Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, P.O.Box: 1419733171, Mirkhani St., Tohid Sq, Tehran, Iran.
Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
BMC Complement Med Ther. 2020 Sep 29;20(1):295. doi: 10.1186/s12906-020-03084-2.
The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo.
The present study was a randomized double-blind controlled clinical trial. A checklist questionnaire was completed by 120, 18 to 35-year-old, college students. And then, 84 eligible women (20 to 35 years old) were enrolled in the trial; they were randomly assigned to two groups of intervention (EA) and control (placebo), with 42 participants in each group. Participants in the intervention group received 450 mg capsules of EA per day (three times a day) from the 21st day of their menstrual cycle until the 3rd day of their next cycle for two consecutive cycles. The severity of PMS was measured and ranked using the premenstrual symptoms screening tool (PSST). The generalized estimating equation was used to compare the total score of the severity of PMS between the two groups.
Sixty-nine women with regular menstrual cycles suffering from PMS completed the study. The mean scores of the symptoms in the EA group were 35.3 and 16.1 (P ≤ 0.001) at baseline and after 2 months, respectively, while the mean scores of the symptoms in the placebo group were 31.0 and 28.3 (P = 0.09) at baseline and after 2 months, respectively. The evaluation of the first and the second follow-ups in the intervention group showed that, after being adjusted for age and body mass index (P ≤ 0.001), the mean scores of the premenstrual syndrome, using GEE analysis, have decreased to 6.2 and 11.6, respectively.
Based on the results, in comparison with the placebo group, EA was found to be more effective in improving the symptoms of PMS, and is highly recommended for treatment of this syndrome.
IRCT2015110822779N3 ; Registration date: 2015-11-27.
本研究旨在评估 Echium amoenum（EA）对经前期综合征（PMS）严重程度的影响，并与安慰剂进行比较。
本研究为随机双盲对照临床试验。采用清单问卷对 120 名 18 至 35 岁的大学生进行调查。然后，纳入 84 名符合条件的女性（20 至 35 岁）进行试验；她们被随机分为两组：干预组（EA）和对照组（安慰剂），每组 42 名参与者。干预组参与者从月经周期的第 21 天开始每天服用 450mg 的 EA 胶囊（每天 3 次），持续两个连续周期，直到下一个周期的第 3 天。使用经前期症状筛查工具（PSST）测量并排列 PMS 的严重程度。使用广义估计方程比较两组 PMS 严重程度的总分。
69 名月经周期规律且患有 PMS 的女性完成了研究。EA 组的症状平均评分分别为 35.3 和 16.1（P≤0.001），在基线和 2 个月后；而安慰剂组的症状平均评分分别为 31.0 和 28.3（P=0.09），在基线和 2 个月后。干预组的第一和第二次随访评估表明，在调整年龄和体重指数（P≤0.001）后，GEE 分析显示，经前期综合征的平均评分分别降至 6.2 和 11.6。
与安慰剂组相比，EA 被发现能更有效地改善 PMS 的症状，强烈推荐用于治疗这种综合征。
IRCT2015110822779N3；注册日期：2015 年 11 月 27 日。
