PPIs for Laryngopharyngeal Reflux?

David A. Johnson, MD

Disclosures

Journal Watch. 2010;30(23) 

In This Article

Abstract and Introduction

Abstract

A close look at findings from a randomized, placebo-controlled trial show that the proton-pump inhibitor rabeprazole provided benefit in treating gastroesophageal — but not laryngopharyngeal — symptoms.

Introduction

Proton-pump inhibitors (PPIs) initially showed promise as a treatment for laryngopharyngeal reflux (LPR; JW Gastroenterol Aug 11 2006). However, small, randomized, placebo-controlled trials have not documented meaningful clinical benefit (e.g., Am J Gastroenterol 2006; 101:1972). Now, in a trial funded in part by the manufacturer of the PPI rabeprazole, researchers randomized 82 patients who had been referred to an ear, nose, and throat (ENT) center for clinical LPR to receive rabeprazole (20 mg twice daily) or placebo for 12 weeks.

Patients met these criteria: (1) ≥1 LPR symptom — hoarseness, globus, persistent throat discomfort, or frequent throat clearing — for ≥1 month during the preceding year; (2) evidence of LPR on video laryngostroboscopy (VLS), with a reflux finding score (RFS) >7; (3) absence of upper respiratory tract infection during the previous 4 weeks and absence of allergic causes for laryngitis; and (4) no use of acid-suppressive therapy during the previous 4 weeks.

All participants underwent manometry and 24-hour pH testing with a probe that had four pH sensors, spanning from a distal position 5 cm above the lower esophageal sphincter to a proximal placement just distal to the upper esophageal sphincter. LPR was documented if the pH for the proximal sensor registered <4.0 for >0.7% of total time, for >1.1% of time in the upright position, or for >0.5% of time in the supine position; gastroesophageal reflux disease (GERD) was documented for corresponding values of >4.6%, >7.0%, and >4.5%. A (blinded) laryngologist performed all ENT evaluations and assessed the VLS exams (intrarater reliability, 0.93). LPR symptoms were also assessed using a reflux symptom index (RSI) and sequential RFS scoring. Evaluations occurred during treatment and at 6 weeks after treatment ended (week 18).

The mean RSI score had improved significantly more with rabeprazole than with placebo at week 6 (P=0.003) and at week 12 (P=0.002), but not at week 18. The benefits of the drug at week 12 were significant improvements in the following: breathing difficulty or choking (P=0.009), troublesome cough (P=0.006), and sensation of something in the throat (P=0.007). RFS scores did not differ significantly between rabeprazole and placebo recipients.

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