The Effect of Ethanol and Aqueous Extract of Iranian Borage (Echium amoenum) on Primary Dysmenorrhea and the Quality of Life Enjoyment and Satisfaction among Students: A Randomized Controlled Trial

Abstract

Abstract Background & objective: There is no evidence about effectiveness of ethanolic and aqueous extract of Echium amoenum on dysmenorrhea and the quality of enjoyment and life satisfaction. The present study was conducted to determine the effectiveness of ethanolic and aqueous extract of Echium amoenum on the severity of primary dysmenorrhea and the quality of enjoyment and life satisfaction in students. Materials & Methods: This triple blind randomized clinical trial was conducted on 90 single female students between 18-30 years old with primary dysmenorrhea who living in Tabriz University of medical science dormitories. Participants were randomized in to three groups: receiving two capsule/day of 500 mg ethanolic and aqueous Iranian borage (Echium amoenum) and placebo. From the onset of pain or menstruation for three days every 12 hours in the following cycle, for three cycle. Pain intensity, number of pain killer and quality of life enjoyment and life satisfaction were considered as main goal while dysmenorrhea intensity symptom, Menstrual bleeding, satisfaction of therapy are the subsidiary purpose. During an one cycle before intervention and three cycle under intervention, pain was assessed using 10-cm visual analog scale (VAS) and Quality of Life Enjoyment and Satisfaction Questionnaire. The groups were compared using repeated measures ANOVA. Results: Time after intervention and interaction of time with group had no significant effects on the outcomes. Compared group, There was no significant difference in the mean pain intensity in the ethanolic extract group compared to placebo (adjusted difference, 95% CI: -0/08, -1/0 to 0/8). There was no significant difference in the mean pain severity in the aqueous extract group compared to placebo (adjusted difference, 95% CI: -0/4, -1/3 to 0/5) Meanwhile, There was no significant difference between the two intervention groups (adjusted difference, 95% CI: -0/3, -0/6 to 1/2). Mean (standard deviation) of the number of used painkillers in the ethanolic extract group was (1.5) 1.8 months before the intervention to (1.5) 0.9 in the third month of intervention, in the aqueous extract group (2.7) 2.4 in the month before the intervention to (1.4) 1/1 in the third month of intervention and in the placebo group decreased from (2) 2.3 to (1.5) 0.1. There was no statistical difference between the groups in the first stage before intervention and the third month of the intervention. Quality of life enjoyment and satisfaction score in the menstrual and late follicular phase in the month before intervention was compared to the third month of intervention in the ethanolic and aqueous extract was not show a significant difference between the groups in terms of quality after intervention. Conclusion: There is no significant effect of ethanol and aqueous extract of Iranian borage (Echium amoenum) on the pain or any of the intervention on the quality of life enjoyment and satisfaction among students.