title: [Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].
abstract: OBJECTIVE
  To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients.
  
  
  METHODS
  A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment.
  
  
  RESULTS
  After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P < 0.05]. Scores for CM syndromes, BASDAI, night pain index, spinal pain index, PGA, CRP were improved in the BSG group (P < 0.05, P < 0.01). The incidence of adverse events in the BSG group was lower than that of the control group.
  
  
  CONCLUSIONS
  BSG based on Shen supplementing, Du-channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.
authors.forename: Wei-ping
authors.initials: WP
authors.lastname: Kong
authors.forename: Qing-wen
authors.initials: QW
authors.lastname: Tao
authors.forename: Ying-ze
authors.initials: YZ
authors.lastname: Zhang
authors.forename: Shu
authors.initials: S
authors.lastname: Yang
authors.forename: Yuan
authors.initials: Y
authors.lastname: Xu
authors.forename: Xiao-xia
authors.initials: XX
authors.lastname: Zhu
authors.forename: Yue
authors.initials: Y
authors.lastname: Jin
authors.forename: Wen-xue
authors.initials: WX
authors.lastname: Yang
authors.forename: Xiao-ping
authors.initials: XP
authors.lastname: Yan
mesh_terms: D044466:Asian People; D035843:Biomedical Research; D001799:Blood Sedimentation; D002097:C-Reactive Protein; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D010146:Pain; D011446:Prospective Studies; D012449:Safety; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*
chemical_list: D004365:Drugs, Chinese Herbal; D002097:C-Reactive Protein