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 (CaCO(3), MgCO(3)) 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.