The objective of the study was to assess whether sucralfate can preven
t or diminish short-term nonsteroidal anti-inflammatory drug (NSAID)-i
nduced damage in the stomach and duodenum. Sixteen healthy subjects we
re randomly treated for 7 days with sucralfate 2 g b.d. or placebo in
a double-blind cross-over manner. Naproxen 500 mg b.d, was given on da
ys 3-7. Gastrointestinal endoscopy was performed before and after each
treatment period. Mucosal damage was measured by counting erosions, s
ubmucosal hemorrhages or ulcers on a fixed point scale of 0-4 for stom
ach and duodenum separately. The mean posttreatment injury score in th
e stomach was 2.13 +/- 1.51 and 2.0 +/- 0.97 for the placebo and sucra
lfate periods, respectively (p = 0.72). The possibility of type II err
or was 7%. In the duodenum, the injury score was 1.69 +/- 1.08 and 1.0
6 +/- 0.93 for the placebo and sucralfate periods, respectively (p = 0
.08). The possibility of type II error was 37%. Sucralfate has no effi
cacy as a prophylactic agent against shortterm NSAID-induced gastroduo
denal injury.