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Re: Metformin and The PillFrom: Pat (anonymous@obgyn.net)Fri, 30 Aug 2002 11:52:55 -0500 (CDT)
Human Reproduction From Human Reproduction July 2002 (Volume 17, Number 7) Clinical, Endocrine and Metabolic Effects of Metformin Added to Ethinyl Estradiol-Cyproterone Acetate in Non-obese Women With Polycystic Ovarian Syndrome: A Randomized Controlled Study Elter K, Imir G, Durmusoglu F Human Reproduction. 2002;17(7):1729-1737 Summary This prospective, randomized study found that lean women with polycystic ovary syndrome (PCOS) who took a cyproterone acetate-containing oral contraceptive (OC) plus metformin had a more favorable metabolic response than those assigned to OC alone. This study was designed to evaluate the combined effects of ethinyl estradiol + cyproterone acetate (an OC) and metformin in the management of PCOS. Women with oligomenorrhea or amenorrhea, hirsutism, or elevated androgen levels and with ovaries that appeared polycystic on ultrasound were eligible. Hirsutism was assessed using the Ferriman-Gallwey score. Those with other endocrine etiologies responsible for the findings and those who were taking medications that affect androgen or glucose levels were considered ineligible. All potential candidates were screened for diabetes with an oral glucose tolerance test. Those who tested positive for diabetes were excluded. All participants had normal BMI. Eligible patients were randomly assigned to receive either the OC pill or the combination of OC + metformin (1500 mg daily in divided doses). Clinical and endocrine assessment was performed at baseline and after 4 months of treatment. Insulin sensitivity was assessed using the ratio of fasting glucose to insulin. The person performing the clinical evaluation was blinded to treatment assignment. Forty women were randomized to 1 of the 2 regimens. Baseline clinical, endocrine, and metabolic parameters were similar. In both groups, the Ferriman-Gallwey score, androgen levels, and ovarian volume significantly decreased, whereas sex hormone-binding globulin (SHBG) levels increased. In the OC group, weight slightly increased, while in the OC + metformin group, weight and waist-to-hip ratio significantly decreased. Serum lipids remained stable except for a significant increase in total cholesterol levels in the OC group. Fasting glucose-to-insulin ratio significantly improved in the OC + metformin group, whereas it was not affected by OC alone. Treatment was generally well tolerated, and there were no dropouts during the study period. This prospective, randomized study found that lean women with PCOS who took a cyproterone acetate-containing OC + metformin had a more favorable metabolic response than those assigned to OC alone. Clinical Commentary PCOS is common endocrine disorder that affects about 10% of reproductive age women. It is characterized by ovulatory problems and hyperandrogenism. In the past decade, several studies investigated PCOS as a metabolic disorder. In more than 50% of cases, insulin resistance was found; diabetes, lipid abnormalities, and hypertensive disorders were also increased among women with PCOS. Treatment is usually directed to restore ovulation and allow pregnancy to occur or to treat the androgen excess. If pregnancy is not desired, the usual first-line treatment is with OCs. With OC use, ovarian androgen production is reduced and SHBG levels are increased. In some cases, however, OC use can lead to poor glucose metabolism and could further worsen already existing insulin resistance. Metformin is an insulin-sensitizing agent that has successfully been used as a single agent or in combination with other ovulation-inducing drugs in women with PCOS who desire pregnancy. This study evaluated whether the combination of metformin and a cyproterone acetate-containing OC has superior effects to the OC alone in the management of PCOS. Patients were recruited according to appropriate criteria, and baseline characteristics were similar after randomization. Treatment was well tolerated in both arms, and there were no dropouts. Although the patients were not blinded, the physician evaluating them was. As expected, androgen levels improved with both treatments. Of interest is that hirsutism scores also improved as early as 3 months after treatment. Usually, it takes somewhat longer with any medical treatment to see improved symptoms of hirsutism. All participants were of normal weight at baseline. Those on OC alone gained some weight, while those on combination therapy lost a significant amount of weight. Obesity alone is a risk factor for insulin resistance; with weight loss, insulin activity typically improves. Improved insulin sensitivity was seen in the group receiving metformin combined with the OC. The question is whether this result was attributable to the drug or to the weight loss. To answer this question, one would have to randomize patients to metformin and to reduced caloric intake or increased physical activity so that patients lose the same amount of weight in both groups. The potential benefits of such combination treatment should also be evaluated among those PCOS patients who are at particularly high risk for developing diabetes (eg, those with positive family history, personal history of gestational diabetes, or obesity). Improving insulin action will not only improve ovarian function but may also reduce the risk of future diabetes and cardiovascular disease. These outcomes need to be evaluated in longer-term studies. If such benefits are proved, metformin should be used among women with PCOS not just when they try to achieve pregnancy but as a preventive measure as well.
At Tue, 27 Aug 2002, Victoria wrote:
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