TY - JOUR
T1 - Bushen Yijing Fang Reduces Fall Risk in Late Postmenopausal Women with Osteopenia
T2 - A Randomized Double-blind and Placebo-controlled Trial
AU - Zheng, Yuxin
AU - Wang, Xuezong
AU - Zhang, Zong-Kang
AU - Guo, Baosheng
AU - Dang, Lei
AU - He, Bing
AU - Zhang, Chi
AU - Zhou, Jiwei
AU - Shi, Wanzhong
AU - Zhao, Yongfang
AU - Zhan, Hongsheng
AU - Xu, Yu
AU - Liang, Chao
AU - Liu, Jin
AU - Guan, Daogang
AU - Wang, Luyao
AU - Wu, Xiaohao
AU - Li, Jie
AU - Zhuo, Zhenjian
AU - Lin, Zhixiu
AU - Qiu, Hong
AU - Zhong, Lidan
AU - Bian, Zhaoxiang
AU - Shi, Yinyu
AU - Zhang, Bao-Ting
AU - Zhang, Ge
AU - Lu, Aiping
N1 - Funding Information:
The study was funded by the Ministry of Science & Technology of China (Project No. 96-906-09-05), Shanghai Science & Technology Commission (Project No. 004319226), National Natural Science Foundation of China (Project No. 81201406), General Research Fund (GRF) of Research Grant Committee (RGC) (Project No. 14112915, HKBU_261113, HKBU_478312). The authors thank Prof. Meiyu Shi and Prof. Hua Lu for his insightful suggestions and comments on the data and statistical guidance; they also thank nurses for their help and the participants for their cooperation.
Publisher copyright:
© The Author(s) 2019
PY - 2019/2/14
Y1 - 2019/2/14
N2 - 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).
AB - 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).
UR - http://www.scopus.com/inward/record.url?scp=85061607245&partnerID=8YFLogxK
U2 - 10.1038/s41598-018-38335-3
DO - 10.1038/s41598-018-38335-3
M3 - Journal article
C2 - 30765762
AN - SCOPUS:85061607245
SN - 2045-2322
VL - 9
JO - Scientific Reports
JF - Scientific Reports
M1 - 2089
ER -