Abstract: Background: Premenstrual Syndrome (PMS) is a common concern among women in India, characterized by a variety of symptoms occurring before menstruation, which can disrupt their daily routines and activities, presenting significant challenges. Evening primrose oil (EPO) is frequently employed as a nutraceutical in addressing PMS symptoms. Additionally, research has demonstrated the effectiveness of vitamin E and vitamin B6 in managing PMS. This study aimed to investigate whether a combination of evening primrose Oil (EPO), tocotrienol, and vitamin B6 could relieve symptoms of PMS.
Methods: It was a prospective, observational, multi-centre, real-world evidence study involving Indian female patients aged 18 or above, with regular menstrual cycles and experiencing at least one PMS symptom. Patients received a study product once daily for three months. The primary outcome measure was the improvement in PMS symptoms, evaluated by observing the reduction in Premenstrual Syndrome Scale (PMSS) score from baseline to the end of treatment. Secondary outcome measures included a reduction in menstrual pain and mastalgia, if present. These were evaluated using the Visual Analog Scale (VAS) for Menstrual Pain and mastalgia.
Results: 510 patients diagnosed with PMS were enrolled in this study. The treatment with a combination of EPO + tocotrienol + Vitamin B6 for a mean duration of 3 months showed a reduction in PMSS score from 134.24 ± 45 at day 0 to 52.31 ± 15.09 at 90 days, indicating a significant percent reduction of 61.03%. Similarly, the VAS score for menstrual pain and mastalgia showed a percent reduction of 75.20% & 82.54%, respectively, following 3 months of treatment as compared to baseline. No major side effects were reported throughout the study.
Conclusion: A unique combination of EPO, tocotrienol, and vitamin B6 administered for 3 months demonstrated a significant improvement in PMS symptoms and should be considered as a treatment option for managing female patients with PMS
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