Treatment of Reflux Oesophagitis with a Carbenoxolone/ Antacid/Alginate Preparation: A Double-Blind Controlled Trial

Abstract

Twenty-nine patients were treated with a carbenoxolone/antacid/alginate preparation (Pyrogastrone) and 30 with antacid/alginate alone four times each day for 8 weeks, in a double-blind study, to ascertain the value of carbenoxolone in the treatment of patients with endoscopically confirmed reflux oesophagitis. Symptom review every 2 weeks and endoscopic findings every 4 weeks were converted to a 6-point grading system to facilitate statistical comparison, using a stochastic model for predicting the rate of change in grades during treatment. Carbenoxolone-treated patients showed an 82% improvement in symptom grades over 8 weeks and improved 50% faster (P less than 0.01) than did control patients, who showed a 63% improvement. Endoscopic improvement was not significantly different in the first 4 weeks, although healing was better maintained in carbenoxolone-treated patients during the second 4 weeks (P less than 0.05). At the low doses used (5 X 20 mg daily) no significant side effects of carbenoxolone were encountered. Pyrogastrone should be considered as a therapeutic alternative in patients who fail to respond to routine management with antacids.

Rationale and Efficacy of Conservative Therapy for Gastroesophageal Reflux Disease

“…In one pédiatrie trial, antacids were shown to be as effective as cimetidine in the management of reflux, although no placebo group was studied.78 Two studies designed to assess the efficacy of bethanechol with respect to antacids showed a substantial and comparable response to both therapies.79,80 A trial of antacids vs antacids with dimethicone in reflux esophagitis showed similar good response rates in the two groups.81 Improvement of symptoms with the use of combined antac¬ id alginate therapy has been reported to be approximately 80% in two open studies without placebo groups.8288 In a trial designed to assess the efficacy of sucralfate compared with a combined alginate and antacid compound in the treatment of reflux esophagitis, symptomatic improvement was noted in about 70% of patients in the alginate-treated group-a result not improved with sucralfate.84 When used with metoclopramide, therapy with alginate and antacid was shown to be as effective as ranitidine in the management of esophagitis among dyspeptic alcoholics.86 In two studies designed to eval¬ uate the effectiveness of combined carbenoxolone, alginate, and antacid therapy for reflux esophagitis, the combination of alginate and antacid alone proved to be very effective in the symptomatic control of this disorder. 86,87 Several studies have compared the effectiveness of therapy with alginate and antacid with that of antacids alone. One nonblinded trial showed equal effectiveness for these two Definitive validation of the presence or absence of a thera¬ peutic benefit of the use of antacids in the treatment of gastroesophageal reflux disease is limited by the scarcity of well-designed blinded, placebo-controlled trials ( Table 2).…”

Efficacy and Safety of a Natural Remedy for the Treatment of Gastroesophageal Reflux: A Double‐Blinded Randomized‐Controlled Study

“…When it encounters low pH gastric content, it is able to create a physical raft on top of the gastric juice, counteracting its reflux. In several in vitro and clinical trials, alginate/antacid effect has been already evaluated in GERD management alone or in coadministration with active compounds [26–28]. Moreover, floating alginate/antacid system has been used as carrier for probiotic, drug, or plant extracts [29–31].…”

Review article: alginate‐raft formulations in the treatment of heartburn and acid reflux

“…Young et al . compared endoscopic and symptomatic improvement of oesophagitis with Pyrogastrone ( n =29), a combination of carbenoxolone (20 mg), antacid (60 mg magnesium trisilicate, 240 mg aluminium hydroxide gel, 210 mg sodium bicarbonate) and alginic acid (600 mg), with an identical alginate/antacid ( n =30) lacking carbenoxolone 91 . In a double‐blind, parallel study, 82% and 63% of patients treated with Pyrogastrone and the alginate/antacid, respectively, reported symptomatic improvement after 8 weeks.…”