Moxibustion versus diclofenac sodium gel for the treatment of knee osteoarthritis: a double-blinded, double-placebo, randomized controlled trial

ObjectiveThe purpose of this study was to evaluate the difference of efficacy between moxibustion (experimental group) and local diclofenac sodium gel (control group) in the treatment of knee osteoarthritis (KOA).MethodsA multicenter, double-blinded, double-placebo, randomized controlled clinical trial was conducted in this research. 144 participants with knee osteoarthritis were randomly divided into two groups according to 1:1 ratio. The participants in the experimental group were treated with active Moxibustion plus placebo gel, whereas the control group was given diclofenac sodium gel plus placebo moxibustion. Moxibustion treatment was administrated at 3 acupoints (EX-LE4, ST35, ST36) for 4 weeks in 12 sessions. The entire trial cycle lasted 13 weeks, including 1 week at baseline, 4 weeks at treatment and 8 weeks at follow-up. Diclofenac sodium gel or placebo gel at a dose of 4 g per knee were applied three times per day for 4 weeks. The primary outcome measures were the changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures included changes in other subscales of WOMAC (pain, stiffness and function), visual analogue scale (VAS) and participant overall assessment (PGA).ResultsThe analysis showed that both the experimental group and the control group at 2 weeks, 4weeks, 8weeks and 12 weeks were statistically significant compared with baseline (P <0.05). There was no significant difference between the two groups in the first four weeks (P > 0.05). At 8 weeks, WOMAC total score (95% CI, 4.3 [0.5 to 8.1], P=0.03), pain score (95% CI, 1.0 [0.2 to 1.9], P=0.02) and functional score (95% CI, 3.0 [0.1 to 5.8], P=0.04) the control group are better than the experimental group (P < 0.05). At 12 weeks, there were no significant difference between the two groups (P > 0.05). ConclusionsDuring the treatment, moxibustion has the same therapeutic effect as local diclofenac sodium gel, which can alleviate the pain of KOA participants to different degrees, rigidity and dysfunction. The therapeutic effect of it can basically maintained until 2 months after treatment. Local diclofenac sodium gel was superior to moxibustion in relieving knee pain and knee dysfunction at 8 weeks.Trial registration number Clinical Trials.gov, NCT02769572.Date of trial registration May 2016＃These authors contributed equally to this work.