Sukatendel Khairani, Hasibuan Reni H, Siregar Muhammad Fg, Faradina Dwi, Edianto Deri, Lintang Letta S, Rusda Muhammad, Inriani Vega
Division of Social Obstetrics and Gynecology, Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.
Obstetrics and Gynecology Residency Program, Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Sumatera Utara, Medan, Indonesia.
Narra J. 2025 Apr;5(1):e1399. doi: 10.52225/narra.v5i1.1399. Epub 2025 Feb 17.
seed extract has been shown to have a significant effect on endometrial thickness and vaginal cytology in ovariectomized animal models, suggesting potential benefits for managing menopausal symptoms. However, to the best of the author's knowledge, no human studies have been done to support these conclusions. The aim of this study was to investigate the effects of seed extract on estradiol, follicle- stimulating hormone (FSH), and the vaginal maturity index (VMI) in postmenopausal women. A single-blinded, randomized placebo-controlled experiment was carried out at Haji Adam Malik Hospital, Medan, Indonesia, with 50 eligible postmenopausal women patients randomized into three groups. Group 1 received a placebo, while groups 2 and 3 were given seed extract at 910 mg/day and 1,365 mg/day, respectively. All participants were blinded to the treatment they received. The study used Shad Nigella Plus, an Indonesian herbal medicine containing 455 mg of seed extract per capsule. Before the treatments, estradiol levels, FSH levels, and VMI were measured at baseline and remeasured after eight weeks of treatment. Two participants in the intervention group withdrew due to nausea, a reported side effect of seed extract consumption. Both treatment groups showed significant increases in estradiol levels ( = 0.01 and = 0.001) and VMI ( = 0.004 and = 0.001) after eight weeks of daily seed extract administration compared to the placebo group. However, no significant differences were found between the two doses in estradiol levels and VMI ( = 0.12 and = 0.673, respectively). Moreover, FSH levels showed no significant difference throughout both interventions ( = 0.53 and = 0.96, respectively). In conclusion, twice-daily seed extract at 910 mg/day or 1,365 mg/day for eight weeks significantly increased estradiol levels and VMI in menopausal women but had no significant effect on FSH levels. These findings support the potential role of seed extract as a natural treatment for menopausal symptoms.
种子提取物已被证明对去卵巢动物模型的子宫内膜厚度和阴道细胞学有显著影响，这表明其在管理更年期症状方面具有潜在益处。然而，据作者所知，尚未有人类研究来支持这些结论。本研究的目的是调查种子提取物对绝经后女性雌二醇、促卵泡激素（FSH）和阴道成熟指数（VMI）的影响。在印度尼西亚棉兰的哈贾·亚当·马利克医院进行了一项单盲、随机、安慰剂对照实验，将50名符合条件的绝经后女性患者随机分为三组。第1组接受安慰剂，而第2组和第3组分别给予每日910毫克和1365毫克的种子提取物。所有参与者对他们接受的治疗均不知情。该研究使用了Shad Nigella Plus，一种每粒胶囊含455毫克种子提取物的印度尼西亚草药。在治疗前，在基线时测量雌二醇水平、FSH水平和VMI，并在治疗八周后重新测量。干预组中有两名参与者因恶心退出，恶心是食用种子提取物报告的副作用。与安慰剂组相比，在每日给予种子提取物八周后，两个治疗组的雌二醇水平（P = 0.01和P = 0.001）和VMI（P = 0.004和P = 0.001）均显著升高。然而，在雌二醇水平和VMI方面，两种剂量之间未发现显著差异（分别为P = 0.12和P = 0.673）。此外，在整个两种干预过程中，FSH水平均未显示出显著差异（分别为P = 0.53和P = 0.96）。总之，每日两次、连续八周服用910毫克/天或1365毫克/天的种子提取物可显著提高绝经后女性的雌二醇水平和VMI，但对FSH水平无显著影响。这些发现支持了种子提取物作为更年期症状自然疗法的潜在作用。
