Effect of exercise and Cimicifuga racemosa (CR BNO 1055) on bone mineral density, 10-year coronary heart disease risk, and menopausal complaints: the randomized controlled Training and Cimicifuga racemosa Erlangen (TRACE) study

Objective: The aim of this study was to determine the effect of periodized exercise training with and without Cimicifuga racemosa (CR) on bone mineral density (BMD) and 10-year coronary heart disease (CHD) risk in early postmenopausal women. Methods: A total of 128 women were randomly assigned to three subgroups: exercise (EG, n = 43), exercise and CR supplementation (EGCR, n = 43), and wellness control (control group [CG], n = 42). Both exercise groups performed a periodized exercise program with high-intensity-resistance/high-impact exercise dedicated to bone parameters interspersed by blocks of 10 weeks of training focusing on CHD parameters. In addition to the exercise program, the EGCR was supplemented with 40 mg/day of CR according to the specification of the manufacturer. A low-intensity exercise program of 60 minutes per week for a period of 10 weeks interspersed with 10-week blocks without exercise was performed in the CG. Primary endpoints were BMD and 10-year CHD risk proposed by Wilson. Secondary endpoints were body composition and menopausal symptoms. Results: BMD at the lumbar spine was maintained in both exercise groups (EG, -0.1% +/- 2.2%, P = 0.74; EGCR, -0.4% +/- 2.4%, P = 0.40) and significantly decreased (P < 0.001) in the CG (2.0% +/- 2.0%). Both exercise groups significantly differed from the CG (P = 0.001 and 0.005 for the EG and EGCR, respectively); however, no differences between the exercise groups with and without CR was determined. Although slight increases in femoral neck BMD were determined in both exercise groups (EG, 0.5% +/- 3.0%, P = 0.36; EGCR, 0.4% +/- 3.1%, P = 0.52), a reduction was assessed in the CG (j0.6% T 2.7%, P = 0.29). No significant differences were determined between the groups. The 10-year CHD risk significantly increased in the EGCR (12.9% +/- 25.1%, P = 0.018) and in the CG (16.5% +/- 27.8%, P = 0.007). The EG did not show corresponding changes (-2.7% +/- 21.9%, P = 0.60). However, no significant between-group differences were observed. Conclusions: In conclusion our exercise program favorably affected bone, menopausal symptoms, lean body mass, and, to a smaller extent, 10-year CHD risk in early postmenopausal women. Adjuvant supplementation of CR did not enhance these positive effects.