Effect of oral naltrexone on pruritus in cholestatic patients

World J Gastroenterol. 2006 Feb 21;12(7):1125-8. doi: 10.3748/wjg.v12.i7.1125.


Aim: To determine the efficacy and potential complications of oral naltrexone used in the treatment of pruritus in cholestatic patients and to compare them with other studies.

Methods: Thirty-four enrolled cholestatic patients complaining of pruritus were studied. In the initial phase, pruritus scores during day and night were evaluated. Subsequently, patients were given a placebo for one week followed by naltrexone for one week. In each therapeutic course (placebo or naltrexone) day and night pruritus scores were distinguished by a visual analogue scale (VAS) system and recorded in patients' questionnaires.

Results: Both naltrexone and placebo decreased VAS scores significantly. Naltrexone was more effective than placebo in decreasing VAS scores. Both day and night scores of pruritus decreased by half of the value prior to therapy in thirteen patients (38%). Daytime pruritus improved completely in two patients (5.9%), but no improvement in the nighttime values was observed in any patient. Sixteen patients (47%) suffered from naltrexone complications, eleven (32%) of them were related to its withdrawal. Complications were often mild. In the case of withdrawal, the complication was transient (within the first 24-28 h of therapy) and self-limited. We had to cease the drug in two cases (5.9%) because of severe withdrawal symptoms.

Conclusion: Naltrexone can be used in the treatment of pruritus in cholestatic patients and is a safe drug showing few, mild and self-limited complications.

Publication types

  • Controlled Clinical Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Cholestasis / complications*
  • Cholestasis / physiopathology
  • Dizziness / chemically induced
  • Headache / chemically induced
  • Humans
  • Middle Aged
  • Muscle Weakness / chemically induced
  • Naltrexone / administration & dosage
  • Naltrexone / adverse effects
  • Naltrexone / therapeutic use*
  • Nausea / chemically induced
  • Pain Measurement
  • Placebos
  • Pruritus / drug therapy*
  • Pruritus / etiology
  • Pruritus / physiopathology
  • Single-Blind Method
  • Substance Withdrawal Syndrome / epidemiology
  • Substance Withdrawal Syndrome / physiopathology
  • Surveys and Questionnaires


  • Placebos
  • Naltrexone