Objective: The objective of this study was to define the outcome of empiric treatment of suspected laryngopharyngeal reflux (LPR) symptoms with proton pump inhibitors (PPIs).
Design: The authors conducted a systematic review of the English and foreign literature. Studies that used PPIs as an empiric treatment modality for suspected LPR, whether alone or in combination with other acid suppressants and/or placebo, were included. Studies that did not include PPIs as a treatment option were excluded.
Main outcome measures: A lack of common outcome measures was evident in the uncontrolled studies. In the randomized, controlled trials, outcome measures included symptom questionnaires and videolaryngoscopy. Only one study used computerized voice analysis.
Results: Fourteen uncontrolled studies together with one unblinded, nonrandomized study with a control group of healthy volunteers and six double-blind, placebo-controlled randomized trials were identified from 1994 to 2004. Selection bias, blinding of the results, and lack of common outcome measures were some of the problems preventing a formal metaanalysis. Although uncontrolled series reported positive results, randomized, controlled trials demonstrated no statistically significant differences for changes in severity or frequency of symptoms associated with suspected reflux between PPIs and placebo.
Conclusions: Recommendations for empiric treatment of suspected LPR with PPIs, by far the most common ear, nose and throat practice in the United Kingdom, are based on poor levels of evidence from uncontrolled studies. The few randomized, controlled trials have failed to demonstrate superiority of PPIs over placebo for treatment of suspected LPR.