bidly obese subgroup of patients (body mass in- dex > 37). No change in fasting glucose concen- trations, fasting insulin, or insulin responses to glucose challenge test was recorded after 14-wk of inositol and placebo therapy. There was an in- verse relationship between body mass of the pa- tients and the efficacy of the treatment. Conclusions: These data support a beneficial effect of inositol in improving ovarian function in women with oligomenorrhea and polycystic ovaries. Key Words: PCO S, Ino sito l, O varian functio n, Insulin re sistance . Introduction Polycystic ovary syndrome (PCOS) is a very common disorder of premenopausal women characterized by hyperandrogenism and chronic anovulation 1,2 . Its etiology is unknown. Although specific population-based studies have not been performed yet, a 5-10% preva- lence of this disorder in women of reproduc- tive age is probably a reasonable conservative estimate. This estimate is based on the upper limit derived from studies on the prevalence of polycystic ovaries, which found that 20% of self-selected normal women had polycystic ovary morphology at ovarian ultrasound ex- amination 3 . Many of these women had subtle endocrine abnormalities 3 . The lower estimate is based on the reported 3% prevalence rate of secondary amenorrhea for 3 or more months 4 and the consideration that up to 75% of women with secondary amenorrhea will fulfill diagnostic criteria for PCOS 5 . PCOS women European Review for Medical and Pharmacological Sciences 151 Abstract. – Background: Women with oligomenorrhea and polycystic ovaries show a high incidence of ovulation failure perhaps linked to insulin resistance and related metabol- ic features. A small number of reports shows that inositol improves ovarian function. Futhermore, in these trials the quality of evi- dence supporting ovulation is suboptimal, and few studies have been placebo-controlled. The aim of this study was to use a double-blind, placebo-controlled approach with detailed as- sessment of ovarian activity (two blood samples per week) to assess the validity of this therapeu- tic approach in this group of women. Methods: Of the 283 patients randomized, 2 withdrew before treatment commenced, 147 re- ceived placebo, and 136 received inositol (100 mg, twice a day). The women which discontined the study prematurely were more numerous in the treatment group (n = 45) than the placebo group (n = 15; P < 0.05). Results: The ovulation frequency estimated by the ratio of luteal phase weeks to observation weeks was significantly (P < 0.01) higher in the treated group (23%) compared with the placebo (13%). The time in which the first ovulation oc- curred was significantly (P < 0.05) shorter [23.6 d; 95% confidence interval (CI), 17, 30; com- pared with 41.8 d; 95% CI, 28, 56]. The number of patients failing to ovulate during the placebo- treatment period was higher ( P < 0.05) in the placebo group, and in most cases ovulations were characterized by normal progesterone con- centrations in both groups. The effect of inositol on follicular maturation was rapid, because the circulating concentration of E2 increased only in the inositol group during the first week of treat- ment. Significant (P < 0.01) weight loss (and lep- tin reduction) was recorded in the inositol group, whereas in the placebo group was recorded an increase of the weight (P < 0.05). A significant increase in circulating high-density lipoprotein was observed only in the inositol- treated group. Metabolic risk factor benefits of inositol treatment were not observed in the mor- Effects of inositol on ovarian function and metabolic factors in women with PCOS: a randomized double blind placebo-controlled trial S. GERLI, M. MIGNOSA, G.C. DI RENZO Department of Obstetrics and Gynecology, Monteluce Hospital, University of Perugia (Italy) 2003; 7: 151-159