pectins and Heartburn

Gastro-oesophageal reflux disease may be treated with a drug forming a floating neutral raft in the stomach. The pectin-based raft-forming anti-reflux agent Aflurax (Idoflux) was examined, first regarding reduction of oesophageal acid exposure, and next as to its efficacy as maintenance treatment in patients with healed oesophagitis.. Double-blind, placebo-controlled randomized clinical trials.. Open access endoscopy unit.. Fourteen patients with erosive oesophagitis had measurement of acid exposure. Eighty-eight patients with healed erosive/ulcerative oesophagitis and relief of heartburn after pre-treatment with omeprazole received maintenance treatment.. Crossover 12-h oesophageal pH monitoring during Aflurax/placebo treatment. Maintenance treatment for up to 6 months with two tablets of Aflurax 1200 mg or placebo four times daily.. Percentage time pH less than 4 in 6 plus 6 h (upright + supine). Time to recurrence of moderate or severe heartburn (life table analysis).. The median (interquartile range) acid exposure times in the upright position were: 3.1% (1.6-13.0%) on Aflurax versus 6.7% (2.5-14.9%) on placebo (P = 0.10). In the supine position no difference was found (Aflurax 13.7%, placebo 13.2%). The time to recurrence of heartburn with Aflurax treatment was prolonged significantly; after 6 months the life table estimates were 48% of patients in remission on Aflurax versus 8% on placebo (P = 0.01). Following treatment, erosive oesophagitis was found in 17/34 on Aflurax versus 28/38 on placebo (P < 0.05).. Aflurax significantly delays recurrence of moderate or severe heartburn and erosive oesophagitis, when used as maintenance treatment. The acid exposure was not significantly reduced with pH monitoring.

Topics: Aged; Anti-Ulcer Agents; Antidiarrheals; Cross-Over Studies; Double-Blind Method; Endoscopy, Digestive System; Esophagitis; Female; Follow-Up Studies; Gastric Acid; Gastroesophageal Reflux; Heartburn; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Omeprazole; Pectins; Recurrence; Safety; Treatment Outcome

Patients with heartburn as their main complaint but normal oesophageal mucosa at endoscopy are classified as having endoscopy-negative gastro-oesophageal reflux disease (GORD). They have mainly postprandial reflux and low total acid exposure and could possibly be managed with a non-systemic drug. In such patients we examined the effect of a pectin-based raft-forming anti-reflux agent (Aflurax (Idoflux)) on the severity of heartburn.. Patients with heartburn but with normal/erythematous oesophageal mucosa (n = 65) were randomized to double-blind treatment with two 1200-mg tablets of Aflurax or two placebo tablets four times daily for 4 weeks. The main outcome measure was heartburn severity on day 15 and day 29.. The number of patients scoring heartburn severity on day 15 as none, mild, moderate, and severe were 6, 14, 8, and 3, respectively, with Aflurax versus 2, 6, 13, and 11 with placebo (P < 0.05). No further treatment effect was found on day 29.. Aflurax reduces heartburn in patients with endoscopy-negative GORD.

Topics: Adult; Aged; Antacids; Double-Blind Method; Drug Combinations; Female; Gastroesophageal Reflux; Gastrointestinal Agents; Gastroscopy; Heartburn; Humans; Logistic Models; Male; Middle Aged; Pectins; Treatment Outcome

A randomized controlled trial was performed to study the efficacy of Syn-Ergel with an active placebo in the treatment of heartburn of pregnancy in ninety-two patients completing 7 days of therapy. Syn-Ergel was significantly better (p less than 0.001) in all groups of pre-treatment pain severity in relieving the symptoms, and had a longer duration of action, than the active placebo. Complete relief of pain was achieved in 79.5% of Syn-Ergel treatments with a further 10% of treatments resulting in marked easing of discomfort at 1 hour following administration. The corresponding figures for the 'active placebo' were 56% and 20%. The combination of an antacid and a protective mucosal coating agent would appear to be a useful approach in the treatment of heartburn of pregnacy.

Topics: Agar; Aluminum; Antacids; Clinical Trials as Topic; Drug Combinations; Drug Evaluation; Female; Heartburn; Humans; Pectins; Placebos; Pregnancy; Pregnancy Complications; Pregnancy Trimester, Third