Treatment of dyspeptic symptoms with YamatoGast. A non-interventional study of a registered traditional herbal Rikkunshito extract product from Japanese Kampo Medicine in routine practice in Germany

Abstract

Introduction Dyspeptic symptoms belong to the most frequent reasons to seek medical advice and are a burden both for the individual affected and the healthcare system. In Japan, the traditional herbal Kampo prescription rikkunshito has proven benefit for this indication.

Methods In a prospective, multicentre, non-interventional study (NIS), the effectiveness, safety, and tolerability of a two-week treatment with the registered rikkunshito extract product YamatoGast was assessed in German patients with an acute episode of dyspeptic symptoms of functional origin under real-world conditions. The primary endpoint was the responsiveness to treatment assessed by the overall treatment effect (OTE) score. Secondary endpoints were the change in severity of dyspeptic symptoms and the change in quality of life (QoL). Safety evaluation was based on reported adverse drug reactions, drug compliance, and ratings of tolerability by physicians and patients.

Results Sixty-six patients were enrolled (mean age 48.9 years, 74% females). The treatment was well tolerated and highly beneficial, as expressed by pronounced responder rates of 78.9% for the primary endpoint OTE. All secondary endpoints were also met. The severity of dyspeptic symptoms significantly improved by 62–77% compared to baseline, confirmed by a remarkable improvement of QoL. Significant symptom relief started from the third day of treatment onwards.

Conclusion In this non-interventional study, two-week treatment with YamatoGast resulted in a significant improvement of dyspeptic symptoms and was associated with high patient response and satisfaction. YamatoGast was confirmed as a safe and clinically relevant therapeutic option for patients suffering upper gastrointestinal complaints in routine practice.

Zusammenfassung

Einleitung Dyspeptische Symptome sind einer der häufigsten Gründe für einen Arztbesuch und belasten sowohl Betroffene als auch das Gesundheitswesen erheblich. In Japan hat sich bei dieser Indikation die Rezeptur rikkunshito aus der Tradition der japanischen Kampo-Medizin bewährt.

Methodik In einer prospektiven, multizentrischen, nicht-interventionellen Studie (NIS) wurden Alltagswirksamkeit, Sicherheit und Verträglichkeit einer zweiwöchigen Therapie mit dem rikkunshito-Präparat YamatoGast bei Patienten mit einer akuten Episode bekannter funktioneller dyspeptischer Beschwerden im Praxisalltag in Deutschland untersucht. Der primäre Endpunkt war die Responderrate in Bezug auf den Gesamteffekt der Behandlung (OTE). Sekundäre Endpunkte waren die Veränderung des Schweregrades der Oberbauchbeschwerden, erfasst durch Arzt und Patient, sowie das Ansprechen der Lebensqualität (QoL). Zusätzlich erfolgte eine Tagebuch-Dokumentation zum Einsetzen des Behandlungseffektes. Die Beurteilung von Unbedenklichkeit und Verträglichkeit basierte auf der Erfassung unerwünschter Arzneimittelwirkungen, Medikamentencompliance und Bewertung durch Arzt und Patient.

Ergebnisse 66 Patienten (m=48,9 Jahre, 74 % Frauen) wurden eingeschlossen. Die Bewertung des Gesamteffekts der Behandlung (OTE) durch die Patienten resultierte in einer bemerkenswerten Responderrate von 78,9%. Auch alle sekundären Endpunkte wurden erreicht. Die Therapie führte zu einer im Vergleich zur Baseline signifikanten und klinisch relevanten Besserung der gastrointestinalen Symptome um 62–77 %, komplettiert durch das deutliche Ansprechen der Lebensqualität. Eine signifikante Symptomlinderung setzte ab dem dritten Therapietag ein. Die Verträglichkeit war sehr gut.

Schlussfolgerung In der vorliegenden nicht-interventionellen Studie führte die zweiwöchige Behandlung mit YamatoGast zu einer signifikanten Besserung dyspeptischer Symptome verbunden mit bemerkenswertem Gesamtansprechen und hoher Patientenzufriedenheit. YamatoGast erwies sich als sichere und klinisch relevante therapeutische Option für Patienten mit dyspeptischen Beschwerden im Praxisalltag.

Keywords

dyspeptic symptoms - functional gastrointestinal disorders - Japanese Kampo medicine - YamatoGast - Rikkunshito

Schlüsselwörter

Dyspeptische Symptome - Funktionelle gastrointestinale Störungen - Japanische Kampo-Medizin - YamatoGast - Rikkunshito

Publikationsverlauf

Eingereicht: 04. April 2023

Angenommen nach Revision: 27. August 2023

Artikel online veröffentlicht:
05. Oktober 2023

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