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Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen® and Smart B® in Women with Climacteric Syndrome in Perimenopause

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Abstract

Introduction

Perimenopause is a time of transition in a woman’s life that links her reproductive years to the cessation of ovulation, or menopause. For many women, this time is characterized by a variety of physiological and lifestyle changes, including increasing irregularity in menstrual bleeding, frequency and severity of vasomotor symptoms, etc. Therapies evaluated specifically for the perimenopausal women are very limited. This study aimed to evaluate the effectiveness and safety of Amberen® (a succinate-based non-hormonal supplement) combined with a Smart B® (vitamin B) complex in women with typical (without complications) mild to moderate climacteric syndrome during perimenopause.

Methods

Women up to 50 years of age, in perimenopause, with vasomotor and psychosomatic symptoms of the climacteric syndrome were enrolled for the study. The trial was randomized, double-blinded, placebo-controlled, comparative, and prospective.

Results

A total of 106 participants were enrolled in the trial and, per protocol, 105 completed the trial. We observed statistically significant improvements in most of the Greene Climacteric Scale symptoms, State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Well-being, Activity, and Mood (WAM) scores. The intervention was well tolerated with few adverse effects reported to be mild and transient.

Conclusion

The use of this dietary supplement is safe and eliminates or improves vasomotor and psychosomatic symptoms of climacteric symptoms in perimenopausal women: it improves sleep and cognitive abilities, lowers depression and anxiety, improves mood and well-being, and positively affects quality of life.

ClinicalTrials.gov Identifier

NCT03897738.

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Acknowledgements

All authors would like to acknowledge the invaluable support and assistance of Ms. Anna Skylar in the development and creation of this manuscript. Ms. Skylar is a scientific affairs manager in Alliance Pharmaceuticals Ltd.

Funding

Amberen® was manufactured by Biogix Inc. during the study period, and the company funded the clinical trial including active and placebo products. The journal's rapid service fee was funded by the Alliance Pharma Inc.

Author information

Authors and Affiliations

  1. Alliance Pharma plc and Alliance Pharmaceuticals Ltd. Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, England

    Vera A. Kachko

  2. Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, 250 East Superior Street, Room 05-2174, Chicago, USA

    Lee P. Shulman

  3. Vitbiomed Medical Center, 11 bld 2 Donskaya Street, Moscow, 119049, Russia

    Irina V. Kuznetsova

  4. International Association of Gynecologists, Endocrinologists and Therapists, 2 bld. 6 Marshal Rybalko Str., Room 14-15, Moscow, 123060, Russia

    Irina V. Kuznetsova

  5. Medsanchast No 14 LLC, 3 bld. 2 Stolyarny Pereulok, Moscow, 123022, Russia

    Yulia B. Uspenskaya

  6. NOCHU DPO “Higher School of Medicine”, 3A bld. 2 Malaya Semenovskaya Street, Moscow, 107023, Russia

    Denis I. Burchakov

Authors
  1. Vera A. Kachko
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  2. Lee P. Shulman
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  3. Irina V. Kuznetsova
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  4. Yulia B. Uspenskaya
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Contributions

There was substantial contribution from all authors to this article: Vera A. Kachko and Lee P. Shulman conception, data analysis, and interpretation, writing and reviewing. Irina V. Kuznetsova, Yulia B. Uspenskaya and Denis I. Burchakov data analysis, interpretation and reviewing. The final version of the article has been approved by all authors.

Corresponding author

Correspondence to Vera A. Kachko.

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Conflict of Interest

Vera A. Kachko is a scientific advisor in Alliance Pharmaceuticals Ltd., Lee P. Shulman is a consultant for Alliance Pharmaceuticals Ltd. Lee P. Shulman is an Editorial Board member of Advances in Therapy. Lee Shulman was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Irina V. Kuznetsova was the main investigator of this trial, Yulia B. Uspenskaya and Denis I. Burchakov were investigators in this trial.

Ethical Approval

The trial was conducted according to the principles of the World Medical Association Declaration of Helsinki “Recommendations guiding physicians in biomedical research involving human subjects” (accepted in 1964, last updated in 2000, with explanations added in 2002, 2004, 2010, and 2013) and the National Standard of the Russian Federation “Clinical practice” (52379–2005, 27.09.2005, No 232-SP). Protocol of the trial, independent review committee (IRC), informed consent form, and other documents were presented and approved by the Ethics Committee of I.M. Sechenov Moscow State Medical University for independent expert analysis (Protocol excerpt No. 04-19, Local Ethics Committee session March 6, 2019). Informed consent forms signed and dated by study subjects indicate their agreement to participate in the study.

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Kachko, V.A., Shulman, L.P., Kuznetsova, I.V. et al. Clinical Evaluation of Effectiveness and Safety of Combined Use of Dietary Supplements Amberen® and Smart B® in Women with Climacteric Syndrome in Perimenopause. Adv Ther (2024). https://doi.org/10.1007/s12325-024-02910-0

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