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.

2019-11-13
Complementary therapies in medicine 48
- Leila Amini
- Faraz Mojab
- Shayesteh Jahanfar
- Mahdi Sepidarkish
- Zahra Raoofi
- Arezoo Maleki-Hajiagha

PubMed: 31987228
DOI: 10.1016/j.ctim.2019.102245

Study Design

Type: Randomized Controlled Trial (RCT)
Population: Sixty PCOS patients diagnosed according to Rotterdam criteria
Methods: Randomized, triple-blinded, controlled trial; 330 mg oral S. officinalis extract or placebo capsules daily for eight weeks
Blinding: Triple-blind
Duration: eight weeks
Funding: Unclear

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).

Research Insights

Sage→Improved Insulin Levels
the consumption of S. officinalis extract, compared to the placebo, resulted in a significant decrease in Insulin levels (P < 0.001)
Effect
Beneficial
Effect size
Large
Dose
330 mg/day
Sage→Improved Insulin Sensitivity
S. officinalis extract supplementation resulted in a greater increase in QUICKI (P < 0.001) compared with placebo groups
Effect
Beneficial
Effect size
Large
Dose
330 mg/day
Sage→Reduced Body Mass Index
Results showed a statistically significant decrease in the BMI (P = 0.001) in S. officinalis group
Effect
Beneficial
Effect size
Moderate
Dose
330 mg/day
Sage→Reduced Diastolic Blood Pressure
using a multivariate model showed a significant difference between two groups regarding diastolic blood pressure (P = 0.025)
Effect
Beneficial
Effect size
Small
Dose
330 mg/day
Sage→Reduced Insulin Resistance
the consumption of S. officinalis extract, compared to the placebo, resulted in a significant decrease in ... HOMA-IR (P < 0.001)
Effect
Beneficial
Effect size
Large
Dose
330 mg/day
Sage→Reduced Systolic Blood Pressure
we failed to find a significant effect of S. officinalis extract on systolic blood pressure (P = 0.283)
Effect
Neutral
Effect size
Small
Dose
330 mg/day
Sage→Reduced Waist Circumference
there were no significant differences between the two groups for WHR (P = 0.164)
Effect
Neutral
Effect size
Small
Dose
330 mg/day