title: [A randomized, double-blind, controlled study: Ji-Tai tablet for the treatment of acute withdrawl syndrome of mild heroin dependence].
abstract: OBJECTIVE
  To investigate the efficacy and safety of Ji-Tai tablet and Ji-Tai tablet combined with buprenorphine in the treatment of patients with acute withdrawal syndrome of mild heroin dependence.
  
  
  METHODS
  A total of 150 patients with mild heroin dependence were recruited, and were randomly assigned to a Ji-Tai tablet group (n=50), a Ji-Tai tablet combined with buprenorphine group (n=50) and a control group (n=50) during a 10-day clinical trial. Opiate withdrawal scale (OWS) was used to measure the severity of withdrawal symptoms. Anxiety symptoms assessments were made at 0 day (baseline), the day 5 (middle), and the day 10 (end) by the Hamilton anxiety scale (HAMA). Symptoms were assessed before and 1 h or 2 h after medication each day. The total withdrawal symptoms scores and the daily reduction rate were used to measure the effect of Ji-Tai tablet vs Ji- Tai tablet plus buprenorphine. Safety evaluation was carried out by the following measures: baseline of treatment, drug side effects after the treatment, vital signs (blood pressure, heart rate, and respiration rate), laboratory examination (routine blood and urine tests and the liver and kidney function tests), and electrocardiograms.
  
  
  RESULTS
  A total of 142 mild heroin dependence patients performed the experiments (including 48 in the Ji-Tai tablet group, 48 in the Ji-Tai tablet with buprenorphine group and 46 in the control group). The scores of baseline withdrawal symptoms were 43.520±19.786, 42.640±17.648 and 47.100±24.450, respectively, with no significant differences among the 3 groups (all P>0.05 ). During the 10-day treatment, the reduction rate of acute withdrawal symptoms scores increased daily, the acute withdrawal syndrome scores and the anxiety symptoms scores declined from day 0 to day 10, there was also no significant difference among the 3 groups (all P>0.05). Ji-Tai tablet did not affect vital signs such as blood pressure, heart rate, and respiration rate.
  
  
  CONCLUSIONS
  Ji-Tai tablet or Ji-Tai tablet combined with buprenorphine had no effect on acute withdrawal symptoms of mild heroin dependence.
authors.affiliation: Department of Addiction Medicine, Mental Health Center, Affi liated Qingyuan Hospital of Jinan University, Qingyuan People's Hospital, Qingyuan Guangdong 511518, China.
authors.forename: Yuhong
authors.initials: Y
authors.lastname: Wang
authors.forename: Cuiqing
authors.initials: C
authors.lastname: Tang
authors.forename: Shuang
authors.initials: S
authors.lastname: Cheng
authors.forename: Guimei
authors.initials: G
authors.lastname: Cui
authors.forename: Ruiling
authors.initials: R
authors.lastname: Zhang
authors.forename: Zhiyong
authors.initials: Z
authors.lastname: Zhang
authors.forename: Lingyin
authors.initials: L
authors.lastname: Xie
authors.forename: Yongxiong
authors.initials: Y
authors.lastname: Lin
authors.forename: Wei
authors.initials: W
authors.lastname: Hao
mesh_terms: D001007:Anxiety; D002047:Buprenorphine / Q000627:therapeutic use; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006556:Heroin Dependence / Q000188:drug therapy*; D006801:Humans; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D013607:Tablets
chemical_list: D004365:Drugs, Chinese Herbal; D013607:Tablets; D002047:Buprenorphine