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Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo.
Gastroenterology 2009; 137(3):885-91, 891.e1G

Abstract

BACKGROUND & AIMS

Hepatic encephalopathy (HE) is associated with a poor prognosis. Lactulose is used for the treatment of HE. There is no study on the prevention of recurrence of HE using lactulose.

METHODS

Consecutive cirrhotic patients who recovered from HE were randomized to receive lactulose (HE-L group) or placebo (HE-NL group). All patients were assessed by psychometry (number connection test [NCT-A and B], figure connection test if illiterate [FCT-A and B], digit symbol test [DST], and object assembly test [OAT]), critical flicker frequency test, and blood ammonia at inclusion. Primary end point was development of overt HE.

RESULTS

Of 300 patients with HE who recovered, 140 (46.6%) met the inclusion criteria and were included. There was a high prevalence of abnormal psychometry test results (NCT-A, 67.5%; NCT-B, 62.5%; DST, 70%; and OAT, 80%), and FCT-A and B were abnormal in 10 of 14 patients. Critical flicker frequency was <38 Hz in 77 patients (55%). Twelve (19.6%) of 61 patients in the HE-L group and 30 (46.8%) of 64 in the HE-NL group (P = .001) developed HE over a median follow-up of 14 months (range, 1-20 months). Readmission rate due to causes other than HE (HE-L vs HE-NL, 9:6; P = NS) and deaths (HE-L vs HE-NL, 5:11; P = .18) in 2 groups were similar. Recurrence of overt HE was significantly associated with 2 or more abnormal psychometric tests after the recovery of an episode of HE (r = 0.369, P = .02).

CONCLUSIONS

Lactulose is effective for prevention of recurrence of HE in patients with cirrhosis.

Authors+Show Affiliations

Department of Gastroenterology, G. B. Pant Hospital, New Delhi, India. drbcsharma@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

19501587

Citation

Sharma, Barjesh Chander, et al. "Secondary Prophylaxis of Hepatic Encephalopathy: an Open-label Randomized Controlled Trial of Lactulose Versus Placebo." Gastroenterology, vol. 137, no. 3, 2009, pp. 885-91, 891.e1.
Sharma BC, Sharma P, Agrawal A, et al. Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. Gastroenterology. 2009;137(3):885-91, 891.e1.
Sharma, B. C., Sharma, P., Agrawal, A., & Sarin, S. K. (2009). Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. Gastroenterology, 137(3), pp. 885-91, 891.e1. doi:10.1053/j.gastro.2009.05.056.
Sharma BC, et al. Secondary Prophylaxis of Hepatic Encephalopathy: an Open-label Randomized Controlled Trial of Lactulose Versus Placebo. Gastroenterology. 2009;137(3):885-91, 891.e1. PubMed PMID: 19501587.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. AU - Sharma,Barjesh Chander, AU - Sharma,Praveen, AU - Agrawal,Amit, AU - Sarin,Shiv Kumar, Y1 - 2009/06/06/ PY - 2009/03/15/received PY - 2009/05/11/revised PY - 2009/05/28/accepted PY - 2009/6/9/entrez PY - 2009/6/9/pubmed PY - 2009/9/16/medline SP - 885-91, 891.e1 JF - Gastroenterology JO - Gastroenterology VL - 137 IS - 3 N2 - BACKGROUND & AIMS: Hepatic encephalopathy (HE) is associated with a poor prognosis. Lactulose is used for the treatment of HE. There is no study on the prevention of recurrence of HE using lactulose. METHODS: Consecutive cirrhotic patients who recovered from HE were randomized to receive lactulose (HE-L group) or placebo (HE-NL group). All patients were assessed by psychometry (number connection test [NCT-A and B], figure connection test if illiterate [FCT-A and B], digit symbol test [DST], and object assembly test [OAT]), critical flicker frequency test, and blood ammonia at inclusion. Primary end point was development of overt HE. RESULTS: Of 300 patients with HE who recovered, 140 (46.6%) met the inclusion criteria and were included. There was a high prevalence of abnormal psychometry test results (NCT-A, 67.5%; NCT-B, 62.5%; DST, 70%; and OAT, 80%), and FCT-A and B were abnormal in 10 of 14 patients. Critical flicker frequency was <38 Hz in 77 patients (55%). Twelve (19.6%) of 61 patients in the HE-L group and 30 (46.8%) of 64 in the HE-NL group (P = .001) developed HE over a median follow-up of 14 months (range, 1-20 months). Readmission rate due to causes other than HE (HE-L vs HE-NL, 9:6; P = NS) and deaths (HE-L vs HE-NL, 5:11; P = .18) in 2 groups were similar. Recurrence of overt HE was significantly associated with 2 or more abnormal psychometric tests after the recovery of an episode of HE (r = 0.369, P = .02). CONCLUSIONS: Lactulose is effective for prevention of recurrence of HE in patients with cirrhosis. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/19501587/Secondary_prophylaxis_of_hepatic_encephalopathy:_an_open_label_randomized_controlled_trial_of_lactulose_versus_placebo_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(09)00904-4 DB - PRIME DP - Unbound Medicine ER -