title: Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms.
abstract: OBJECTIVE
  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.affiliation: Surgical Medical Research Centre, Havana, Cuba.
authors.forename: Roberto
authors.initials: R
authors.lastname: Puente
authors.affiliation: Surgical Medical Research Centre, Havana, Cuba.
authors.forename: José
authors.initials: J
authors.lastname: Illnait
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
authors.forename: Rosa
authors.initials: R
authors.lastname: Mas
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
authors.forename: Daisy
authors.initials: D
authors.lastname: Carbajal
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
authors.forename: Sarahí
authors.initials: S
authors.lastname: Mendoza
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
authors.forename: Julio César
authors.initials: JC
authors.lastname: Fernández
authors.affiliation: Surgical Medical Research Centre, Havana, Cuba.
authors.forename: Meilis
authors.initials: M
authors.lastname: Mesa
authors.affiliation: Centre of Natural Products, National Centre for Scientific Research, Havana, Cuba.
authors.forename: Rafael
authors.initials: R
authors.lastname: Gámez
authors.affiliation: Software Group, National Centre for Scientific Research, Havana, Cuba.
authors.forename: Pablo
authors.initials: P
authors.lastname: Reyes
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003462:Cuba; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005233:Fatty Alcohols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D011795:Surveys and Questionnaires; D013607:Tablets; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000890:Anti-Infective Agents; C104511:D 002; D005233:Fatty Alcohols; D013607:Tablets
keywords: Anti-inflammatory agents; Beeswax alcohols; D 002; Osteoarthritis; Western Ontario and McMaster Individual Osteoarthritis Index score