A Randomized, Double-Blind, Placebo-Controlled Study Investigating the Safety And Efficacy of a Herbal Formulation on Knee Joint Function in Adults with Knee Osteoarthritis.

Abstract

Background: Current treatments for osteoarthritis (OA) pain and stiffness have limitations, including adverse effects. Therefore, effective and safe complementary or alternative therapies are needed. Dietary supplement GJ 191, comprising Epimedium, Dioscorea, and Salvia miltiorrhiza extracts, may address this need. Methods: This randomized, double-blind, placebo-controlled study investigated GJ 191 supplementation on knee OA symptoms. Seventy-two adults (40-75 years) with mild to moderate knee OA and mild to moderate knee pain were enrolled. The Knee Injury and Osteoarthritis Outcome Score (KOOS), Pain Visual Analog Scale (VAS), Quality of Life questionnaire, knee joint range of motion, serum C-reactive protein, and rescue medication use were assessed. The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores were computed using KOOS scores. Results: Decreases in WOMAC pain scores were reported by both GJ 191 and placebo groups after 6 (-1.78 ± 2.71 and -1.34 ± 1.93, respectively; p < 0.01) and 12 (-2.31 ± 2.83 and -1.59 ± 2.69, respectively; p < 0.01) weeks, with no significant difference between groups. There were decreases in WOMAC stiffness scores for participants supplemented with GJ 191 by 0.53 ± 1.22 and 0.72 ± 1.46 (p ≤0.02) after 6 and 12 weeks, respectively, with respective decreases of 0.81 ± 1.51 and 0.75 ± 1.85 (p ≤0.03) for those on placebo. Significant improvements in current pain, as assessed by the Pain VAS, and bodily pain were reported by the GJ 191 group after 6 and 12 weeks, while the placebo group only reported significant improvements in these measures after 12 weeks. GJ 191 supplementation was safe and well tolerated. Conclusion: There was no significant difference in pain and stiffness scores between GJ 191 and placebo over the 12 weeks. While both groups reported improvements in WOMAC pain from baseline, improvements in current and bodily pain were experienced sooner with GJ 191 than placebo and were sustained over the study period. GJ 191 supplementation was safe and well tolerated. (CTR#: NCT04395547).