Efficacy and safety of Qudu Huiyuan Pills in the treatment of opioid withdrawal syndrome: a randomized, double-blind, placebo-controlled clinical trial.

Abstract

This randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Qudu Huiyuan Pills (QHP), a novel Traditional Chinese Medicine (TCM) formulation, in treating opioid withdrawal syndrome (OWS). The study involved 124 adults (aged 18-65 years) diagnosed with opioid dependence and the TCM syndrome of Qi-blood deficiency and toxin-stasis. Participants were randomized to receive either QHP (n = 63) or a placebo (n = 61) at a dosage of 10 g three times daily for 5 months. Primary outcomes included changes in major and minor TCM symptom scores. Secondary outcomes encompassed neurobiological markers, liver function tests, and safety assessments. QHP treatment resulted in a statistically significant reduction in both major and minor TCM symptom scores compared with baseline and the placebo group (P < 0.01 for both). The safety profile of QHP was favorable; reported adverse events were predominantly mild and transient gastrointestinal discomfort. Notably, QHP treatment was associated with improved liver function markers, suggesting potential hepatoprotective effects. No significant between-group differences were observed in the assessed neurotransmitter or cytokine levels at the study endpoint. In conclusion, QHP appears to be an effective and safe therapeutic option for individuals with OWS, particularly in alleviating the constellation of symptoms defined by TCM. Further research is warranted to explore its long-term efficacy and underlying mechanisms of action.