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

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 the effects 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 Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analog scale (VAS) scores. Patients without symptom improvement at week 3 were titrated to two daily tablets. The primary outcome was the total WOMAC score. WOMAC pain, joint stiffness and physical function scores, VAS score, and use of rescue medications were secondary outcomes.

RESULTS:

All randomized patients (n = 60) completed the study, and 23 experienced dose 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%), and physical function (66.9%) WOMAC scores, and the VAS score (46.8%) versus placebo. These reductions were significant beginning in the second week, and became 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 was well 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 weeks ameliorated arthritic symptoms and was well tolerated.

• Authors: Roberto Puente, José Illnait, Rosa Mas, Daisy Carbajal, Sarahí Mendoza, Julio César Fernández, Meilis Mesa, Rafael Gámez, Pablo Reyes
• Journal: The Korean journal of internal medicine (Korean J Intern Med) Vol. 29 Issue 2 Pg. 191-202 (Mar 2014) ISSN: 2005-6648 [Electronic] Korea (South)
• PMID: 24648802 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Infective Agents
• D 002
• Fatty Alcohols
• Tablets

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Anti-Infective Agents (administration & dosage, adverse effects, therapeutic use)
• Cuba
• Double-Blind Method
• Drug Administration Schedule
• Fatty Alcohols (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Osteoarthritis (diagnosis, drug therapy, physiopathology)
• Pain Measurement
• Surveys and Questionnaires
• Tablets
• Time Factors
• Treatment Outcome
• Young Adult