Effects of the PREMEN-CALM® in the Management of the Premenstrual Syndrome: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

Abstract

Premenstrual syndrome is a common disorder in women of reproductive age characterized by a variety of cyclical symptoms with a great impact on their lifestyle. Available pharmacological options include both antidepressants and oral contraceptives, both of which have side effects, are expensive and not always effective. Vitamins, minerals and plant extracts have been proven to alleviate the symptomatology of the premenstrual syndrome. For this reason, the purpose of this study was to test the effectiveness of a commercial phytotherapeutic dietary supplement (PREMEN-CALM^®: γ-aminobutyric acid, Rhodiola rosea L., Vitex agnus-castus, vitamin B6 and melatonin) as an alternative treatment for this condition. A randomized, double-blind, and placebo-controlled pilot study was performed. Participants (n = 42) were assessed before and after 3 months of taking the supplement (n = 21) or the placebo (n = 21). Outcome measures include antioxidant and inflammatory biomarkers, body composition, subjective sleep quality, mood state profile, quality of life, and certain characteristics of the menstrual cycle. The within-group analysis revealed a significant improvement in the total antioxidant status (1.49 ± 0.34 vs reference value 1, p = 0.002), mood state profile (p = 0.02), and affective symptoms (p = 0.01) in the women receiving the commercial phytotherapeutic dietary supplement PREMEN-CALM^®. On the contrary, the between-group analysis showed no statistical differences, suggesting a plausible placebo effect. The phytotherapeutic supplement PREMEN-CALM^® might be effective in treating or alleviating the symptoms of the premenstrual syndrome without adverse events. Integrative medicine approaches in the clinical practice may help improve the health of women suffering from this and other gynecological conditions.

Keywords:

• Integrative medicine
• melatonin
• mood state profile
• oxidative stress
• premenstrual syndrome
• Rhodiola rosea L
• sleep quality
• Vitex agnus-castus

Acknowledgments

The research team would like to thank all the participants who have collaborated in the study in an unselfish manner.

Authors’ contributions

Conceptualization: CC, ABR, MA; Methodology: CC, ABR, MA; Investigation: AH, CC, ABR; Visualization: CC, ABR; Supervision: CC, ABR; Writing—original draft: AH, CC; Writing—review & editing: AH, CC, ABR, MA.

Disclosure statement

Authors declare that they have no competing interests.

Data availability statement

The data presented in this study are available on request from the corresponding author. The data are not publicly available due to ethical restrictions.

Additional information

Funding

This work was supported by the Regional Government of Extremadura-ERDF funds under Grant BBB021- GR21042; Naturlider S.L. under research agreement with the University of Extremadura (ref. 100/21). Neither the government agency nor the sponsoring company have played a role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Notes on contributors

Andrea Herrera

Andrea Herrera, degree in biology, pre-doctoral student at the dept. of physiology, university of extremadura (spain). research interests: nutrition and women’s health.

Miriam Al Adib

Miriam Al Adib, doctor of gynaecology and obstetrics. pre-doctoral student at the dept. of physiology, university of extremadura (spain). research interests: women’s health.

Ana Beatriz Rodríguez

Ana B. Rodríguez, university professor and coordinator of the neuroinmunophysiology and chrononutrition research group (dept. of physiology, university of extremadura, spain). research interests: oxidative stress and chrononutrition.

Cristina Carrasco

Cristina Carrasco, lecturer in the dept. of physiology at the university of extremadura (spain). research interests: oxidative stress, nutrition and women’s health.