Evidence map›Paper›PMID 36849190›Full record

Trial reportBMJ open gastroenterology2023

Heartburn relief with bicarbonate-rich mineral water: results of the randomised, placebo-controlled phase-III trial STOMACH STILL.

Joachim Labenz, Maria Anschütz, Jutta Walstab, Ralph-Steven Wedemeyer, Heiner Wolters, Barbara Schug

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IIIEquivalence Trial
In one paragraph

Trial report in BMJ open gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Non-Chinese herbal medicines for functional dyspepsia.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Joachim LabenzProtestant Jung Stilling Hospital, Siegen, Germany Joachim.Labenz@diakonie-sw.de.ORCID 0000-0002-6010-7841
Maria AnschützSocraTec R&D Concepts in Drug Research and Development GmbH, Oberursel, Germany.
Jutta WalstabSocraTec R&D Concepts in Drug Research and Development GmbH, Erfurt, Germany.
Ralph-Steven WedemeyerSocraTec R&D Concepts in Drug Research and Development GmbH, Oberursel, Germany.
Heiner WoltersFachingen Heil- und Mineralbrunnen GmbH, Birlenbach OT Fachingen/Lahn, Germany.
Barbara SchugSocraTec R&D Concepts in Drug Research and Development GmbH, Oberursel, Germany.
SocraTec R&D (Germany) · DEDiakonie Klinikum Jung-Stilling · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe assessed whether the bicarbonate-rich mineral water Staatl. Fachingen STILL is superior over conventional mineral water in relieving heartburn.

designMulticentre, 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.

resultsOf 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).

conclusionSTOMACH 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.

Indexed as

BicarbonatesMineral WatersAdultEmotionsHumansQuality of LifeStomachBicarbonatesMineral Watersacid-related diseasesanti-reflux therapydyspepsiagastric diseasesgastroesophageal reflux disease

Identifiers

PMID36849190
PMCPMC9972411
OpenAlexW4322505267

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.