Table 2. Primary and secondary efficacy outcomes.
| Outcome | Resveratrol n = 71 |
Placebo n = 71 |
Absolute difference (resveratrol minus placebo) (95% CI) |
Relative risk (resveratrol vs. placebo) (95% CI) |
p-Value |
|---|---|---|---|---|---|
| Primary efficacy outcome | |||||
| 3 months after randomization | |||||
| • Change in knee pain (NRS, 0–100), mean (95% CI)§ | −15.7 (−21.1 to −10.3) | −15.2 (−20.5 to −9.8) | −0.6 (−8.0 to 6.9) | - | 0.88 |
| Secondary efficacy outcomes | |||||
| 3 months after randomization | |||||
| • Change in WOMAC function subscore (0–68), mean (95% CI)|| | −9.2 (−13.0 to −5.4) | −10.6 (−14.3 to −6.8) | 1.4 (−3.9 to 6.7) | - | 0.59 |
| • Change in PGA (NRS, 0–100), mean (95% CI)¶ | 1.4 (−3.3 to 6.2) | 1.2 (−3.5 to 5.9) | 0.2 (−5.9 to 6.4) | - | 0.95 |
| • OARSI-OMERACT response, n (%) | 34/66 (52) | 34/68 (50) | 1.5 (−15.3 to 18.3) | 1.03 (0.74 to 1.43) | 0.86 |
| • Intra-articular corticoids and/or hyaluronan since last contact | 5/67 (8) | 6/67 (9) | −1.6 (−10.7 to 7.5) | 0.82 (0.27 to 2.51) | 0.73 |
| • Non-opioid analgesics since last contact, n (%) | 38/67 (57) | 39/64 (61) | −4.5 (−21.4 to 12.4) | 0.93 (0.70 to 1.24) | 0.60 |
| • Weak opioid analgesics since last contact, n (%)* | 12/62 (19) | 14/64 (22) | −2.4 (−16.5 to 11.7) | 0.89 (0.45 to 1.76) | 0.74 |
| • Strong opioid analgesics since last contact, n (%)* | 1/62 (2) | 1/60 (2) | −0.2 (−4.9 to 4.5) | 0.90 (0.05 to 15.55) | 0.94 |
| • Nonsteroidal anti-inflammatory drugs since last contact, n (%) | 18/66 (27) | 24/67 (36) | −8.9 (−24.4 to 6.8) | 0.75 (0.46 to 1.25) | 0.27 |
| 6 months after randomization | |||||
| • Change in knee pain (NRS, 0–100), mean (95% CI)§ | −16.8 (−23.4 to −10.3) | −17.1 (−23.4 to −10.9) | 0.4 (−8.4 to 9.1) | - | 0.93 |
| • Change in WOMAC function subscore (0–68), mean (95% CI)|| | −12.6 (−17.3 to −8.0) | −9.4 (−14.0 to −4.9) | −3.2 (−9.5 to 3.1) | - | 0.32 |
| • Change in PGA (NRS, 0–100), mean (95% CI)¶ | 1.8 (−4.2 to 7.9) | 1.9 (−3.9 to 7.8) | −0.2 (−7.7 to 7.5) | - | 0.98 |
| • OARSI-OMERACT response, n (%) | 29/60 (48) | 34/66 (52) | −3.6 (−21.1 to 13.9) | 0.93 (0.74 to 1.43) | 0.68 |
| • Intra-articular corticoids and/or hyaluronan since last contact | 7/60 (12) | 5/65 (8) | 4.0 (−6.2 to 14.1) | 1.51 (0.55 to 4.39) | 0.44 |
| • Non-opioid analgesics since last contact, n (%) | 30/59 (51) | 33/63 (52) | −2.6 (−20.2 to 15.0) | 0.95 (0.68 to 1.34) | 0.77 |
| • Weak opioid analgesics since last contact, n (%)* | 9/60 (15) | 17/62 (27) | −12.3 (−26.5 to 1.9) | 0.55 (0.27 to 1.13) | 0.09 |
| • Strong opioid analgesics since last contact, n (%)* | 1/60 (2) | 1/60 (1) | 0.0 (−4.6 to 4.5) | 0.97 (0.06 to 15.25) | 0.99 |
| • Nonsteroidal anti-inflammatory drugs since last contact, n (%) | 15/60 (25) | 20/65 (31) | −6.5 (−22.0 to 9.0) | 0.79 (0.45 to 1.39) | 0.41 |
*Weak opioids include codeine, dihydrocodeine, and tramadol. Strong opioids include morphine, diamorphine, fentanyl, buprenorphine, oxymorphone, oxycodone, and hydromorphone.
§Higher scores indicate greater pain, n = 71 in resveratrol group and n = 71 in placebo group at baseline, n = 67 and n = 68 at 3 months, n = 60 and n = 66 at 6 months.
||Higher scores indicate more limitations, n = 71 in resveratrol group and n = 71 in placebo group at baseline, n = 66 and n = 67 at 3 months, n = 60 and n = 65 at 6 months.
¶Higher scores indicate better health, n = 71 in resveratrol group and n = 71 in placebo group at baseline, n = 67 and n = 68 at 3 months, n = 60 and n = 66 at 6 months.
CI, confidence interval; PGA, patient global assessment; NRS, numeric rating scale; SD, standard deviation; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index; OARSI-OMERACT, Outcome Measures in Rheumatology-Osteoarthritis Research Society International.