The effect of clomiphene citrate, herbal mixture, and herbal mixture along with clomiphene citrate on clinical and para-clinical parameters in infertile women with polycystic ovary syndrome: a randomized controlled clinical trial

Abstract

Introduction: To evaluate the effect of a herbal mixture (i.e., Mentha spicata, Zingiber officinale, Cinnamomum zeylanicum, and Citrus sinensis) alone and in combination with clomiphene citrate (CC) compared to CC on the treatment of polycystic ovary syndrome (PCOS). Material and methods: This single-blind randomized clinical trial was conducted on 60 infertile participants with PCOS who were randomly divided into three groups. After spontaneous or progestin-induced withdrawal bleeding, group 1 (n = 20) received routine treatment with CC (50-150 mg) for three menstrual cycles from the 3 rd to 5 th day of menstruation for 5 days while group 2 (n = 20) and group 3 (n = 20) received herbal mixture capsules 700 mg/day and the herbal mixture along with CC for 3 months, respectively. Finally, several related parameters were measured, including the level of sex steroids, homeostatic model assessment for insulin resistance (HOMA-IR), lipid profile (primary outcomes), thyroid hormones, and clinical features. The analysis was based on intention-to-treat analysis. Results: No statistically significant differences were observed between the groups in terms of socio-demographic characteristics. However, after adjustment for baseline, luteinizing hormone (aMD = 4.9; 95% CI: 3.7-6.2), luteinizing hormone/follicle-stimulating hormone (aMD = 0.9; 95% CI: 0.7-1.2), total testosterone (aMD =-0.12; 95% CI:-0.2 to-0.01) in group 2 and free testosterone (aMD =-6.0; 95% CI:-9.7 to-2.3) in group 3 revealed a significant difference compared to group 1. In addition, HOMA-IR in group 2 (aMD =-1.3; 95% CI:-2.4 to-0.2) decreased significantly compared to group 1. Further, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and very low-density lipoprotein cholesterol decreased significantly

The Effect of Herbal Medicine Supplementation on Clinical and Para-clinical Outcomes in Women With PCOS: A Systematic Review and Meta-analysis

“…We also appraised the hypothesis "potency of herbal medicine supplementation in PCOS women has beneficial effects. " Similar studies have been published (15)(16)(17). However, authors aimed to omit the irrelevant data and perform it in a strictly focused way.…”

“…Forest plot of this study demonstrate that serum level of TC, LDL, TG reduced more significantly in herbal mixture (15) in comparison with 2 studies (26, 27) which consumed cinnamon alone. Also, it is worth noting that both Hajimonfarednejad et al (27) and Borzoei et al (30) research which prescribed 500 mg cinnamon capsule for 3 times a day for 12 and 8 weeks respectively, the serum level of FBS and insulin of PCOS women in Borzoei et al (30) study reduced much more than Hajimonfarednejad et al (27) study; however the study duration was lesser than Hajimonfarednejad et al From perspective of mechanism, insulin resistance decreases the activity of hormone-sensitive lipase in adipose tissue and prevents hepatic lipase activity in liver, leading to release free fatty acids (48).…”

“…From 16 articles, 15 were written in English and 1 in Persian. Eight articles measured cinnamon efficacy on PCOS alone (24,(26)(27)(28)(29)(30)(31)(32), and another 8 articles measured herbal mixture that all of them contain cinnamon along with other herbs like spearmint, ginger, Glycyrrhiza glabra, etc (15,16,25,(33)(34)(35); just one RCT evaluated spearmint effect in PCOS women (13). Studies were conducted in United States, Australia, the United Kingdom, Japan, Iran, India, Indonesia, and Egypt.…”

“…Three trials (15,26,27) with 183 participants evaluated the effect of cinnamon alone and herbal mixture versus placebo or control on LDL level. As the I 2 of 17% represents no statistic heterogeneity among the studies (P = 0.30), a fixed effect model was applied to pool the outcomes.…”

GnRH antagonist versus depot GnRH agonist protocol in polycystic ovary syndrome (PCOS): analysis using propensity score matching

“…The primary pathophysiology of PCOS is insulin resistance, rebound hyperinsulinemia and hyperandrogenemia [1]. These actions result in several clinical features such as persistent anovulation, polycystic ovarian changes, hirsutism, acne and obesity [2].…”