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

Autor: Kachko VA; Alliance Pharma plc and Alliance Pharmaceuticals Ltd. Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, England. Vera.Kachko@allianceph.com., Shulman LP; Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, 250 East Superior Street, Room 05-2174, Chicago, USA., Kuznetsova IV; Vitbiomed Medical Center, 11 bld 2 Donskaya Street, Moscow, 119049, Russia.; International Association of Gynecologists, Endocrinologists and Therapists, 2 bld. 6 Marshal Rybalko Str., Room 14-15, Moscow, 123060, Russia., Uspenskaya YB; Medsanchast No 14 LLC, 3 bld. 2 Stolyarny Pereulok, Moscow, 123022, Russia., Burchakov DI; NOCHU DPO 'Higher School of Medicine', 3A bld. 2 Malaya Semenovskaya Street, Moscow, 107023, Russia.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2024 Aug; Vol. 41 (8), pp. 3183-3195. Date of Electronic Publication: 2024 Jun 21.
DOI: 10.1007/s12325-024-02910-0
Abstrakt: 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.
Gov Identifier: NCT03897738.
(© 2024. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.)
Databáze: MEDLINE
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