Leila Amini1, Faraz Mojab2, Shayesteh Jahanfar3, Mahdi Sepidarkish4, Zahra Raoofi5, Arezoo Maleki-Hajiagha6. 1. Department of Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: amini.l@iums.ac.ir. 2. Department of Pharmacognosy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: sfmojab@sbmu.ac.ir. 3. Department of Public Health, the Herbert H. & Grace A. Dow College of Health Professions, Central Michigan University, United States. Electronic address: jahan2s@cmich.edu. 4. Department of Biostatistics and Epidemiology, Babol University of Medical Sciences, Babol, Iran. Electronic address: mahdisepidarkish@gmail.com. 5. Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran. Electronic address: raoofi.z@iums.ac.ir. 6. Department of Midwifery, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran; Research Development Center, Arash Women's Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a-maleki@farabi.tums.ac.ir.
Abstract
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).
RCT Entities:
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 PCOSpatients diagnosed according to Rotterdam criteria. INTERVENTIONS: Consumption of the 330 mg oral S. officinalisextract 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. officinalisextract 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. officinalisextract, 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. officinalisextract supplementation resulted in a greater increase in QUICKI (P < 0.001) compared with placebo groups. CONCLUSION:S. officinalisextract at a dose of 330 mg/day could decrease BMI and systolic blood pressure, and it could enhance insulin resistance markers in euglycemic PCOSpatients. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT201504146917N2, 2015-10-03).