Diclofenac delays healing of gastroduodenal mucosal lesions. Double-blind, placebo-controlled endoscopic study in healthy volunteers.

The effects of the water-soluble and delayed-release formulations of a nonsteroidal antiinflammatory drug, diclofenac, on the healing of gastroduodenal mucosal lesions were compared in a double-blind, double cross-over, placebo-controlled endoscopic study conducted in 14 healthy volunteers. Severe endoscopic lesions (petechiae, erosions, ulcers, and esophageal candidiasis) were found only in the group taking the soluble formulation of diclofenac (P less than 0.05 vs placebo). The endoscopic healing of biopsies at one week was delayed by both preparations in comparison to placebo (P less than 0.05 vs placebo). Neither formulation produced significantly more histological inflammation or minor endoscopic lesions (erythema, red striae) than placebo. Both formulations were equally well tolerated and produced no more symptoms than placebo. This study suggests that soluble diclofenac acts topically to delay gastroduodenal healing and produce gastroduodenal injury; it thus provides a model for future studies of the production, perpetuation, and healing of peptic lesions.

RCT Entities:   Population Interventions Outcomes