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

Abstract

This paper aimed to evaluate the effect of herbal mixture (Mentha spicata, Zingiberofficinale, Cinnamomumzeylanicum, and Citrussinensis) 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.

Keywords: PCOS; clomiphene citrate; enzymatic antioxidants; glycemic index; herbal mixture; insulin resistance.

Figure 1

Gas chomatography–mass chromatogram (GC–MS) of the essential oil of herbal mixture. TIC*1.00: total ion current (1.0 std).

Figure 2

Polycystic ovary syndrome (PCOS) patients’ flow diagram. Group 1: Clomiphene citrate (CC), group 2: Herbal mixture, and group 3: CC along with herbal mixture. IUI: intrauterine insemination, IVF: in vitro fertilization.