A placebo-controlled double-blind add-on study of Ginseng in opioid withdrawal syndrome

Objectives: Pharmacological treatment of opiate withdrawal syndrome is used to facilitate a safe transition to a relapse prevention program, while ameliorating signs and symptoms of withdrawal in the opioid-dependant individuals. Ginseng, the root of the Panax species, is a well-known remedy in traditional medicine. Pharmacological studies have determined the inhibitory effects of Ginseng Total Saponin (GTS) on morphine-induced tolerance and physical dependency. This effect might be due to up-regulation inhibition of the cAMP pathway. Since conclusive human clinical data is missing, we performed this randomized, double-blind, placebo-controlled study to assess the effects of ginseng augmentation therapy on withdrawal symptoms of opioid-dependent patients treated with methadone.

Methods: A total of 36 male opioid-dependent patients, aged between 18 and 50 years who met the DSM-IV criteria for opioid dependence, were randomly assigned into two groups of 18 members, to receive either ginseng (two 250 mg capsules daily) or placebo for the first 15 days of detoxification. All patients were treated with a Methadone Maintenance Treatment (MMT) protocol. Opioid withdrawal syndrome severity was measured by the Clinical Opioid Withdrawal Scale (COWS) on days 0, 1, 7, 10, and 15. In addition, the required daily methadone dosage was recorded and compared between the groups. This trial was registered in the Iranian Registry of Clinical trials (IRCT) under ID of IRCT201009063106N4 and was approved by the Ethics Committee of Azad University (approval number: 4115).

Results: Patients in the two treatment groups did not differ significantly in socio-demographic and clinical variables at the baseline. As expected, a statistically significant decrease in the COWS total score and symptoms was observed from the first day to the end of the study in both treatment groups. As shown in figure 1, the required daily methadone dosage was lower in the ginseng group from day 5 to the end of the study (P<0.05). Although no significant difference was observed in the COWS total score between the two groups, these scores were achieved with lower methadone dosages in the ginseng group.

Conclusions: The differences in severity of symptoms were not statistically significant between two groups, but patients receiving ginseng experienced similar withdrawal symptoms with lower methadone dosages.