Efficacy of Salvia officinalis extract on the prevention of insulin resistance in euglycemic patients with polycystic ovary syndrome: A double-blinded placebo-controlled clinical trial.

OBJECTIVES

At the present study, we aimed at evaluating the effect of Salvia officinalis (S. officinalis) extract on "anthropometric indices" and "insulin resistance markers" in Polycystic Ovary Syndrome (PCOS) patients.

DESIGN AND

SETTING

This was a randomized, triple-blinded, controlled trial performed in gynecology hospitals affiliated to Iran University of Medical Sciences.

PARTICIPANTS

Sixty PCOS patients diagnosed according to Rotterdam criteria.

INTERVENTIONS: Consumption of the 330 mg oral S. officinalis extract or placebo capsules daily for eight weeks.

MAIN OUTCOME MEASURES: Body mass index (BMI), waist to hip ratio (WHR), blood pressure, homoeostatic model assessment-insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI).

RESULTS

Results showed a statistically significant decrease in the BMI (P = 0.001) in S. officinalis group, but, there were no significant differences between the two groups for WHR (P = 0.164). Although we failed to find a significant effect of S. officinalis extract on systolic blood pressure (P = 0.283) but using a multivariate model showed a significant difference between two groups regarding diastolic blood pressure (P = 0.025). Also, the consumption of S. officinalis extract, compared to the placebo, resulted in a significant decrease in Insulin levels (P < 0.001), and HOMA-IR (P < 0.001). As well as, S. officinalis extract supplementation resulted in a greater increase in QUICKI (P < 0.001) compared with placebo groups.

CONCLUSION

S. officinalis extract at a dose of 330 mg/day could decrease BMI and systolic blood pressure, and it could enhance insulin resistance markers in euglycemic PCOS patients.

TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT201504146917N2, 2015-10-03).