Heat-sensitive moxibustion in patients with osteoarthritis of the knee: a three-armed multicentre randomised active control trial

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.