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Treatment of Chronic Posterior Laryngitis With Esomeprazole
Author(s) -
Vaezi Michael F.,
Richter Joel E.,
Stasney C Richard,
Spiegel Joseph R.,
Iannuzzi Ralph A.,
Crawley Joseph A.,
Hwang Clara,
Sostek Mark B.,
Shaker Reza
Publication year - 2006
Publication title -
the laryngoscope
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.181
H-Index - 148
eISSN - 1531-4995
pISSN - 0023-852X
DOI - 10.1097/01.mlg.0000192173.00498.ba
Subject(s) - esomeprazole , medicine , laryngoscopy , placebo , proton pump inhibitor , laryngitis , sore throat , clinical endpoint , reflux , randomized controlled trial , gastroenterology , anesthesia , intubation , alternative medicine , disease , pathology
Objective: To evaluate the efficacy of acid‐suppressive therapy with the proton pump inhibitor esomeprazole on the signs and symptoms of chronic posterior laryngitis (CPL) in patients with suspected reflux laryngitis. Study Design: Prospective, multicenter, randomized, parallel‐group trial that compared twice‐daily esomeprazole 40 mg with placebo for 16 weeks. Methods: Eligible patients had a history of one or more CPL symptoms (throat clearing, cough, globus, sore throat, or hoarseness) and laryngoscopic signs indicating reflux laryngitis based on CPL index (CPLI) scores measured during a screening laryngoscopy. Patients were randomized to treatment if their 7‐day screening diary‐card recordings showed a cumulative primary symptom score of 9 or higher and they had 3 or more days with moderately severe symptoms based on a 7‐point scale. Efficacy was assessed by changes in symptoms as recorded by patients and investigators and by changes in CPLI scores based on laryngoscopic examinations. Results: The patients' primary CPL symptom at final visit (primary efficacy end point) was resolved in 14.7% (14/95) and 16.0% (8/50) of patients in the esomeprazole and placebo groups, respectively ( P = .799). Esomeprazole and placebo were not significantly different for change from baseline to the final visit in mean total CPLI (–1.66 ± 2.13 vs. –2.0 ± 2.55, respectively; P = .446) or any other secondary efficacy end points based on patient diary card or investigator assessments. Conclusion: This study provides no evidence of a therapeutic benefit of treatment with esomeprazole 40 mg twice daily for 16 weeks compared with placebo for signs and symptoms associated with CPL.