title: An open-label pilot study of the combination therapy of metformin and fluoxetine for weight reduction.
abstract: BACKGROUND
  Obesity is a very important risk factor for cardiovascular disease, type 2 diabetes mellitus, hypertension, osteoarthritis, fatty liver, metabolic syndrome and respiratory problems. Many weight-reducing drugs cannot be used in obese patients because of numerous complications. Fluoxetine, an antidepressant, and metformin, an antidiabetic drug, reduce weight as their side effect, but the potency of each drug is not always enough. Here, we studied the effects of combination therapy of them for weight reduction in obese women.
  
  
  METHODS
  This study was designed as an open, prospective, controlled clinical trial. Obese and overweight patients referred to obesity clinics were first put under a diet and behavior therapy education program before being invited to this study. The patients who accepted drug therapy were put in the case group. Those who did not accept drug therapy were put in the control group. Fluoxetine, 20 mg daily, and metformin, 500 mg three times daily, were prescribed to the participants. Weight and body mass index (BMI) changes within case and control groups were analyzed by paired t-tests and between groups by t-testing. Side effects were evaluated by interview and questionnaire.
  
  
  METHODS
  Two hundred and three patients were referred to obesity clinics. Of these, 177 were female with 91 being volunteers for this study. Of this 91, 66 were in the case group and 25 in the control group.
  
  
  RESULTS
  In a 6.68-month period, a 7.89 kg decrease in weight (9.32%) and a 3.43 U decrease in BMI (10.14%) were observed in participants of the case group that was statistically significant (P<0.0001). The participants of the control group were followed for a mean period of 8.12 months. In this period, the participants of the control group showed a 0.48 kg decrease in weight (0.52%) and a 0.11 U decrease in BMI (0.42%). This was not significant. No serious side effects of the drugs were observed in the case group.
  
  
  CONCLUSIONS
  This open-label pilot study of combination therapy of metformin and fluoxetine gave encouraging weight reduction, and these results suggest the need for a randomized double-blind clinical trial comparing the two components and the combination to placebo.
authors.affiliation: Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan Endocrine & Metabolism Research Center, Sedigheh Tahereh Medical Research Complex, Isfahan, Iran. siavash@med.mui.ac.ir
authors.forename: M Siavash
authors.initials: MS
authors.lastname: Dastjerdi
authors.forename: F
authors.initials: F
authors.lastname: Kazemi
authors.forename: A
authors.initials: A
authors.lastname: Najafian
authors.forename: M
authors.initials: M
authors.lastname: Mohammady
authors.forename: A
authors.initials: A
authors.lastname: Aminorroaya
authors.forename: M
authors.initials: M
authors.lastname: Amini
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D015992:Body Mass Index; D004359:Drug Therapy, Combination; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008687:Metformin / Q000009:adverse effects / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
chemical_list: D018687:Antidepressive Agents, Second-Generation; D007004:Hypoglycemic Agents; D005473:Fluoxetine; D008687:Metformin