title: Hypouricemic and arthritis relapse-reducing effects of compound tufuling oral-liquid in intercritical and chronic gout: A double-blind, placebo-controlled, multicenter randomized trial.
abstract: METHODS
  In the double-blind, randomized, controlled trial, we aimed to evaluate the effects of compound tufuling oral liquid (CoTOL) on serum uric acid (sUA) levels and recurrence of acute gouty arthritis in intercritical and chronic gout treatment.
  
  
  METHODS
  A total of 210 patients with gout were screened from 8 hospitals to observe the sUA and acute gouty arthritis recurrence rate-reducing effects of CoTOL in intercritical and chronic gout during a 12-week treatment. We treated 139 and 71 patients with CoTOL and the placebo, respectively, and evaluated their sUA levels, acute gouty arthritis recurrence rate, and adverse events at week 0, 6, and 12.
  
  
  RESULTS
  Twenty-five and 12 patients in the treatment and control groups, respectively, had interrupted treatments, whereas 114 and 59 cases, respectively, completed their treatments. At the end of the 12-week treatment, the average decrease in sUA was 74.26 (95% confidence interval [CI]: 56.74-91.77 μmol/L) and 28.81 μmol/L (95% CI: 4.91-52.71 μmol/L) in the treatment and control groups, respectively (P = 0.004). The average decrease rate of sUA was 12.76% (95% CI: 9.82%-15.70%) and 4.57% (95% CI: 0.42%-8.71%) in the treatment and control groups, respectively (P = 0.004), and the gouty arthritis recurrence rate of the treatment group was lower than that of the control group (from week 6 to 12, 21.93% and 50.88% in the treatment and control group, respectively, P < 0.001; from baseline to week 12, 38.5% and 63.16%, respectively, P = 0.003). Severe adverse events were not observed in either groups, and fewer leucopenia incidences were observed in the treatment group than those in the control group (3/139 vs. 7/71, respectively, P = 0.033).
  
  
  CONCLUSIONS
  CoTOL reduced sUA levels and effectively prevented acute arthritis recurrence in intercritical and chronic gout without serious adverse events.
authors.affiliation: College of Basic Medical Science, Zhejiang Chinese Medical University Department of Rheumatism, The Second Affiliated Hospital of Zhejiang University Medical College Department of Rheumatism, Zhejiang Hospital Department of Public Health, Medical College, Zhejiang University Department of Rheumatism, Zhejiang People's Hospital Department of Rheumatism, Sir Run Run Shaw Hospital of Zhejiang University Medical College Department of Rheumatism, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou Department of Rheumatism, Chinese Medical Academy Gate Hospital, Beijing Department of Rheumatism, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, P.R. China.
authors.forename: Zhijun
authors.initials: Z
authors.lastname: Xie
authors.forename: Huaxiang
authors.initials: H
authors.lastname: Wu
authors.forename: Xiaoqing
authors.initials: X
authors.lastname: Jing
authors.forename: Xiuyang
authors.initials: X
authors.lastname: Li
authors.forename: Yasong
authors.initials: Y
authors.lastname: Li
authors.forename: Yongmei
authors.initials: Y
authors.lastname: Han
authors.forename: Xiangfu
authors.initials: X
authors.lastname: Gao
authors.forename: Xiaopo
authors.initials: X
authors.lastname: Tang
authors.forename: Jing
authors.initials: J
authors.lastname: Sun
authors.forename: Yongshen
authors.initials: Y
authors.lastname: Fan
authors.forename: Chengping
authors.initials: C
authors.lastname: Wen
mesh_terms: D000328:Adult; D000368:Aged; D015210:Arthritis, Gouty / Q000097:blood / Q000188:drug therapy; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006073:Gout / Q000097:blood / Q000188:drug therapy*; D006074:Gout Suppressants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D014527:Uric Acid / Q000097:blood*
chemical_list: D004365:Drugs, Chinese Herbal; D006074:Gout Suppressants; D014527:Uric Acid