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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.

Mönnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Lühmann R, Sander P, Tholen A - BMC Gastroenterol (2013)

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Medicine and Institute of Neurogastroenterology, Academic Teaching Hospital Martin Luther, Charité - Universitätsmedizin Berlin, Caspar-Theyß-Str, 27-31, Berlin, 14193, Germany. moennikes@web.de.

ABSTRACT

Background: 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.

Methods: 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™).

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov identifier: NCT00325676.

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Related in: MedlinePlus

Treatment algorithm. START, V0; STOP, last visit of Observational Phase; m, months; w, weeks.
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Figure 1: Treatment algorithm. START, V0; STOP, last visit of Observational Phase; m, months; w, weeks.

Mentions: The design and primary results of this prospective clinical trial (ClinicalTrials.gov identifier: NCT00325676) have been previously described elsewhere [18]. This report includes prospectively defined subgroup analyses of therapy-associated changes of GI symptomatology and HRQoL. In brief, this randomized, multicenter, multinational, parallel group study (June 2006 to May 2007) was conducted in patients with GERD diagnosed endoscopically according to the Los Angeles classification (LA grade A–D) (full inclusion and exclusion criteria have been previously presented [18]). To assess the treatment effects based on duration and intensity of PPI administration, patients were randomized to two different treatment concepts: classical healing (CH) and complete remission (CR) (Figure 1). The CH group was treated up to 8 weeks until esophageal healing only (according to the LA classification), whereas the CR group was treated up to 16 weeks until 'complete remission’ occurred. This was defined as esophageal healing and a ReQuest™ (Reflux Questionnaire, Nycomed GmbH, Nycomed: a Takeda Company, Konstanz, Germany) -GI score below the predefined symptom threshold [19]. The trial was further divided into two periods: a treatment phase and a subsequent observational phase. During the treatment phase, patients were administered pantoprazole 40 mg od until resolution of GERD as pre-specified for each group. Healed patients entered an observational phase, which consisted of clinical follow-up for up to 6 months without PPI treatment and monitoring for endoscopically-confirmed relapse of reflux esophagitis according to the LA classification. To further assess concurrent symptoms affecting the upper and lower GI tract, a questionnaire was implemented asking for heartburn and modified symptomatic Rome II/III criteria, the latter suggesting diagnoses of FD and IBS [18].


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.

Mönnikes H, Schwan T, van Rensburg C, Straszak A, Theek C, Lühmann R, Sander P, Tholen A - BMC Gastroenterol (2013)

Treatment algorithm. START, V0; STOP, last visit of Observational Phase; m, months; w, weeks.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3852834&req=5

Figure 1: Treatment algorithm. START, V0; STOP, last visit of Observational Phase; m, months; w, weeks.
Mentions: The design and primary results of this prospective clinical trial (ClinicalTrials.gov identifier: NCT00325676) have been previously described elsewhere [18]. This report includes prospectively defined subgroup analyses of therapy-associated changes of GI symptomatology and HRQoL. In brief, this randomized, multicenter, multinational, parallel group study (June 2006 to May 2007) was conducted in patients with GERD diagnosed endoscopically according to the Los Angeles classification (LA grade A–D) (full inclusion and exclusion criteria have been previously presented [18]). To assess the treatment effects based on duration and intensity of PPI administration, patients were randomized to two different treatment concepts: classical healing (CH) and complete remission (CR) (Figure 1). The CH group was treated up to 8 weeks until esophageal healing only (according to the LA classification), whereas the CR group was treated up to 16 weeks until 'complete remission’ occurred. This was defined as esophageal healing and a ReQuest™ (Reflux Questionnaire, Nycomed GmbH, Nycomed: a Takeda Company, Konstanz, Germany) -GI score below the predefined symptom threshold [19]. The trial was further divided into two periods: a treatment phase and a subsequent observational phase. During the treatment phase, patients were administered pantoprazole 40 mg od until resolution of GERD as pre-specified for each group. Healed patients entered an observational phase, which consisted of clinical follow-up for up to 6 months without PPI treatment and monitoring for endoscopically-confirmed relapse of reflux esophagitis according to the LA classification. To further assess concurrent symptoms affecting the upper and lower GI tract, a questionnaire was implemented asking for heartburn and modified symptomatic Rome II/III criteria, the latter suggesting diagnoses of FD and IBS [18].

Bottom Line: 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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Medicine and Institute of Neurogastroenterology, Academic Teaching Hospital Martin Luther, Charité - Universitätsmedizin Berlin, Caspar-Theyß-Str, 27-31, Berlin, 14193, Germany. moennikes@web.de.

ABSTRACT

Background: 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.

Methods: 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™).

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov identifier: NCT00325676.

Show MeSH
Related in: MedlinePlus