Yuki Ikeda1*, Mizuho Nasu1 and Jean-Yves Bruxer2
Introduction: Pre-Menstrual Syndrome (PMS) is considered as a disorder with neuro-hormonal and gynecological dimensions. As a high prevalent condition that affects the quality of life for women, there is an increasing demand in using nutritional supplements to alleviate the symptoms of PMS. Pomegranate is a fruit containing different bioactive molecules that are previously shown to have anti-inflammatory and anti-depression properties suggesting its possible efficacy in physiological as well as psychological symptoms seen associated with PMS. This study attempted to evaluate the efficacy and safety profiles of VIQUA®, a pomegranate based polyphenol complex in subjects with PMS.
Materials and methods: This was a single center, prospective, randomized, double blind, two arm, parallel, placebo controlled; clinical study adhered to the good clinical practice guidelines and was approved by the ethical review board. Forty female adult subjects aged between 25-35 years participated in the study and all subjects completed the study without any adverse events. PMS symptoms were assessed using Premenstrual Symptoms Screening Tools Questionnaire (PSST) for 3 consecutive menstrual cycles. Plasma Brain Derived Neurotrophic Factor (BDNF) levels and serum 14-Dihydro-15- Keto Prostaglandin F2-Alpha (PGFM) were evaluated to understand the impact of test product supplementation in neurotransmitter and prostaglandin levels.
Results: At the end of 3rd menstrual cycle, mean PSST score in VIQUA® group showed a statistically significant reduction compared to baseline (P value>0.0001). In the subgroup analysis of PSST score, VIQUA® group showed significant reduction in physical symptoms score, psychological symptoms score and interfering symptoms scores. Compared to baseline, VIQUA® group showed a significant improvement in BDNF levels (P value>0.05) and significant reduction in 14- Dihydro-15-Keto Prostaglandin F2-Alpha (PGFM) levels (P value>0.05). It was also noted that VIQUA® group had a considerable increase in the fecal Short Chain Fatty Acids (SCFA) levels.
Conclusion: Considering the significant improvement in different aspects of PMS including inflammation, pain and psychological and psycho-somatic factors, VIQUA® shows great prospects as an effective supplement in treating PMS symptoms.
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