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

Yuxin Zheng,Luyao Wang,Bing He,Chao Liang,Baosheng Guo,Hong Qiu,Zongkang Zhang ,Hongsheng Zhan ,Ge Zhang,Wanzhong Shi,Zhi‐Xiu Lin ,Zhuo Zhang ,Jin Liu,Xuezong Wang,Daogang Guan,Yongfang Zhao ,Zhaoxiang Bian,Jie Li,Chi Zhang,Jiwei Zhou,Xu G Yu ,Xiaohao Wu,Lei Dang,Linda L D Zhong ,Bao-Ting Zhang,Yue Shi ,Aiping Lu

doi:10.1038/s41598-018-38335-3

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).

Highlights

Such as the tendency to fall, needs to be taken into consideration to reduce fall-related fractures in late postmenopausal women with osteopenia
For the 36-month trial, twenty-seven participants withdrew from the trial: 13/70 in BSYJF and 14/70 in placebo
For the 10-year observational follow-up, 15 participants were lost to follow-up: 7/57 in BSYJF and 8/56 in placebo The reason was family relocation (Fig. 1)

Summary

Introduction

Such as the tendency to fall, needs to be taken into consideration to reduce fall-related fractures in late postmenopausal women with osteopenia. Both decreased muscle mass and impaired functional mobility (muscular and neurological) are two important risk contributors to falls[8]. The two contributors should be targeted to reduce fall risk for preventing fall-related fracture in late postmenopausal women with osteopenia. Many clinical trials have been performed to study the effects of Vitamin D on fracture and falls[9,10]. We performed a 36-month randomized, double-blind and placebo-controlled trial in late postmenopausal women with osteopenia to investigate efficacy of BSYJF on fall risk and long-term safety in the 36-month administration. We explored and validated the underlying mechanism of BSYJF by bioinformatics analysis

Methods

Results

Conclusion