PMID- 21083673 OWN - NLM STAT- MEDLINE DCOM- 20110314 LR - 20220309 IS - 1365-2036 (Electronic) IS - 0269-2813 (Print) IS - 0269-2813 (Linking) VI - 33 IP - 2 DP - 2011 Jan TI - Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study. PG - 225-34 LID - 10.1111/j.1365-2036.2010.04511.x [doi] AB - BACKGROUND: Cough may be a manifestation of gastro-oesophageal reflux disease (GERD). The utility of acid suppression in GERD-related cough is uncertain. AIM: To assess the impact of high-dose acid suppression with proton pump inhibitors (PPI) on chronic cough in subjects with rare or no heartburn. METHODS: Subjects were nonsmokers without history of asthma, with chronic cough for >8 weeks. All subjects underwent a baseline 24-h pH/impedance study, methacholine challenge test and laryngoscopy. Subjects were randomised to either 40 mg of esomeprazole twice daily or placebo for 12 weeks. The primary outcome measure was the Cough-Specific Quality of Life Questionnaire (CQLQ). Secondary outcomes were response on Fisman Cough Severity/Frequency scores and change in laryngeal findings. RESULTS: Forty subjects were randomised (22 PPI, 18 placebo) and completed the study. There was no difference between PPI and placebo in CQLQ (mean improvement 9.8 vs. 5.9 respectively, P = 0.3), or Fisman Cough Severity/Frequency scores. Proportion of patients who improved by >1 s.d. on the CQLQ was 27.8% (five of 18) and 31.8% (seven of 22) in the placebo and PPI groups respectively. CONCLUSION: In subjects with chronic cough and rare or no heartburn, high-dose proton pump inhibitor does not improve cough-related quality of life or symptoms. CI - (c) 2010 Blackwell Publishing Ltd. FAU - Shaheen, N J AU - Shaheen NJ AD - Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, 27599-7080, USA. nshaheen@med.unc.edu FAU - Crockett, S D AU - Crockett SD FAU - Bright, S D AU - Bright SD FAU - Madanick, R D AU - Madanick RD FAU - Buckmire, R AU - Buckmire R FAU - Couch, M AU - Couch M FAU - Dellon, E S AU - Dellon ES FAU - Galanko, J A AU - Galanko JA FAU - Sharpless, G AU - Sharpless G FAU - Morgan, D R AU - Morgan DR FAU - Spacek, M B AU - Spacek MB FAU - Heidt-Davis, P AU - Heidt-Davis P FAU - Henke, D AU - Henke D LA - eng GR - T32 DK007634/DK/NIDDK NIH HHS/United States GR - T32 DK007634-22/DK/NIDDK NIH HHS/United States GR - P30 DK3497/DK/NIDDK NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20101117 PL - England TA - Aliment Pharmacol Ther JT - Alimentary pharmacology & therapeutics JID - 8707234 RN - 0 (Proton Pump Inhibitors) RN - N3PA6559FT (Esomeprazole) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Chronic Disease MH - Cough/complications/*drug therapy MH - Double-Blind Method MH - Esomeprazole/*therapeutic use MH - Female MH - Gastroesophageal Reflux/*complications/drug therapy MH - Humans MH - Male MH - Middle Aged MH - Proton Pump Inhibitors/*therapeutic use MH - Severity of Illness Index MH - Statistics as Topic MH - Treatment Outcome MH - Young Adult PMC - PMC3073617 MID - NIHMS280491 COIS- Statement of interests: 1. Authors' declaration of personal interests: i. Dr. Shaheen has served as a consultant to Astra Zeneca and CSA Medical, and has received research support from Astra Zeneca, Takeda, Procter & Gamble, BARRX Medical, CSA Medical and Oncoscope. ii. Dr. Madanick is on the speakers bureau and has received honoraria from Astra Zeneca iii. Dr. Dellon has received research support from Astra Zeneca. iv. Dr. Morgan has received research support from Astra Zeneca. v. Dr. Henke is on the speakers bureau for Astra Zeneca. vi. Other co-authors have no competing interests to declare 2. Declaration of funding interests: i. This research was conducted with support from the Investigator-Sponsored Study Program of AstraZeneca, LLP. ii. This research was also supported, in part, by funding from the National Institutes of Health for the Digestive Disease Epidemiology Training Program (T32 DK007634), and the Center for Gastrointestinal Biology and Disease (P30 DK3497). iii. The study sponsor had no role in the study design or the collection, analysis, or interpretation of data. EDAT- 2010/11/19 06:00 MHDA- 2011/03/15 06:00 PMCR- 2012/01/01 CRDT- 2010/11/19 06:00 PHST- 2010/11/19 06:00 [entrez] PHST- 2010/11/19 06:00 [pubmed] PHST- 2011/03/15 06:00 [medline] PHST- 2012/01/01 00:00 [pmc-release] AID - 10.1111/j.1365-2036.2010.04511.x [doi] PST - ppublish SO - Aliment Pharmacol Ther. 2011 Jan;33(2):225-34. doi: 10.1111/j.1365-2036.2010.04511.x. Epub 2010 Nov 17.