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Acidifying enemas (lactitol and lactose) vs. nonacidifying enemas (tap water) to treat acute portal‐systemic encephalopathy: A double‐blind, randomized clinical trial
Author(s) -
Uribe Misael,
Campollo Octavio,
Vargas Florencia,
Ravelli Gian Paolo,
Mundo Fernando,
Zapata Laura,
Gil Sofia,
GarciaRamos Guillermo
Publication year - 1987
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.1840070404
Subject(s) - medicine , randomized controlled trial , double blind , enema , gastroenterology , hepatic encephalopathy , placebo , cirrhosis , alternative medicine , pathology
A double‐blind, controlled trial to study the efficacy of acidifying enemas of lactitol, a new galactoside‐sorbitol disaccharide, and lactose vs. nonacidifying tapwater enemas was performed in 45 episodes of acute portal‐systemic encephalopathy. At the time of randomization, all patients had encephalopathy of at least Grade 2+ severity, delay in the performance of number connection tests and hyperammonemia. A sequential analysis was performed which revealed after the inclusion of the first 20 patients, a significant failure of the non‐acidifying enemas as compared to the lactitol enemas (p < 0.004). The tap‐water enema group was, therefore, suspended but the rest of the study continued after rerandomization for lactose and lactitol groups. A favorable response to treatment was obtained in 19 (86%) of the patients receiving lactitol enemas and in 14 (78%) of those receiving lactose enemas. A similar significant improvement in portal‐systemic encephalopathy parameters and index was observed after both treatments. Both types of acidifying enemas induced a significant pH decrease in stool (p < 0.05). These data suggest that acidifying agents like lactose and lactitol are effective and superior to tap‐water enemas for the treatment of acute nitrogenous portal‐systemic encephalopathy.