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.


CONCLUSIONS
Jinniu capsules may be an effective and safe agent in the management of opiate withdrawal.
Shi
Jie
J
National Institute on Drug Dependence, Peking University, Beijing, China.
Xu
Guo-Zhu
GZ
Liu
Ting-Ting
TT
Wang
Xi
X
Shen
Li-Yang
LY
Li
Jing
J
Hao
Wei
W
Chen
Hong-Xian
HX
Li
Su-Xia
SX
Lu
Lin
L
D000328:Adult; D003000:Clonidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006556:Heroin Dependence / Q000534:rehabilitation; D006801:Humans; D008297:Male; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D004365:Drugs, Chinese Herbal; D009292:Narcotic Antagonists; D003000:Clonidine; C025655:lofexidine