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

Vera A. Kachko*, Lee P. Shulman, Irina V. Kuznetsova, Yulia B. Uspenskaya, Denis I. Burchakov

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)3183-3195
Number of pages13
JournalAdvances in Therapy
Volume41
Issue number8
DOIs
StatePublished - Aug 2024

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.

Keywords

  • Climacteric symptoms
  • Greene Climacteric Scale
  • HADS
  • Perimenopause
  • STAI
  • Succinate-based dietary supplement
  • WAM

ASJC Scopus subject areas

  • Pharmacology (medical)

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