Gastroenterology

Gastroenterology

Volume 117, Issue 1, July 1999, Pages 11-16
Gastroenterology

Alimentary Tract
Gastric Helicobacter pylori infection accelerates healing of reflux esophagitis during treatment with the proton pump inhibitor pantoprazole,☆☆,,★★

https://doi.org/10.1016/S0016-5085(99)70544-5Get rights and content

Abstract

Background & Aims: In previous studies an exaggerated effect of proton pump inhibitors (PPIs) on intragastric pH in Helicobacter pylori–infected patients was observed. Because healing and improvement of symptoms in patients with gastroesophageal reflux disease (GERD) is directly associated with an increase of intragastric pH during treatment, we hypothesized that the response to treatment with a PPI in patients with reflux esophagitis would be better in H. pylori–infected patients than in patients without H. pylori infection. Methods: We recruited 971 patients with endoscopically verified reflux esophagitis grades II and III (Savary/Miller). At study entry, H. pylori status was assessed by a 13C-urea breath test and baseline characteristics were recorded. Physicians and patients were not notified about the results of the breath test until completion of the study. All patients underwent treatment with pantoprazole, 40 mg orally once daily for 4 weeks. Healing was verified by endoscopy after 4 or 8 weeks of treatment. If the esophagitis had not completely healed at this time, treatment was continued for a further 4-week period. Healing rates and symptom relief were compared for patients with and without H. pylori infection. Results: The prevalence of H. pylori was 39.9% (95% confidence interval [CI], 36.9–42.9), and neither gender, smoking, nor alcohol consumption were associated with the H. pylori infection (P > 0.4). The trial was completed by 846 patients without protocol violation. Overall healing rates of reflux esophagitis were 80.4% (95% CI, 77.7–83.1) and 93.6% (95% CI, 91.8–95.2) after 4 and 8 weeks, respectively. In H. pylori–positive patients, healing rates were significantly higher after 4 (86.6% vs. 76.3%; P = 0.0005) and 8 weeks (96.4% vs. 91.8%; P < 0.004). Relief of symptoms after 4 weeks was also significantly (P < 0.05) better in H. pylori–infected patients than in uninfected patients. Conclusions: Patients with reflux esophagitis and H. pylori infection respond significantly better than H. pylori–negative patients to the PPI pantoprazole.

GASTROENTEROLOGY 1999;117:11-16

Section snippets

Patients and methods

After written informed consent, 971 patients were recruited for the study. All patients were at least 18 years old and had, according to Savary and Miller,9 endoscopically confirmed reflux esophagitis of grades II (erosions that communicate but no circumferential lesions) or III (circumferential lesions). Patients were excluded from the trial if they had duodenal or gastric ulcers; Zollinger–Ellison syndrome; a history of esophageal surgery, pyloric stenoses, or malignancies; a history of

Demographic data

Nine hundred seventy-one patients fulfilled the entry criteria and were enrolled. The characteristics of H. pylori–positive and –negative patients are summarized in Table 1. Of the 971 patients in the intention-to-treat/safety population, 125 patients were excluded from the efficacy analysis (30 patients were excluded because of a violation of inclusion criteria, 35 patients withdrew from the study, 30 patients were excluded because of noncompliance with regard to the study medication, 26

Discussion

This study shows that in patients with grade II or grade III reflux esophagitis, healing of lesions and relief of symptoms during treatment with a standard dose of pantoprazole are significantly better in H. pylori–infected patients than in patients without H. pylori infection. The better response to treatment in H. pylori–infected patients is most likely due to a higher intragastric pH in H. pylori–infected patients. Indeed, previous studies in healthy volunteers and duodenal ulcer patients

Acknowledgements

The authors thank Dr. A. Zachmann for valuable help with the analyses of the data and the preparation of the manuscript, all study personnel who took part in the patient care and data collection in each study site, and those who were involved in packing the study drugs, monitoring the study, and processing the data.

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    Supported by Byk Gulden, Konstanz, Germany.

    ☆☆

    Address requests for reprints to: Gerald Holtmann, M.D., Department of Gastroenterology and Hepatology, University of Essen, Hufelandstrasse 55, 45122 Essen, Germany. e-mail: [email protected]; fax: (49) 201-723-5970.

    Kendle/GMI, Germany was responsible for monitoring at the study sites, data collection, and source data verification.

