Background & aims: In patients with persistent laryngeal symptoms despite aggressive proton pump inhibitor therapy, gastroesophageal reflux disease (GERD) continues to be implicated. The role of surgical fundoplication as the definitive therapy for these patients is uncertain.
Methods: In this prospective concurrent controlled study, 72 patients with suspected GERD-related laryngeal symptoms received aggressive acid-suppressive therapy. Four-month symptomatic nonresponders (<50% improvement) with continued laryngeal inflammation and normalized esophageal acid exposure were offered laparoscopic Nissen fundoplication. The primary outcome was symptom improvement/resolution at 1 year after surgery.
Results: Twenty-five of 72 (35%) patients remained unresponsive after 4 months of acid-suppressive therapy. Ten patients (40%) underwent surgical fundoplication (median age, 54 y; men, 4) and 15 patients (60%) continued medical therapy (median age, 52; men, 4). The most common laryngeal symptoms were sore throat, hoarseness, and cough. pH studies at 3 and 12 months were normal in all patients after fundoplication (median % time pH < 4, .0% and .3%; respectively). One of 10 (10%) patients in the surgery group reported improvement of laryngeal symptoms at 1 year compared with 1 of 15 in the control group (6.7%) (P = 1.0). Treatment of causes other than GERD improved symptoms in an additional 2 of 10 (20%) patients in the surgical group, and 10 of 15 (66%) patients in the nonsurgical cohort.
Conclusions: Surgical fundoplication does not improve laryngeal symptoms reliably in patients unresponsive to aggressive proton pump inhibitor therapy. The argument of low volume or intermittent reflux as the cause of persistent laryngeal symptoms needs to be replaced with evaluation and therapy for other potential non-GERD causes.