Succinate-Based Dietary Supplement for Menopausal Symptoms: A Pooled Analysis of Two Identical Randomized, Double-Blind, Placebo-Controlled Clinical Trials

Background. To evaluate the efficacy of a succinate-based dietary supplement (SBDS; Amberen) in symptomatic menopausal women using a larger sample size derived by pooling data from two identical trials. Methods. Raw data were pooled from two identical randomized, multicenter, double-blinded, placebo...

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Published in:Obstetrics and gynecology international 2019, Vol.2019 (2019), p.1-9
Main Authors: Kuznetsova, Irina V., Shulman, Lee P., Uspenskaya, Yulia, Radzinsky, Viktor E.
Format: Article
Language:English
Subjects:
Apolipoproteins
Body mass index
Body weight
Clinical trials
Dietary supplements
Estrogen
Follicle-stimulating hormone
Glycoproteins
Leptin
Luteinizing hormone
Menopause
Physiological aspects
Product development
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Summary:Background. To evaluate the efficacy of a succinate-based dietary supplement (SBDS; Amberen) in symptomatic menopausal women using a larger sample size derived by pooling data from two identical trials. Methods. Raw data were pooled from two identical randomized, multicenter, double-blinded, placebo-controlled, 90-day clinical trials. Women aged 42–60 years with mild to moderate vasomotor and psychosomatic menopausal symptoms were included (114 in the treatment group and 113 in the placebo group). Symptoms were assessed by the Greene Climacteric Scale and State-Trait Anxiety Inventory. Changes in body mass index, body weight, waist and hip circumferences, and plasma levels of follicle stimulating hormone, luteinizing hormone, estradiol, leptin, and apolipoproteins A1 and B were also evaluated. Results. SBDS use resulted in significant improvements in several endpoints including alleviation of 16 of 21 menopausal symptoms (p≤0.05, Greene Scale) and a decrease in anxiety (p
ISSN:1687-9589
1687-9597
1687-9589
DOI:10.1155/2019/1572196