title: Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial.
abstract: BACKGROUND
  Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. One of the main adverse effects of AIs is musculoskeletal symptoms, which leads to a lower quality of life and poor adherence to AI treatment. To date, no effective management of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) has been developed.
  
  
  METHODS
  To determine whether the traditional Chinese medicine Yi Shen Jian Gu granules could effectively manage AIMSS we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients experiencing musculoskeletal symptoms after taking AIs will be enrolled and treated with traditional Chinese medicine or placebo for 12 weeks. The primary outcome measures include Brief Pain Inventory-Short Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks.
  
  
  CONCLUSIONS
  The results of this study will provide a new strategy to help relieve AIMSS.
  
  
  BACKGROUND
  ISRCTN06129599 (assigned 14 August 2013).
authors.forename: Nan
authors.initials: N
authors.lastname: Peng
authors.forename: Yi
authors.initials: Y
authors.lastname: Zhang
authors.forename: Cong
authors.initials: C
authors.lastname: Ma
authors.forename: Ming-Wei
authors.initials: MW
authors.lastname: Yu
authors.forename: Guo-Wang
authors.initials: GW
authors.lastname: Yang
authors.forename: Qi
authors.initials: Q
authors.lastname: Fu
authors.forename: Wei-Ru
authors.initials: WR
authors.lastname: Xu
authors.affiliation: Oncology Department, Beijing Hospital of Traditional Chinese Medicine affiliated with Capital Medical University, No 23, Back Road of Art Gallery, Dong Cheng District, Beijing 100010, China. wangxiaomin_bhtcm@126.com.
authors.forename: Xiao-Min
authors.initials: XM
authors.lastname: Wang
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D047072:Aromatase Inhibitors / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002681:China; D002985:Clinical Protocols; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D009140:Musculoskeletal Diseases / Q000139:chemically induced / Q000175:diagnosis / Q000188:drug therapy*; D010147:Pain Measurement; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D004365:Drugs, Chinese Herbal; C000595122:yi shen jian gu