Beabsichtigte und unbeabsichtigte Wirkungen von E-Zigaretten in klinischen Studien – ein Plädoyer für (mehr) Transparenz

Zusammenfassung

E-Zigaretten werden in klinischen Studien zur Tabakentwöhnung eingesetzt. Aufgrund der Gesundheitsrisiken, die mit dem Gebrauch von E-Zigaretten verbunden sind, sollten die Ergebnisse klinischer Studien vollständig berichtet werden, einschließlich des fortgesetzten ausschließlichen Gebrauchs und des gemeinsamen Gebrauchs von Tabak und E-Zigaretten. Die Ergebnisse zur Nikotinentwöhnung sollten als primärer Endpunkt ebenso wie die Analyse der bloßen Beendigung des Tabakkonsums berichtet werden. Da es derzeit keine stichhaltigen Belege dafür gibt, dass die Reduzierung des Zigarettenkonsums wesentliche gesundheitliche Vorteile mit sich bringt, sollte die Reduzierung des Zigarettenkonsums nicht als Gesundheitsendpunkt in klinischen Studien verwendet werden. Die fortbestehende Nikotinabhängigkeit sollte als „unerwünschtes Ereignis“ in die Berichterstattung über die Studienergebnisse aufgenommen werden.

Abstract

E-cigarettes are used in clinical trials to facilitate smoking cessation. Due to the health risks associated with the use of e-cigarettes, the results of clinical trials should be fully reported, including continued exclusive use and dual use of tobacco and e-cigarettes. Nicotine cessation outcomes should be reported as the primary endpoint as well as the analysis of tobacco cessation alone. As there is currently no robust evidence that reducing cigarette consumption provides substantial health benefits, cigarette consumption reduction should not be used as a health outcome in clinical trials. Continued nicotine dependence should be included as an “adverse event” in the reporting of trial results.

Schlüsselwörter

elektronische Zigaretten - Rauchstopp - Nikotinabhängigkeit - klinische Studien

Keywords

electronic cigarettes - smoking cessation - nicotine dependence - clinical study

Publication History

Received: 21 December 2023

Accepted after revision: 09 January 2024

Article published online:
24 January 2024

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