    ★★

    The following persons also participated in the study (in alphabetic order): Achim A, Iserlohn; Adami B, Alzey; Adlkofer M, Berlin; Affani M, Bad Driburg; Aldenhoff D, Kamp-Lintfort; Apelt T, Neubiberg; Aßmus D, Nürnberg; Auchter K-H, Aalen-Wassersalfingen; Bach G, Karlsruhe; Bahlmann E, Morsbach; Bartfeld K-P, Henstedt-Ulzburg; Bayer H, Hamburg; Bechtel HE, Berlin; Bechtler H-J, Frankenthal; Beckmann B, Rochlitz; Beder E, Naumburg; Besch J, Neunkirchen; Biedermann A, Blankenhain; Bierbaum C, Hoyerswerda; Birke N, Saarbrücken; Bornscheuer V, Kassel; Braun K, Neubrandenburg; Bruns H, Lathen; Busch D, Salzkotten; Caspari J, Neuss; Christ J, Worbis; Dames J, Eschershausen; Deutscher R, Demmin; Dietz A, Ludwigsfelde; Döbbeler R, Brilon; Donecker R, Heringen; Döppenschmidt H, Germersheim; Döse H-J, Neumünster; Drost D, Bad Brückenau; Eisenbach T, Leverkusen-Schlebusch; Elsel W, Zwickau; Fabian-Krause J, Bad Tölz; Fante B, Dingolfing; Feinauer B, Mühlacker; Feyerabend H, Hagen; Fink R-R, Freising; Franke G-R, Dinkelsbühl; Frasch W, Viersen; Fricke U, Hemer; Fries J, Viernheim; Gabriel F, Düsseldorf; Glatzel C, Ludwigshafen/Oggersh; Glück W, Immenstadt; Gockel B, Dortmund; Goes R, Ditzingen; Groeneveld G, Fürth; Grosse W, Potsdam; Grothoff M, Ahlen; Güldütuna S, Frankfurt; Hagel H-J, Schwabach; Haimerl R, Simbach a. Inn; Hampel M, Schwedt; Hartl J, Nittenau; Hartmann H, Berlin; Heptner G, Dresden; Hering R, Baesweiler; Hoffmann N, Schweinfurt; Hust D, Kusel; Jakobeit C, Radevormwald; Janz R, Bergkamen; Jentzen F, Kiel; Jerwan-Keim R, Dietzenbach; Kaspari S, Lüneburg; Kirchhof M, Hamburg; Klein D, Köln; Kluge F, Freiburg; Knüpfer C, Wittenberg; Kohler B, Bühl; Kölbel W, Husum; König I, Bautzen; Koppenhöfer H, Walldorf; Kosmowski J, Frankfurt; Kraus H, Würselen; Kriszeleit H-J, Oberursel; Kühn A, Cottbus; Künzlen C, Bietigheim-Bissingen; Labitzke A, Reichenbach; Lange I, Vöhringen; Lange H, Bad Ems; Lautenschütz B, Germering; Leischik C, Köln-Weidenpesch; Lichtenstein A, Aachen; Linde B, Gera; Lohr E, Essen; Mackenroth T, Lübeck; Marheineke D, Neuwied; Marx W, Elmshorn; Mayr P, Stockach; Mayr-Städt J, Lohr a. M.; Mbamba H, Warstein; Mühlhausen U, Cuxhaven; Müller F, Arnsdorf; Müller H, Brandenburg; Nalbach B, Steinheim; Oehler R, Herford; Offermann M, Ahlen; Ott B, Remscheid; Panijel M, Frankfurt; Pape S, Paderborn-Kernstadt; Pfaff RKE, Gießen; Pietzsch T, Bochum; Pingel B, Niederstetten; Plass H, Nürnberg; Pustlauk U, Meinerzhagen; Raabe A, Berlin; Rachel T, Rastatt; Rehs H-U, Berlin; Reinicke A, Schwetzingen; Riddermann T, Marl; Rogalli A, Bensheim; Sabarstinski G, Marl; Schäfer B, Bochum; Schattenberg J, Wiesbaden; Schmidt H, Büdelsdorf; Schulz W, Halberstadt; Schweizer B, Stuttgart; Sehland D, Rostock; Simon T, München; Stock H, Pinneberg; Stölzle L, Traunstein; Thiemann R, Forchheim; Tibroni T, Coesfeld; Trabold G, Wernau; Türck I, Stuttgart; Uhlig K, Berlin; Vogl P, Osterhofen; Völler T, Storkow; Wagner T, Rostock; Walker H, Wangen; Wegner D, Leipzig; Wehnert J, Dresden; Westphal R, Germersheim; Weylandt J, Pinneberg; Wiesenhaken U, Leipzig; Wiest G, Nürnberg; Woywod G, Warendorf; Zäh W-D, Reutlingen; Zimmer E, Merzig-Hilbringen; Zimmerer E, Gerlingen; Zimmermann H, Hamburg; Zöllner K, Dippoldiswalde.

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