided some evidence of the superiority of HSM in patients with KOA, suggesting that the observed differences might be due to superiority effects of a heat-sensitive point, although the effect of expectation cannot be ruled out. TRIAL REGISTRATION NUMBER: The trial was registered at Controlled Clinical Trials: ChiCTR-TRC-09000600. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Eric Manheimer; Ke Cheng; L Susan Wieland; Xueyong Shen; Lixing Lao; Menghu Guo; Brian M Berman Journal: Cochrane Database Syst Rev Date: 2018-05-05