Controlled trial of a new dosage form of carbenoxolone (Pyrogastrone) in the treatment of reflux esophagitis.

A new preparation combining carbenoxolone sodium with alginate antacid (Pyrogastrone), taken for 8 weeks, was compared with alginate antacid alone (Gaviscon-like) in a controlled double-blind study in 37 patients with endoscopically proved reflux esophagitis. Complete remission or persistence of only minimal symptoms was obtained in 89%, and esophageal ulcer healing was achieved in 100% of subjects taking Pyrogastrone, compared with only 50% (P less than 0.025) and 33% (P equal 0.02), respectively, on control treatment. Complete endoscopic healing or persistence of only minimal inflammation was seen in 95% on Pyrogastrone and 67% of controls (P less than 0.05). Mild biochemical and clinical changes were noted in 9 of 19 patients on Pyrogastrone and 6 of 18 on the control drug, but none required treatment or alteration in regime. Thus Pyrogastrone is more effective in the treatment of reflux esophagitis than the most efficacious compound in current use.

RCT Entities:   Population Interventions Outcomes