Five-year follow-up study of a kidney-tonifying herbal Fufang for prevention of postmenopausal osteoporosis and fragility fractures.

To observe the kidney-tonifying herbal Fufangs with phytoestrogenic epimedium for prevention of postmenopausal osteoporosis with both bone mineral density (BMD) and fracture as study endpoints, a 5-year multicenter follow-up study in 194 postmenopausal women (47-70 years old) was conducted in which the subjects were given oral administration of herbal Fufang (10 g/day, twice per day, n = 101) or placebo (n = 93). Both groups were supplemented daily with calcium (600 mg) and vitamin D (400 IU). BMD at distal radius, potential adverse events, and fracture incidence were evaluated at baseline and at 6, 12, 24, 36, 48, and 60 months. At the end of 5 years, 155 subjects had completed the study, with better adherence in the treatment group (13% dropouts, n = 88 at year 5) as compared with the control group (28% dropouts, n = 67 at year 5) (P < 0.05). No notable adverse events were observed in either group. In the treatment group BMD increased significantly from baseline (0.211 ± 0.022 g/cm(2)) to the end of the study (0.284 ± 0.015 g/cm(2)), whereas the control group decreased significantly from baseline (0.212 ± 0.023 g/cm(2)) to 5 years later (0.187 ± 0.022 g/cm(2)) (P < 0.05). The fracture incidence was 2.4 fold lower in the treatment group than in the control group, with a relative risk of 0.57 for the treatment group (95% CI, 0.43-0.70, P < 0.05). In conclusion, in addition to the beneficial effects of oral herbal Fufang on prevention of postmenopausal bone loss, this 5-year multi-center clinical study demonstrated for the first time its potential for reduction in fragility fracture incidence.