A comparative clinical study of the effects of the traditional Chinese medicine Jinniu capsules and lofexidine on acute heroin withdrawal symptoms.

OBJECTIVE: Jinniu capsules, comprised of herbs and marine product extracts, are traditionally used in Chinese medicine. In this randomized multicenter clinical trial we evaluated the efficacy and safety of Jinniu capsules used to treat the symptoms of heroin withdrawal, as compared with lofexidine. METHODS: Two hundred and twelve patients with heroin dependence were randomly assigned to the Jinniu capsule or lofexidine treatment groups during a 10-day double-blind clinical trial. The severity of their opiate withdrawal symptoms was measured daily for 10 days. Anxiety was measured on days 0, 5, and 10. Safety assessment of the drugs included measurement of vital signs and side effects, as well as laboratory tests. RESULTS: Withdrawal symptom and anxiety scores decreased gradually over the treatment period, and no significant differences were found between two groups. No severe adverse events occurred during the treatment. CONCLUSION: Jinniu capsules may be an effective and safe agent in the management of opiate withdrawal.