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Persistent regurgitation tied to clinically relevant QOL decline
Symptoms of regurgitation had a significant and clinically meaningful detrimental impact on health-related quality of life before and after acid suppression therapy in a recent study.
Researchers evaluated data from two randomized trials in which 25 mg/day to 75 mg/day of potassium-competitive acid blocker AZD0865 was compared with 20 mg/day or 40 mg/day of esomeprazole over 4 weeks. The cohort included 1,415 patients with nonerosive reflux disease (NERD) and 1,460 with reflux esophagitis (RE). Patients’ health-related quality of life (HRQOL) was measured via the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire.
Ninety-three percent of all patients reported regurgitation symptoms at baseline. Similar mean QOLRAD scores were noted at baseline and after 4 weeks of treatment in both groups, with an inverse association observed between mean score and regurgitation frequency. After treatment, 66% of NERD and 62% of RE patients continued to experience persistent regurgitation.
Mean QOLRAD scores increased after treatment by 2 to 3 points, primarily due to symptoms of substernal burning, regardless of regurgitation symptoms. QOLRAD scores were higher among those whose heartburn symptoms responded to treatment; 28% of NERD patients and 23% of RE patients whose heartburn responded to therapy, however, continued experiencing persistent regurgitation.
In both groups, patients with frequent, persistent symptoms (4≥symptomatic days/weekly) had significantly lower QOLRAD scores than patients reporting less frequent symptoms before and after treatment. This difference was larger than the 0.5-point margin indicating clinical relevance, and investigators identified 4 symptomatic days/week as a potentially useful threshold for clinically meaningful impact of regurgitation on HRQOL.
“We demonstrate that frequent symptoms of regurgitation are detrimental to HRQOL in patients with GERD, and establish quantitative metrics for gauging this relationship,” researcher Nesta Hughes, PhD, Oxford PharmaGenesis, Tubney, UK, told Healio.com. “Importantly, we show that the negative impact of regurgitation on HRQOL is clinically relevant and is beyond that associated with heartburn both before and after potent acid suppression therapy.
“These findings are of particular interest to clinicians because they highlight the importance of regurgitation to patients, and we usefully suggest a threshold at which regurgitation should be considered troublesome.”
Disclosure: See the study for a full list of relevant disclosures.