| Objectives1. To investigate the efficacy and safety of Ji-Tai Tablet (a Chinese traditional medicine formula) and Ji-Tai tablet combined with Buprenorphine for the treatment of heroin withdrawal syndrome.2. To investigate the efficacy and safety of Ji-Tai Tablet, a Chinese traditional medicine formula, for the treatment of Protracted heroin withdrawal syndrome.MethodsAcute period and recovery period were included in this study. A randomized, double-blind, double-dummy clinical study was conducted.1. A total of one hundred and fifty patients with heroin dependence were rectuited, and were randomly assigned to the Ji-Tai tablet group, Ji-Tai tablet combined with buprenorphine group or placebo group during a10-day double-blind clinical trial. Approximately50patients were needed in each group. Opiate Withdrawal Scale (OWS) was used to measure the severity of withdrawal symptoms daily for10days. Anxiety assessments were made at day0(baseline), day5(middle), and day10(end) with the Hamilton Anxiety Scale (HAMA). Symptoms were assessed before and1h or2h after medicine administration each day. The total withdrawal syndrome scores and the daily reduction rate were used to measure the effect of Ji-Tai tablet vs. Ji-Tai tablet with buprenorphine. The primary outcome was the total OWS score, and secondary outcomes were the scores of the main OWS symptoms and the HAMA scale. For safety, the following measures were completed at baseline and then following completion of treatment:drug side effects, vital signs (blood pressure, heart rate, and respiration rate), laboratory examination (routine blood and urine tests and the liver and kidney function tests ALT, AST, BUN, Cr), and electrocardiograms.2. After15days treatment, the scores of withdrawal syndrome reduced10or more. one hundred patients met criteria were rectuited, and were randomly assigned to the Ji-Tai tablet group or placebo group for a24-week treatment. Opiate Withdrawal Scale (OWS) was measured at week0(baseline), week1, week2, week4, week8, week12(middle), week16, week20and week24(end). Anxiety assessments were made at week0(baseline), week4, week12(middle), week18and week24(end) with the Hamilton Anxiety Scale (HAMA). For safety, the following measures were completed at week0(baseline), week4, week12(middle), week18and week24(end):drug side effects, vital signs (blood pressure, heart rate, and respiration rate), laboratory examination (routine blood and urine tests and the liver and kidney function tests ALT, AST, BUN, Cr), and electrocardiograms.Results1. In the period of onset, one hundred and forty-two patients were enrolled in this study (forty-eight assigned in Ji-Tai tablet group, forty-eight in Ji-Tai tablet with buprenorphine group and forty-six in placebo group). At baseline, the scores of withdrawal syndrome were43.520±19.786,42.640±17.648and47.100±24.450respectively. There were no significant differences between each other. During the10-day treatment, The reduction rate of withdrawal syndrome scores increased daily, the acute withdrawal syndrome scores and the anxiety scales declined from day0to day10. While there were no significant differences between each group of the three (P>0.05). No participants dropped out because of adverse events. No severe adverse events occurred in either group. Ji-Tai tablet had no effect on vital signs such as blood pressure, heart rate, and respiration rate.2. In the period of recovery, eighty-one patients were enrolled in this stage (forty assigned in Ji-Tai tablet group, forty-one in placebo group). Before treatment, the scores of protracted withdrawal syndrome were13.50±4.967and13.10±2.528respectively. There were no significant differences between the two group. During the24-week treatment, The reduction rate of protracted withdrawal syndrome scores increased daily, the protracted withdrawal syndrome scores and the anxiety scales declined from week0to week24. While there were no significant differences between the two groups (P>0.05). No participants dropped out because of adverse events. No severe adverse events occurred in either group. Ji-Tai tablet had no effect on vital signs such as blood pressure, heart rate, and respiration rate.Conclusions1. The efficecy of Ji-Tai tablet or Ji-Tai tablet combined with buprenorphine on acute heroin withdrawal symptoms was not obviously. Because of heroin be cleaned in vivo, the heroin withdrawal symptoms released daily, which did not associate with Ji-Tai tablet or Ji-Tai combined with Buprenorphine treatment. The main resean for the inefficacy of Ji-Tai tablet is that the heroin withdrawal symptoms of the participants in our study were not severity. Ji-Tai tablet had no effect on vital signs, the safety of it is well.2. The efficecy of Ji-Tai tablet on protracted heroin withdrawal symptoms during recovery was not obviously. Because of heroin be cleaned in vivo, the protracted heroin withdrawal symptoms released daily, which did not associate with Ji-Tai tablet treatment. The main resean for the inefficacy of Ji-Tai tablet is that the protracted heroin withdrawal symptoms of the participants in our study were not severity. The safety of Ji-Tai tablet on recovery is well. |
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