Objectives: To compare the efficacy and safety of the black cohosh root extract Cr 99 with placebo in women with climacteric complaints.
Methods: A multicenter, randomized, placebo-controlled, double-blind, parallel group study was conducted in 122 menopausal women (intention-to-treat population) with > or =3 hot flashes a day, treated over 12 weeks. Two main efficacy measures - weekly weighted score of hot flashes and Kupperman Index - and secondary efficacy variables, e.
A controlled randomized double-blind study was carried out in 72 female patients to compare tolerance and efficacy of two therapeutic agents containing vitamins of the B-group and L-cystine in different compositions versus a placebo in diffuse effluvia and hair structure lesions. Hair swelling as a criterion of hair quality and frontal and parietal anagen rates in trichograms as criteria of hair growth were determined before and after 4 months of therapy. Treatment with active medication 1 was statistically significantly superior to treatment with the placebo according to these criteria.
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