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The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis

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Abstract

Summary

This multicenter and randomized clinical trial showed that daily oral herbal formula Xian Ling Gu Bao (XLGB) was safe in postmenopausal women over a 1-year treatment. Those patients (n ∼ 50) treated with XLGB at the conventional dose demonstrated a statistically significant increase in dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) at lumbar spine at 6 months and a numerically increased BMD at 12 months.

Introduction

The aim of this study was to examine the safety and efficacy of a herbal formula XLGB in postmenopausal women (ChiCTR-TRC-00000347).

Methods

One hundred eighty healthy postmenopausal women (≥60 years old) with BMD T-score ≤ −2.0 (lumbar spine or femoral neck) were recruited from four clinical centers to receive low-dose (conventional dose) XLGB (L-XLGB group, 3 g/day, n = 61) or high-dose XLGB (H-XLGB group, 6 g/day, n = 58) or placebo (CON group, n = 61). Women received daily calcium (500 mg) and vitamin D (200 IU) supplementation. Primary endpoints were lumbar spine BMD and safety; secondary endpoints were femoral neck BMD and bone turnover markers measured at baseline and at 6 and 12 months.

Results

Of 180 women recruited, 148 completed the study. The compliance in each group was comparable. Prominent adverse events were not observed in either group. In the L-XLGB group at 6 months, lumbar spine BMD by DXA increased significantly from baseline (+2.11% versus CON +0.58%, p < 0.05), but femoral neck BMD did not; at 12 months, BMD in the L-XLGB group decreased from 6-month levels yet remained higher than baseline, but without difference from the CON group. There was no dose-dependent response. Bone turnover marker levels declined during the first 6 months after XLGB treatment. There was no significant difference in the overall incidence of side effects among treatment and control groups.

Conclusion

XLGB over 1-year treatment at the conventional dose demonstrated safe and only a statistically significant increase in BMD at lumbar spine at 6 months in postmenopausal women.

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Conflicts of interest

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Author information

Authors and Affiliations

  1. Centre of Osteoporosis, Shanghai Hua Dong Hospital, Fu Dan University, Shanghai, China

    H. M. Zhu, W. Li & H. Li

  2. Department of Orthopedics of the Ninth People Hospital, Jiao Tong University, Shanghai, China

    K. Dai, Y. Hao, J. Yang, X. Zhang & Q. Wu

  3. Department of Orthopedics of the First Hospital, Ji Lin University, Changchun, Ji Lin Province, China

    G. Gu, X. Zhao & C. Li

  4. Beijing Sino-Japan Friendship Hospital, Capital Medical University, Beijing, China

    Z. Li, D. Shi & J. Zhao

  5. Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong, Hong Kong, SAR, China

    L. Qin & G. Zhang

  6. INSERM Research Unit 664 and Synarc Biochemical Marker Division, Lyon, France

    P. Garnero

  7. Synarc Clinical Research Center, San Francisco, CA, USA

    H. K. Genant, Y. Zhao, T. Fuerst & S. J. Zhao

  8. Institute of Traditional Chinese Medicine & Natural Products, Ji Nan University, Guangzhou, China

    X. Yao

  9. Translational Medicine Research & Development Center, Institute of Biomedical and Health Engineering, Shenzhen Institutes of Advanced Technology, Chinese Academy of Science, Shenzhen, China

    L. Qin

  10. Synarc Clinical Research Center, Stanford, CA, 94305-5101, USA

    Y. Lu

Authors
  1. H. M. Zhu
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  2. L. Qin
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  3. P. Garnero
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  4. H. K. Genant
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  5. G. Zhang
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  6. K. Dai
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  7. X. Yao
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  8. G. Gu
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  9. Y. Hao
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  10. Z. Li
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  11. Y. Zhao
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  12. W. Li
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  13. J. Yang
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  14. X. Zhao
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  15. D. Shi
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  16. T. Fuerst
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  17. Y. Lu
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  18. H. Li
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  19. X. Zhang
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  20. C. Li
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  21. J. Zhao
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  22. Q. Wu
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  23. S. J. Zhao
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Corresponding authors

Correspondence to H. M. Zhu or L. Qin.

Additional information

H.M. Zhu, L. Qin, P. Garnero, H.K. Genant, and G. Zhang are co-first authors.

Electronic supplementary material

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Supplement 1

CONSORT 2010 checklist of information to include when reporting a randomized trial (DOC 218 kb)

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Zhu, H.M., Qin, L., Garnero, P. et al. The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis. Osteoporos Int 23, 1317–1327 (2012). https://doi.org/10.1007/s00198-011-1577-2

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  • DOI: https://doi.org/10.1007/s00198-011-1577-2

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