Effectiveness and safety of lactulose retention enema in cirrhotic patients with grade 3 or grade 4 hepatic encephalopathy


  • Kaushal Madan Department of Digestive and Liver Diseases, Artemis Hospital, Haryana, India
  • Praveen Sharma Department of Gastroenterology, Sir Ganga Ram Hospital, New Delhi, India
  • Neeraj Saraf Department of Gastroenterology, Medanta-The Medicity, Haryana, India
  • Sanjay Choudhari Department of Medical Affairs, Abbott India Limited, Goregoan, Mumbai, Maharashtra, India
  • Dyotona Sen Roy Department of Medical Affairs, Abbott India Limited, Goregoan, Mumbai, Maharashtra, India




Complete reversal, Grade 3 and Grade 4 Hepatic encephalopathy, Hepatic encephalopathy, Hospitalization, Lactulose retention enema, West haven criteria


Background: Hepatic encephalopathy (HE) is a complex, reversible neuropsychiatric syndrome. The present study evaluated the clinical effectiveness and safety of lactulose retention enema for the treatment of Grade 3 or 4 HE (West Haven Criteria, WHC) in Indian patients.

Methods: This retrospective, open-label, uncontrolled cohort study was conducted at three study centers in India. Patients of either gender (18-65 years) admitted to the hospital with liver cirrhosis having Grade 3 or 4 HE were included. The primary endpoint was to evaluate complete reversal of Grade 3 and 4 HE after 24 h and 48h. The secondary endpoints were grade shift at 24 and 48 h before and after administration of lactulose enema, time to complete reversal of Grade 3 or 4 HE, and mortality. Safety was also evaluated.

Results: Overall, retrospective records of 50 patients were evaluated. Complete reversal of Grade 3 or 4 HE was observed in a statistically significant (p<0.0001) proportion (95% confidence interval) of patients at 24 h (n=40, 80% [66. 3%-90.0%]) and 48 h (n=45, 90% [78. 2%-96.7%]) after treatment. After 24 h of treatment, majority of the patients were noted with Grade 2 (78%) HE. Further improvement was noted after 48 h of treatment with majority of the patients having Grade 2 (40%) and Grade 1 (48%) HE. Mean (SD) time for complete reversal of Grade 3 or 4 HE was 25.39±8.85 h after treatment. All death cases observed (n=6, 12.0%) were assessed as unrelated to the treatment by the investigator, but rather related to the underlying disease and/or precipitating factors. Four non-serious adverse drug reactions in two patients and one rectal device-associated complication in one patient were noted during the patient record reviews.

Conclusions: Lactulose retention enema was clinically effective and resulted in complete reversal of Grade 3 or 4 HE in the majority of patients. It was overall well-tolerated.


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How to Cite

Madan, K., Sharma, P., Saraf, N., Choudhari, S., & Roy, D. S. (2017). Effectiveness and safety of lactulose retention enema in cirrhotic patients with grade 3 or grade 4 hepatic encephalopathy. International Journal of Basic & Clinical Pharmacology, 6(2), 365–372. https://doi.org/10.18203/2319-2003.ijbcp20170331



Original Research Articles