Efficacy of intensive acupuncture versus sham acupuncture in knee osteoarthritis: A randomized controlled trial.

OBJECTIVE To assess the efficacy of intensive acupuncture (3 times weekly for 8 weeks) versus sham acupuncture for knee osteoarthritis (KOA). METHODS In this multicenter randomized sham-controlled trial, participants with KOA were randomly assigned to receive electro-acupuncture (EA), manual acupuncture (MA) or sham acupuncture (SA) 3 times weekly for 8 weeks. Participants, outcome assessors and statisticians were masked to treatment group assignment. The primary outcome was the response rate, which is the proportion of participants who simultaneously achieved minimal clinically important improvement in pain and function at week 8. The primary analysis was analyzed by the Z-test for proportions with the modified intention-to-treat population, which included all randomized participants who have at least one post-baseline measurement. RESULTS Out of 480 participants recruited in the trial, 442 were evaluated for efficacy. The response rates at week 8 were 60.3% (91/151), 58.6% (85/145), and 47.3% (69/146) in the EA, MA, and SA groups, respectively. The between-group differences were 13.0% (97.5%CI, 0.2% to 25.9%; P=0.0234) for EA vs SA and 11.3% (97.5%CI, -1.6% to 24.4%; P=0.0507) for MA vs SA. The response rates in EA and MA groups were both significantly higher than the SA group at weeks 16 and 26. CONCLUSION Among patients with KOA, compared with SA, intensive EA resulted in less pain and better function at week 8 and these effects persisted though week 26. Intensive MA had no benefit for KOA at week 8, although it showed benefits during follow-up.