Abstract
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 < 0.0001, State-Trait Anxiety Inventory) when compared to placebo. Significant reductions were observed in weight, body mass index, and waist and hip circumferences in the supplement cohort. Evaluation of physiological parameters showed a significant increase in serum estradiol levels compared to baseline (p < 0.0001) among users of the SBDS. Levels of follicle stimulating hormone and luteinizing hormone decreased slightly in both groups, without significant differences between the groups. Leptin levels decreased with statistical significance in the SBDS cohort compared to placebo (p=0.027). For those with initial leptin concentrations above the reference range, leptin decreased significantly in the SBDS group compared to the baseline (p < 0.0001) and to placebo (p=0.027). Conclusions The pooled analysis reaffirms the outcomes from the individual trials. A nonhormonal, succinate-based dietary supplement is shown to relieve menopausal symptoms when compared to a placebo regimen in a randomized, double-blinded clinical trial.
Highlights
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
Results of the initial Greene Climacteric Scale assessments were mostly similar between the two cohorts. e categories that were not similar at baseline included “difficulty sleeping”, “sadness or depression”, “hot flashes”, and “lack of sex drive,” symptoms that occurred more frequently in the SBDS cohort (Table 3)
Analysis of the Greene Climacteric Scale data showed a significant decrease in the number of complaints and degree of bother for most symptoms in the SBDS cohort (Table 3), except for “numbness or tingling in some body parts”, “numbness of hands and feet”, and “difficulty breathing” in which no significant changes were observed
Summary
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. 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 evaluated. 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 < 0.0001, State-Trait Anxiety Inventory) when compared to placebo. Leptin levels decreased with statistical significance in the SBDS cohort compared to placebo (p 0.027). A nonhormonal, succinate-based dietary supplement is shown to relieve menopausal symptoms when compared to a placebo regimen in a randomized, double-blinded clinical trial
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