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Submitted on September 6, 2005
Accepted on December 7, 2005
From Departments of Gynecological Endocrinology and Reproductive Medicine, Obstetrics and Gynecology, Internal Medicine, Division of Endocrinology and Metabolism, and Biostatistics, University of Heidelberg, Germany
* To whom correspondence should be addressed. E-mail: stefan.eisenhardt{at}med.uni-heidelberg.de.
Context: Metformin is successfully used in the treatment of cycle disorders and anovulation in women with polycystic ovary syndrome (PCOS). No data of the exact point and the impact of insulin resistance (IR) on metformin's efficacy exist.
Objective: To evaluate the early potential effects of metformin treatment, their time of onset and the role of IR on metformin's efficacy.
Design: Prospective randomized double-blind placebo-controlled trial.
Setting: University of Heidelberg, Germany.
Patients: Fourty-five oligo-/anovulatory PCOS women with typical ovaries.
Interventions: Women were stratified for IR (32/13) and then randomly allocated to receive either metformin (n = 22) or placebo (n = 23) and were assessed before and every four weeks within a treatment period of 12 weeks.
Main outcome measures: Menstrual disturbance and markers of insulin metabolism.
Results: The main outcome criterion menstrual disturbance was successfully improved in the metformin treated group depending on IR (12/15 vs. 3/17) while women without IR (4/7 vs. 4/6) had no significant amelioration of their menstrual irregularities (P < 0.05). Estradiol levels increased continuously only in the treatment group (P < 0.005) indicating an improvement of ovulatory function. 67% of metformin treated women had at least one ovulation compared with only 45% in the placebo group shown by biphasic body temperature curves. Insulin sensitivity improved within four weeks after beginning of metformin as shown by an increased AUC glucose/insulin ratio compared with baseline (P < 0.005).
Conclusions: IR is a baseline predictor of clinical efficacy in metformin treatment in PCOS women measured by improved menstrual cyclicity and ovulatory function.
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