Polyethylene Glycol and Lactulose Versus Lactulose Alone in the Treatment of Hepatic Encephalopathy in Patients with Cirrhosis: A Non-Inferiority Randomized Controlled Trial

Overview

Journal Middle East J Dig Dis

Specialty Gastroenterology

Date 2017 Mar 21

PMID 28316761

Citations 13

Authors

Mohammadreza Naderian

Heshmatollah Akbari

Morteza Saeedi

Amir Ali Sohrabpour

Affiliations

Soon will be listed here.

Abstract

BACKGROUND In this clinical trial, polyethylene glycol (PEG) solution was compared with lactulose in the treatment of hepatic encephalopathy in patients with cirrhosis. METHODS This randomized controlled trial was performed on 40 patients in two groups. The patients in the lactulose group received either 20-30 grams of lactulose orally or by a nasogastric tube, or 200 grams of lactulose enema by a rectal tube. The patients in the PEG-lactulose group received the same amount of oral or rectal lactulose, plus 280 grams of PEG in 4 liters of water orally as a single dose in 30-120 minutes. Serial physical examinations, hepatic encephalopathy scoring algorithm (HESA), blood level of ammonia, and serum biochemical studies were used to evaluate the severity of hepatic encephalopathy. RESULTS In comparison with lactulose alone, PEG-lactulose could improve HESA score in 24 hours more effectively ( =0.04). Overall, PEG-lactulose regimen was associated with a decrease in length of hospital stay compared with lactulose treatment ( =0.03) but in subgroup analysis we found that PEG-lactulose regimen could only decrease the length of hospital stay in women significantly ( =0.01). CONCLUSION The use of PEG along with lactulose in comparison with lactulose alone is more effective in the treatment of hepatic encephalopathy in patients with cirrhosis and results in more rapid discharge from hospital.

Citing Articles

Prophylaxis of hepatic encephalopathy: current and future drug targets.

Maharshi S, Sharma B Hepatol Int. 2024; 18(4):1096-1109.

PMID: 38492132 DOI: 10.1007/s12072-024-10647-9.

Active Clinical Trials in Hepatic Encephalopathy: Something Old, Something New and Something Borrowed.

Balzano T Neurochem Res. 2023; 48(8):2309-2319.

PMID: 36977964 PMC: 10047473. DOI: 10.1007/s11064-023-03916-w.

Novel Drugs for the Management of Hepatic Encephalopathy: Still a Long Journey to Travel.

Rajpurohit S, Musunuri B, Shailesh , Basthi Mohan P, Shetty S J Clin Exp Hepatol. 2022; 12(4):1200-1214.

PMID: 35814520 PMC: 9257922. DOI: 10.1016/j.jceh.2022.01.012.

Evidence-based approach to management of hepatic encephalopathy in adults.

Hoilat G, Suhail F, Adhami T, John S World J Hepatol. 2022; 14(4):670-681.

PMID: 35646276 PMC: 9099111. DOI: 10.4254/wjh.v14.i4.670.

Management of Hepatic Encephalopathy Associated with Advanced Liver Disease.

Garcia-Martinez R, Diaz-Ruiz R, Poncela M Clin Drug Investig. 2022; 42(Suppl 1):5-13.

PMID: 35536537 PMC: 9205788. DOI: 10.1007/s40261-022-01146-6.

References

Romero-Gomez M, Boza F, Garcia-Valdecasas M, Garcia E, Aguilar-Reina J . Subclinical hepatic encephalopathy predicts the development of overt hepatic encephalopathy. Am J Gastroenterol. 2001; 96(9):2718-23. DOI: 10.1111/j.1572-0241.2001.04130.x. View

Hassanein T, Blei A, Perry W, Hilsabeck R, Stange J, Larsen F . Performance of the hepatic encephalopathy scoring algorithm in a clinical trial of patients with cirrhosis and severe hepatic encephalopathy. Am J Gastroenterol. 2009; 104(6):1392-400. DOI: 10.1038/ajg.2009.160. View

Sturgeon J, Shawcross D . Recent insights into the pathogenesis of hepatic encephalopathy and treatments. Expert Rev Gastroenterol Hepatol. 2013; 8(1):83-100. DOI: 10.1586/17474124.2014.858598. View

