RESUMO
Menopause is characterized by various physical, mental and emotional symptoms. ERr 731 ® is a standardized extract from Rheum rhaponticum root and has been clinically studied for its role in reducing menopausal symptoms. The current systematic review and meta-analysis aimed to evaluate the efficacy of ERr 731 ® supplementation in alleviating the severity of menopausal symptoms. In this review, we searched across three online databases up to March 2023, evaluated the quality of the included studies by the Physiotherapy Evidence Database scale, and assessed the risk of bias by the Cochrane Risk of Bias tool. We then performed a meta-analysis using RevMan software to estimate the pooled mean difference (MD). The study protocol was registered in the Prospective Register of Systematic Reviews (CRD42023416808). After screening and evaluation, we included four high-quality studies (a total of 390 participants; the ERr 731 ® group: 193 participants; the control group: 197 participants) in the meta-analysis. The results showed that ERr 731 ® supplementation significantly reduced the Menopause Rating Scale score (MD: -15.12; P < 0.001), compared with control therapy. Sensitivity analysis revealed no effect of individual studies on the overall pooled estimate or overall observed heterogeneity. The current review provides evidence that ERr 731 ® supplementation is effective in reducing menopause symptoms. Potential bias and high heterogeneity in the results warrant further clinical studies.
RESUMO
Background Pre-menstrual syndrome (PMS) is a condition associated with altered hormone levels during the menstrual phase of females and is characterised by physical, emotional, and behavioural symptoms that have a negative impact on the quality of life of females. The symptoms of PMS may vary between individuals, but the major complication is pain, especially during menstrual days. The current treatment strategy involves the use of hormonal therapies and analgesics for symptomatic relief, but these therapies have a risk of potential side effects. The use of herbal and nutraceutical supplements in PMS conditions is increasing due to their long-term safety and proven efficacy. The current real-world study aimed to evaluate the efficacy and tolerability of Ezedayz® tablets containing Vitex agnus-castus extract (EVX40™), vitamin B6, and magnesium in PMS subjects. Methodology A real-world, open-label study was conducted involving 64 participants with varied severity of PMS symptoms. Participants were categorised into Group A (N=23) receiving standard therapies, Group B (N=20) receiving Ezedayz® tablets, or Group C (N=21) receiving standard and Ezedayz® therapy. Standard therapies were provided as per physician supervision, and Ezedayz® tablets were given for 90 days. All subjects were evaluated on core symptoms of PMS like menstrual backache, menstrual cramps, joint or muscle pain, and headache using the numerical rating scale (NRS), and quality-of-life (QoL) was evaluated using a QoL questionnaire. A spontaneous reporting methodology was used to evaluate the tolerability of the therapies provided. Statistical analysis was performed as per the statistical plan. A p-value of <0.05 was considered statistically significant. Results Out of 64 participants, five were lost to follow-up, and the data of 59 participants were included in the final analysis. All groups showed improvement in all evaluated parameters, but Group B and Group C showed greater improvement at the end of the study in all evaluated parameters. The quality-of-life assessment revealed greater improvement in Group B and Group C participants compared to Group C in all evaluated QoL parameters. No serious side effects were observed in any subjects. Conclusion The results of the current study conclude that the nutraceutical composition of Vitex agnus-castus extract, vitamin B6, and magnesium is effective in reducing the severity of PMS symptoms and improving the quality of life of PMS subjects. The nutraceutical therapy provided greater relief from PMS symptoms compared to standard therapy alone, and this effect was augmented when the nutraceutical therapy was provided in combination with standard therapies. Similarly, the improvement in quality-of-life parameters was greater in subjects treated with nutraceuticals alone or in combination therapy. Despite the limitations of the study, the results of the current study are promising, and the nutraceutical composition (Ezedayz®) can be effectively used in clinical settings to control symptoms and improve the quality of life of PMS patients.
