Hubert Mönnikes1, Bernd Pfaffenberger, Gudrun Gatz, Jasper Hein, Karna Dev Bardhan. 1. Department of Medicine, Division Hepatology, Charité Medical Center-Campus Virchow Hospital, Medical School of Free University and Humboldt University, Augustenburgerplatz 1, DE-13353 Berlin, Germany. hubert.moennikes@charite.de
Abstract
BACKGROUND/AIMS: A prime concern for gastroesophageal reflux disease (GERD) patients is fast symptom control. Sparse valid information is available on the rapidity of the effect of proton pump inhibitors in provid ing symptom relief. The new reflux questionnaire ReQuest is validated for daily assessment of changes in GERD symptoms. Therefore, this study investigated the efficacy of 20 mg pantoprazole and 20 mg esomeprazole with regard to the time to symptom relief in patients with endoscopy-negative GERD (enGERD) using ReQuest. METHODS:529 patients were treated withpantoprazole or esomeprazole over 4 weeks. ReQuest symptom scores were assessed daily. The mean and median times to first and sustained symptom relief were determined. RESULTS:Median time to first symptom relief was 2 days for both drugs (intention-to-treat population). The median time to sustained symptom relief was 3 days shorter with pantoprazole (10.0 vs. 13.0 days). The Hodges-Lehmann estimator for the difference in time to reach first and sustained symptom relief between both groups was 0.00 days. For both variables the one-sided 95% CI (Moses) was [0.00; infinity] documenting no significant differences between the treatment groups. CONCLUSIONS: The rapidity of symptom control can be evaluated by clinically significant parameters using ReQuest. Pantoprazole and esomeprazole are equally effective in the time to first and sustained symptom relief.
RCT Entities:
BACKGROUND/AIMS: A prime concern for gastroesophageal reflux disease (GERD) patients is fast symptom control. Sparse valid information is available on the rapidity of the effect of proton pump inhibitors in provid ing symptom relief. The new reflux questionnaire ReQuest is validated for daily assessment of changes in GERD symptoms. Therefore, this study investigated the efficacy of 20 mg pantoprazole and 20 mg esomeprazole with regard to the time to symptom relief in patients with endoscopy-negative GERD (enGERD) using ReQuest. METHODS: 529 patients were treated with pantoprazole or esomeprazole over 4 weeks. ReQuest symptom scores were assessed daily. The mean and median times to first and sustained symptom relief were determined. RESULTS: Median time to first symptom relief was 2 days for both drugs (intention-to-treat population). The median time to sustained symptom relief was 3 days shorter with pantoprazole (10.0 vs. 13.0 days). The Hodges-Lehmann estimator for the difference in time to reach first and sustained symptom relief between both groups was 0.00 days. For both variables the one-sided 95% CI (Moses) was [0.00; infinity] documenting no significant differences between the treatment groups. CONCLUSIONS: The rapidity of symptom control can be evaluated by clinically significant parameters using ReQuest. Pantoprazole and esomeprazole are equally effective in the time to first and sustained symptom relief.