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Prophylaxis of hepatic encephalopathy in acute variceal bleed: a randomized controlled trial of lactulose versus no lactulose.
J Gastroenterol Hepatol. 2011 Jun; 26(6):996-1003.JG

Abstract

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 the role of lactulose for prophylaxis of HE after AVB.

METHODS

Consecutive patients of cirrhosis with AVB enrolled. Patients included if >18 years old 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 h of randomization.

RESULTS

Seventy patients were randomized into group-L (Gp-L, n = 35) and group-P (Gp-P, n = 35). There was no significant difference in baseline characteristics between the 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 ± 2.3 g/dL], blood transfusion requirement [1.6 ± 1.1 vs 1.3 ± 0.9 units], time to endoscopy [6.3 ± 2.8 vs 7.0 ± 3.1 h], and esophageal source of bleed [92% vs 88%]). Nineteen (27%) patients developed HE; five 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; three (8.5%) patients in Gp-L and six (17%) patients in Gp-P, P = 0.23. Patients who developed HE had significantly higher baseline Child-Turcotte-Pugh score score (10.2 ± 1.2 vs 9.4 ± 1.4 P = 0.04), model for end stage liver disease 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 leukocyte count (10,505.2 ± 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.

Authors+Show Affiliations

Department of Gastroenterology, G. B. Pant Hospital, New Delhi, India.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21129028

Citation

Sharma, Praveen, et al. "Prophylaxis of Hepatic Encephalopathy in Acute Variceal Bleed: a Randomized Controlled Trial of Lactulose Versus No Lactulose." Journal of Gastroenterology and Hepatology, vol. 26, no. 6, 2011, pp. 996-1003.
Sharma P, Agrawal A, Sharma BC, et al. Prophylaxis of hepatic encephalopathy in acute variceal bleed: a randomized controlled trial of lactulose versus no lactulose. J Gastroenterol Hepatol. 2011;26(6):996-1003.
Sharma, P., Agrawal, A., Sharma, B. C., & Sarin, S. K. (2011). Prophylaxis of hepatic encephalopathy in acute variceal bleed: a randomized controlled trial of lactulose versus no lactulose. Journal of Gastroenterology and Hepatology, 26(6), 996-1003. https://doi.org/10.1111/j.1440-1746.2010.06596.x
Sharma P, et al. Prophylaxis of Hepatic Encephalopathy in Acute Variceal Bleed: a Randomized Controlled Trial of Lactulose Versus No Lactulose. J Gastroenterol Hepatol. 2011;26(6):996-1003. PubMed PMID: 21129028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prophylaxis of hepatic encephalopathy in acute variceal bleed: a randomized controlled trial of lactulose versus no lactulose. AU - Sharma,Praveen, AU - Agrawal,Amit, AU - Sharma,Barjesh C, AU - Sarin,Shiv K, PY - 2010/12/7/entrez PY - 2010/12/7/pubmed PY - 2011/9/7/medline SP - 996 EP - 1003 JF - Journal of gastroenterology and hepatology JO - J. Gastroenterol. Hepatol. VL - 26 IS - 6 N2 - 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 the role of lactulose for prophylaxis of HE after AVB. METHODS: Consecutive patients of cirrhosis with AVB enrolled. Patients included if >18 years old 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 h of randomization. RESULTS: Seventy patients were randomized into group-L (Gp-L, n = 35) and group-P (Gp-P, n = 35). There was no significant difference in baseline characteristics between the 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 ± 2.3 g/dL], blood transfusion requirement [1.6 ± 1.1 vs 1.3 ± 0.9 units], time to endoscopy [6.3 ± 2.8 vs 7.0 ± 3.1 h], and esophageal source of bleed [92% vs 88%]). Nineteen (27%) patients developed HE; five 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; three (8.5%) patients in Gp-L and six (17%) patients in Gp-P, P = 0.23. Patients who developed HE had significantly higher baseline Child-Turcotte-Pugh score score (10.2 ± 1.2 vs 9.4 ± 1.4 P = 0.04), model for end stage liver disease 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 leukocyte count (10,505.2 ± 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. SN - 1440-1746 UR - https://www.unboundmedicine.com/medline/citation/21129028/Prophylaxis_of_hepatic_encephalopathy_in_acute_variceal_bleed:_a_randomized_controlled_trial_of_lactulose_versus_no_lactulose_ L2 - https://doi.org/10.1111/j.1440-1746.2010.06596.x DB - PRIME DP - Unbound Medicine ER -