Saghafi Fatemeh, Javaheri Atiyeh, Mohammadi Farhad, Hatamizadeh Nooshin, Khanizadeh Fatemeh, Safakish Mahdieh, Sahebnasagh Adeleh
Department of Clinical Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Department of Obstetrics and Genecology, Faculty of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
J Pharm Health Care Sci. 2025 Aug 8;11(1):69. doi: 10.1186/s40780-025-00432-7.
Polycystic ovary syndrome (PCOS) is the most common endocrine-metabolic disorder in women of reproductive age. Crocin is known as the main component of saffron, which has antioxidant properties and has the ability to scavenge free radicals. Considering the pathophysiology of PCOS and also the anti-inflammatory and antioxidant properties of crocin in improving insulin resistance, we aimed to evaluate the efficacy of the combination of crocin and metformin compared to metformin alone in PCOS patients.
This study is a prospective, double-blind randomized controlled clinical trial. Fifty patients with PCOS and hirsutism were included from Baqaipour Obstetrics and Gynecology Clinic in Yazd and randomly assigned into the two study arms of control group [metformin and placebo (n = 25)] or intervention group [metformin and crocin (n = 25)]. Patients were administered crocin 15 mg tablets once a day in combination with metformin 500 mg twice a day for 12 weeks to complete three full periods of the monthly cycle. The studied endpoints were evaluated at the beginning and end of the study.
Crocin significantly improved the serum level of follicle-stimulating hormone (FSH) (P = 0.048) and Ferriman- Gallwey score (P = 0.042) at day 90. Furthermore, crocin group had a significant improvement in terms of acne severity at the end of the study (P = 0.03), so that none of the patients in the crocin group had severe acne at the end of the study. However, the comparisons between two groups were not statistically significant for other evaluated outcomes including fasting blood sugar (FBS), dihydroepiandrosterone-sulfate (DHEA-S), luteinizing hormone (LH), dermatology life quality index (DLQI), and blood pressure (BP) at the end of the study.
In the present study, concurrent use of crocin along with metformin was significantly effective in ameliorating the unpleasant side effects of PCOS, including hirsutism and acne, and increasing FSH sex hormone levels in patients with PCOS.
26/08/2021, Trial Registry number: IRCT20210730052027N1.
多囊卵巢综合征（PCOS）是育龄期女性最常见的内分泌代谢紊乱疾病。藏红花素是藏红花的主要成分，具有抗氧化特性，能够清除自由基。鉴于PCOS的病理生理学特点以及藏红花素在改善胰岛素抵抗方面的抗炎和抗氧化特性，我们旨在评估藏红花素与二甲双胍联合使用相较于单独使用二甲双胍对PCOS患者的疗效。
本研究是一项前瞻性、双盲随机对照临床试验。从亚兹德的巴凯普尔妇产科诊所纳入50例患有PCOS和多毛症的患者，并随机分为对照组[二甲双胍和安慰剂（n = 25）]或干预组[二甲双胍和藏红花素（n = 25）]两个研究组。患者每天服用一次15毫克藏红花素片，同时每天服用两次500毫克二甲双胍，持续12周以完成三个完整的月经周期。在研究开始和结束时评估研究终点。
在第90天时，藏红花素显著改善了促卵泡生成素（FSH）的血清水平（P = 0.048）和费里曼-盖尔维评分（P = 0.042）。此外，在研究结束时，藏红花素组的痤疮严重程度有显著改善（P = 0.03），以至于在研究结束时藏红花素组没有患者患有重度痤疮。然而，在研究结束时，两组在其他评估结果方面的比较无统计学意义，包括空腹血糖（FBS）、硫酸脱氢表雄酮（DHEA-S）、促黄体生成素（LH）、皮肤病生活质量指数（DLQI）和血压（BP）。
在本研究中，藏红花素与二甲双胍同时使用在改善PCOS的不良副作用（包括多毛症和痤疮）以及提高PCOS患者的FSH性激素水平方面具有显著效果。
2021年8月26日，试验注册号：IRCT20210730052027N1。
