Background: Efforts toward researching effective and safe therapies for the treatment of drug addiction and acute heroin withdrawal syndrome remain important objectives in the field of drug addiction. Traditional Chinese medicine (TCM) is viewed as a potential approach to the treatment of drug addiction, and especially to opiate addiction.
Objectives: The objective is to investigate the efficacy and safety of Fu-Yuan Pellet (FYP), a Chinese traditional medicine formula, for the treatment of acute heroin withdrawal syndrome.
Methods: A multicenter, randomized, double-blind, double-dummy, and positive-controlled trial was conducted at 3 drug abuse treatment centers in China. Patients (n = 225) who met a diagnosis of opiate dependence based on DSM IV classification were recruited for this study, ranging in age from 18 to 55 years. Inclusion criteria included a heroin-positive urinalysis, as measured between 8 to 36 hours from last use of heroin, and total withdrawal syndrome scores above 50 before treatment (actual range 65-140). These patients were treated with either FYP or lofexidine in a fixed schedule of doses for 10 days. The total withdrawal syndrome scores and the daily reduction rate were used to measure the effect of FYP vs. lofexidine.
Results: Both treatments significantly reduced withdrawal symptoms by day 3, but there was no significant difference overall between lofexidine and FYP in efficacy or safety.
Conclusions and scientific significance: This clinical trial has shown that FYP is effective in the treatment of moderate-to-severe acute heroin withdrawal and has few adverse effects compared to lofexidine. Further study is warranted to determine whether FYP is similar to lofexidine in its potential for reducing stress induced opiate relapse.