title: A randomised, double-blinded study comparing giving etoricoxib vs. placebo to female patients with fibromyalgia.
abstract: OBJECTIVE
  Current therapeutic approaches to fibromyalgia syndrome (FMS) do not provide satisfactory pain control to a high percentage of patients. This unmet need constantly fuels the pursuit for new modalities for pain relief. This randomised, double-blind, controlled study assessed the efficacy and safety of adding etoricoxib vs. placebo to the current therapeutic regimen of female patients with FMS.
  
  
  METHODS
  In this double-blind, placebo-controlled study, female patients were randomised to receive either 90 mg etoricoxib once daily or placebo for 6 weeks. Several physical and mental parameters were assessed throughout the study. The primary end-point was the response to treatment, defined as ≥ 30% reduction in the average Brief Pain Inventory score. Secondary outcomes were changes in the Fibromyalgia Impact Questionnaire, SF-36 Quality of Life assessment questionnaire and Hamilton rating scales for anxiety and depression.
  
  
  RESULTS
  Overall, 73 patients were recruited. Although many outcome measures improved throughout the study, no difference was recorded between the etoricoxib- and placebo-treated groups. The Brief Pain Inventory, Fibromyalgia Impact Questionnaire, The Hamilton Anxiety and Depression scores did not differ between the two groups.
  
  
  CONCLUSIONS
  This is the first randomised, double-blind study assessing the effect of adding etoricoxib to pre-existing medications for female patients with FMS. Although being mildly underpowered this study clearly has shown that etoricoxib did not improve pain scores and did not lead to any beneficial mental or physical effects.
authors.affiliation: Department of Medicine 'B', Sheba Medical Center, Tel Hashomer, Israel.|Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: H
authors.initials: H
authors.lastname: Mahagna
authors.affiliation: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.|Ness Ziona Beer Yaacov Mental Health Center, Beer-Yaacov, Israel.
authors.forename: D
authors.initials: D
authors.lastname: Amital
authors.affiliation: Department of Medicine 'B', Sheba Medical Center, Tel Hashomer, Israel.|Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: H
authors.initials: H
authors.lastname: Amital
mesh_terms: D000328:Adult; D000368:Aged; D001007:Anxiety / Q000517:prevention & control; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D003863:Depression / Q000517:prevention & control; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008875:Middle Aged; D059408:Pain Management / Q000379:methods; D010147:Pain Measurement; D011725:Pyridines / Q000627:therapeutic use*; D011788:Quality of Life; D013450:Sulfones / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib