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ABSTRACT
Objective Estrogen is the most effective treatment for vasomotor symptoms. Given its potential risks, herbal preparations and nutritional supplements have been developed as alternative remedies. The main aim of this double-blind, randomized, placebo-controlled trial was to assess any impact of a nutritional supplement containing 12 vitamins and nine minerals on the frequency and severity of hot flushes in postmenopausal women over a 3-month period.
Subjects and methods Ninety-one postmenopausal women were randomized to either the placebo (n = 45) or the treatment arm (n = 46). Seventy out of the 91 women completed the study (36 from the treatment group and 34 from the placebo group). At baseline and the 14-week post-intervention assessments, study participants completed questionnaires on the frequency and severity of hot flushes and night sweats, the Profile of Mood State questionnaire, the World Health Organization Quality of Life Questionnaire, the National Adult Reading Test and the Rey Auditory-Verbal Learning Test. Between assessments, the women also completed hot flush diaries.
Results There was a significant decrease (p < 0.01) in the number (±standard error of the mean) of hot flushes experienced per week for treatment (pre 31.3 ± 4.7; post 23.1 ± 4.8) and placebo groups (pre 28.1 ± 4.7; post 17.3 ± 4.0). A significant decrease (p < 0.001) in the number of night sweats experienced per week was also observed in the treatment (pre 6.1 ± 1.0; post 4.2 ± 0.7) and placebo groups (pre 5.9 ± 0.7; post 3.7 ± 0.7).
Conclusions This study demonstrates a significant placebo effect on hot flushes and night sweats, as consistent with other studies. The micronutrient supplement containing 21 vitamins and minerals was not superior over placebo in effects on hot flushes and night sweat experiences.
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Conflict of interest The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
Source of funding This study was supported by Vitabiotics Ltd.