title: Double-blind, placebo-controlled trial with single-dose pantoprazole for laryngopharyngeal reflux.
abstract: OBJECTIVE
  Results of randomized treatment trials for laryngopharyngeal reflux (LPR) are mixed. The cause and effect between gastroesophageal reflux and laryngeal symptoms remain elusive.
  
  
  OBJECTIVE
  To determine the efficacy of single-dose pantoprazole in newly diagnosed LPR and to correlate hypopharyngeal reflux with symptom improvement.
  
  
  METHODS
  Randomized, double-blind, placebo-controlled trial was performed with a 2-wk run-in, 12-wk treatment period (pantoprazole 40 mg q.a.m. or placebo), and 4-wk follow-up. Study criteria were laryngeal complaints >3 days/wk and a positive triple-sensor pH test. Laryngeal exam was graded using a reflux finding score before and after treatment. Repeat pH test was performed on study drug at week 12. Weekly diaries were kept on symptom severity and global assessment. Total laryngeal symptom score was defined as the sum of six laryngeal symptoms. Mann-Whitney U, Wilcoxon, and Pearson tests were used.
  
  
  RESULTS
  Thirty-nine subjects (13 M/26 F, median age 39 yr) were randomized; 35 completed the study. During the treatment period, total laryngeal symptom scores significantly improved compared with pretreatment scores in both study groups, but there were no significant differences between them. Forty percent of pantoprazole group reported adequate relief at week 12, compared with 42% of placebo group (p= 0.89). No significant improvement in hypopharyngeal reflux was found in either study group. There were no significant correlations between laryngeal reflux finding scores and hypopharyngeal reflux episodes with symptom improvement.
  
  
  CONCLUSIONS
  Response was similar between single-dose pantoprazole and placebo in newly diagnosed LPR. Our results suggested that laryngeal exam was not useful in following treatment response. Hypopharyngeal reflux may represent acid reflux or artifacts, but is not likely the underlying cause.
authors.affiliation: Division of Gastroenterology/Hepatology, University of Louisville School of Medicine, Louisville, Kentucky 40202, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Wo
authors.forename: Jennifer
authors.initials: J
authors.lastname: Koopman
authors.forename: Steven P
authors.initials: SP
authors.lastname: Harrell
authors.forename: Ken
authors.initials: K
authors.lastname: Parker
authors.forename: Welby
authors.initials: W
authors.lastname: Winstead
authors.forename: Eric
authors.initials: E
authors.lastname: Lentsch
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D050782:Esophageal pH Monitoring; D004947:Esophagus / Q000378:metabolism / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D006801:Humans; D008297:Male; D008365:Manometry; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077402:Pantoprazole; D011312:Pressure; D054328:Proton Pump Inhibitors; D013454:Sulfoxides / Q000008:administration & dosage* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D054328:Proton Pump Inhibitors; D013454:Sulfoxides; D000077402:Pantoprazole; D009853:Omeprazole