The Effectiveness of Herbal Mixture Supplements with and without Clomiphene Citrate in Comparison to Clomiphene Citrate on Serum Antioxidants and Glycemic Biomarkers in Women with Polycystic Ovary Syndrome Willing to Be Pregnant: A Randomized Clinical Trial

Nava Ainehchi,Arash Khaki,Azizeh Farshbaf-Khalili,Mohamad Hammadeh,Elaheh Ouladsahebmadarek

doi:10.3390/biom9060215

Abstract

This paper aimed to evaluate the effect of herbal mixture (Mentha spicata, Zingiber officinale, Cinnamomum zeylanicum, and Citrus sinensis) only and along with clomiphene citrate (CC) compared to CC on serum antioxidants, glycemic status, menstrual regulation, and rate of pregnancy. This single-blind randomized clinical trial was carried out on 60 infertile participants with polycystic ovary syndrome (PCOS) willing to be pregnant. They were randomly allocated into group 1 (n = 20) who received routine dose of CC pills (50–150 mg) for three menstrual cycles from the fifth day of menstruation for five days; group 2 (n = 20) who consumed herbal mixture daily (700 mg); and group 3 (n = 20) who used up herbal mixture along with CC for 3 months. Catalase (CAT), glutathione peroxidase (GPx), superoxide dismutase (SOD), malondialdehyde (MDA), fasting blood sugar (FBS), insulin, and homeostatic model assessment for insulin resistance (HOMA-IR) were measured in their blood samples. No statistically significant differences were observed between the three groups in terms of socio-demographic characteristics. After intervention, however, the levels of CAT in group 2 (adjusted mean difference (aMD): = 9.0; confidence interval (CI) 95% = 1.1–16.9) and group 3 (aMD = 12.2; CI 95% = 4.5–19.9), GPx in group 2 (aMD = 986.1; CI 95% = 141.1–1831.1) and group 3 (aMD = 1781.2; CI 95% = 960.7–2601.8), and SOD in group 2 (aMD = 55.1; CI 95% = 26.0–84.2) increased. While FBS in group 3 (aMD = −8.7; CI 95% = −14.7 to −2.7), insulin in group 2 (aMD = −5.6; CI 95% = −10.8 to −0.4), and HOMA-IR in group 2 (aMD = −1.3; CI 95% = −2.4 to −0.2) significantly decreased compared to the group 1. To summarize, herbal mixture supplements along with CC have beneficial effects on serum antioxidant levels, as well as glycemic biomarkers of infertile PCOS, menstrual regulation, and pregnancy rate.

Highlights

Polycystic ovary syndrome (PCOS) is recognized as a leading cause of infertility with the incidence of 6–26% among women at child bearing age [1]
Oxidative stress is dramatically increased in PCOS patients, when oxidant/antioxidant status is measured by circulating serum markers, including catalase (CAT), glutathione peroxidase (GPx), superoxide dismutase (SOD), and malondialdehyde (MDA) [3]
The levels of DPPH, ferric reducing antioxidant potential (FRAP), total phenolic content (TPC), and total flavonoid content (TFC) were measured from this methanolic extract

Summary

Introduction

Polycystic ovary syndrome (PCOS) is recognized as a leading cause of infertility with the incidence of 6–26% among women at child bearing age [1]. Polycystic ovary syndrome has been associated with oxidative stress (OS) and metabolic factors, for instance insulin resistance, obesity, and diabetes [3,4]. Oxidative stress is dramatically increased in PCOS patients, when oxidant/antioxidant status is measured by circulating serum markers, including catalase (CAT), glutathione peroxidase (GPx), superoxide dismutase (SOD), and malondialdehyde (MDA) [3]. In vivo and in vitro studies have demonstrated that an excess level of OS results in impaired insulin secretion and insulin resistance [8]. Antioxidant treatment may ameliorate insulin sensitivity in insulin resistant patients [9]. Whether high levels of OS in PCOS patients derive from PCOS or other potential complications still remains undetermined [10]

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