Oral resveratrol in adults with knee osteoarthritis: A randomized placebo-controlled trial (ARTHROL)
What this study found
Oral resveratrol did not reduce knee pain compared with placebo, so the trial does not support its use for painful knee osteoarthritis. In the resveratrol arm, baseline knee pain intensity was 56.9 (14.0) on a 0 to 100 NRS, with mean changes of -15.7 (-21.1 to -10.3) at 3 months and -16.8 (-23.4 to -10.3) at 6 months. OARSI-OMERACT response in the resveratrol arm was 34/66 (52) at 3 months and 29/60 (48) at 6 months. Adverse events were common: 29/71 (41%) had at least 1 serious or minor adverse event, 28/71 (39%) had at least 1 minor adverse event, and 3/71 (4%) had at least 1 serious…
- Study & population
- This was a randomized, placebo-controlled trial conducted at 3 tertiary centers in France in adults with painful radiographic knee osteoarthritis.
- Intervention
- Oral resveratrol in caplets was given as add-on therapy to usual care: 40 mg twice daily for 1 week, then 20 mg twice daily for 6 months, compared with matched placebo.
- Key limitation
- The active arm was modest in size, and outcome denominators were lower than randomized numbers at follow-up, which may reduce precision.
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Open PDFOriginal abstract
Background Resveratrol is a natural compound found in red wine. It has demonstrated anti-inflammatory properties in preclinical models. We compared the effect of oral resveratrol in a new patented formulation to oral placebo for individuals with painful knee osteoarthritis. Methods and findings ARTHROL was a double-blind, randomized, placebo-controlled, Phase 3 trial conducted in 3 tertiary care centers in France. We recruited adults who fulfilled the 1986 American College of Rheumatology criteria for knee osteoarthritis and reported a pain intensity score of at least 40 on an 11-point numeric rating scale (NRS) in 10-point increments (0, no pain, to 100, maximal pain). Participants were randomly assigned (1:1) by using a computer-generated randomization list with permuted blocks of variable size (2, 4, or 6) to receive oral resveratrol (40 mg [2 caplets] twice a day for 1 week, then 20 mg [1 caplet] twice a day; resveratrol group) or matched oral placebo (placebo group) for 6 months. The primary outcome was the mean change from baseline in knee pain on a self-administered 11-point pain NRS at 3 months. The trial was registered at ClinicalTrials.gov: (NCT02905799). Between October 20, 2017 and November 8, 2021, we assessed 649 individuals for eligibility, and from November 9, 2017, we recruited 142 (22%) participants (mean age 61.4 years [standard deviation (SD) 9.6] and 101 [71%] women); 71 (50%) were randomly assigned to the resveratrol group and 71 (50%) to the placebo group. At baseline, the mean knee pain score was 56.2/100 (SD 13.5). At 3 months, the mean reduction in knee pain was −15.7 (95% confidence interval (CI), −21.1 to −10.3) in the resveratrol group and −15.2 (95% CI, −20.5 to −9.8) in the placebo group (absolute difference −0.6 [95% CI, −8.0 to 6.9]; p = 0.88). Serious adverse events (not related to the interventions) occurred in 3 (4%) in the resveratrol group and 2 (3%) in the placebo group. Our study has limitations in that it was underpowered and the effect size, estimated to be 0.55, was optimistically estimated. Conclusions In this study, we observed that compared with placebo, oral resveratrol did not reduce knee pain in people with painful knee osteoarthritis. Trial registration ClinicalTrials.gov ID: NCT02905799.