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The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis.
Osteoporos Int. 2012 Apr; 23(4):1317-27.OI

Abstract

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.

Authors+Show Affiliations

Centre of Osteoporosis, Shanghai Hua Dong Hospital, Fu Dan University, Shanghai, China. zhuhanmin@yeah.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

21505910

Citation

Zhu, H M., et al. "The First Multicenter and Randomized Clinical Trial of Herbal Fufang for Treatment of Postmenopausal Osteoporosis." Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 23, no. 4, 2012, pp. 1317-27.
Zhu HM, Qin L, Garnero P, et al. The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis. Osteoporos Int. 2012;23(4):1317-27.
Zhu, H. M., Qin, L., Garnero, P., Genant, H. K., Zhang, G., Dai, K., Yao, X., Gu, G., Hao, Y., Li, Z., Zhao, Y., Li, W., Yang, J., Zhao, X., Shi, D., Fuerst, T., Lu, Y., Li, H., Zhang, X., ... Zhao, S. J. (2012). The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis. Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 23(4), 1317-27. https://doi.org/10.1007/s00198-011-1577-2
Zhu HM, et al. The First Multicenter and Randomized Clinical Trial of Herbal Fufang for Treatment of Postmenopausal Osteoporosis. Osteoporos Int. 2012;23(4):1317-27. PubMed PMID: 21505910.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis. AU - Zhu,H M, AU - Qin,L, AU - Garnero,P, AU - Genant,H K, AU - Zhang,G, AU - Dai,K, AU - Yao,X, AU - Gu,G, AU - Hao,Y, AU - Li,Z, AU - Zhao,Y, AU - Li,W, AU - Yang,J, AU - Zhao,X, AU - Shi,D, AU - Fuerst,T, AU - Lu,Y, AU - Li,H, AU - Zhang,X, AU - Li,C, AU - Zhao,J, AU - Wu,Q, AU - Zhao,S J, Y1 - 2011/04/20/ PY - 2010/07/29/received PY - 2011/01/22/accepted PY - 2011/4/21/entrez PY - 2011/4/21/pubmed PY - 2012/6/5/medline SP - 1317 EP - 27 JF - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JO - Osteoporos Int VL - 23 IS - 4 N2 - UNLABELLED: 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. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/21505910/The_first_multicenter_and_randomized_clinical_trial_of_herbal_Fufang_for_treatment_of_postmenopausal_osteoporosis_ L2 - https://doi.org/10.1007/s00198-011-1577-2 DB - PRIME DP - Unbound Medicine ER -