title: Health-related quality of life improves with treatment-related GERD symptom resolution after adjusting for baseline severity.
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.
authors.affiliation: Center for Health Outcomes Research, MEDTAP International, Inc, Bethesda, Maryland, USA. Revicki@medtap.com
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.forename: Marc W
authors.initials: MW
authors.lastname: Zodet
authors.forename: Sandra
authors.initials: S
authors.lastname: Joshua-Gotlib
authors.forename: Douglas
authors.initials: D
authors.lastname: Levine
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Crawley
mesh_terms: D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy; D006304:Health Status; D006356:Heartburn / Q000453:epidemiology / Q000209:etiology / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects; D011594:Psychometrics; D011788:Quality of Life; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D000897:Anti-Ulcer Agents; D011899:Ranitidine; D009853:Omeprazole