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

Sci Rep. 2025 May 7;15(1):15896. doi: 10.1038/s41598-025-98558-z.

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.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Antacids* / administration & dosage
  • Antacids* / therapeutic use
  • Calcium Carbonate* / administration & dosage
  • Calcium Carbonate* / therapeutic use
  • Female
  • Gastroesophageal Reflux* / drug therapy
  • Heartburn* / drug therapy
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Treatment Outcome

Substances

  • Antacids
  • Calcium Carbonate