Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms

다국어 초록 (Multilingual Abstract)

Background/Aims: Nonsteroidal anti-inflammatory drugs relieve osteoarthritis(OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols,is effective against experimental OA. A pilot study found that D-002 (50 mg/day)for 8 weeks improves OA symptoms. The aim of this study was to investigate theeffects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms.
Methods: Patients with OA symptoms were double-blindly randomized to D-002(50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontarioand McMaster Individual Osteoarthritis Index (WOMAC) and the visual analogscale (VAS) scores. Patients without symptom improvement at week 3 were titratedto two daily tablets. The primary outcome was the total WOMAC score. WOMACpain, joint stiffness and physical function scores, VAS score, and use of rescuemedications were secondary outcomes.
Results: All randomized patients (n = 60) completed the study, and 23 experienceddose titration (two in the D-002 and 21 in the placebo groups). At study completion,D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), andphysical function (66.9%) WOMAC scores, and the VAS score (46.8%) versusplacebo. These reductions were significant beginning in the second week, andbecame enhanced during the trial. The use of rescue medication by the D-002(6/30) group was lower than that in the placebo (17/30) group. The treatment waswell tolerated. Seven patients (two in the D-002 and five in the placebo group)reported adverse events.
Conclusions: These results indicate that D-002 (50 to 100 mg/day) for 6 weeksameliorated arthritic symptoms and was well tolerated.

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