|
J Clin Endocrinol metab. 2006 Oct;91(10):3970-80.
Treatment with flutamide, metformin, and their combination added to a hypocaloric diet in overweight-obese women with polycystic ovary syndrome: a randomized, 12-month, placebo-controlled study.Gambineri A,Patton L,Vaccina A, Cacciari M,Morselli-Labate AM, Cavazza C,Pagotto U,Pasquali R.
Division of Endocrinology, Department of Internal Medicine, S. Orsola-Malpighi Hospital, Via Massarenti 9, 40138 Bologna, Italy.
Context:
The few controlled trials performed so far indicate that the addition of metformin and/or flutamide to a hypocaloric diet in obese women with polycystic ovary syndrome (PCOS) effectively influences different phenotypic aspects of the syndrome. All these studies are, however, characterized by a short to medium period of treatment.
Objectives:
Our objective was to investigate the long-term effects of these therapies.
Design and Settings:
We conducted a prospective, randomized, placebo-controlled trial at a medical center.
Patients:
Of 80 overweight-obese women with PCOS, 76 completed the study.
Interventions:
Patients were placed on a hypocaloric diet for the first month and then on a hypocaloric diet plus placebo, metformin (850 mg, orally, twice a day), flutamide (250 mg, orally, twice a day), or metformin plus flutamide for the subsequent 12 months (20 subjects in each group).
Settings, Design and Main Outcome Measures:
We assessed clinical features, computerized tomography measurement of fat distribution, androgens, lipids, and fasting and glucose-stimulated glucose and insulin levels at baseline and after 6 and 12 months of treatment.
Results:
After 6 months, compared with placebo, flutamide further decreased visceral/sc fat mass (P = 0.044), androstenedione (P<0.001), dehydroepiandrosterone sulfate (P<0.001), and hirsutism score (P<0.001), whereas metformin further increased Frequency of menstruation (P = 0.039). After 12 months, flutamide maintained the effects observed after 6 months on visceral/sc fat mass (P = 0.033) and androstenedione (P<0.001), whereas it produced an additional decrease in dehydroepiandrosterone sulfate (P = 0.020) and hirsutism score (P = 0.019); metformin further improved the menstrual pattern (P = 0.013). Moreover, after 12 months, flutamide improved more than placebo the menstrual pattern (P = 0.008), glucose-stimulated glucose levels (P = 0.041), insulin sensitivity (P<0.001), and low-density lipoprotein cholesterol levels (P = 0.003), whereas metformin decreased glucose-stimulated insulin levels (P = 0.014). The combination of the two drugs maintained the specific effect of each of the compounds, without any additive or synergistic effect.
Conclusions:
These findings add relevance to the usefulness of metformin and flutamide in the treatment of dieting overweight-obese PCOS women and provide a rationale for targeting different therapeutic options according to the required outcomes in the long term.
   
See Also:
PCOS -
Polycystic Ovary Syndrome
Do you have an unanswered women's health question?
Please let us have your general question on our
NEW FORUM
/ MESSAGE BOARDS facility and we will try
to answer it for you. I am sure that you will appreciate that we cannot offer advice on the management of an individual's specific problem.
DISCLAIMER
The aim of this web site is to provide a general guide and it is
not intended as a substitute for a consultation with an appropriate specialist
in respect of individual care and treatment.
Thank you for your visiting us at 2womenshealth.com.
This is the personal website of David A Viniker MD FRCOG, Consultant Obstetrician and Gynaecologist at Whipps Cross University Hospital, London.
I do hope that you find the answers to your questions in the patient information and medical advice provided.
If you still have unanswered questions, please consider entering them into one of our forums and I will try to assist you.
 | |
