1. More patients treated with polyethylene glycol had improvement in their hepatic encephalopathy scoring algorithm (HESA) score, as compared to patients treated with lactulose.
2. Patients receiving polyethylene glycol had larger mean improvement of the HESA score and had faster resolution of symptoms, as compared to those receiving lactulose.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Hepatic encephalopathy (HE) is a condition that occurs frequently in cirrhotic patients, resulting in neuropsychiatric symptoms. It is thought that ammonia production by gastrointestinal bacteria drives the pathophysiology of this disease. The standard of care in acute treatment has been lactulose, which is thought to increase ammonia excretion in the stool. It has been proposed that if bowel catharsis is the primary mechanism for treating HE, polyethylene glycol (PEG) may be more effective than lactulose. This study investigated whether PEG would be effective in the acute treatment of HE.
The results of the study found that PEG decreased the hepatic encephalopathy scoring algorithm (HESA) score in more patients than lactulose, and resulted in a larger mean HESA score improvement. Strengths of the study include its randomized design, as well as using a validated scoring system for HE. However, the study was not blinded. The study authors attempted to mitigate this by having different investigators perform treatment administration and HESA evaluation when feasible. Another limitation of the study was its small size, with only 25 patients randomized to each arm. Moreover, this was a single center study, and the results may not be generalizable to other populations.
Click to read the study, published today in JAMA Internal Medicine
In-Depth [randomized clinical trial]: This single-center, randomized clinical trial examined patients aged 18 to 80 years presenting to the emergency department with known cirrhosis and symptoms typical of HE, including altered mental status without an obvious other cause. Patients were excluded if they had acute liver failure, altered mental status from another cause, treatment with rifaximin or neomycin in the previous 7 days, or more than one dose of lactulose prior to consent. A total of 25 patients were randomized to each study arm. Patients received HESA evaluation and then were started on standard of care lactulose therapy or PEG 3550 electrolyte solution.
The primary endpoint was improvement of 1 or more in HESA score at 24 hours. Intention to treat analysis was performed. In the lactulose arm, 9 of 25 (36%) patients had improvement of HESA score of 1, 3 (12%) improved by 2 grades, and 1 (4%) improved by 3 grades at 24 hours. In the PEG arm, 10 of 23 (43%) had improvement of 1 grade, 9 (39%) by 2 grades, and 1 (4%) by 3 grades. About 52% of patients in the lactulose group met the primary endpoint, compared to 91% of the PEG group (P<0.01). The PEG arm had significantly lower HESA scores at 24 hours (0.9, SD 1.0) compared to the lactulose group (1.6, SD 0.9) (P=0.04). The mean time to resolution of HE was 1 day in the PEG group compared to 2 days in the lactulose group (P=0.01).
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