Abstract
Objective. Substances such as inositol and N-acetylcysteine (NAC) have been recently shown to be effective in treatment of PCOS patients. The aim of this prospective trial is to evaluate the efficacy of NAC + Inositol + folic acid on ovulation rate and menstrual regularity in PCOS patients with and without insulin resistance. Methods. Among the 91 PCOS patients treated with NAC + Inositol + folic, insulin resistance was present in 44 subjects (A) and absent in 47 (B). The primary endpoint was the ovulation rate/year, determined by menstrual diary, serum progesterone performed between 21° and 24° days, ultrasound findings of growth follicular or luteal cysts, and luteal ratio. HOMA-index assessment after 6 and 12 months of treatment was evaluated as secondary endpoint. Results. In both groups there was a significant increase in ovulation rate and no significant differences were found in the primary outcome between two groups. In group A, a significant reduction of HOMA-index was observed. Conclusions. The association NAC + Inositol + folic, regardless of insulin-resistance state, seems to improve ovarian function in PCOS patients. Therefore, inositol and NAC may have additional noninsulin-related mechanisms of action that allow achieving benefits also in those patients with negative HOMA-index.
Highlights
Polycystic ovary syndrome (PCOS) is characterized by chronic oligo/anovulation and hyperandrogenism and is the most common cause of anovulatory infertility and menstrual irregularities [1]
Insulin resistance is found in 30–40% of women with PCOS [3], and it is characterized by resistance to the effects of insulin and in uptake in the metabolism of glucose with subsequent reduction of body’s ability to eliminate glucose from the bloodstream
On the basis of the observed data, we conducted a prospective study whose objective was to compare the efficacy in terms of ovulation induction and normalization of menstrual cycles of combined treatment with NAC + Inositol + folic acid (Ovaric HP) in insulin-resistant patients with PCOS compared with the effects of the same drug in non-insulin-resistant patients with PCOS
Summary
Substances such as inositol and N-acetylcysteine (NAC) have been recently shown to be effective in treatment of PCOS patients. The aim of this prospective trial is to evaluate the efficacy of NAC + Inositol + folic acid on ovulation rate and menstrual regularity in PCOS patients with and without insulin resistance.Methods. HOMA-index assessment after 6 and 12 months of treatment was evaluated as secondary endpoint.Results. In both groups there was a significant increase in ovulation rate and no significant differences were found in the primary outcome between two groups. Inositol and NAC may have additional noninsulin-related mechanisms of action that allow achieving benefits in those patients with negative HOMA-index
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