Abstract
Severity and frequency of gastroesophageal reflux disease (GERD) related symptoms are associated with impaired health-related quality of life (HRQL). This study evaluated the association between baseline heartburn severity and endpoint HRQL of patients treated for heartburn and the relationship between complete resolution of heartburn symptoms and HRQL outcomes after controlling for baseline severity. We completed a secondary analysis of clinical symptom and HRQL data from three clinical trials in adult patients receiving either omeprazole or ranitidine treatment for GERD. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in each of the three clinical trials, and two of the trials also included the Medical Outcomes Study Sleep disturbance scale. Gastrointestinal symptoms were evaluated using either the Gastrointestinal Symptom Rating Scale or a modified version of the scale. Baseline heartburn severity (none/minor, mild, moderate or severe) was defined based on patient-reported symptoms. Analysis of covariance (ANCOVA) models were used to compare mean HRQL scores by baseline level of heartburn symptom severity and whether or not patients experienced complete heartburn resolution. At baseline, PGWB scores were significantly worse (p < 0.05) for patients with more severe heartburn symptoms. There were no statistically significant baseline severity by symptom resolution interactions in any of the ANCOVA models. For all three trials and across all follow-up assessments, mean PGWB scores were statistically significantly higher for patients with completely resolved heartburn symptoms versus those whose symptoms were unresolved (all p-values < 0.05). Few significant effects were observed for sleep disturbance scores. While the severity of heartburn symptoms at the start of medical treatment for GERD is not associated with improvements in HRQL in subsequent weeks of treatment, complete resolution of symptoms is associated with improvements in psychological well-being.
Highlights
Gastroesophageal reflux disease (GERD) is common in for visits in primary care practices [1,2,3,4]
To evaluate whether baseline heartburn severity is associated with endpoint health-related quality of life (HRQL) scores, we focused on the interaction between baseline symptom severity and complete resolution status at follow-up, based on an analysis of covariance (ANCOVA) model
There were no statistically significant differences observed by heartburn symptom resolution on mean Sleep Disturbance scores in the Analysis of covariance (ANCOVA) models. This secondary analysis was designed to evaluate the relationship between baseline level of heartburn symptom severity, resolution of heartburn symptoms, and HRQL outcomes assessed at various time-points during pharmaceutical treatment for GERD
Summary
Gastroesophageal reflux disease (GERD) is common in for visits in primary care practices [1,2,3,4]. The primary objectives of this study were to evaluate the association between baseline heartburn severity and endpoint HRQL in patients treated for heartburn; and to examine the relationship between complete resolution of heartburn symptoms, while controlling for baseline severity, and HRQL outcomes. Previous research indicates that baseline severity of disease and health status scores may be associated with changes in HRQL outcomes [16,17] where patients with very severe disease (and worse HRQL) may demonstrate differential impact of effective medical therapy than those with milder disease. A secondary objective was to evaluate whether complete resolution of heartburn symptoms, while controlling for baseline severity, results in improved wellbeing and functioning. The latter objective extends previous work that demonstrated complete resolution of these symptoms improves HRQL [15]
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