title: Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Osteoporosis is a growing worldwide problem, with the greatest burden resulting from fractures. Nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (BMD) only moderately lower than young normal individuals). Since long-term drug therapy is an expensive option with uncertain consequences and side effects, natural herbal therapy offers an attractive alternative. The purpose of this study is to evaluate the effect on BMD and safety of the Classic Yin and Yang Tonic Formula for treatment of osteopenia and to investigate the mechanism by which this efficacy is achieved.
  
  
  METHODS
  We propose a multicenter double-blind randomized placebo-controlled trial to evaluate the efficacy and safety of the Classic Yin and Yang Tonic Formula for the treatment of osteopenia. Participants aged 55 to 75 with low bone mineral density (T-score between -1 and -2.5) and kidney deficiency in TCM will be included and randomly allocated into two groups: treatment group and control group. Participants in the treatment group will be treated with Classic Yin and Yang Tonic Granule, while the controlled group will receive placebo. Primary outcome measure will be BMD of the lumbar spine and proximal femur using dual-energy X-ray absorptiometry. Secondary outcomes will include pain intensity measured with visual analogue scales, quality of life, serum markers of bone metabolism, indices of Neuro-endocrino-immune network and safety.
  
  
  CONCLUSIONS
  If the Classic Yin and Yang Tonic Formula can increase bone mass without adverse effects, it may be a novel strategy for the treatment of osteoporosis. Furthermore, the mechanism of the Chinese medical formula for osteoporosis will be partially elucidated.
  
  
  BACKGROUND
  This study is registered at ClinicalTrials.gov, NCT01271647.
authors.affiliation: Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, PR China.
authors.forename: Feng
authors.initials: F
authors.lastname: Yang
authors.forename: De-Zhi
authors.initials: DZ
authors.lastname: Tang
authors.forename: Xue-Jun
authors.initials: XJ
authors.lastname: Cui
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Holz
authors.forename: Qin
authors.initials: Q
authors.lastname: Bian
authors.forename: Qi
authors.initials: Q
authors.lastname: Shi
authors.forename: Yong-Jun
authors.initials: YJ
authors.lastname: Wang
mesh_terms: D015502:Absorptiometry, Photon; D000368:Aged; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001851:Bone Diseases, Metabolic / Q000097:blood / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016723:Bone Remodeling / Q000187:drug effects; D002681:China; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005269:Femur / Q000000981:diagnostic imaging / Q000187:drug effects; D050723:Fractures, Bone / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects; D008875:Middle Aged; D010146:Pain / Q000209:etiology / Q000517:prevention & control; D010147:Pain Measurement; D015990:Placebo Effect; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D016709:Yin-Yang
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D004365:Drugs, Chinese Herbal