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The impact of combined nutraceutical supplementation on quality of life and metabolic changes during the menopausal transition: a pilot randomized trial

  • General Gynecology
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Abstract

Purpose

The aim of this study was to assess the efficacy of a combined nutraceutical supplement on symptoms and early metabolic alterations during the menopausal transition. This pilot randomized study was conducted at the service for menopause disorders of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.

Methods

Ninety women in menopausal transition who attended our service with menopausal symptoms were enrolled in the study. Sixty patients, randomly assigned to the treatment group, were prescribed one daily tablet of a combined nutraceutical compound with phytoestrogen substances, vitamins, micronutrients and passion flower herbal medicine for 6 months. Thirty patients did not receive any treatment and comprised the control group. The intensity of perimenopausal symptoms was assessed by the modified Kuppermann Index (KI) at enrollment and at 3 and 6 months of treatment. At baseline and at the end of the study, patients underwent a clinical evaluation, a pelvic ultrasound and analysis of blood samples.

Results

In the nutraceutical supplemented group, a significant reduction in menopausal symptoms was demonstrated according to the KI after 3 and 6 months of supplementation (p < 0.01). The within-group analysis of different KI parameters in the treated group showed a significant improvement in hot flushes (p < 0.001), insomnia (p < 0.01), fatigue (p < 0.01) and irritability (p < 0.01). Metabolic parameters did not change significantly in the nutraceutical supplemented group. In the control group, total cholesterol level showed a significant increase (p < 0.05).

Conclusions

Combined nutraceutical supplementation provides an effective and safe solution for early symptoms occurring during menopausal transition.

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Acknowledgements

We are grateful to Elisa Tempestilli for her help and her unrestricted support of this study. We also thank Ray Hill, an independent medical writer, who provided English-language editing and journal styling prior to submission on behalf of Springer Healthcare Communications. This medical writing assistance was supported by Biofutura, Italy.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy

    Paola Villa, Inbal D. Amar, Carolina Bottoni, Clelia Cipolla, Giorgia Dinoi, Maria C. Moruzzi, Giovanni Scambia & Antonio Lanzone

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  1. Paola Villa
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  2. Inbal D. Amar
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  3. Carolina Bottoni
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  4. Clelia Cipolla
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  8. Antonio Lanzone
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Contributions

PV: project development, manuscript writing, data analysis. IDA: data collection, manuscript editing. CB: data collection, data analysis. CC: data collection. GD: data collection. MCM: data analysis. GS: project development. AL: protocol development.

Corresponding author

Correspondence to Paola Villa.

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Funding

This study was independently developed from a project sponsored by Avantgarde S.p.A. (Sigma-Tau group). The sponsor was not involved in the design and conduct of the study, in the collection, management, analysis, or interpretation of data.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study protocol was approved by the Institutional Review Board of the Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy (registration number 14394/14, January 10th, 2015) and conformed to the ethical guidelines of the 1975 Helsinki Declaration.

Informed consent

A written informed consent was obtained from all individuals enrolled in the study.

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Villa, P., Amar, I.D., Bottoni, C. et al. The impact of combined nutraceutical supplementation on quality of life and metabolic changes during the menopausal transition: a pilot randomized trial. Arch Gynecol Obstet 296, 791–801 (2017). https://doi.org/10.1007/s00404-017-4491-9

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  • DOI: https://doi.org/10.1007/s00404-017-4491-9

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