Effects of colloidal bismuth subcitrate on aspirin-induced gastric microbleeding, DNA loss, and prostaglandin formation in humans.

Ten healthy young male subjects took part in a double-blind, placebo-controlled, crossover trial to assess the effect of colloidal bismuth subcitrate (De-No) on prostaglandin (PG) E2 generation and mucosal integrity in an aspirin (ASA)-treated stomach. After administration of ASA (2.5 g) plus placebo, a marked reduction in mucosal generation of PGE2 (by about 85%) was observed, and this was accompanied by a significant increase in gastric microbleeding and DNA loss and endoscopic and histologic damage of the mucosa. After the combination of De-Nol (300 mg four times daily) with ASA, mucosal generation of PGE2 showed a reduction similar to that in tests with ASA plus placebo, but gastric microbleeding and mucosal damage were significantly reduced. It is concluded that De-Nol has a protective action on ASA-induced gastric microbleeding and that this protection occurs despite a marked suppression of mucosal production of prostaglandins.

RCT Entities:   Population Interventions Outcomes