Efficacy and tolerability of hydrogen carbonate-rich waterfor heartburn

作     者：andré-michael beer ralf uebelhack ute pohl 

作者机构：Klinik BlankensteinRuhr-Universität Bochum45527 HattingenGermany Analyze and Realize GmbH13456 BerlinGermany 

出 版 物：《World Journal of Gastrointestinal Pathophysiology》 (世界胃肠病理生理学杂志（英文版）（电子版）)

年 卷 期：2016年第7卷第1期

页      面：171-180页

学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学] 

基　　金：Supported by Deutsche Heilbrunnen im Verband Deutscher Mineralbrunnen e.V. Kennedyallee 28 53175 Bonn Germany www.vdm-bonn.de 

主　　题：Heartburn Hydrogen carbonate-rich mineralwater Open clinical pilot study Patients Regurgitation Gastroesophageal reflux disease symptoms Dyspepsia Blood pressure Tolerability Quality of life 

摘      要：AIM To investigate the efficacy and safety of mineralwater with a high content of hydrogen carbonate inpatients with ***： This open, single-center, single-armclinical pilot study enrolled 50 patients, 18-64 yearsold, who had been suffering from heartburn at leasttwice a week for at least 3 mo before entering thestudy. Pharmacological treatment of heartburn was notpermitted, and patients with severe organic diseaseswere excluded. After a run-in period of one week, theparticipants received 1.5 L of the test water for thefollowing 6 wk; 300 mL with meals t.i.d., the remainderto be drunk throughout the day. During the trial, therewere five visits at the study center （screening, baseline,two interim visits and the final visit）. The efficacyendpoints included incidence and duration of heartburnepisodes per week by patient＇s self-assessment （heartburndiary） as well as changes in symptom severity asper symptom specific questionnaires [Reflux Disease Questionnaire （RDQ）; Quality of Life in Reflux andDyspepsia （QOLRAD）; Gastrointestinal Quality of LifeIndex] and overall health-related quality of life per SF-12（12-question short form） at each visit. At the end of thestudy, patients and investigators independently ratedthe overall efficacy of the test water on a 4-point Likertscale. Safety was assessed by evaluation of adverseevents （AEs）, vital signs （heart rate, blood pressure）and laboratory parameters. Changes from initial to finalexaminations were assessed by the non-parametricWilcoxon test; categorical variables were comparedusing the χ 2 test, and for more than 5 categories, by ***： Twenty-eight participants were men, 22women. The mean age of the patients in the fullanalysis set/intention-to treat population （FAS/ITT） was40.6 years. Forty-two participants completed the studyaccording to the study protocol and formed the perprotocolset （PP population）; 48 participants drank thewater at least once as requested and were analyzedas ITT population.