Abstract |
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.
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Authors | Wei-Min Deng, Peng Zhang, Hai Huang, You-Gao Shen, Qin-Hua Yang, Wei-Li Cui, Yang-Shu He, Song Wei, Zhu Ye, Fang Liu, Ling Qin |
Journal | Journal of bone and mineral metabolism
(J Bone Miner Metab)
Vol. 30
Issue 5
Pg. 517-24
(Sep 2012)
ISSN: 1435-5604 [Electronic] Japan |
PMID | 22722637
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drugs, Chinese Herbal
- Plant Preparations
- Vitamin D
- Calcium
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Topics |
- Aged
- Bone Density
(drug effects)
- Bone Resorption
(drug therapy, prevention & control)
- Calcium
(administration & dosage)
- Dietary Supplements
- Drugs, Chinese Herbal
(adverse effects, therapeutic use)
- Epimedium
- Female
- Follow-Up Studies
- Fractures, Bone
(drug therapy, prevention & control)
- Humans
- Middle Aged
- Osteoporosis, Postmenopausal
(drug therapy, prevention & control)
- Phytotherapy
(methods)
- Plant Preparations
(adverse effects, therapeutic use)
- Vitamin D
(administration & dosage)
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