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Randomized controlled trial of polyethylene glycol versus lactulose for the treatment of overt hepatic encephalopathy

Shehata, Hala H.a; Elfert, Asem A.a; Abdin, Amany A.b; Soliman, Samah M.a; Elkhouly, Reham A.a; Hawash, Nehad I.a; Soliman, Hanan H.a

European Journal of Gastroenterology & Hepatology: December 2018 - Volume 30 - Issue 12 - p 1476–1481
doi: 10.1097/MEG.0000000000001267
Original Articles: Hepatology

Background Overt hepatic encephalopathy (HE) is a frequent complication of cirrhosis and one of the most debilitating manifestations that necessitates hospitalization. Although many treatment modalities are being investigated, none of them are satisfactory. So, newer treatment modalities have to be tried.

Objective To evaluate the safety and efficacy of polyethylene glycol (PEG) versus lactulose in the management of HE.

Patients and methods This clinical trial included 100 patients with post-hepatitis C cirrhosis who were admitted with HE. Patients were randomized into two equal groups: group I patients received lactulose and group II patients received PEG. The clinico-epidemiological characteristics of patients, Child–Pugh score, and HE scoring algorithm were registered before and 24 h after administration of the drug. Moreover, any suspected adverse effects were recorded.

Results All 100 patients received treatment. Three patients died within 24 h of admission and did not complete the follow-up period. According to intention-to-treat approach, they were considered as treatment failure. On analysis, 36/50 (72%) patients improved one grade or more in HE scoring algorithm score after 24 h of lactulose therapy versus 47/50 (94%) of those on PEG therapy (P<0.05). The time needed for resolution of HE and length of hospital stay were significantly lower in PEG group versus lactulose group (P<0.001). Both therapies were tolerated, and no significant adverse events were reported.

Conclusion Both lactulose and PEG were safe and effective in the treatment of HE. PEG significantly decreased the time needed for resolution of HE and significantly shortened the hospital stay.

Departments of aTropical Medicine and Infectious Diseases

bPharmacology, Faculty of Medicine, Tanta University, Tanta, Egypt

Correspondence to Samah M. Soliman, MD, Department of Tropical Medicine, Faculty of Medicine, Tanta University, El-Giash Street, Tanta 31111, Egypt Tel: +20 128 822 6394; fax: +20 40 330 2785; e-mail: samahsoliman1@gmail.com

Received May 15, 2018

Accepted July 17, 2018

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.