Korean J Intern Med.  2014 Mar;29(2):191-202. 10.3904/kjim.2014.29.2.191.

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

• Puente R
• Illnait J
• Mas R
• Carbajal D
• Mendoza S
• Fernandez
• Mesa M
• Gamez R
• Reyes P

• KMID: 1792035
• DOI: http://doi.org/10.3904/kjim.2014.29.2.191

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.

Keyword

Anti-inflammatory agents; D 002; Beeswax alcohols; Osteoarthritis; Western Ontario and McMaster Individual Osteoarthritis Index score

MeSH Terms

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
Questionnaires
Tablets
Time Factors
Treatment Outcome
Young Adult
Anti-Infective Agents
Fatty Alcohols
Tablets