Evaluation of omeprazole in the treatment of reflux laryngitis: A prospective, placebo-controlled, randomized, double-blind study

Objectives: Proton-pump inhibitors are often recommended in the treatment o f laryngitis secondary to gastric reflux. Despite prospective treatment stu dies reporting high efficacy, only one previous report has been placebo-con trolled and blinded. The objective of this study was to determine the effic acy of omeprazole in treating proven reflux laryngitis. Study Design. Prosp ective, placebo-controlled, randomized, double-blind clinical trial. Method s: Fifty-three patients with one or more reflux laryngitis symptoms were re cruited to undergo 24-hour dual-channel pH probe testing. Thirty patients w ith more than four episodes of laryngopharyngeal reflux were enrolled. By r andom assignment, 15 patients received 40 mg omeprazole twice a day and the other 15 received placebo for a period of 2 months. Symptoms (hoarseness, throat pain, lump in throat sensation, throat clearing, cough, excessive ph legm, dysphagia, odynophagia, and heartburn) and endoscopic laryngeal signs (erythema, edema, and mucus accumulation) were recorded initially, at 1 mo nth, and 2 months. Results. In general, most symptom scores improved over t ime for both the omeprazole and placebo groups. Hoarseness, when patients b egin with low hoarseness symptom scores, and throat clearing improved signi ficantly more in patients on omeprazole than in those on placebo during the 2-month study. Throat pain, lump in throat sensation, excessive phlegm, di fficulty swallowing, pain with swallowing, and heartburn showed improvement in both treatment arms, signifying the possibility of a placebo effect. En doscopic laryngeal signs did not change significantly over the course of th e study for either treatment group. Conclusions. A placebo effect appears t o exist in the treatment of reflux laryngitis. However, hoarseness, when in itially scored low, and throat clearing resulting from reflux laryngitis ar e effectively treated by omeprazole.