Ferenci P, Herneth A, Steindl P . Newer approaches to therapy of hepatic encephalopathy. Semin Liver Dis. 1996; 16(3):329-38. DOI: 10.1055/s-2007-1007245. View

Sharma B, Sharma P, Agrawal A, Sarin S . Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. Gastroenterology. 2009; 137(3):885-91, 891.e1. DOI: 10.1053/j.gastro.2009.05.056. View

. Global, regional, and national age-sex specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014; 385(9963):117-71. PMC: 4340604. DOI: 10.1016/S0140-6736(14)61682-2. View

Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei A . Hepatic encephalopathy--definition, nomenclature, diagnosis, and quantification: final report of the working party at the 11th World Congresses of Gastroenterology, Vienna, 1998. Hepatology. 2002; 35(3):716-21. DOI: 10.1053/jhep.2002.31250. View

Lockwood A . Blood ammonia levels and hepatic encephalopathy. Metab Brain Dis. 2004; 19(3-4):345-9. DOI: 10.1023/b:mebr.0000043980.74574.eb. View

Doran A, Shah N . Polyethylene glycol for hepatic encephalopathy: a new solution to purge an old problem?. JAMA Intern Med. 2014; 174(11):1734-5. DOI: 10.1001/jamainternmed.2014.3501. View

10.

Poordad F . Review article: the burden of hepatic encephalopathy. Aliment Pharmacol Ther. 2007; 25 Suppl 1:3-9. DOI: 10.1111/j.1746-6342.2006.03215.x. View

11.

Jones E, Mullen K . Theories of the pathogenesis of hepatic encephalopathy. Clin Liver Dis. 2012; 16(1):7-26. DOI: 10.1016/j.cld.2011.12.010. View

12.

Kimer N, Krag A, Moller S, Bendtsen F, Gluud L . Systematic review with meta-analysis: the effects of rifaximin in hepatic encephalopathy. Aliment Pharmacol Ther. 2014; 40(2):123-32. DOI: 10.1111/apt.12803. View

13.

Rahimi R, Singal A, Cuthbert J, Rockey D . Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial. JAMA Intern Med. 2014; 174(11):1727-33. PMC: 5609454. DOI: 10.1001/jamainternmed.2014.4746. View

14.

Huang E, Esrailian E, Spiegel B . The cost-effectiveness and budget impact of competing therapies in hepatic encephalopathy - a decision analysis. Aliment Pharmacol Ther. 2007; 26(8):1147-61. DOI: 10.1111/j.1365-2036.2007.03464.x. View

15.

BIRCHER J, Muller J, GUGGENHEIM P, Haemmerli U . Treatment of chronic portal-systemic encephalopathy with lactulose. Lancet. 1966; 1(7443):890-2. DOI: 10.1016/s0140-6736(66)91573-x. View

16.

Bajaj J, Wade J, Gibson D, Heuman D, Thacker L, Sterling R . The multi-dimensional burden of cirrhosis and hepatic encephalopathy on patients and caregivers. Am J Gastroenterol. 2011; 106(9):1646-53. PMC: 3989143. DOI: 10.1038/ajg.2011.157. View

17.

Blanc P, Daures J, Liautard J, Buttigieg R, Desprez D, Pageaux G . [Lactulose-neomycin combination versus placebo in the treatment of acute hepatic encephalopathy. Results of a randomized controlled trial]. Gastroenterol Clin Biol. 1994; 18(12):1063-8. View

18.

Wang V, Saab S . Ammonia levels and the severity of hepatic encephalopathy. Am J Med. 2003; 114(3):237-8. DOI: 10.1016/s0002-9343(02)01571-1. View

19.

Davis G, Alter M, El-Serag H, Poynard T, Jennings L . Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2009; 138(2):513-21, 521.e1-6. DOI: 10.1053/j.gastro.2009.09.067. View

20.

Eltawil K, Laryea M, Peltekian K, Molinari M . Rifaximin vs. conventional oral therapy for hepatic encephalopathy: a meta-analysis. World J Gastroenterol. 2012; 18(8):767-77. PMC: 3286139. DOI: 10.3748/wjg.v18.i8.767. View