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 3rd to 5th 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 in group 2 (aMD = –21.8; 95% CI: –31.5 to –12.1; aMD = –29.9; 95% CI: –47.9 to –12.0; aMD = –21.2; 95% CI: –31.3 to –11.1; aMD = –5.1; 95% CI: –7.5 to –2.7) and group 3 (aMD = –18.3; 95% CI: –27.4 to –9.2; aMD = –26.9; 95% CI: –43.8 to –9.9; aMD = –21.4; 95% CI: –31.1 to –11.7; aMD = –5.9; 95% CI: –8.3 to –3.6) compared to group 1, respectively. However, high-density lipoproteins cholesterol in group 2 (aMD = 6.8; 95% CI: 2.9–10.7) and group 3 (aMD = 10.7; 95% CI: 7.2–14.7) increased remarkably compared to group 1. Overall, clinical outcomes improved significantly in all groups (p < 0.05).

Conclusions
In general, the herbal mixture along with CC was found to improve free testosterone, HOMA-IR, lipid profile, and clinical features of PCOS women.



中文翻译：

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克罗米芬柠檬酸盐、草药混合物和草药混合物与克罗米芬柠檬酸盐对多囊卵巢综合征不孕妇女临床和副临床参数的影响：一项随机对照临床试验

引言
评估草药混合物（即薄荷、生姜、肉桂和柑橘）单独和与克罗米芬柠檬酸盐 (CC) 组合与 CC 相比对治疗多囊卵巢综合征 (PCOS) 的效果。

材料与方法
这项单盲随机临床试验对 60 名患有 PCOS 的不孕症参与者进行，他们被随机分为三组。自发性或孕激素引起的撤退性出血后，第 1 组（n = 20）从月经的第 3 天到第 5 天接受 CC（50-150 mg）常规治疗三个月经周期，共 5 天，而第 2 组（n = 20）第 3 组 (n = 20) 分别接受 700 毫克/天的草药混合物胶囊和草药混合物以及 CC 3 个月。最后，测量了几个相关参数，包括性类固醇水平、胰岛素抵抗的稳态模型评估 (HOMA-IR)、血脂谱（主要结果）、甲状腺激素和临床特征。该分析基于意向治疗分析。

结果
就社会人口特征而言，各组之间没有观察到统计学上的显着差异。然而，在调整基线、促黄体激素 (aMD = 4.9; 95% CI: 3.7–6.2)、促黄体激素/促卵泡激素 (aMD = 0.9; 95% CI: 0.7–1.2)、总睾酮 (aMD = – 0.12；95% CI：–0.2 到 –0.01）在第 2 组和第 3 组中的游离睾酮（aMD = –6.0；95% CI：–9.7 到 –2.3）显示与第 1 组相比存在显着差异。此外，HOMA与第 1 组相比，第 2 组的 -IR（aMD = –1.3；95% CI：–2.4 至 –0.2）显着降低。此外，总胆固醇、甘油三酯、低密度脂蛋白胆固醇和极低密度脂蛋白胆固醇显着降低在第 2 组中（aMD = –21.8；95% CI：–31.5 至 –12.1；aMD = –29.9；95% CI：–47.9 至 –12.0；aMD = –21.2；95% CI：–31。3 至 –11.1；aMD = –5.1；95% CI：–7.5 至 –2.7）和第 3 组（aMD = –18.3；95% CI：–27.4 至 –9.2；aMD = –26.9；95% CI：–43.8 至 –9.9；aMD = –21.4；95 % CI：–31.1 至 –11.7；aMD = –5.9；95% CI：–8.3 至 –3.6）分别与第 1 组相比。然而，与第 1 组相比，第 2 组（aMD = 6.8；95% CI：2.9-10.7）和第 3 组（aMD = 10.7；95% CI：7.2-14.7）的高密度脂蛋白胆固醇显着增加。总体而言，临床结果各组均有显着改善（p < 0.05）。

结论
总的来说，发现草药混合物与 CC 一起改善 PCOS 女性的游离睾酮、HOMA-IR、血脂和临床特征。