PMID- 26909240
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160224
LR  - 20200930
IS  - 2150-5330 (Print)
IS  - 2150-5330 (Electronic)
IS  - 2150-5330 (Linking)
VI  - 7
IP  - 1
DP  - 2016 Feb 15
TI  - Efficacy and tolerability of hydrogen carbonate-rich water for heartburn.
PG  - 171-80
LID - 10.4291/wjgp.v7.i1.171 [doi]
AB  - 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 chi(2) 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.
FAU - Beer, Andre-Michael
AU  - Beer AM
AD  - Andre-Michael Beer, Klinik Blankenstein, Ruhr-Universitat Bochum, 45527 
      Hattingen, Germany.
FAU - Uebelhack, Ralf
AU  - Uebelhack R
AD  - Andre-Michael Beer, Klinik Blankenstein, Ruhr-Universitat Bochum, 45527 
      Hattingen, Germany.
FAU - Pohl, Ute
AU  - Pohl U
AD  - Andre-Michael Beer, Klinik Blankenstein, Ruhr-Universitat Bochum, 45527 
      Hattingen, Germany.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - World J Gastrointest Pathophysiol
JT  - World journal of gastrointestinal pathophysiology
JID - 101547471
PMC - PMC4753184
OTO - NOTNLM
OT  - Blood pressure
OT  - Dyspepsia
OT  - Gastroesophageal reflux disease symptoms
OT  - Heartburn
OT  - Hydrogen carbonate-rich mineral water
OT  - Open clinical pilot study
OT  - Patients
OT  - Quality of life
OT  - Regurgitation
OT  - Tolerability
EDAT- 2016/02/26 06:00
MHDA- 2016/02/26 06:01
PMCR- 2016/02/15
CRDT- 2016/02/25 06:00
PHST- 2015/07/14 00:00 [received]
PHST- 2015/11/17 00:00 [revised]
PHST- 2015/12/16 00:00 [accepted]
PHST- 2016/02/25 06:00 [entrez]
PHST- 2016/02/26 06:00 [pubmed]
PHST- 2016/02/26 06:01 [medline]
PHST- 2016/02/15 00:00 [pmc-release]
AID - 10.4291/wjgp.v7.i1.171 [doi]
PST - ppublish
SO  - World J Gastrointest Pathophysiol. 2016 Feb 15;7(1):171-80. doi: 
      10.4291/wjgp.v7.i1.171.