Possible etiology of improvements in both quality of life and overlapping gastroesophageal reflux disease by proton pump inhibitor treatment in a prospective randomized controlled trial
1 Department of Medicine and Institute of Neurogastroenterology, Academic Teaching Hospital Martin Luther, Charité - Universitätsmedizin Berlin, Caspar-Theyß-Str. 27-31, Berlin, 14193, Germany
2 Nycomed GmbH, Nycomed: a Takeda Company, Konstanz, Germany
3 Tygerberg Academic Hospital, Stellenbosch University, Cape Town, South Africa
4 Department of Internal Medicine, City Hospital, Siemianowice Śląskie, Poland
5 Pierrel Research, Essen, Germany
6 Takeda Pharmaceuticals International GmbH, Zürich, Switzerland
BMC Gastroenterology 2013, 13:145 doi:10.1186/1471-230X-13-145Published: 1 October 2013
Symptoms suggestive of functional dyspepsia (FD) and irritable bowel syndrome (IBS) frequently overlap with those of gastroesophageal reflux disease. Despite the high prevalence of symptomatic overlap, the underlying etiology remains poorly defined. We assessed the correlation of symptomatic relief and health-related quality of life (HRQoL) with healing of reflux esophagitis to further derive insights into the underlying etiology.
626 patients with reflux esophagitis were enrolled into one of two treatment groups (classical healing concept or the complete remission concept) to investigate differences in treatment intensity. Patients were treated with pantoprazole until esophageal mucosal healing. Remission was followed for up to 6 months without treatment. Gastro-intestinal symptoms and HRQoL were analyzed using disease-specific, psychometrically validated patient-reported outcome instruments (ReQuest™, GERDyzer™).
Symptomatic burden reflected by ReQuest™ substantially decreased from baseline to end of treatment by 83% and 88% in either treatment group, respectively. ReQuest™ scores significantly decreased in patients with or without heartburn and in those with symptoms suggestive of FD and IBS, indicating response of all symptom categories to treatment (p < 0.005). Therapy-associated relief of symptoms was paralleled by substantial gains in HRQoL, which continued to stabilize post-treatment.
Pantoprazole is effective in relieving upper and lower gastro-intestinal symptoms overlapping with erosive esophagitis, and provides sustained improvement in HRQoL post-treatment. Our results propose a link between both healing of erosive esophagitis and the slower remission of upper and lower gastro-intestinal symptoms. Since the improvement observed is likely to be multifactorial, the possibility for an immune-mediated etiology and identification of putative susceptibility factors by genome-wide association study may provide focus for future research.
ClinicalTrials.gov identifier: NCT00325676.