Changes in the laryngeal signs of patients with reflux laryngitis: a prospective, placebo-controlled, randomized, double-blinded evaluation of omeprazole

Abstract

Reflux laryngitis (RL) is becoming an increasingly reported clinical finding. Unfortunately, there are several problems associated with its diagnosis: total reliance on laryngeal symptoms leading to over-diagnosis, reliance on lower esophageal pH values for diagnosis leading to missed diagnosis, and lack of consensus on how to evaluate and rate the most sensitive laryngeal signs leading to questionable diagnosis. These are further aggravated by the inherent research problems of outcome study designs. The current study has used positive laryngeal symptoms and positive laryngopharyngeal reflux (LPR) for diagnosis. Fifty-three subjects with positive persistent RL symptoms for 2 months were recruited. Only 30 had positive LPR (>4 episodes of pH<4.0 in 24 h). The study was double blinded, and patients were randomly assigned to the placebo group (n=15, M/F=8:7, mean age 45.3, mean number of LPR episodes 15.0±2.9), or the omeprazole group (n=15, M/F=8:7, mean age 51.7, mean number of reflux episodes 14.2±2.6). Subjects received a sugar pill or omeprazole 40 mg b.i.d. (respectively) for 2 months. Seven laryngeal signs were rated from recorded laryngeal images with no information on patient identity or time of evaluation (entry, post-1 month and post-2 months). Intra-rater reliability varied across laryngeal parameters and across raters. The rater with the longest experience in laryngeal ratings had the highest intra-rater reliability scores. Also, inter-rater reliability values varied across laryngeal parameters, but were generally poor. Significant improvement in hoarseness and throat clearing were found in RL patients in the omeprazole group after 2 months of therapy. No similar significant improvement was found in any of the laryngeal signs in the omeprazole group after 2 months of therapy.