PMA – Zeolite (Clinoptilolite) in the Management of Irritable Bowel Syndrome – a Non-Interventional Study

Abstract

In clinical practice, the treatment of patients with irritable bowel syndrome (IBS) can be very challenging. The aims of the present non-interventional study (NIS) were to investigate the tolerability and efficacy of PMA-zeolite under everyday conditions in patients with diarrheic IBS type (IBS-D) or constipated type (IBS-C) or mixed type (IBS-M).

Methods To document prospective data on tolerability and symptom frequency in the frame of a nationwide NIS, we recruited 204 IBS patients. The study focused on the IBS-related quality of life (measured by the SF-36 questionnaire) and improvements of IBS-related symptoms according to specific ROM-III criteria and stool consistency (Bristol stool scale). The participants documented their abdominal pain, bloating, number of bowel movements, and stool consistency through a web-based internet platform (initial and exit questionnaires) and daily diary entries over the period of intake (8 weeks).

Results A total of 82.2% of the recruited patients had filled in the questionnaires before and after the 8-week treatment with PMA-zeolite. Seven of the eight subscales of the SF-36 improved significantly (p<0,001); the reduction in abdominal pain was especially significant (p<0,001). The diary entries confirmed the reduction in abdominal pain and revealed a significant reduction in days with bloating (p<0,001). The Bristol-stool-scale analysis showed improvements; particularly, patients with IBS-D benefited from the treatment (p<0,001).

Conclusion The treatment duration of 8 weeks was well tolerated by most patients. Under everyday life conditions, PMA-zeolite alleviated the global IBS-related symptoms and raised the quality of life (QOL). The PMA-zeolite, thus, may represent a good adjuvant therapeutic option for patients with irritable bowel syndrome.

Zusammenfassung

Die medizinische Betreuung von Patienten mit Reizdarmsyndrom (RDS) kann sehr herausfordernd sein. Die Ziele der vorliegenden Nicht-Interventionellen-Studie (NIS) waren die Dokumentation der Verträglichkeit und Wirksamkeit des PMA-Zeoliths unter Alltagsbedingungen bei Patienten mit durchfallartigem RDS-Typ (RDS-D) oder Obstipationstyp (RDS-C) oder Mischtyp (RDS-M).

Methoden Im Rahmen einer bundesweiten NIS wurden 204 Patienten mit RDS rekrutiert, um Daten zu Verträglichkeit, Lebensqualität, und Symptomfrequenz zu gewinnen. Die Studie konzentrierte sich auf die RDS-bezogene Lebensqualität (gemessen mit dem SF-36-Fragebogen) und Verbesserungen der RDS-bezogenen Symptome gemäß der RDS-spezifischen ROM-III-Kriterien, sowie der Stuhlkonsistenz (gemessen per Bristol-Stuhlformen-Skala). Die Teilnehmer dokumentierten ihre Symptome wie Bauchschmerzen und Blähungen, sowie die Anzahl der Stuhlgänge und die Stuhlkonsistenz über eine webbasierte Internetplattform (Anfangs- und Ausstiegsfragebögen) und führten ein Tagebuch über den Einnahmezeitraum von 8 Wochen.

Ergebnisse 82,2% der rekrutierten Patienten hatten die Fragebögen vor und nach der 8-wöchigen Behandlung mit PMA-Zeolith ausgefüllt. Sieben der acht Subskalen des SF-36 verbesserten sich signifikant (p<0,001), die Reduktion der Bauchschmerzen war ebenfalls signifikant (p<0,001). Die Analysen der Tagebucheinträge bestätigten die Verringerung der Bauchschmerzen und zeigten eine deutliche Abnahme der Tage mit Blähungen. Die Bristol-Stuhlformen Analyse zeigte Verbesserungen. Besonders Patienten mit RDS-D profitierten von der Behandlung (p<0,001).

Schlussfolgerung Unter Alltagsbedingungen linderte PMA-Zeolith die globalen RDS-bedingten Symptome und verbesserte die Stuhlkonsistenz und krankheitsassoziierte Lebensqualität.

Keywords

IBS - irritable bowel syndrome - PMA-zeolite as adjuvant remedy - observational (non-interventional) study

Schlüsselwörter

RDS – Reizdarm-Syndrom - PMA-Zeolith als adjuvante Therapieoption - Anwenderbeobachtung - Nicht-interventionelle-Studie (NIS)

Publikationsverlauf

Eingereicht: 20. Oktober 2022

Angenommen nach Revision: 27. November 2023

Artikel online veröffentlicht:
15. Januar 2024

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