Menthacarin for long-term treatment of functional dyspepsia – Results from a clinical trial follow-up

Abstract

Background Menthacarin was shown to be effective and safe in clinical trials in patients with functional dyspepsia (FD). Long-term treatment results have not been reported yet.

Methods An open-label, 11-month follow-up (FU) was offered to FD patients who had undergone treatment with Menthacarin (1 gastro-resistant capsule b.i.d. vs. placebo (PL)) in a 4-week, double-blind, clinical trial. During FU, all patients (former verum and PL) were treated with 1 gastro-resistant capsule Menthacarin b.i.d. Main outcomes were the changes in pain intensity and severity of sensation of pressure, heaviness, and fullness from original baseline and global improvement.

Results 70 patients were included in the analyses (former Menthacarin group: 36, former PL group: 34). At the end of the PL-controlled study phase, all 3 main efficacy variables were statistically significantly improved in the Menthacarin group compared to PL. In the FU phase, former PL patients started to improve under Menthacarin treatment towards the outcomes seen in the former Menthacarin group (alignment at approximately 6 months), while former Menthacarin patients showed sustained or even continuously improved outcomes by month 12. At study end, more than 90% of patients were “much or very much improved" in both groups. Menthacarin treatment was well tolerated.

Conclusions The favorable effects seen in the FU period suggest that Menthacarin is a valuable treatment option in FD patients who require symptomatic treatment also in the longer term for up to 12 months.

Zusammenfassung

Hintergrund Menthacarin hat sich in klinischen Studien bei Patienten mit funktioneller Dyspepsie (FD) als wirksam und sicher erwiesen. Langzeitergebnisse einer Behandlung wurden bisher nicht berichtet.

Methodik FD-Patienten, die in einer 4-wöchigen klinischen Doppelblindstudie mit Menthacarin (1 gastroresistente Kapsel b.i.d. vs. Placebo [PL]) behandelt worden waren, wurde ein offenes, 11-monatiges Follow-up (FU) angeboten. Während des FU erhielten alle Patienten (sowohl ehemalige Verum- als auch PL-Patienten) 1 magensaftresistente Kapsel Menthacarin b.i.d. Wichtigste Zielparameter waren die Veränderung der Schmerzintensität und des Schweregrads des Druck-, Schwere- und Völlegefühls sowie die globale Verbesserung.

Ergebnisse Die Analyse umfasste insgesamt 70 Patienten (36 ehemals Menthacarin, 34 ehemals PL). Alle 3 Hauptwirksamkeitsvariablen waren in der Menthacarin-Gruppe am Ende der PL-kontrollierten Studienphase im Vergleich zu PL statistisch signifikant verbessert. In der FU-Phase begannen sich die vormaligen PL-Patienten unter Menthacarin-Behandlung zu verbessern und sich den Ergebnissen der vormaligen Menthacarin-Gruppe anzunähern (Angleichung nach etwa 6 Monaten), während die letztere Gruppe bis Monat 12 eine anhaltende oder fortschreitende Besserung zeigte. Am Studienende waren über 90% der Patienten beider Gruppen stark oder sehr stark verbessert. Die Menthacarin-Behandlung war gut verträglich.

Schlussfolgerungen Die in der FU-Periode beobachteten günstigen Effekte legen nahe, dass Menthacarin eine wertvolle Therapieoption bei FD-Patienten ist, welche eine symptomatische Behandlung benötigen, auch bei einer längerfristigen Einnahme über bis zu 12 Monate.

Schlüsselwörter

Funktionelle Dyspepsie - Follow-up-Studie - Kümmelöl - Pfefferminzöl - Menthacarin

Keywords

Functional Dyspepsia - Follow-up Study - Caraway oil - Peppermint oil - Menthacarin

Publication History

Received: 23 September 2021

Accepted after revision: 15 March 2022

Article published online:
13 June 2022

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