title: The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study.
abstract: BACKGROUND
  Diacerein is a drug used in osteoarthritis (OA) that elicits an inhibitory effect on interleukin-1 and metalloproteases. Although diacerein has shown modest efficacy and safety in the treatment of knee and hip OA, there have been no placebo-controlled clinical trials for hand OA.
  
  
  OBJECTIVE
  The aim of the current study was to investigate the efficacy and tolerability of diacerein in patients with hand OA.
  
  
  METHODS
  Patients fulfilling the American College of Rheumatology criteria for hand OA participated in this randomized, double-blind, placebo-controlled study. Eligible patients were >40 years of age, had at least 1 tender joint, and had a joint pain visual analog scale of >30 mm. Patients received diacerein (50 mg) or placebo BID for 12 weeks. The primary end point was the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 weeks. Secondary end points were AUSCAN pain score at 12 weeks and AUSCAN physical function and stiffness score, patient and physician global assessment, functional index of hand OA scores, and multidimensional health assessment questionnaire results at 4 weeks and 12 weeks.
  
  
  RESULTS
  Eighty-six Korean patients were enrolled (42 diacerein, 44 placebo). The intention-to-treat and per-protocol analyses revealed no significant differences between the 2 groups in terms of change in AUSCAN pain score at 4 weeks, except for improvement in physician global assessment at 4 weeks (per-protocol analysis, P = 0.004). The safety profile of diacerein was comparable to placebo, except for frequent discoloration of the urine (88% vs 20%).
  
  
  CONCLUSIONS
  These results suggest that diacerein 50 mg BID may be ineffective in controlling the symptoms of hand OA. ClinicalTrials.gov identifier: NCT00685542.
authors.affiliation: Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea.
authors.forename: Kichul
authors.initials: K
authors.lastname: Shin
authors.forename: Joon Wan
authors.initials: JW
authors.lastname: Kim
authors.forename: Ki Won
authors.initials: KW
authors.lastname: Moon
authors.forename: Ji Ae
authors.initials: JA
authors.lastname: Yang
authors.forename: Eun Yeong
authors.initials: EY
authors.lastname: Lee
authors.forename: Yeong Wook
authors.initials: YW
authors.lastname: Song
authors.forename: Eun Bong
authors.initials: EB
authors.lastname: Lee
mesh_terms: D000880:Anthraquinones / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006225:Hand / Q000473:pathology*; D006801:Humans; D010003:Osteoarthritis / Q000188:drug therapy*; D010919:Placebos
chemical_list: D000880:Anthraquinones; D000893:Anti-Inflammatory Agents; D010919:Placebos; C025292:diacerein