Double-blind, placebo-controlled trial with esomeprazole for symptoms and signs associated with laryngopharyngeal reflux

OBJECTIVE: To determine the efficacy of proton pump inhibitor (PPI) therapy with esomeprazole on symptoms and signs associated with laryngopharyngeal reflux (LPR). STUDY DESIGN AND METHODS: Prospective, double-blind, randomized, placebo-controlled study. Sixty-two patients with a reflux finding score (RFS) > 7 and a reflux symptom index (RSI) > 13 were enrolled and received either esomeprazole 20 mg twice daily or placebo for three months. RSI and RFS were assessed at baseline, after six weeks, and after three months. RESULTS: Reductions of total RSI and RFS as well as of several subscores were significantly higher in the treatment group compared to placebo after three months (P < 0.05 each). The difference between study groups was most pronounced for posterior commissure hypertrophy (P < 0.01). CONCLUSION: in the treatment of LPR-related symptoms a high placebo effect can be observed. However, compared to control, twice-daily PPI treatment for three months demonstrated a significantly greater improvement in laryngeal appearance and LPR symptoms. (c) 2008 American Academy of Otolaryngology-Head and Neck Surgery Foundation. All rights reserved.