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An open-label pilot study of the combination therapy of metformin and fluoxetine for weight reduction.
Int J Obes (Lond). 2007 Apr; 31(4):713-7.IJ

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.

MATERIALS AND 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.

SUBJECTS

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.

CONCLUSION

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+Show Affiliations

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.irNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Controlled Clinical Trial
Journal Article

Language

eng

PubMed ID

16969361

Citation

Dastjerdi, M Siavash, et al. "An Open-label Pilot Study of the Combination Therapy of Metformin and Fluoxetine for Weight Reduction." International Journal of Obesity (2005), vol. 31, no. 4, 2007, pp. 713-7.
Dastjerdi MS, Kazemi F, Najafian A, et al. An open-label pilot study of the combination therapy of metformin and fluoxetine for weight reduction. Int J Obes (Lond). 2007;31(4):713-7.
Dastjerdi, M. S., Kazemi, F., Najafian, A., Mohammady, M., Aminorroaya, A., & Amini, M. (2007). An open-label pilot study of the combination therapy of metformin and fluoxetine for weight reduction. International Journal of Obesity (2005), 31(4), 713-7.
Dastjerdi MS, et al. An Open-label Pilot Study of the Combination Therapy of Metformin and Fluoxetine for Weight Reduction. Int J Obes (Lond). 2007;31(4):713-7. PubMed PMID: 16969361.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label pilot study of the combination therapy of metformin and fluoxetine for weight reduction. AU - Dastjerdi,M Siavash, AU - Kazemi,F, AU - Najafian,A, AU - Mohammady,M, AU - Aminorroaya,A, AU - Amini,M, Y1 - 2006/09/12/ PY - 2006/9/14/pubmed PY - 2007/11/14/medline PY - 2006/9/14/entrez SP - 713 EP - 7 JF - International journal of obesity (2005) JO - Int J Obes (Lond) VL - 31 IS - 4 N2 - 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. MATERIALS AND 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. SUBJECTS: 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. CONCLUSION: 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. SN - 0307-0565 UR - https://www.unboundmedicine.com/medline/citation/16969361/An_open_label_pilot_study_of_the_combination_therapy_of_metformin_and_fluoxetine_for_weight_reduction_ L2 - https://doi.org/10.1038/sj.ijo.0803447 DB - PRIME DP - Unbound Medicine ER -