PDF(Pubmed)
Abstract：
BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in reproductive age and the most common cause of infertility due to anovulation. PCOS in adolescents is concerning. Nigella sativa is effective in improving gonadotropins and sex hormones. The current study was designed to investigate the effect of Nigella sativa supplementation on PCOS symptoms and their severity in adolescents.
METHODS: The current randomized clinical trial was conducted on 114 adolescents with PCOS who were referred to gynecologist offices and clinics in Gonabad, Iran from March 2022 to March 2023. Participants were randomly allocated to the intervention (Nigella sativa 1000 mg/day) and control (10 mg/day medroxyprogesterone from the 14th day of the cycle for 10 nights) groups. The study duration was 16 weeks. Ovarian volume (measured by ultrasound), anthropometric and blood pressure; serum testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), luteinizing hormone (LH), hirsutism severity (Ferriman-Gallwey score) levels were evaluated before and after the study.
RESULTS: Data from 103 participants (control group = 53, intervention group = 50) were analyzed. The mean age of participants was 17.0 (Interquartile range [IQR]:2.0). The mean difference in hirsutism score changes (p < 0.001), right (p = 0.002), and left (p = 0.010) ovarian volume, serum LH (p < 0.001) and testosterone (p = 0.001) were significantly higher in the intervention group compared to the control group. The frequency of oligomenorrhea, menometrorrhagia, and amenorrhea, were significantly reduced after the study in the intervention group compared to the control group (ps < 0.001).
CONCLUSIONS: Short-term Nigella sativa supplementation may be effective in reducing ovarian volume and improving hormonal balance, and menstrual irregularities in adolescents with PCOS. Further research and long-term studies are warranted to validate the potential therapeutic effects of Nigella sativa in adolescents with PCOS.
UNASSIGNED: IRCT20221017056209N1 Registration date: 2022-11-22.
METHODS: The current randomized clinical trial was conducted on 114 adolescents with PCOS who were referred to gynecologist offices and clinics in Gonabad, Iran from March 2022 to March 2023. Participants were randomly allocated to the intervention (Nigella sativa 1000 mg/day) and control (10 mg/day medroxyprogesterone from the 14th day of the cycle for 10 nights) groups. The study duration was 16 weeks. Ovarian volume (measured by ultrasound), anthropometric and blood pressure; serum testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S), luteinizing hormone (LH), hirsutism severity (Ferriman-Gallwey score) levels were evaluated before and after the study.
RESULTS: Data from 103 participants (control group = 53, intervention group = 50) were analyzed. The mean age of participants was 17.0 (Interquartile range [IQR]:2.0). The mean difference in hirsutism score changes (p < 0.001), right (p = 0.002), and left (p = 0.010) ovarian volume, serum LH (p < 0.001) and testosterone (p = 0.001) were significantly higher in the intervention group compared to the control group. The frequency of oligomenorrhea, menometrorrhagia, and amenorrhea, were significantly reduced after the study in the intervention group compared to the control group (ps < 0.001).
CONCLUSIONS: Short-term Nigella sativa supplementation may be effective in reducing ovarian volume and improving hormonal balance, and menstrual irregularities in adolescents with PCOS. Further research and long-term studies are warranted to validate the potential therapeutic effects of Nigella sativa in adolescents with PCOS.
UNASSIGNED: IRCT20221017056209N1 Registration date: 2022-11-22.
摘要：
背景：多囊卵巢综合征（PCOS）是育龄期最常见的内分泌疾病，也是无排卵导致不孕的最常见原因。PCOS在青少年中令人担忧。黑麦草能有效改善促性腺激素和性激素。本研究旨在研究补充紫花苜蓿对青少年PCOS症状及其严重程度的影响。
方法：目前的随机临床试验是对114名PCOS青少年进行的，他们被转诊到戈纳巴德的妇科医生办公室和诊所，伊朗从2022年3月到2023年3月。参与者被随机分配到干预组（Nigellasativa1000mg/天）和对照组（从周期的第14天开始，持续10个晚上，10mg/天的甲羟孕酮）。研究持续时间为16周。卵巢体积（通过超声测量），人体测量和血压;血清睾酮,脱氢表雄酮（DHEA），硫酸脱氢表雄酮（DHEA-S），黄体生成素(LH),在研究前后评估多毛症严重程度(Ferriman-Gallwey评分)水平.
结果：分析了来自103名参与者（对照组=53，干预组=50）的数据。参与者的平均年龄为17.0（四分位距[IQR]：2.0）。多毛症评分变化的平均差异（p<0.001），右（p=0.002），和左（p=0.010）卵巢体积，干预组血清LH(p<0.001)和睾酮(p=0.001)明显高于对照组。月经少发的频率，月经过多,和闭经,与对照组相比，干预组研究后显著降低(ps<0.001)。
结论：短期补充黑麦草可能有效减少卵巢体积和改善荷尔蒙平衡，和青春期PCOS患者的月经不调。需要进一步的研究和长期研究来验证黑麦草在PCOS青少年中的潜在治疗效果。
■IRCT20221017056209N1注册日期：2022-11-22。
方法：目前的随机临床试验是对114名PCOS青少年进行的，他们被转诊到戈纳巴德的妇科医生办公室和诊所，伊朗从2022年3月到2023年3月。参与者被随机分配到干预组（Nigellasativa1000mg/天）和对照组（从周期的第14天开始，持续10个晚上，10mg/天的甲羟孕酮）。研究持续时间为16周。卵巢体积（通过超声测量），人体测量和血压;血清睾酮,脱氢表雄酮（DHEA），硫酸脱氢表雄酮（DHEA-S），黄体生成素(LH),在研究前后评估多毛症严重程度(Ferriman-Gallwey评分)水平.
结果：分析了来自103名参与者（对照组=53，干预组=50）的数据。参与者的平均年龄为17.0（四分位距[IQR]：2.0）。多毛症评分变化的平均差异（p<0.001），右（p=0.002），和左（p=0.010）卵巢体积，干预组血清LH(p<0.001)和睾酮(p=0.001)明显高于对照组。月经少发的频率，月经过多,和闭经,与对照组相比，干预组研究后显著降低(ps<0.001)。
结论：短期补充黑麦草可能有效减少卵巢体积和改善荷尔蒙平衡，和青春期PCOS患者的月经不调。需要进一步的研究和长期研究来验证黑麦草在PCOS青少年中的潜在治疗效果。
■IRCT20221017056209N1注册日期：2022-11-22。
