Impact of regurgitation on health-related quality of life in gastro-oesophageal reflux disease before and after short-term potent acid suppression therapy

Abstract

Objective: Limited data exist on the impact of regurgitation on health-related quality of life (HRQOL) in gastro-oesophageal reflux disease (GORD). We assessed the relationship between regurgitation frequency and HRQOL before and after acid suppression therapy in GORD.

Method: We used data from two randomised trials of AZD0865 25-75 mg/day versus esomeprazole 20 or 40 mg/day in non-erosive reflux disease (NERD) (n=1415) or reflux oesophagitis (RO) (n=1460). The Reflux Disease Questionnaire was used to select patients with frequent and intense heartburn for inclusion and to assess treatment response. The Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire was used to assess HRQOL.

Results: At baseline, 93% of patients in both the NERD and RO groups experienced regurgitation. Mean QOLRAD scores were similar for NERD and RO at baseline and at week 4 and disclosed decremental HRQOL with increasing frequency of regurgitation; a clinically relevant difference of >0.5 in mean QOLRAD scores was seen with regurgitation ≥4 days/week versus <4 days/week. The prevalence of frequent, persistent regurgitation (≥4 days/week) at week 4 among heartburn responders (≤1 day/week of mild heartburn) was 28% in NERD and 23% in RO. QOLRAD scores were higher among heartburn responders. There was a similar pattern of impact related to regurgitation frequency in heartburn responders compared with the group as a whole.

Conclusions: Frequent regurgitation was associated with a clinically relevant, incremental decline in HRQOL beyond that associated with heartburn before and after potent acid suppression in both NERD and RO.

Clinical trial numbers: NCT00206284 and NCT00206245.

Keywords: Anti-Reflux Therapy; Gastroesophageal Reflux Disease; Oesophageal Reflux; Oesophagitis; Quality of Life.

Conflict of interest statement

Competing interests: Peter Kahrilas has acted as a consultant for AstraZeneca, Eisai, EndoGastric Solutions, Ironwood, Novartis, and XenoPort. Andreas Jonsson, Hans Denison and Börje Wernersson are employees of AstraZeneca R&D, Mölndal, Sweden. Nesta Hughes is an employee of Oxford PharmaGenesis™ Ltd, Oxford, UK, which has received funding from AstraZeneca R&D, Mölndal, Sweden. Colin Howden has acted as a consultant for Boehringer Ingelheim, Novartis Consumer Health, Novartis Oncology, Otsuka, Takeda, Perrigo and XenoPort, and as a speaker for Novartis, Otsuka, Ironwood, Forest Laboratories, Takeda and GlaxoSmithKline.

Figures

Figure 1

The proportion of patients with regurgitation at baseline. NERD, non-erosive reflux disease; regurgitation–movement, unpleasant movement of material upwards from the stomach; regurgitation–taste, an acid taste in the mouth; regurgitation, the presence of an acid taste in the mouth and/or unpleasant movement of material upwards from the stomach; RO, reflux oesophagitis.

Figure 2

Mean QOLRAD scores (error bars represent 95% confidence intervals) according to the presence and frequency of regurgitation at baseline for patients with (A) NERD (B) RO. *The number of patients with daily regurgitation in the physical/social functioning dimension was 387, rather than 388 as in the other dimensions (missing data). NERD, non-erosive reflux disease; QOLRAD, The Quality of Life in Reflux and Dyspepsia; regurgitation, the presence of an acid taste in the mouth and/or unpleasant movement of material upwards from the stomach; RO, reflux oesophagitis.

Figure 3

Mean QOLRAD scores (error bars represent 95% confidence intervals) according to the presence and frequency of persistent regurgitation at week 4 for patients with (A) NERD and (B) RO. NERD, non-erosive reflux disease; QOLRAD, The Quality of Life in Reflux and Dyspepsia; regurgitation, the presence of an acid taste in the mouth and/or unpleasant movement of material upwards from the stomach; RO, reflux oesophagitis.