The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis
文献类型:期刊论文
作者 | H. M. Zhu; L. Qin; P. Garnero; H. K. Genant; G. Zhang; K. Dai; X. Yao; G. Gu; Y. Hao; Z. Li |
刊名 | OSTEOPOROSIS INTERNATIONAL
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出版日期 | 2012 |
英文摘要 | 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. |
收录类别 | SCI |
原文出处 | http://link.springer.com/article/10.1007/s00198-011-1577-2 |
语种 | 英语 |
源URL | [http://ir.siat.ac.cn:8080/handle/172644/4031] ![]() |
专题 | 深圳先进技术研究院_医工所 |
作者单位 | OSTEOPOROSIS INTERNATIONAL |
推荐引用方式 GB/T 7714 | H. M. Zhu,L. Qin,P. Garnero,et al. The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis[J]. OSTEOPOROSIS INTERNATIONAL,2012. |
APA | H. M. Zhu.,L. Qin.,P. Garnero.,H. K. Genant.,G. Zhang.,...&S. J. Zhao.(2012).The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis.OSTEOPOROSIS INTERNATIONAL. |
MLA | H. M. Zhu,et al."The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis".OSTEOPOROSIS INTERNATIONAL (2012). |
入库方式: OAI收割
来源:深圳先进技术研究院
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