TO COMPARE THE EFFECT OF POLYETHYLENE GLYCOL VS LACTULOSE IN THE TREATMENT OF OVERT HEPATIC ENCEPHALOPATHY.

Introduction: Hepatic Encephalopathy is one of the most common causes of hospitalization for cirrhotic patients. Lactulose has long been used as the standard therapy for the treatment of acute HE. This study evaluated the efficacy of PEG as compared with lactulose for the initial treatment of HE. Aims and Objective: (1) To compare efficacy of PEG 3350 electrolyte solution over lactulose in patients admitted for hepatic encephalopathy. (2) To determine whether treatment with PEG will reduce duration of hospital stay, and whether PEG can be an effective additional treatment option for HE. Material and methods: This prospective, randomized, comparative study was conducted in the Department of Gastroenterology Medical Trust hospital, Kochi–Kerala India, over a period of two year from May 2015–April 2017 following its approval by the Institutional ethical committee. 50 patients with cirrhosis and altered mental status attributed to HE were randomized to a standard lactulose protocol or a PEG protocol (25 in each group). Interventions: Patients in the PEG group (n=25) received 2 L of PEG orally or via NG tube as a single dose over 4 hours. Patients in the lactulose group (n=25) received 20-30 g lactulose orally or via NG tube for 3 or more doses over 24 hours, or a single dose of 200 g lactulose via rectal tube. Grade of HE was determined prior to treatment and again at 24 hours using the Hepatic Encephalopathy Scoring Algorithm (HESA). After 24 hours, all patients received lactulose per the standard of care. Main outcomes and measures: The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the Hepatic Encephalopathy Scoring Algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay. Results: In our study, the gender distribution among two study groups showed a male predominant. Majority of HE patients were found in age group of 55-64 years. The most common underlying etiology of Liver Cirrhosis was Alcoholic liver disease 70%, Cryptogenic 14%, followed by Hepatitis C. The most common precipitant for Hepatic encephalopathy was GI Bleeding, followed by Constipation and Sepsis. The two groups were comparable in terms of baseline laboratory parameters. All patients were of Child Turcot Pugh (CTP) class C, with a Mean MELD score of 19.08 ± 2.23 in PEG group vs. 18.76 ± 2.36 in Lactulose group (p-value=0.625, NS). Majority of the patients were in grade 3 encephalopathy 58% (29/50), followed by grade 2 in 32% (16/50) at the time of presentation. A significant difference was seen between two groups in terms of mean change in grade of encephalopathy (HESA score) after 24 hours of therapy, with 1.00 ± 1.04 in PEG group compared to 1.76 ± 0.87 in lactulose group, with a significant p-value of <0.007. A significant difference between two groups in terms of mean time taken for complete resolution of hepatic encephalopathy, with 2.12 ± 0.52 days in PEG group compared to 3.76 ± 1.05 days in Lactulose group, with a significant p-value of <0.001, However there was no significant difference in length of hospital stay between two groups, with a mean hospital stay of 8.32 ± 1.77 days in PEG group compared to 8.28 ± 1.51 days in Lactulose group, with a (pvalue= 0.93). There was no significant difference in terms of mean change in serum ammonia level, serum Na+ and K+ after 24 hours, between the treatment groups. Overall, treatment regimens were similar in terms of tolerability, with the exception that in the lactulose arm, there was more bloating, while PEG patients experienced more of diarrheal symptoms. Conclusions: PEG led to more rapid HE resolution than standard therapy, as compared with lactulose alone, the use of PEG alone during the first 24 hours of presentation worked better at improving symptoms of HE. The benefit beyond this time is less clear as both groups in this study received lactulose after 24 hours.