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Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding.
Can J Gastroenterol Hepatol. 2018; 2018:3015891.CJ

Abstract

Background and Aim

Variceal bleeding is the second most important precipitating factor related to the development of episodic hepatic encephalopathy; but to date there are no recommendations to prevent this complication. The aim of this study was to compare if primary prophylaxis with lactulose or L-ornithine L-aspartate or rifaximin, in cirrhotic patients with variceal bleeding, is better than placebo for avoiding the development of hepatic encephalopathy.

Methods

A randomized, double-blind, placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT02158182) which included cirrhotic patients with variceal bleeding, without minimal or clinical hepatic encephalopathy at admission.

Findings

87 patients were randomized to one of four groups. The basal characteristics were similar between groups. Comparatively with placebo, the frequency with regard to the development of hepatic encephalopathy was as follows: lactulose (54.5% versus 27.3%; OR = 0.3, 95% CI 0.09-1.0; P = 0.06); L-ornithine L-aspartate (54.5% versus 22.7%, OR = 0.2, 95% CI 0.06-0.88; P = 0.03); rifaximin (54.5% versus 23.8%; OR = 0.3, 95% CI 0.07-0.9; P = 0.04). There was no significant difference between the three groups receiving any antiammonium drug (P = 0.94). In the group receiving lactulose, 59.1% had diarrhea, and 45.5% had abdominal discomfort, bloating, and flatulence. Two patients (10%) treated with lactulose and a patient (4.5%) in the placebo group developed spontaneous bacterial peritonitis due to E. coli; one of them died due to recurrent variceal bleeding. There were no other adverse effects.

Conclusions

Antiammonium drugs, particularly L-ornithine L-aspartate and rifaximin, proved to be effective in preventing the development of hepatic encephalopathy in those cirrhotic patients with variceal bleeding.

Authors+Show Affiliations

Gastroenterology and Hepatology Department, Mexico's General Hospital, Mexico City 06726, Mexico.Internal Medicine Department, Mexico's General Hospital, Mexico City 06726, Mexico.Gastroenterology and Hepatology Department, Mexico's General Hospital, Mexico City 06726, Mexico.Gastroenterology and Hepatology Department, Mexico's General Hospital, Mexico City 06726, Mexico.Gastroenterology and Hepatology Department, Mexico's General Hospital, Mexico City 06726, Mexico.Internal Medicine Department, Mexico's General Hospital, Mexico City 06726, Mexico.Research Department, Chief of the Medical Direction of "Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado" (ISSSTE), Mexico City 14050, Mexico. Cognitive Science A.C., Mexico City 10700, Mexico.Research Department, Chief of the Medical Direction of "Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado" (ISSSTE), Mexico City 14050, Mexico. Cognitive Science A.C., Mexico City 10700, Mexico.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30079329

Citation

Higuera-de-la-Tijera, Fátima, et al. "Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients With Acute Variceal Bleeding." Canadian Journal of Gastroenterology & Hepatology, vol. 2018, 2018, p. 3015891.
Higuera-de-la-Tijera F, Servín-Caamaño AI, Salas-Gordillo F, et al. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018;2018:3015891.
Higuera-de-la-Tijera, F., Servín-Caamaño, A. I., Salas-Gordillo, F., Pérez-Hernández, J. L., Abdo-Francis, J. M., Camacho-Aguilera, J., Alla, S. N., & Jiménez-Ponce, F. (2018). Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. Canadian Journal of Gastroenterology & Hepatology, 2018, 3015891. https://doi.org/10.1155/2018/3015891
Higuera-de-la-Tijera F, et al. Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients With Acute Variceal Bleeding. Can J Gastroenterol Hepatol. 2018;2018:3015891. PubMed PMID: 30079329.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Primary Prophylaxis to Prevent the Development of Hepatic Encephalopathy in Cirrhotic Patients with Acute Variceal Bleeding. AU - Higuera-de-la-Tijera,Fátima, AU - Servín-Caamaño,Alfredo I, AU - Salas-Gordillo,Francisco, AU - Pérez-Hernández,José L, AU - Abdo-Francis,Juan M, AU - Camacho-Aguilera,Jaime, AU - Alla,Sai N, AU - Jiménez-Ponce,Fiacro, Y1 - 2018/07/10/ PY - 2018/04/07/received PY - 2018/05/25/revised PY - 2018/05/31/accepted PY - 2018/8/7/entrez PY - 2018/8/7/pubmed PY - 2019/2/12/medline SP - 3015891 EP - 3015891 JF - Canadian journal of gastroenterology & hepatology JO - Can J Gastroenterol Hepatol VL - 2018 N2 - Background and Aim: Variceal bleeding is the second most important precipitating factor related to the development of episodic hepatic encephalopathy; but to date there are no recommendations to prevent this complication. The aim of this study was to compare if primary prophylaxis with lactulose or L-ornithine L-aspartate or rifaximin, in cirrhotic patients with variceal bleeding, is better than placebo for avoiding the development of hepatic encephalopathy. Methods: A randomized, double-blind, placebo-controlled clinical trial (ClinicalTrials.gov identifier: NCT02158182) which included cirrhotic patients with variceal bleeding, without minimal or clinical hepatic encephalopathy at admission. Findings: 87 patients were randomized to one of four groups. The basal characteristics were similar between groups. Comparatively with placebo, the frequency with regard to the development of hepatic encephalopathy was as follows: lactulose (54.5% versus 27.3%; OR = 0.3, 95% CI 0.09-1.0; P = 0.06); L-ornithine L-aspartate (54.5% versus 22.7%, OR = 0.2, 95% CI 0.06-0.88; P = 0.03); rifaximin (54.5% versus 23.8%; OR = 0.3, 95% CI 0.07-0.9; P = 0.04). There was no significant difference between the three groups receiving any antiammonium drug (P = 0.94). In the group receiving lactulose, 59.1% had diarrhea, and 45.5% had abdominal discomfort, bloating, and flatulence. Two patients (10%) treated with lactulose and a patient (4.5%) in the placebo group developed spontaneous bacterial peritonitis due to E. coli; one of them died due to recurrent variceal bleeding. There were no other adverse effects. Conclusions: Antiammonium drugs, particularly L-ornithine L-aspartate and rifaximin, proved to be effective in preventing the development of hepatic encephalopathy in those cirrhotic patients with variceal bleeding. SN - 2291-2797 UR - https://www.unboundmedicine.com/medline/citation/30079329/Primary_Prophylaxis_to_Prevent_the_Development_of_Hepatic_Encephalopathy_in_Cirrhotic_Patients_with_Acute_Variceal_Bleeding_ L2 - https://dx.doi.org/10.1155/2018/3015891 DB - PRIME DP - Unbound Medicine ER -