Citation

Zheng Y, Wang X, Zhang ZK, Guo B, Dang L, He B, Zhang C, Zhou J, Shi W, Zhao Y, Zhan H, Xu Y, Liang C, Liu J, Guan D, Wang L, Wu X, Li J, Zhuo Z, Lin Z, Qiu H, Zhong L, Bian Z, Shi Y, Zhang BT, Zhang G, Lu A. Sci. Rep. 2019; 9(1): 2089.

Affiliation

School of Basic Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China. aipinglu@hkbu.edu.hk.

Copyright

(Copyright © 2019, Nature Publishing Group)

DOI

10.1038/s41598-018-38335-3

PMID

30765762

Abstract

Falls in late postmenopausal women with osteopenia usually cause fractures with severe consequences. This 36-month randomized, double-blind and placebo-controlled trial with a 10-year observational follow-up study aimed to investigate the long-term effect of herbal formula Bushen Yijing Fang (BSYJF) on fall risk in the late postmenopausal women with osteopenia. 140 late postmenopausal women (Femoral neck T-score, -2.5~-2 SD) were recruited and randomized to orally receive calcium carbonate 300 mg daily with either BSYJF or placebo for 36 months. The effect was further investigated for another 10-year follow-up. During the 36-month administration, there were 12 falls in BSYJF group and 28 falls in placebo group, respectively, indicating 64% lower risk of falls (RR 0.36 [95% CI, 0.18 to 0.71]; P = 0.004) in BSYJF group. During the 10-year follow-up, 36% lower fall risk (RR 0.64 [95% CI, 0.46 to 0.89]; P = 0.009) was observed in BSYJF group. No significant difference was found in safety profile between two groups. Thirty-six-month administration of BSYJF reduced fall risk with an increase in bone mass, and its latent effect on fall risk was continually observed in the 10-year follow-up in late postmenopausal women with osteopenia. This clinical trial was registered at Chinese clinical trial registry (ChiCTR-IOR-16008942).

Language: en