HSC Section 6 Nov2016 Green Book

Kavitt RT, Yuksel ES, Slaughter JC, et al. The role of impedance monitoring in patients with extraesophageal symptoms. Laryngoscope . 2013; 123(10):2463-2468. EBM level 2b.....................................................................................................................139-144 Summary: Kavitt et al demonstrate that typical gastroesophageal reflux disease (GERD) testing parameters cannot predict the same conclusions when impedance is performed while the patient is on proton pump inhibitor therapy and recommend caution on over-interpreting impedance data in laryngopharyngeal reflux. Reichel O, Dressel H, Wiederänders K, Issing WJ. Double-blind, placebo-controlled trial with esomeprazole for symptoms and signs associated with laryngopharyngeal reflux. Otolaryngol Head Neck Surg . 2008; 139(3):414-420. EBM level 1......................145-151 Summary: This study is a prospective, double-blinded randomized controlled trial examining esomeprazole versus placebo in managing the symptoms and signs of laryngopharyngeal reflux (LPR). A total of 62 patients with LPR were enrolled, and ultimately 30 patients were in the esomeprazole group, with 28 in the control group. Study subjects were given either esomeprazole 20 mg twice daily or identical placebo. They underwent laryngoscopic examinations and completed a Reflux Symptom Index (RSI) at 6 weeks and 12 weeks. There was minimal difference between the two groups at 6 weeks, but at 12 weeks, there was a significant difference in RSI as well as the Reflux Finding Score on laryngoscopy. The authors also found a high percentage of placebo patients (42%) experienced complete relief of symptoms at the end of the 3-month trial, though the percentage of the esomeprazole group was significantly higher (over 78%). One possible limitation is that pH monitoring was not used to diagnose LPR. Youssef TF, Ahmed MR. Treatment of clinically diagnosed laryngopharyngeal reflux disease. Arch Otolaryngol Head Neck Surg . 2010; 136(11):1089-1092. EBM level 1.......................................................................................................................152-155 Summary: This randomized controlled trial looked at the difference between monotherapy with esomeprazole versus triple therapy with esomeprazole, amoxicillin, and clarithromycin in treating patients with laryngopharyngeal reflux disease (LPRD) that have been found to be positive for H. pylori stool antigen (HPSA). The authors first determined that there is no statistical difference in symptoms between HPSA-positive and HPSA-negative patients with LPRD. Next, patients with clinically diagnosis of LPRD confirmed on pH testing were divided into two treatment groups based on HPSA status. HPSA-negative patients received esomeprazole 40 mg once daily for 4 weeks, while HPSA-positive patients were divided into monotherapy and triple therapy groups. The monotherapy treatment was identical to the HPSA-negative treatment, while the triple therapy group received esomeprazole 40 mg daily, 1 g amoxicillin daily, and 500 mg clarithromycin daily for 4 weeks. The HPSA-negative group showed improvement in 97% of patients, while in the HPSA-positive group, patients on monotherapy showed improvement in 40%, and 90% of those on triple therapy showed improvement. A major weakness of the study is that “improvement” is based on self-reporting by patients and by blinded laryngoscopic evaluation by the senior author. While these are no doubt important factors to take into consideration, they do not make use of objective testing, such as repeat 24-hour pH probe or validated questionnaires.