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Cited by 216Ovarian function and disordersDiabetes, Cardiovascular Risks, and LipoproteinsGenetic and Kidney Cyst Diseases

Effect of flutamide and metformin administered alone or in combination in dieting obese women with polycystic ovary syndrome

Gambineri, Alessandra, Pelusi, Carla, Genghini, Silvia, Morselli‐Labate, Antonio Maria, Cacciari, Mauro, Pagotto, Uberto, Pasquali, Renato·2004·Clinical Endocrinology
DOI 10.1111/j.1365-2265.2004.01973.x
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Abstract

Summary: 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.

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Authors
Gambineri, A., Pelusi, C., Genghini, S., Morselli‐Labate, A. M., Cacciari, M., Pagotto, U., & Pasquali, R.
Affiliations
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
Corresponding author
Pasquali, Renato
ORCID
Venue
Clinical Endocrinology
Publisher
Wiley
Published
2004-01-16
Volume
60
Issue
2
Pages
241-249
ISSN
  • 0300-0664 (ISSN-L)
  • 1365-2265
DOI
10.1111/j.1365-2265.2004.01973.x
OpenAlex
W2102239047
Cited by
216
References
49
Citations by year
2026: 3 · 2025: 2 · 2024: 3 · 2023: 4 · 2022: 8 · 2021: 10 · 2020: 6 · 2019: 2 · 2018: 6 · 2017: 12 · 2016: 5 · 2015: 11 · 2014: 10 · 2013: 7 · 2012: 11
FWCI
19.48
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • Clinical Endocrinology (publishedVersion)
  • PubMed (publishedVersion)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Topics
  • Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Genetic and Kidney Cyst Diseases
Keywords
polycystic ovary syndrome, obesity, flutamide, metformin, hypocaloric diet, weight loss, androgen receptor antagonists, insulin sensitivity, hyperinsulinemia, hyperandrogenism, visceral fat, hirsutism, menstrual status, sex hormone-binding globulin, lipid profile, testosterone, combination therapy, adipose tissue
MeSH terms
Adult, Analysis of Variance, Androgen Antagonists, Combined Modality Therapy, Diet, Reducing, Drug Therapy, Combination, Female, Flutamide, Humans, Hypoglycemic Agents, Metformin, Obesity, Pilot Projects, Polycystic Ovary Syndrome, Single-Blind Method

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