Treatment of chronic posterior laryngitis with esomeprazole.
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.


METHODS
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.


CONCLUSIONS
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.
Vaezi
Michael F
MF
Center for Swallowing and Esophageal Disorders, Department of Gastroenterology and Hepatology, Cleveland Clinic Foundation, OH, and the Department of Medicine, Temple University School of Medicine, Philadelphia, PA, USA. Michael.Vaezi@vanderbilt.edu
Richter
Joel E
JE
Stasney
C Richard
CR
Spiegel
Joseph R
JR
Iannuzzi
Ralph A
RA
Crawley
Joseph A
JA
Hwang
Clara
C
Sostek
Mark B
MB
Shaker
Reza
R
D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D064098:Esomeprazole / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007827:Laryngitis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors; D016896:Treatment Outcome
D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D064098:Esomeprazole