OBJECTIVES:The Reflux Disease Questionnaire (RDQ) contains six symptom items for diagnosing and gauging gastroesophageal reflux disease (GERD) severity. However, clinical trials have generally focused only on the substernal burning item and limited data exist on the effect of concomitant items on the treatment response of substernal burning.METHODS:Data from two large randomized trials of AZD0865 25-75 mg/day vs. esomeprazole 20 or 40 mg/day in patients with GERD defined by moderate to severe (4 days per week) substernal burning (non-erosive reflux disease (NERD), N1,460; reflux esophagitis (RE), N1,514) were re-analyzed. As no differences were found between drugs or doses in treatment response of substernal burning, pooled data were used to determine the impact of additional RDQ items on the response of substernal burning to acid suppression.RESULTS:At baseline, patients reported an average of four RDQ items. Substernal burning was the most responsive to therapy in the 3.3% of individuals with this as their only baseline RDQ symptom. The report of any other RDQ item was associated with a reduction in the responsiveness of substernal burning to acid suppression (e.g., RE patients with high severity dyspepsia-pain had an odds ratio of 0.20 for an improvement in substernal burning to treatment).CONCLUSIONS:Other concomitant RDQ items, particularly substernal pain or dyspepsia-pain, were associated with a reduced treatment effect of acid suppression on substernal burning. These findings support the use of a more comprehensive assessment of disease state and treatment response in GERD trials and clinical practice.
ASJC Scopus subject areas