NEW ORLEANS — The proton pump inhibitor esomeprazole was no more effective than placebo in resolving signs and symptoms of suspected reflux laryngitis in a 16-week multicenter study.
“Although this study shows there is no response, I don't want to give the impression that there is no such thing as reflux laryngitis,” Michael Vaezi, M.D., said at the annual Digestive Disease Week. “There is such a thing, it's just that it is not as prevalent as perhaps once believed. That's what this study is showing.”
He added that the diagnosis of reflux laryngitis “based on laryngeal sign is unpredictable.”
Dr. Vaezi and his associates enrolled patients with suspected reflux laryngitis based on one or more symptoms: throat clearing, cough, globus, sore throat, or hoarseness for more than 3 consecutive months, or a score of at least 5 on a laryngeal sign index based on a videostroboscopic evaluation of erythema and other laryngeal signs suggesting reflux etiology.
A 1-week run-in period identified patients with moderate symptom severity for at least 3 of 7 days. Patients with moderate to severe heartburn were excluded.
Of the 145 patients in the study, 95 received 40 mg esomeprazole (Nexium) twice daily and 50 received placebo. The researchers assessed symptoms by patient diary, and laryngoscopy was repeated at weeks 8 and 16. Baseline symptoms were similar between groups: In each, 50% had throat clearing, 20% had hoarseness, 13% had cough, 9% had globus, and 8% had sore throat.
By the end of the study, 42% of patients in the esomeprazole group reported improvement of suspected reflux laryngitis symptoms, compared with 46% of patients in the placebo group, while reported resolution of symptoms occurred in 14·7% of patients in the esomeprazole group and 16% of patients in the placebo group.
Improvement in the reflux laryngitis index over time was also similar between groups, said Dr. Vaezi of the department of gastroenterology and hepatology at the Cleveland Clinic Foundation.
AstraZeneca, which manufactures Nexium, sponsored the trial.