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Bushen Yijing Fang Reduces Fall Risk in Late Postmenopausal Women with Osteopenia: A Randomized Double-blind and Placebo-controlled Trial

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)...

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Detalles Bibliográficos
Autores principales: Zheng, Yuxin, Wang, Xuezong, Zhang, Zong-Kang, Guo, Baosheng, Dang, Lei, He, Bing, Zhang, Chi, Zhou, Jiwei, Shi, Wanzhong, Zhao, Yongfang, Zhan, Hongsheng, Xu, Yu, Liang, Chao, Liu, Jin, Guan, Daogang, Wang, Luyao, Wu, Xiaohao, Li, Jie, Zhuo, Zhenjian, Lin, Zhixiu, Qiu, Hong, Zhong, Lidan, Bian, Zhaoxiang, Shi, Yinyu, Zhang, Bao-Ting, Zhang, Ge, Lu, Aiping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6375933/
https://www.ncbi.nlm.nih.gov/pubmed/30765762
http://dx.doi.org/10.1038/s41598-018-38335-3
Descripción
Sumario: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).