The efficacy of flumazenil in subclinical to mild hepatic encephalopathic ambulatory patients. A prospective, randomised, double-blind, placebo-controlled study.

Abstract

OBJECTIVES:

Hepatic encephalopathy (HE) is a neuropsychiatric syndrome associated with fulminant hepatic failure and chronic liver disease. Its pathogenesis is unclear. One of the factors implicated is enhanced GABA-ergic tone, which is probably related to increased concentrations of cerebral benzodiazepine (BNZ). In the present study, we tested flumazenil, a cerebral BNZ antagonist, in cirrhosis patients with hepatic encephalopathy.

METHODS:

Out of 47 patients, 7 were excluded prior to randomization for various reasons. Twenty patients were included in the flumazenil group and 20 in the placebo group in a prospective, randomized, double-blind, placebo-controlled study. Patients were given flumazenil (1 mg/h, continuous IV infusion) or an equal volume of saline solution for 5 hours. Before and after treatment, portosystemic encephalopathy (PSE) stage and number connection test (NCT) scores were checked every half hour for 5 hours. EEG was recorded 15 minutes before and 1 hour after treatment.

RESULTS:

While significant improvements were determined in PSE stage and NCT score in the flumazenil group, there were no such improvements in the placebo group. There was no statistically significant difference between pre- and post-treatment EEGs in either group.

CONCLUSION:

It was concluded that continuous IV infusion of flumazenil had beneficial and safe effects in the treatment of hepatic encephalopathy patients.

• Authors: Mehmet Dursun, Mustafa Caliskan, Fikri Canoruc, Ufuk Aluclu, Naime Canoruc, Alpaslan Tuzcu, Serif Yilmaz, Abdurrahman Isikdogan, Meliksah Ertem
• Journal: Swiss medical weekly (Swiss Med Wkly) Vol. 133 Issue 7-8 Pg. 118-23 (Feb 22 2003) ISSN: 1424-7860 [Print] Switzerland
• PMID: 12644958 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)

Chemical References

• GABA Modulators
• Flumazenil

Topics

• Adult
• Aged
• Ambulatory Care
• Double-Blind Method
• Female
• Flumazenil (administration & dosage, therapeutic use)
• GABA Modulators (administration & dosage, therapeutic use)
• Hepatic Encephalopathy (drug therapy)
• Humans
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome