title: Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study.
abstract: OBJECTIVE
  To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement.
  
  
  METHODS
  367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks. The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain, WOMAC stiffness, and WOMAC function scores. Adverse events (AEs) were also recorded.
  
  
  RESULTS
  185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups, respectively. The baseline characteristics were no different between groups. The mean of all WOMAC scores at weeks 0, 2, and 4 showed significant improvement when compared with the baseline in both groups. After using the noninferiority test, the mean difference (95% confidence interval) of WOMAC total, WOMAC pain, and WOMAC function scores at week 4 adjusted by values at week 0 of C. domestica extracts were noninferior to those for the ibuprofen group (P=0.010, P=0.018, and P=0.010, respectively), except for the WOMAC stiffness subscale, which showed a trend toward significance (P=0.060). The number of patients who developed AEs was no different between groups. However, the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group (P=0.046). Most subjects (96%-97%) were satisfied with the treatment, and two-thirds rated themselves as improved in a global assessment.
  
  
  CONCLUSIONS
  C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis. The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group.
authors.affiliation: Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Vilai
authors.initials: V
authors.lastname: Kuptniratsaikul
authors.affiliation: Department of Rehabilitation Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
authors.forename: Piyapat
authors.initials: P
authors.lastname: Dajpratham
authors.affiliation: Sirindhorn National Medical Rehabilitation Center, Ministry of Public Health, Nonthaburi, Thailand.
authors.forename: Wirat
authors.initials: W
authors.lastname: Taechaarpornkul
authors.affiliation: Department of Rehabilitation Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
authors.forename: Montana
authors.initials: M
authors.lastname: Buntragulpoontawee
authors.affiliation: Department of Rehabilitation Medicine, Ratchaburi Hospital, Ministry of Public Health, Ratchaburi, Thailand.
authors.forename: Pranee
authors.initials: P
authors.lastname: Lukkanapichonchut
authors.affiliation: Department of Rehabilitation Medicine, Songkhla Hospital, Ministry of Public Health, Songkhla, Thailand.
authors.forename: Chirawan
authors.initials: C
authors.lastname: Chootip
authors.affiliation: Department of Rehabilitation Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Jittima
authors.initials: J
authors.lastname: Saengsuwan
authors.affiliation: Department of Rehabilitation Medicine, Rajvithi Hospital, Ministry of Public Health, Bangkok, Thailand.
authors.forename: Kesthamrong
authors.initials: K
authors.lastname: Tantayakom
authors.affiliation: Department of Rehabilitation Medicine, Vachira Phuket Hospital, Ministry of Public Health, Phuket, Thailand.
authors.forename: Supphalak
authors.initials: S
authors.lastname: Laongpech
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D030024:Curcuma; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D008517:Phytotherapy / Q000009:adverse effects / Q000379:methods*; D010936:Plant Extracts / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010936:Plant Extracts; D007052:Ibuprofen
keywords: Curcuma domestica; curcumin; efficacy; ibuprofen; knee osteoarthritis; safety