Does the PMSoff supplement help PMS and PMDD symptoms?

Background: Premenstrual syndrome (PMS) is a prevalent and often debilitating health conditions affecting women of reproductive age. The natural PMSoff supplement contains several active ingredients, including spirulina, whey protein, calcium citrate, vitamin B1, chamomile, turmeric, marigold, lavender, saffron, valerian, and aftimoon. This clinical trial aimed to assess the efficacy and safety of PMSoff, a natural supplement, in alleviating the symptoms of PMS. Methods: In this double-blind, randomized trial, women diagnosed with PMS were randomly assigned to receive either PMSoff or placebo. The primary objective of the study was to evaluate the impact of PMSoff on symptom severity, with secondary objectives focusing on safety and adherence. The primary outcome of this study was the severity of PMS symptoms, evaluated using the Daily Record of Severity of Problems (DRSP) questionnaire. The secondary outcome focused on the presence of premenstrual dysphoric disorder (PMDD), a more severe and debilitating form of PMS. Symptom severity was assessed at multiple time points: pre-intervention, one month post-intervention, and two months post-intervention. Results: Of the 255 randomized participants, 218 (85.4%) patients aged 14 to 30 years were enrolled and completed the clinical trial. No significant difference was observed between groups at baseline characteristics. Medication adherence in the first and second month of treatment was reported 72%. Following one month of treatment, the intervention group showed a significant reduction in DRSP scores compared to the control group (P-value = 0.043). This reduction became even more pronounced after two months of taking the supplement (P-value = 0.001). In patients with PMDD, a more severe form of PMS, a statistically significant difference emerged two months after the intervention (P-value = 0.04), indicating that the PMSoff was effective in alleviating PMDD-related symptoms, particularly during the second month of treatment. Conclusion: The results of this randomized placebo-controlled clinical trial were suggestive of the use of PMSoff in patients with PMS and PMDD to ameliorate its unpleasant symptoms, with sustained improvements observed over two months of treatment. Our findings suggest that PMSoff could be a viable alternative or adjunct to conventional pharmacological treatments for PMS and PMDD. Further studies are still demanded to explore the long-term effects, mechanisms of action, and broader applicability of this supplement. Trial registration: Trial Registry Date: 2025-03-02, Trial Registry number: IRCT20190810044500N30.

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