Effects of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms: a randomized placebo-controlled study

Background and purpose: Non selective non-steroidal anti-inflammatory drugs and ciclooxygenase 2 inhibitors provide symptoms relief in osteoarthritis (OA), but produce several adverse effects (AE), which supports the search for other options. D-002, a mixture of higher aliphatic beeswax alcohols, has been shown to produce anti-inflammatory effects experimentally. This double-blind study investigated the effects of D002 (50 mg/day) on patients with OA symptoms randomized to D-002 (50 mg) or placebo for 8 weeks. Methods: The primary efficacy outcome was the reduction of the total Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) score. The decrease on pain, joint stiffness, physical activity scores, and use of rescue medications were secondary outcomes. Treatment tolerability was assessed. Results: Four patients (3 D-002, 1 placebo) discontinued the study, none due to adverse experiences (AE). At study completion D-002 significantly reduced the total WOMAC score versus baseline (p<0.0001, 49.9%) and placebo (p <0.001, 38.0%), and also decreased the pain (p <0.001; 30.6%), joint stiffness (p <0.05 26.5%) and physical activity (p <0.0001, 41.2%) scores versus placebo. After 2 weeks on therapy all benefits were significant already. The use of rescue medication in D-002 (3/30, 10%) was lower (p <0.05) than in placebo (10/30; 33.3%). Treatment was well tolerated. Five patients (2 D-002, 3 placebo) reported mild AE. Conclusions: D-002 (50 mg/day) given for 8 weeks improved OA symptoms, the benefits being evident from week 2, and was well tolerated. D-002 could be a suitable option for managing OA symptoms, but this appreciation requires extensive further research. Keywords––anti-inflammatory, beeswax alcohols, D-002, osteoarthritis, WOMAC score