دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Heartburn relief with bicarbonate-rich mineral water: results of the randomised, placebo-controlled phase-III trial STOMACH STILL.
المؤلفون: Labenz J; Protestant Jung Stilling Hospital, Siegen, Germany Joachim.Labenz@diakonie-sw.de., Anschütz M; SocraTec R&D Concepts in Drug Research and Development GmbH, Oberursel, Germany., Walstab J; SocraTec R&D Concepts in Drug Research and Development GmbH, Erfurt, Germany., Wedemeyer RS; SocraTec R&D Concepts in Drug Research and Development GmbH, Oberursel, Germany.; SocraMetrics GmbH, Erfurt, Germany., Wolters H; Fachingen Heil- und Mineralbrunnen GmbH, Birlenbach OT Fachingen/Lahn, Germany., Schug B; SocraTec R&D Concepts in Drug Research and Development GmbH, Oberursel, Germany.; SocraMetrics GmbH, Erfurt, Germany.
المصدر: BMJ open gastroenterology [BMJ Open Gastroenterol] 2023 Feb; Vol. 10 (1).
نوع المنشور: Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd & British Society of Gastroenterology Country of Publication: England NLM ID: 101660690 Publication Model: Print Cited Medium: Print ISSN: 2054-4774 (Print) Linking ISSN: 20544774 NLM ISO Abbreviation: BMJ Open Gastroenterol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd & British Society of Gastroenterology, [2014]-
مواضيع طبية MeSH: Bicarbonates* , Mineral Waters*/therapeutic use, Adult ; Humans ; Quality of Life ; Stomach ; Emotions
مستخلص: 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.
Competing Interests: Competing interests: During conduct of the trial and preparation of the manuscript, JL received honoraria for consultancy from Fachingen Heil- und Mineralbrunnen GmbH. MA and JW were employees of SocraTec R&D GmbH. R-SW was an employee of SocraTec R&D GmbH and SocraMetrics GmbH. HW was an employee of Fachingen Heil- und Mineralbrunnen GmbH. BS was cofounder and managing director of SocraTec R&D GmbH and SocraMetrics GmbH.
(© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
References: J Gastroenterol. 2022 Apr;57(4):267-285. (PMID: 35226174)
Aliment Pharmacol Ther. 2012 Jan;35(1):154-64. (PMID: 22070159)
Digestion. 2006;74(3-4):162-8. (PMID: 17351321)
Health Qual Life Outcomes. 2008 Apr 30;6:31. (PMID: 18447946)
Am J Gastroenterol. 2022 Jan 1;117(1):27-56. (PMID: 34807007)
Pharmacol Res. 2002 Dec;46(6):525-31. (PMID: 12457626)
World J Gastrointest Pathophysiol. 2016 Feb 15;7(1):171-80. (PMID: 26909240)
Health Qual Life Outcomes. 2009 Apr 27;7:36. (PMID: 19397800)
World J Gastroenterol. 2006 Apr 28;12(16):2556-62. (PMID: 16688801)
Am Fam Physician. 2020 Sep 1;102(5):291-296. (PMID: 32866357)
Gastroenterology. 2018 Jan;154(2):267-276. (PMID: 28780072)
J Clin Epidemiol. 1994 Jan;47(1):81-7. (PMID: 8283197)
Aliment Pharmacol Ther. 2010 Jul;32(1):29-42. (PMID: 20353496)
Am J Gastroenterol. 2004 Aug;99(8):1442-7. (PMID: 15307857)
World J Gastroenterol. 2013 Sep 21;19(35):5787-97. (PMID: 24124323)
Eur J Gastroenterol Hepatol. 2005 Feb;17(2):229-33. (PMID: 15674102)
Digestion. 2009;80(2):74-88. (PMID: 19546560)
Surg Endosc. 2014 Jun;28(6):1753-73. (PMID: 24789125)
Gut. 2014 Jun;63(6):871-80. (PMID: 23853213)
Am J Gastroenterol. 2001 Jan;96(1):52-7. (PMID: 11197287)
Aliment Pharmacol Ther. 2004 Oct 1;20(7):751-60. (PMID: 15379835)
Aliment Pharmacol Ther. 1995 Jun;9(3):251-62. (PMID: 7654887)
Eur J Surg Suppl. 1998;(583):41-9. (PMID: 10027672)
Am J Gastroenterol. 2001 Jul;96(7):1998-2004. (PMID: 11467624)
Clin Gastroenterol Hepatol. 2012 Jun;10(6):612-9. (PMID: 22343515)
Dig Dis. 2004;22(2):108-14. (PMID: 15383750)
BMJ. 2020 Nov 23;371:m3786. (PMID: 33229333)
Biometrics. 1994 Dec;50(4):1029-41. (PMID: 7786985)
Aliment Pharmacol Ther. 2003 Oct 15;18(8):767-76. (PMID: 14535869)
Scand J Gastroenterol. 2001 Sep;36(9):934-41. (PMID: 11521983)
فهرسة مساهمة: Keywords: acid-related diseases; anti-reflux therapy; dyspepsia; gastric diseases; gastroesophageal reflux disease
المشرفين على المادة: 0 (Bicarbonates)
0 (Mineral Waters)
تواريخ الأحداث: Date Created: 20230227 Date Completed: 20230301 Latest Revision: 20230320
رمز التحديث: 20240829
مُعرف محوري في PubMed: PMC9972411
DOI: 10.1136/bmjgast-2022-001048
PMID: 36849190
قاعدة البيانات: MEDLINE
الوصف
تدمد:2054-4774
DOI:10.1136/bmjgast-2022-001048