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Reprinted by permission of Otolaryngol Head Neck Surg. 2008; 139(3):414-420.

Otolaryngology–Head and Neck Surgery (2008) 139, 414-420

ORIGINAL RESEARCH—LARYNGOLOGY AND NEUROLARYNGOLOGY

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

Oliver Reichel, MD, Holger Dressel, MD, Katrin Wiederänders, and Wolfgang J. Issing, MD, PhD, Munich, Germany; and Newcastle Upon Tyne, UK

study was to evaluate the effect of a three-month treatment with esomeprazole 20 mg twice daily on symptoms and laryngeal signs in patients with suspected LPR. We chose esomeprazole for this study as we could show adequate measurable acid suppression with a once-daily dose of this PPI in a large number of LPR patients in a former trial 4 and because esomeprazole provides greater 24-hour control of intragastric acid than all other available PPIs at standard doses used to treat erosive esophagitis. 10 MATERIALS AND METHODS The following procedures were performed in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements. The study was ap- proved by the Ethics Committee of the Medical Faculty of Ludwig Maximilians University Munich (project number 265-05). Before initiation of any procedure, signed in- formed consent was obtained from all patients. Participants Between February 2006 and July 2007, 62 consecutive patients (30 women and 32 men; age range, 21-77 years; mean, 48.7 years) were enrolled. They presented to the Department of Otorhinolaryngology–Head and Neck Sur- gery of Ludwig Maximilians University, Munich, with un- specific otolaryngologic and respiratory disorders such as chronic cough, dysphagia, throat clearing, globus sensation, hoarseness, sore throat, and heartburn. All patients were examined by one otolaryngologist and rigid or flexible la- ryngoscopy had to reveal mucosal abnormalities consistent with LPR reflected by a reflux finding score (RFS) 7. 11 In addition, the reflux symptom index (RSI), 12 a self-adminis- tered nine-item outcomes instrument for the diagnosis of LPR, had to exceed the value of 13 for inclusion. None of the study patients were treated with PPIs or any other antireflux medication for at least three months. Further

OBJECTIVE: To determine the efficacy of proton pump inhib- itor (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 poste- rior commissure hypertrophy ( P 0.01). CONCLUSION: In the treatment of LPR-related symptoms a high placebo effect can be observed. However, compared to con- trol, twice-daily PPI treatment for three months demonstrated a significantly greater improvement in laryngeal appearance and LPR symptoms. © 2008 American Academy of Otolaryngology–Head and Neck Surgery Foundation. All rights reserved. L aryngopharyngeal reflux (LPR) has had a significantly increasing impact on otolaryngologist office visits in the last decade. In the three-year period 1990-1993, annual visits to otolaryngologists by patients suffering from reflux- related problems averaged 89,000; this average increased to 421,000 annual visits during the three-year time span 1998- 2001. 1 The generally recommended treatment in patients with LPR is twice-daily-dose proton pump inhibitor (PPI) therapy for three to six months. 2,3 However, there is some controversy regarding the adequate PPI dosage and even the efficacy of these drugs for LPR treatment. 3,4 Some authors criticize these recommendations for LPR treatment as being based on poor levels of evidence from uncontrolled studies. 5 In addition, several studies in the past could not demonstrate superiority of PPIs over placebo for treatment of suspected LPR. 6-9 Therefore, the primary objective of this prospec- tive, double-blind, randomized, and placebo-controlled

Received April 9, 2008; revised May 27, 2008; accepted June 3, 2008.

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