Prophylaxis of Hepatic Encephalopathy in Acute Variceal Bleed: A Randomized Controlled Trial of Lactulose versus no Lactulose.

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Prophylaxis of Hepatic Encephalopathy in Acute Variceal Bleed: A Randomized Controlled Trial of Lactulose versus no Lactulose.

J Gastroenterol Hepatol. 2010 Dec 6;

Authors: Praveen S, Amit A, Chander SB, Kumar SS

Background and Aims: Acute variceal bleed (AVB) is an important precipitating factor for development of hepatic encephalopathy (HE) .However there is paucity of data on the role of lactulose for prevention of HE after AVB. We evaluated role of lactulose for prophylaxis of HE after AVB. Patients and Methods: Consecutive patients of cirrhosis with AVB enrolled. Patients included if >18 yr and had no HE at the time of presentation. Patients were randomized to receive lactulose (Group-L) or no lactulose (Group-P) along with standard treatment of AVB as per Baveno 4 guidelines. Primary endpoint was development of overt HE as per West Haven criteria within 120 hr of randomization. Results: Seventy patients randomized into group-L (Gp-L, n = 35) and group-P (Gp-P, n = 35).There was no significant difference in baseline characteristics between two groups. Characteristics of variceal bleed were also similar [ Gp-L vs Gp-P(mean arterial pressure 81.0 ± 10.5 vs 79.5 ± 9.9 mmHg), Hb(8.4 ± 1.5 vs 9.3 ± 2.3gm%),blood transfusion requirement (1.6 ± 1.1vs 1.3 ± 0.9 units), time to endoscopy (6.3 ± 2.8 vs 7.0 ± 3.1 hr),esophageal source of bleed (92% vs 88%)]. Nineteen (27%) patients developed HE, 5 patients (14%) in Gp-L and 14 patients (40%) in Gp-P, p = 0.03. The median grade of HE was 2(range 2-4) and median time interval of development of HE after randomization was 2 days (range 1-4).Nine patients (13%) died, 3 (8.5%) patients in Gp-L and 6(17%) patients in Gp-P, p = 0.23. Patients who developed HE had significantly higher baseline CTP score (10.2 ± 1.2 vs 9.4 ± 1.4,p = 0.04), MELD score(18.2 ± 3.9 vs 15.4 ± 4.5, p = 0.02),arterial ammonia level(112.2 ± 22.7 vs 94.8 ± 17.6 umol/l, p = 0.001), baseline total leucocyte count(10505.2 ± 8911.9 vs 5784.3 ± 3387.0, p = 0.002),total bilirubin (3.4 ± 1.3 vs 2.1 ± 1.8 mg%, p = 0.008) as compared to patients who did not develop HE. On multivariate analysis only baseline arterial ammonia, blood requirement during hospital stay and lactulose therapy were predictors of development of HE Conclusions: Lactulose is effective in prevention of HE in patients with cirrhosis and acute variceal bleed.

PMID: 21129028 [PubMed - as supplied by publisher]

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