Saffron for the management of premenstrual dysphoric disorder: A randomized controlled trial

Abstract

Background: Selective serotonin reuptake inhibitors are among the most common agents have been used for the treatment of the premenstrual dysphoric disorder (PMDD); however, due to the diversity in the outcomes and adverse effects, efforts are in progress to find an agent with maximal efficacy and minimal adverse effects. Saffron is an herbal agent consisted of ingredients shown to act as an antidepressant, pain tranquilizer, and antioxidant. In the current study, it is aimed to assess the efficacy of saffron on PMDD treatment. Materials and Methods: In the current randomized controlled trial, 120 females with the diagnosis of PMDD were randomly allocated to three groups of treatment with fluoxetine (20 mg, twice daily), saffron (15 mg, twice daily) or placebo for 2 weeks in the luteal phase of two menstruation cycles. Daily record of severity of problems (DRSP) and Hamilton questionnaires had been filled before the interventions and then following the treatment cessation. The questionnaires' scores and drug-related adverse effects were compared among the studied groups. Results: Post-intervention assessment of three groups revealed significant improvement in all of the treatment approaches in terms of DRSP and Hamilton assessments (P < 0.001). Although DRSP assessments showed remarkable superiority of saffron to placebo (P = 0.027), Hamilton evaluations showed insignificant differences among the three interventions (P > 0.05). Fluoxetine posed a significantly higher rate of adverse effects as compared to the other agents (P = 0.01). Conclusion: Based on the findings of this study, saffron was an efficacious herbal agent for the treatment of PMDD with minimal adverse effects.