Novel Measurement of Rapid Treatment Success with ReQuest^TM: First and Sustained Symptom Relief as Outcome Parameters in Patients with Endoscopy-Negative GERD Receiving 20 mg Pantoprazole or 20 mg Esomeprazole

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 providing symptom relief. The new reflux questionnaire ReQuest^TM 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^TM. Methods: 529 patients were treated with pantoprazole or esomeprazole over 4 weeks. ReQuest^TM 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; ∞[, documenting no significant differences between the treatment groups. Conclusions: The rapidity of symptom control can be evaluated by clinically significant parameters using ReQuest^TM. Pantoprazole and esomeprazole are equally effective in the time to first and sustained symptom relief.

A note on the Hodges–Lehmann estimator

“…The two papers enlarged the scope of non-parametric statistics from testing to point estimation without the need of making specific assumptions on the distribution of the data. Though the idea of the two authors applies to rank statistics in general, the estimator based on the Wilcoxon Rank Sum statistics [3] became particularly prominent in applications as an estimate for a difference between two treatment groups, probably because it can be calculated in closed form (see, for example, Svedsen et al [4], Mo¨nnikes et al [5], LaVange and Koch [6]). It has also found its way into the summary of product characteristics (SPC) of medicines [7] as reproduced in Table I.…”

“…Koch [6]. Svedsen et al [4] state that the HL-estimate provides a point estimate of the treatment effect by estimating the difference in pain scores, while Mo¨nnikes et al [5] used it to provide as they say a point estimate for the treatment effect. In the SPC for darifenacin [7], the HL-estimator is said to estimate the median difference from placebo in change (of incontinence episodes per week) from baseline.…”

Development and Psychometric Assessment of a Self-evaluation Questionnaire for Gastroesophageal Reflux Disease

“…The responsiveness index was obtained by dividing the standard deviation of the mean of the pre-post difference in the responsive group by that of the non-responsive group. 15,16 P-values < 0.05 are statistically significant.…”