Assessment of N-acetylcysteine as an Alternative for the Treatment of the Premenstrual Dysphoric Disorder: A Randomized Clinical Trial

Abstract

Background: Premenstrual dysphoric disorder (PMDD) is a common condition affecting females' quality of life in a significant negative manner. Verities of medical treatments have been investigated for whether the prevention or treatment of this condition with uncertain outcomes. Currently, evidence has shown the role of oxidant and antioxidant agents in the etiology of PMDD. N-acetylcysteine (NAC) is an anti-inflammatory and antioxidant agent that we have aimed to assess its efficacy for the treatment of PMDD, and compare it with fluoxetine, as one of the choice treatment of this disorder.

Methods: The current randomized clinical trial has been conducted on 119 childbearing females, randomly divided into three groups of either treatment with 10 mg of fluoxetine twice daily or 450 mg of NAC twice daily or placebo in 2016-2018. The agents were administered daily for two weeks within the initiation of menstruation cycle for two menstruation cycles. The questionnaires of Hamilton and daily record of severity of problems (DRSP) were filled before and following the interventions for groups, and the results were compared.

Results: The baseline DRSP and Hamilton scores were not statistically different among the three groups (P>0.05) while by the end of the study all of the groups presented significantly improved scores (P<0.001). Comparison of three groups revealed remarkable inferiority of placebo to the other two groups (P<0.05) while no statistical difference was found between N-acetylcysteine with fluoxetine in terms of neither Hamilton (P:0.12) nor DRSP scores (P:0.75).

Conclusion:  Findings of our study are in favor of NAC use for the treatment of PMDD. Further studies with larger sample size and elongated duration of treatment and follow-ups are strongly recommended.

J Pharm Care 2019; 7(4): 94-99