title: Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis: a multi-center parallel-group double-blind randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy. and safety of Xinfeng capsule in patients suffering rheumatoid arthritis (RA).
  
  
  METHODS
  A multi-center parallel-group designed, double-blind, randomized, controlled trial was conducted. Totally 304 RA patients were assigned to two groups: one group was administered Xinfeng capsule (XFC) plus the placebo of leflunomide and the other given leflunomide (LEF) plus the placebo of XFC for twelve weeks. The clinical and laboratory parameters were compared at baseline and fourth, eighth, and twelfth weeks.
  
  
  RESULTS
  After twelve-week treatment, patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association (ACR) recommended 20%, 50%, 70% improvement criteria, but it was insignificant. The validity in ameliorate modified disease activity score (DAS28) and laboratory indexes as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF) were also found no difference. The score of health assessment questionnaire (HAQ), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and quality of life questionnaire with rheumatoid arthritis (RAQOL) both lower than the first week and the changes showed no difference. However, the score of SDS dropped more in XFC group than in the other. A total of 147 adverse reaction cases were reported, which shows no difference between the two groups. The most common adverse reactions were hepatic impairment, anemia, leukocytopenia, epigastric discomfort and phalacrosis.
  
  
  CONCLUSIONS
  XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.
authors.forename: Jian
authors.initials: J
authors.lastname: Liu
authors.forename: Yuan
authors.initials: Y
authors.lastname: Wang
authors.forename: Chuanbing
authors.initials: C
authors.lastname: Huang
authors.forename: Jianhua
authors.initials: J
authors.lastname: Xu
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Li
authors.forename: Liang
authors.initials: L
authors.lastname: Xu
authors.forename: Liyun
authors.initials: L
authors.lastname: He
authors.forename: Yue
authors.initials: Y
authors.lastname: Sun
authors.forename: Yali
authors.initials: Y
authors.lastname: Wang
authors.forename: Shengqian
authors.initials: S
authors.lastname: Xu
authors.forename: Ping
authors.initials: P
authors.lastname: Zhao
authors.forename: Tongjun
authors.initials: T
authors.lastname: Mao
authors.forename: Bin
authors.initials: B
authors.lastname: Tan
authors.forename: Fubing
authors.initials: F
authors.lastname: Zhu
authors.forename: Pingheng
authors.initials: P
authors.lastname: Zhang
authors.forename: Li
authors.initials: L
authors.lastname: Fang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001007:Anxiety; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004365:Drugs, Chinese Herbal; C533622:xinfeng