Document Detail

Effect of flutamide and metformin administered alone or in combination in dieting obese women with polycystic ovary syndrome.
MedLine Citation:
PMID:  14725687     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Hyperandrogenism, hyperinsulinaemia and obesity play a key and coordinating roles in the pathogenesis of polycystic ovary syndrome (PCOS), contributing in different ways to the clinical expression of the syndrome. Weight loss is beneficial, but the additional administration of insulin-lowering drugs, such as metformin, and antiandrogens may produce further benefits, due to their different spectrum of action. The effects of long-term metformin and flutamide, an antiandrogen drug, added alone or in combination with a low-calorie diet, on body weight and fat distribution, androgens, metabolic parameters and clinical status in obese women with PCOS were investigated. METHODS: Forty obese women with PCOS were enrolled in the study. After a 1-month diet, according to single-blind design, the patients were allocated to treatment with placebo, metformin (850 mg/orally, twice daily), flutamide (250 mg/orally, twice daily) or metformin (850 mg/orally, twice daily) + flutamide (250 mg/orally, twice daily) for the following 6 months, while continuing hypocaloric dieting. At baseline and at the end of the study, sex hormone, SHBG, lipid, insulin and insulin sensitivity determinations were evaluated. At the same time, clinical parameters such as anthropometry, total (TAT), visceral (VAT) and subcutaneous (SAT) adipose tissue, hirsutism and menses were also measured. RESULTS: We found that, in obese PCOS women, following a hypocaloric diet the addition of metformin, flutamide or the combined metformin + flutamide treatment had some specific additional favourable effects with respect to the low-calorie diet alone. In particular, flutamide treatment seemed to add a significant effect in decreasing visceral fat, androstenedione, DHEA-S, total and low density lipoprotein (LDL) cholesterol and in improving hirsutism. Conversely, metformin had significant benefits on the menstrual status. The two drugs showed an additive effect in reducing testosterone concentrations and a synergistic effect in increasing high density lipoprotein (HDL) cholesterol and SHBG levels. Improvement of insulin sensitivity and hyperinsulinaemia appeared to depend on hypocaloric diet, without any further significant effect of the pharmacological treatments, either alone or in combination. CONCLUSIONS: We conclude that, in obese PCOS women, following a hypocaloric diet the addition of metformin, flutamide or the combined metformin + flutamide treatment appears to have a more favourable outcome on body fat distribution, androgens, lipids, hirsutism and menses. However, our data emphasize the dominant role of hypocaloric dieting in improving insulin resistance and hyperinsulinaemia. Therefore, this study provides a rationale for specifically targeting different therapeutical options for PCOS according to the required outcomes.
Alessandra Gambineri; Carla Pelusi; Silvia Genghini; Antonio Maria Morselli-Labate; Mauro Cacciari; Uberto Pagotto; Renato Pasquali
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Clinical endocrinology     Volume:  60     ISSN:  0300-0664     ISO Abbreviation:  Clin. Endocrinol. (Oxf)     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2004-01-16     Completed Date:  2004-03-25     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0346653     Medline TA:  Clin Endocrinol (Oxf)     Country:  England    
Other Details:
Languages:  eng     Pagination:  241-9     Citation Subset:  IM    
Division of Endocrinology, Department of Internal Medicine, S. Orsola-Malpighi Hospital, University of Bologna, Italy.
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MeSH Terms
Analysis of Variance
Androgen Antagonists / therapeutic use*
Combined Modality Therapy
Diet, Reducing*
Drug Therapy, Combination
Flutamide / therapeutic use*
Hypoglycemic Agents / therapeutic use*
Metformin / therapeutic use*
Obesity / diet therapy
Pilot Projects
Polycystic Ovary Syndrome / diet therapy,  drug therapy*
Single-Blind Method
Reg. No./Substance:
0/Androgen Antagonists; 0/Hypoglycemic Agents; 13311-84-7/Flutamide; 657-24-9/Metformin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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