N. Hudson et al., RANITIDINE BISMUTH CITRATE AND ASPIRIN-INDUCED GASTRIC-MUCOSAL INJURY, Alimentary pharmacology & therapeutics, 7(5), 1993, pp. 515-521
The aim of this study was to investigate the protective action of a ne
w compound, ranitidine bismuth citrate, in the prevention of aspirin-i
nduced acute mucosal injury to the upper gastrointestinal tract of hea
lthy human volunteers. In a double-blind randomized three-way cross-ov
er study 24 male volunteers received placebo, 900 mg aspirin or 900 mg
aspirin and 800 mg ranitidine bismuth citrate at 12-h intervals for n
ine doses with a 2-week wash-out period between each treatment. The me
dian (interquartile range) number of erosions seen at endoscopy when r
anitidine bismuth citrate was given with aspirin (1 [04]) was signific
antly lower than aspirin alone (24 [16-32]) (P < 0.001) and not signif
icantly different from either baseline or placebo (0 [0-2]). These fin
dings were similarly reflected in the effects on microbleeding followi
ng the ninth dose: 12.1 (7.1-21.0) mu L/10 min following aspirin alone
compared to levels with placebo of 1.2 (0.4-2.9), and with aspirin an
d ranitidine bismuth citrate of 1.6 (0.8-2.6) (P < 0.005). Ranitidine
bismuth citrate conferred substantial protection from aspirin-induced
injury to the gastric and duodenal mucosa as determined by both endosc
opic assessment and microbleeding rates, reducing injury to placebo le
vels.