PT  - JOURNAL ARTICLE
AU  - Joachim Labenz
AU  - Maria Anschütz
AU  - Jutta Walstab
AU  - Ralph-Steven Wedemeyer
AU  - Heiner Wolters
AU  - Barbara Schug
TI  - Heartburn relief with bicarbonate-rich mineral water: results of the randomised, placebo-controlled phase-III trial STOMACH STILL
AID  - 10.1136/bmjgast-2022-001048
DP  - 2023 Feb 01
TA  - BMJ Open Gastroenterology
PG  - e001048
VI  - 10
IP  - 1
4099  - http://bmjopengastro.bmj.com//content/10/1/e001048.short
4100  - http://bmjopengastro.bmj.com//content/10/1/e001048.full
SO  - BMJ Open Gastro2023 Feb 01; 10
AB  - Objective We assessed whether the bicarbonate-rich mineral water Staatl. Fachingen STILL is superior over conventional mineral water in relieving heartburn.Design Multicentre, double-blind, randomised, placebo-controlled trial STOMACH STILL in adult patients with frequent heartburn episodes since ≥6 months and without moderate/severe reflux oesophagitis. Patients drank 1.5 L/day verum or placebo over the course of the day for 6 weeks. Primary endpoint was the percentage of patients with reduction of ≥5 points in the Reflux Disease Questionnaire (RDQ) score for ‘heartburn’. Secondary endpoints included symptom reduction (RDQ), health-related quality of life (HRQOL, Quality of Life in Reflux and Dyspepsia (QOLRAD)), intake of rescue medication and safety/tolerability.Results Of 148 randomised patients (verum: n=73, placebo: n=75), 143 completed the trial. Responder rates were 84.72% in the verum and 63.51% in the placebo group (p=0.0035, number needed to treat=5). Symptoms improved under verum compared with placebo for the dimension ‘heartburn’ (p=0.0003) and the RDQ total score (p=0.0050). HRQOL improvements under verum compared with placebo were reported for 3 of 5 QOLRAD domains, that is, ‘food/drink problems’ (p=0.0125), ‘emotional distress’ (p=0.0147) and ‘vitality’ (p=0.0393). Mean intake of rescue medication decreased from 0.73 tablets/day at baseline to 0.47 tablets/day in week 6 in the verum group, whereas in the placebo group it remained constant during the trial. Only three patients had treatment-related adverse events (verum: n=1, placebo: n=2).Conclusion STOMACH STILL is the first controlled clinical trial demonstrating superiority of a mineral water over placebo in relieving heartburn, accompanied by an improved HRQOL.Trial registration number EudraCT 2017-001100-30.Data are available on reasonable request.