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.