Abstract
BackgroundThe present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo.MethodsThe 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.ResultsSixty-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.ConclusionBased 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.Trial registrationIRCT2015110822779N3; Registration date: 2015–11–27.
Highlights
The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo
Premenstrual Syndrome (PMS) is referred to as the periodic recurrence of a set of physical, psychological, and behavioral variations during the second half of the menstrual cycle, which is prevalent among women of reproductive ages and affects their health [2]
15 of all the eligible college students who participated in the present study, (5 in the EA group and 10 in the placebo group) were not willing to continue the study
Summary
The present study aimed to evaluate the effect of Echium amoenum (EA) on the severity of premenstrual syndrome (PMS) in comparison with placebo. Premenstrual Syndrome (PMS) is referred to as the periodic recurrence of a set of physical, psychological, and behavioral variations during the second half of the menstrual cycle, which is prevalent among women of reproductive ages and affects their health [2]. This syndrome with a high prevalence (80–90%) [3] has no clear etiology; there are some theories such as sensitivity to hormonal changes or disruption of endogenous opioids during the menstrual cycle, stress, and diet which could be related to its etiology [2, 4,5,6]. In Iran, people have been growing Echiuma Amoneum in the mountain areas in the north of the country [10] and it was conventionally believed that EA can have sedative effects on patients which is well-documented in old Persian medical textbooks such as the Qanoon by Avicenna [11]
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