Therapeutic efficacy and safety of Polypodium vulgare L. in psychosomatic and behavioural symptoms and health-related quality of life in premenstrual women: A randomized placebo-controlled study

IF 1.7 Q2 Medicine

Advances in integrative medicine Pub Date : 2025-08-22 DOI:10.1016/j.aimed.2025.100560

Marhaba Khanam , Arshiya Sultana , Taseen Banu

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Abstract

Background and objectives

Premenstrual syndrome (PMS) significantly affects the quality of life and disrupts personal and social relationships among women of reproductive age. This study aimed to evaluate the efficacy and safety of Polypodium vulgare L. (Bisfayej) in alleviating PMS symptoms and improving health-related quality of life (HRQoL) in affected women.

Methods

Sixty women diagnosed with PMS were randomly assigned to receive either two capsules of P. vulgare (1000 mg) or a placebo. The treatment was administered twice daily for three menstrual cycles, starting from day 16 of the cycle until day 5 of the following cycle. The primary outcomes were changes in symptom severity, measured by the Premenstrual Syndrome Scale (PMSS), and symptom duration, recorded using a premenstrual tracker sheet. The secondary outcome was assessed using the EQ-5D-5L (EuroQol 5-Dimensions 5-Levels) health questionnaire. Data were analyzed using both parametric and non-parametric tests at a 5 % significance level.

Results

Following the intervention, the P. vulgare group showed a significant reduction in PMS symptom severity and duration, along with an improvement in EQ-5D-5L scores, compared to the placebo group (p < 0.001). The mean reduction in PMSS scores from baseline to the end of the third treatment cycle was 44.23 (95 % CI: 39.81–48.65) in the treatment group and 24.7 (95 % CI: 21.43–27.96) in the placebo group, indicating a statistically significant difference (p < 0.001). No adverse effects were reported in either group.

Discussion

The findings suggest that P. vulgare is both effective and safe in reducing the severity and duration of PMS symptoms while enhancing HRQoL. The therapeutic effects may be attributed to its anti-inflammatory and antioxidant properties, as well as its potential to modulate serotonin levels. These results support the potential of P. vulgare as a promising treatment option for women suffering from PMS.

Conclusion

P. vulgare was more efficacious than the placebo in reducing PMS and improving the woman’s HRQoL.

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紫参对经前妇女心身、行为症状和健康相关生活质量的疗效和安全性：一项随机安慰剂对照研究

背景与目的经前综合征（PMS）严重影响育龄妇女的生活质量，扰乱个人和社会关系。本研究旨在评价茯苓多糖（Bisfayej）缓解经前症候症状和改善健康相关生活质量（HRQoL）的有效性和安全性。方法60名确诊为经前综合症的妇女被随机分配接受两粒普通假单抗胶囊（1000 mg）或安慰剂。从月经周期的第16天到下一个月经周期的第5天，每天两次给予治疗，持续三个月经周期。主要结果是症状严重程度的变化，由经前综合征量表（PMSS）测量，以及症状持续时间的变化，使用经前跟踪表记录。次要结局采用EQ-5D-5L （EuroQol 5-Dimensions 5-Levels）健康问卷进行评估。使用参数检验和非参数检验对数据进行分析，显著性水平为5 %。结果干预后，与安慰剂组相比，p . vulgare组经前症候群症状严重程度和持续时间显著降低，EQ-5D-5L评分显著改善（p <； 0.001）。从基线到第三个治疗周期结束时，治疗组PMSS评分平均下降44.23(95 % CI: 39.81-48.65)，安慰剂组平均下降24.7(95 % CI: 21.43-27.96)，差异有统计学意义（p <； 0.001）。两组均无不良反应报告。本研究结果提示，在降低经前症候群症状的严重程度和持续时间，同时提高HRQoL方面，缬草既有效又安全。这种治疗效果可能归因于它的抗炎和抗氧化特性，以及它调节血清素水平的潜力。这些结果支持了普通假单胞菌作为治疗经前综合症女性的一种有希望的选择。vulgare在减少经前综合症和改善女性HRQoL方面比安慰剂更有效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.20

自引率

11.80%

发文量

审稿时长

15 weeks

期刊介绍： Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.