Madisch Ahmed, Pace Fabio, Menzel Daniel, Funk Petra, Stracke Berenike, Schön Christiane, Labenz Joachim
Gastroenterology Center Bethanien, Im Prüfling 21-25, 60389, Frankfurt am Main, Germany.
GI Unit, Bolognini Hospital, Via Paderno 21, 24068, Seriate, Bergamo, Italy.
Sci Rep. 2025 May 7;15(1):15896. doi: 10.1038/s41598-025-98558-z.
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, MgCO) 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.
烧心和胃酸反流是胃食管反流的主要症状，这是一种普遍存在的病症，对生活质量（QoL）有重大影响。Refluthin®烧心咀嚼片（Refluthin）是一种对症治疗药物，含有抗酸剂（碳酸钙、碳酸镁）和富含多糖的提取物，该提取物含有来自仙人掌肉质茎的具有粘膜保护作用的物质。为了研究Refluthin在实际使用条件下快速、持久缓解烧心和胃酸相关胃部不适的效果及安全性，开展了一项前瞻性、临床、非对照、开放标签研究。有症状性烧心、胃酸反流和/或复发性胃酸相关胃部不适的成年人根据需要每天服用1片Refluthin，最多4次，持续4周。观察终点包括症状缓解的起效时间和持续时间；反流症状强度/频率；整体评估（生活质量、表现、满意度、易用性、耐受性）；以及安全性。81/100名参与者（81%）在≥50%的单次用药中在≤20分钟内出现首次症状缓解。83/100名（83%）参与者报告有超过120分钟的持久效果。在间歇性使用的4周内，烧心事件的频率和强度显著降低（分别为p<0.0001）。整体评估结果和与安全性相关的结果也很理想。因此，结果表明服用Refluthin后能明显快速且持久地缓解症状，且使用安全简便。随着时间推移，烧心事件的频率和强度显著降低，表明治疗有持续效果。这些长期效果可能是由于Refluthin对受刺激的粘膜有舒缓和保护作用。
