Acidifying enemas (lactitol and lactose) vs. nonacidifying enemas (tap water) to treat acute portal-systemic encephalopathy: a double-blind, randomized clinical trial.
A double-blind, controlled trial to study the efficacy of acidifying enemas of lactitol, a new galactoside-sorbitol disaccharide, and lactose vs. nonacidifying tap-water 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 nonacidifying enemas as compared to the lactitol enemas (p less than 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 less than 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.
Uribe
M
M
Campollo
O
O
Vargas
F
F
Ravelli
G P
GP
Mundo
F
F
Zapata
L
L
Gil
S
S
Garcia-Ramos
G
G
D000641:Ammonia / Q000097:blood; D001364:Awareness; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004733:Enema / Q000379:methods*; D005243:Feces / Q000032:analysis; D006501:Hepatic Encephalopathy / Q000523:psychology / Q000628:therapy*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007361:Intelligence Tests; D007785:Lactose / Q000627:therapeutic use*; D011897:Random Allocation; D013402:Sugar Alcohols / Q000627:therapeutic use*; D014867:Water / Q000627:therapeutic use*
D013402:Sugar Alcohols; D014867:Water; D000641:Ammonia; D007785:Lactose; C014635:lactitol