Karimi Fatemeh Zahra, Hosseini Hamideh, Mazlom Seyed Reza, Rakhshandeh Hassan
Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
Eur J Med Res. 2024 Jul 16;29(1):367. doi: 10.1186/s40001-024-01965-7.
Menopause, characterized by various physical and mental changes, is primarily caused by hormonal fluctuations, resulting in numerous complications. Recently, herbal treatments have gained significant attention for their minimal side effects compared to chemical drugs. This study aimed to investigate the effects of oral capsules containing Ocimum basilicum leaf extract (OBLE) on menopausal symptoms.
This placebo-controlled clinical trial study was conducted in 2020. The research focused on 60 menopausal women referred to Mashhad health centers. Eligible participants were administered either an OBLE 500 mg capsule or a placebo daily for 1 month. Menopause symptoms were evaluated using the Menopause Rating Scale (MRS) before, two weeks, and one month after the intervention. Data were analyzed using SPSS21, independent t, Mann-Whitney, and Friedman tests. A significance level of p < 0.05 was considered significant.
The independent t-test indicated that the mean (SD) scores of menopausal symptoms in both the OBLE and placebo groups were initially similar before the intervention (P = 0.141). Two weeks after the intervention, the menopausal symptom scores were 9.5 ± 3.5 and 11.2 ± 5.6 in the OBLE and placebo groups, respectively (P = 0.163, df = 58, t = 1.4). After one month, the menopausal symptom scores were 6.9 ± 0.3 in the OBLE group and 11.26 ± 0.6 in the placebo group (P = 0.001, df = 58, t = 3.4). This indicates a significant difference between the two groups one month after the intervention, compared to before and two weeks after the intervention. Additionally, there was a significant difference in the scores of the physical and somato-vegetative dimension between the intervention and placebo groups two weeks and one month after the intervention (P < 0.05).
The study results suggested that taking OBLE capsules led to a decrease in the scores of menopausal symptoms. This indicates that OBLE can be considered as a safe and cost-effective medicinal plant for alleviating menopausal symptoms among women.
更年期以各种身心变化为特征，主要由激素波动引起，会导致多种并发症。最近，与化学药物相比，草药疗法因其副作用极小而备受关注。本研究旨在调查含有罗勒叶提取物（OBLE）的口服胶囊对更年期症状的影响。
这项安慰剂对照临床试验于2020年进行。该研究聚焦于60名转诊至马什哈德健康中心的更年期女性。符合条件的参与者每天服用一粒500毫克的OBLE胶囊或一粒安慰剂，持续1个月。在干预前、干预两周后和干预一个月后，使用更年期评定量表（MRS）对更年期症状进行评估。使用SPSS21、独立t检验、曼-惠特尼检验和弗里德曼检验对数据进行分析。p < 0.05的显著性水平被视为具有统计学意义。
独立t检验表明，在干预前，OBLE组和安慰剂组更年期症状的平均（标准差）得分最初相似（P = 0.141）。干预两周后，OBLE组和安慰剂组的更年期症状得分分别为9.5 ± 3.5和11.2 ± 5.6（P = 0.163，自由度 = 58，t = 1.4）。一个月后，OBLE组的更年期症状得分为6.9 ± 0.3，安慰剂组为11.26 ± 0.6（P = 0.001，自由度 = 58，t = 3.4）。这表明与干预前和干预两周后相比，干预一个月后两组之间存在显著差异。此外，在干预两周和一个月后，干预组和安慰剂组在身体和躯体-植物神经维度的得分存在显著差异（P < 0.05）。
研究结果表明，服用OBLE胶囊可降低更年期症状得分。这表明OBLE可被视为一种安全且经济有效的药用植物，用于缓解女性的更年期症状。
