l-arginine plus drospirenone-ethinyl estradiol in the treatment of patients with PCOS: a prospective, placebo controlled, randomised, pilot study.

Objective. To verify the effects of a pill containing drospirenone on the surrogate markers of arterial function and to evaluate the possible improvements induced by the addition of l-arginine. Design. A prospective, placebo controlled, randomised, pilot study. Setting. University of Bologna. Population. Twenty-eight young women with PCOS. Methods. Random submission to: drospirenone + ethinylestradiol+ a placebo (Group I; n = 15) or drospirenone + ethinylestradiol + oral l-arginine (4 g x 2/daily) (Group II, n = 13). Main outcome measures. Medical examination; blood measurement of nitrites/nitrates, biochemical and hormonal parameters; ultrasonographic analysis and colour Doppler evaluation of uterine, stromal ovarian and ophthalmic arteries; analysis of brachial artery flow-mediated vasodilatation; and 24-h ambulatory blood pressure monitoring. The above parameters were evaluated before and after 6 months. Results. The low dose oral contraceptive containing drospirenone favoured a pre-hypertensive state The l-arginine supplementation increased the circulating levels of nitrites/nitrates and improved the endothelium-dependent vasodilatation counteracting the negative effect of the contraceptive pill. Conclusions. Although, the present pilot study was conducted in a limited number of patients, it seems that the l-arginine co-treatment may improve the long-term side effects of the pill reducing the risk of cardiovascular diseases.