The Effects of Lemon balm (Melissa officinal is L.) Alone and in Combination with Napata methodizes on the Menstrual Bleeding in Students With Premenstrual Syndrome: A Randomized Controlled Trial

Abstract

Abstract Objective: To assess the efficacy of lemon balm only and combined lemon balm-Napata methodizes on premenstrual syndrome and quality of life. Methods: This triple-blind randomized controlled trial was conducted on 93 female students from dormitories of Medical Sciences University in Tabriz city. They completed the Daily Record of Severity of Problems questionnaire for two consecutive menstrual cycles for confirming the PMS. Then subjects were allocated into three groups (n=31 per group). The intervention groups received 500 mg capsules of lemon balm only or lemon balm in combination with Napata methodizes. The control group received 500 mg capsule of placebo, in the luteal phase for two consecutive menstrual cycles, twice- daily. Data was analyzed using one- way ANOVA, general linear model and chi-square tests. Results: Adjusted for baseline scores, the decrease in the mean scores of PMS symptoms in the first [adjusted difference: -55.5 (95% Confidence interval, -96.8 to -14.1)] and second [-57.3 (-99.9 to -14.7)] months after intervention in lemon balm group was significantly greater than that for the placebo group. The decrease in the mean scores of PMS symptoms in the first [adjusted difference: -28.2 (95% Confidence interval, -70.2 to 13.6)] and second [-35.7 (-78.9 to 7.4)] months after intervention in lemon balm-Napata methodizes group was greater than that for the placebo group. However, there was no significant difference between the lemon balm-Napata methodizes and the placebo groups (P=0.135). Also, there was no significant difference between lemon balm-Napata methodizes and lemon balm only (P=0.526). There was statistical significant difference between the intervention groups in terms of physical aspect (P=0.009) and psychological aspect of quality of life (P=0.001) at the end of second month after treatment. Conclusion: Lemon balm herb can reduce the severity of symptoms in women with PMS. However, further clinical studies should be performed to assess the long-term effectiveness and adverse effects after discontinuation medication in order to decide whether this medication is appropriate to treat PMS or not. Clinical trial registration: This study was approved by Ethics Committee of Tabriz University of Medical Sciences (code: 9313) and registered at the Iranian Registration Clinical Trial center (code: IRCT2014031710324N17)