BACKGROUND: A large collaborative 8-week study has shown fluoxetine to be effective and safe in treating patients with bulimia nervosa. The present study evaluated fluoxetine over 16 weeks. METHOD: Fifteen US out-patient psychiatry clinics conducted a double-blind parallel study in men and women with DSM-III-R bulimia nervosa (483 patients entered, 398 randomised [3:1 ratio, fluoxetine 60 mg/day or placebo], 225 completed). Outcome measures included change in vomiting and binge-eating episodes per week. Eating Disorder Inventory, Clinical Global Impressions and Patient's Global Impression. RESULTS: Compared with placebo, fluoxetine treatment resulted in significantly greater reductions in vomiting (F[1,360] = 14.73, P < 0.0001) and binge-eating (F[1,360] = 14.39, P = 0.0002) episodes per week at endpoint and improvement in other outcome measures. Adverse event, vital sign and laboratory analyses indicated that fluoxetine was safe. CONCLUSION:Fluoxetine appeared to be safe and effective in patients with bulimia nervosa for up to 16 weeks.
RCT Entities:
BACKGROUND: A large collaborative 8-week study has shown fluoxetine to be effective and safe in treating patients with bulimia nervosa. The present study evaluated fluoxetine over 16 weeks. METHOD: Fifteen US out-patient psychiatry clinics conducted a double-blind parallel study in men and women with DSM-III-R bulimia nervosa (483 patients entered, 398 randomised [3:1 ratio, fluoxetine 60 mg/day or placebo], 225 completed). Outcome measures included change in vomiting and binge-eating episodes per week. Eating Disorder Inventory, Clinical Global Impressions and Patient's Global Impression. RESULTS: Compared with placebo, fluoxetine treatment resulted in significantly greater reductions in vomiting (F[1,360] = 14.73, P < 0.0001) and binge-eating (F[1,360] = 14.39, P = 0.0002) episodes per week at endpoint and improvement in other outcome measures. Adverse event, vital sign and laboratory analyses indicated that fluoxetine was safe. CONCLUSION:Fluoxetine appeared to be safe and effective in patients with bulimia nervosa for up to 16 weeks.
Authors: James E Mitchell; Stewart Agras; Scott Crow; Katherine Halmi; Christopher G Fairburn; Susan Bryson; Helena Kraemer Journal: Br J Psychiatry Date: 2011-03-17 Impact factor: 9.319
Authors: H Blair Simpson; Chad T Wetterneck; Shawn P Cahill; Joanna E Steinglass; Martin E Franklin; Rachel C Leonard; Theodore E Weltzin; Bradley C Riemann Journal: Cogn Behav Ther Date: 2013-01-15