Observational Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Pathophysiol. Feb 15, 2016; 7(1): 171-180
Published online Feb 15, 2016. doi: 10.4291/wjgp.v7.i1.171
Efficacy and tolerability of hydrogen carbonate-rich water for heartburn
André-Michael Beer, Ralf Uebelhack, Ute Pohl
André-Michael Beer, Klinik Blankenstein, Ruhr-Universität Bochum, 45527 Hattingen, Germany
Ralf Uebelhack, Ute Pohl, Analyze and Realize GmbH, 13456 Berlin, Germany
Author contributions: Beer AM contributed to writing of the article; Uebelhack R was principal investigator and medical expert; Pohl U contributed to study conception and design, data acquisition as well as data analysis and interpretation; All authors contributed to editing, reviewing and final approval of the article.
Supported by Deutsche Heilbrunnen im Verband Deutscher Mineralbrunnen e. V., Kennedyallee 28, 53175 Bonn, Germany, www.vdm-bonn.de.
Institutional review board statement: The study protocol was approved by the relevant ethics committee [State Office of Health and Social Affairs Berlin (Landesamt für Gesundheit und Soziales Berlin)] and the competent authority [Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn)]. The presence of the approval document was verified by the editorial office. The document is available upon request.
Informed consent statement: Both the patients and the investigator signed the informed consent form before inclusion. The presence of the approval document was verified by the editorial office. The document is available upon request.
Conflict-of-interest statement: The preparation of the manuscript, and thus indirectly the authors Uebelkack R and Pohl U, were supported by Deutsche Heilbrunnen im Verband Deutscher Mineralbrunnen e. V., Kennedyallee 28, 53175 Bonn, Germany, www.vdm-bonn.de. The authors declare that besides this no conflict of interest exists.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Ute Pohl, Analyze and Realize GmbH, Waldseeweg 6, 13456 Berlin, Germany. upohl@a-r.com
Telephone: +49-30-40008100 Fax: +49-30-40008100
Received: July 14, 2015
Peer-review started: July 17, 2015
First decision: August 31, 2015
Revised: November 17, 2015
Accepted: December 16, 2015
Article in press: December 18, 2015
Published online: February 15, 2016
Processing time: 200 Days and 19.2 Hours
Abstract

AIM: To investigate the efficacy and safety of mineral water with a high content of hydrogen carbonate in patients with heartburn.

METHODS: This open, single-center, single-arm clinical pilot study enrolled 50 patients, 18-64 years old, who had been suffering from heartburn at least twice a week for at least 3 mo before entering the study. Pharmacological treatment of heartburn was not permitted, and patients with severe organic diseases were excluded. After a run-in period of one week, the participants received 1.5 L of the test water for the following 6 wk; 300 mL with meals t.i.d., the remainder to be drunk throughout the day. During the trial, there were five visits at the study center (screening, baseline, two interim visits and the final visit). The efficacy endpoints included incidence and duration of heartburn episodes per week by patient’s self-assessment (heartburn diary) as well as changes in symptom severity as per symptom specific questionnaires [Reflux Disease Questionnaire (RDQ); Quality of Life in Reflux and Dyspepsia (QOLRAD); Gastrointestinal Quality of Life Index] and overall health-related quality of life per SF-12 (12-question short form) at each visit. At the end of the study, patients and investigators independently rated the overall efficacy of the test water on a 4-point Likert scale. Safety was assessed by evaluation of adverse events (AEs), vital signs (heart rate, blood pressure) and laboratory parameters. Changes from initial to final examinations were assessed by the non-parametric Wilcoxon test; categorical variables were compared using the χ2 test, and for more than 5 categories, by the U-test.

RESULTS: Twenty-eight participants were men, 22 women. The mean age of the patients in the full analysis set/intention-to treat population (FAS/ITT) was 40.6 years. Forty-two participants completed the study according to the study protocol and formed the per-protocol set (PP population); 48 participants drank the water at least once as requested and were analyzed as ITT population. The occurrence of heartburn was statistically significantly reduced at wk 6 in both the ITT and the PP populations. At wk 6, the mean number of heartburn episodes/week decreased by 5.1 episodes (P < 0.001) and the mean duration of heartburn symptoms by 19 min (ITT) (P = 0.002). The frequency of heartburn symptoms was reduced in 89.6% of the patients (P < 0.001), and the duration of symptoms in 79.2% of patients (ITT) (P < 0.001). All dimensions of the RDQ (heartburn, regurgitation, gastro-esophageal reflux disease symptoms, dyspepsia) showed a significant improvement at 6 wk. Likewise, disease-specific quality of life improved significantly (QOLRAD, GIQLI). Overall, 89.4% of patients rated the efficacy of the test water as “good” or “very good”, as did the investigators for 91.5% of the patients. There were no serious AEs. After 6 wk, systolic and diastolic blood pressure values decreased slightly but significantly [-3.5 and -3.0 mmHg, respectively (P = 0.008 and P = 0,002)]. Ninety-six percent of patients and investigators for the same percentage of patients rated the tolerability of the water as “good” or “very good”.

CONCLUSION: The data demonstrate effectiveness of a hydrogen carbonate-rich mineral water in alleviating heartburn frequency and severity, thereby improving quality of life. The water has excellent tolerability.

Keywords: Heartburn; Hydrogen carbonate-rich mineral water; Open clinical pilot study; Patients; Regurgitation; Gastroesophageal reflux disease symptoms; Dyspepsia; Blood pressure; Tolerability; Quality of life

Core tip: This open, single-center, single-arm clinical study investigated the efficacy and safety of mineral water with a high content of hydrogen carbonate in patients with heartburn. After 6 wk, the occurrence of heartburn was statistically significantly reduced both in the intention-to-treat (48 patients) and the per-protocol populations (42 patients). All dimensions of the Reflux Disease Questionnaire (heartburn, regurgitation, gastroesophageal reflux disease symptoms, dyspepsia) showed significant improvement at week 6. Likewise, disease-specific quality of life improved significantly, and there was a slight but significant decrease in blood pressure. The tolerability was rated good or very good by 96% of patients and investigators.