UNLABELLED: This multicenter and randomized clinical trial showed that daily oral herbal formulaXian 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.
RCT Entities:
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.
Authors: José M Aldrighi; Deborah C Quail; Jacques Levy-Frebault; Fernanda Aguas; Kurt Kosian; Lurdes Garrido; Brigitte Bosio-Le Goux; Max Saráchaga; Alice Graebe; Antonio J Niño; Thomas Nickelsen Journal: Am J Obstet Gynecol Date: 2004-12 Impact factor: 8.661
Authors: Warren T K Lee; Catherine S K Cheung; Yee Kit Tse; Xia Guo; Ling Qin; Suzanne C Ho; Joseph Lau; Jack C Y Cheng Journal: Osteoporos Int Date: 2005-02-23 Impact factor: 4.507
Authors: Steven R Cummings; Bruce Ettinger; Pierre D Delmas; Peter Kenemans; Victoria Stathopoulos; Pierre Verweij; Mirjam Mol-Arts; Lenus Kloosterboer; Lori Mosca; Claus Christiansen; John Bilezikian; Eduardo Mario Kerzberg; Susan Johnson; Jose Zanchetta; Diederich E Grobbee; Wilfried Seifert; Richard Eastell Journal: N Engl J Med Date: 2008-08-14 Impact factor: 91.245