title: The first multicenter and randomized clinical trial of herbal Fufang for treatment of postmenopausal osteoporosis.
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.
  
  
  BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.affiliation: Centre of Osteoporosis, Shanghai Hua Dong Hospital, Fu Dan University, Shanghai, China. zhuhanmin@yeah.net
authors.forename: H M
authors.initials: HM
authors.lastname: Zhu
authors.forename: L
authors.initials: L
authors.lastname: Qin
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authors.initials: P
authors.lastname: Garnero
authors.forename: H K
authors.initials: HK
authors.lastname: Genant
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authors.initials: G
authors.lastname: Zhang
authors.forename: K
authors.initials: K
authors.lastname: Dai
authors.forename: X
authors.initials: X
authors.lastname: Yao
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authors.lastname: Gu
authors.forename: Y
authors.initials: Y
authors.lastname: Hao
authors.forename: Z
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authors.lastname: Li
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authors.lastname: Zhao
authors.forename: W
authors.initials: W
authors.lastname: Li
authors.forename: J
authors.initials: J
authors.lastname: Yang
authors.forename: X
authors.initials: X
authors.lastname: Zhao
authors.forename: D
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authors.lastname: Shi
authors.forename: T
authors.initials: T
authors.lastname: Fuerst
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authors.lastname: Lu
authors.forename: H
authors.initials: H
authors.lastname: Li
authors.forename: X
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authors.lastname: Zhang
authors.forename: C
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mesh_terms: D015502:Absorptiometry, Photon / Q000379:methods; D000368:Aged; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016723:Bone Remodeling / Q000187:drug effects / Q000502:physiology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D016903:Drug Monitoring
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D004365:Drugs, Chinese Herbal; C572489:xian ling gu bao; D015675:Osteocalcin