Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 May 7;15(1):15896.
doi: 10.1038/s41598-025-98558-z.

Prospective uncontrolled clinical study shows rapid and long lasting relief of heartburn and acid related gastric discomfort with Refluthin

Ahmed Madisch  1 , Fabio Pace  2 , Daniel Menzel  3 , Petra Funk  4 , Berenike Stracke  5 , Christiane Schön  3 , Joachim Labenz  6
Affiliations
Clinical Trial

Prospective uncontrolled clinical study shows rapid and long lasting relief of heartburn and acid related gastric discomfort with Refluthin

Ahmed Madisch et al. Sci Rep. .

Abstract

Heartburn and acid regurgitation are main symptoms of gastro-esophageal reflux, a widespread complaint with a significant impact on quality of life (QoL). Refluthin® for Heartburn chewable tablets (Refluthin) are a symptomatic treatment option containing a combination of an antacid (CaCO3, MgCO3) and a polysaccharide-rich extract with mucoprotective substances from Opuntia ficus-indica cladodes. To investigate performance and safety of Refluthin in the rapid and long lasting relief of heartburn and acid related gastric discomfort under practical use conditions, a prospective, clinical, uncontrolled, open-label study was conducted. Adults with symptomatic heartburn, acid regurgitation, and/or recurrent acid related gastric discomfort took one tablet Refluthin up to four times/day as needed for up to 4 weeks. Endpoints were both time to onset and duration of symptom relief; reflux symptom intensity/frequency; global assessments (QoL, performance, satisfaction, usability, tolerability); and safety. 81/100 participants (81%) responded with a first symptom relief within ≤ 20 min in ≥ 50% of the individual applications. Long lasting effects of > 120 min were reported by 83/100 (83%) participants. Significant reductions in heartburn event frequency and intensity were seen within the 4 weeks of intermittent use (p < 0.0001, respectively). Global assessment results and safety-relevant findings were also favorable. Results thus demonstrated a distinct rapid and long lasting symptom relief after intake of Refluthin, with a safe and easy use. The significant reductions in frequency and intensity of heartburn events over time indicate sustained effects under treatment. These long-term effects might be explainable by soothing and protection of the irritated mucous membrane by Refluthin.

Keywords: Opuntia ficus-indica extract; Acid regurgitation; Gastro-esophageal reflux; Heartburn; Refluthin; Symptom relief.

PubMed Disclaimer

Conflict of interest statement

Declarations. Competing interests: AM, FP, DM, CS, and JL have received honoraria from Dr. Willmar Schwabe GmbH & Co. KG. PF and BS are employees of Dr. Willmar Schwabe GmbH & Co. KG. Ethics approval and consent to participate: The study was conducted with the approval of the Ethical Committee (Landesärztekammer Baden-Württemberg, May 18, 2022; reference no. F-2022-038). It was prospectively registered at the German Clinical Trials Register (DRKS, identifier DRKS00029344) and carried out in accordance with the principles of the Declaration of Helsinki, the Professional Code for Physicians in Baden-Württemberg, and in orientation to the International Organisation for Standardization (ISO) 14155:2020 (Clinical investigation of medical devices for human subjects). Written informed consent was obtained from all individual participants included in the study.

Figures

Fig. 1
Fig. 1
Study flow chart.
Fig. 2
Fig. 2
(a) Time to Onset of First Relief as rated by the participants (relative numbers of participants and individually calculated median categories; ITT/FAS; total study population; week 1–4: n = 100, week 1: n = 98, week 2: n = 94, week 3: n = 74, week 4: n = 72). (b) Time to Acceptable Symptom Relief as rated by the participants (relative numbers of participants and individually calculated median categories; ITT/FAS; total study population; week 1–4: n = 100, week 1: n = 98, week 2: n = 94, week 3: n = 73, week 4: n = 72).
Fig. 3
Fig. 3
Duration of effect as rated by the participants (relative numbers of participants and individually calculated median categories; ITT/FAS; total study population; week 1–4: n = 100, week 1: n = 97, week 2: n = 93, week 3: n = 72, week 4: n = 71).
Fig. 4
Fig. 4
Global assessment of treatment effects based on single heartburn symptoms (relative numbers of participants; ITT/FAS; total study population; n = 100).
Fig. 5
Fig. 5
Global assessment of quality of life by participants at baseline and at study end (IU = intermittent use, DU = daily use; relative numbers of participants; ITT/FAS; total study population; n = 100).
See this image and copyright information in PMC

References

    1. Dent, J., El-Serag, H. B., Wallander, M. A. & Johansson, S. Epidemiology of gastro-oesophageal reflux disease: A systematic review. Gut54(5), 710–717 (2005). - PMC - PubMed
    1. Eusebi, L. H. et al. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: A meta-analysis. Gut67(3), 430–440 (2018). - PubMed
    1. Nocon, M., Keil, T. & Willich, S. N. Prevalence and sociodemographics of reflux symptoms in Germany—Results from a national survey. Aliment Pharmacol Ther23(11), 1601–1605 (2006). - PubMed
    1. Wiklund, I. Review of the quality of life and burden of illness in gastroesophageal reflux disease. Dig. Dis.22(2), 108–114 (2004). - PubMed
    1. Tack, J. & Pandolfino, J. E. Pathophysiology of gastroesophageal reflux disease. Gastroenterology154(2), 277–288 (2018). - PubMed

Publication types

LinkOut - more resources