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Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptoms and oesophagitis in gastro-oesophageal reflux disease.
Eur J Gastroenterol Hepatol. 1997 May; 9(5):509-14.EJ

Abstract

OBJECTIVE

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.

DESIGN

Double-blind, placebo-controlled randomized clinical trials.

SETTING

Open access endoscopy unit.

PARTICIPANTS

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.

INTERVENTIONS

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.

MAIN OUTCOME MEASURES

Percentage time pH less than 4 in 6 plus 6 h (upright + supine). Time to recurrence of moderate or severe heartburn (life table analysis).

RESULTS

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).

CONCLUSION

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.

Authors+Show Affiliations

Department of Medical Gastroenterology, Odense University Hospital, Denmark.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9187886

Citation

Havelund, T, et al. "Efficacy of a Pectin-based Anti-reflux Agent On Acid Reflux and Recurrence of Symptoms and Oesophagitis in Gastro-oesophageal Reflux Disease." European Journal of Gastroenterology & Hepatology, vol. 9, no. 5, 1997, pp. 509-14.
Havelund T, Aalykke C, Rasmussen L. Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptoms and oesophagitis in gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol. 1997;9(5):509-14.
Havelund, T., Aalykke, C., & Rasmussen, L. (1997). Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptoms and oesophagitis in gastro-oesophageal reflux disease. European Journal of Gastroenterology & Hepatology, 9(5), 509-14.
Havelund T, Aalykke C, Rasmussen L. Efficacy of a Pectin-based Anti-reflux Agent On Acid Reflux and Recurrence of Symptoms and Oesophagitis in Gastro-oesophageal Reflux Disease. Eur J Gastroenterol Hepatol. 1997;9(5):509-14. PubMed PMID: 9187886.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of a pectin-based anti-reflux agent on acid reflux and recurrence of symptoms and oesophagitis in gastro-oesophageal reflux disease. AU - Havelund,T, AU - Aalykke,C, AU - Rasmussen,L, PY - 1997/5/1/pubmed PY - 1997/5/1/medline PY - 1997/5/1/entrez SP - 509 EP - 14 JF - European journal of gastroenterology & hepatology JO - Eur J Gastroenterol Hepatol VL - 9 IS - 5 N2 - OBJECTIVE: 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. DESIGN: Double-blind, placebo-controlled randomized clinical trials. SETTING: Open access endoscopy unit. PARTICIPANTS: 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. INTERVENTIONS: 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. MAIN OUTCOME MEASURES: Percentage time pH less than 4 in 6 plus 6 h (upright + supine). Time to recurrence of moderate or severe heartburn (life table analysis). RESULTS: 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). CONCLUSION: 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. SN - 0954-691X UR - https://www.unboundmedicine.com/medline/citation/9187886/Efficacy_of_a_pectin_based_anti_reflux_agent_on_acid_reflux_and_recurrence_of_symptoms_and_oesophagitis_in_gastro_oesophageal_reflux_disease_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&amp;PAGE=linkout&amp;SEARCH=9187886.ui DB - PRIME DP - Unbound Medicine ER -