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Inadequate safety reporting in the publications of randomised clinical trials in irritable bowel syndrome: drug versus probiotic interventions
Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the Netherlands.
Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the Netherlands.
Örebro University, School of Medical Sciences. (Nutrition-Gut-Brain Interactions Research Centre)ORCID iD: 0000-0002-0362-0008
University of Ghent, Heymans Institute of Pharmacology, Ghent, Belgium.
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2022 (English)In: Beneficial Microbes, ISSN 1876-2883, E-ISSN 1876-2891, Vol. 13, no 3, p. 195-204Article, review/survey (Refereed) Published
Abstract [en]

Randomised controlled clinical trials (RCTs) offer a unique opportunity to obtain controlled efficacy and safety data to support clinical decisions. However, most RCT reporting has a stronger focus on efficacy rather than safety. This study aimed to identify the safety profile of both probiotic and drug interventions in irritable bowel syndrome (IBS). In connection to this paper, an accompanying paper was published in which a meta-analysis was conducted to evaluate the efficacy of probiotic interventions compared to that of drug interventions in IBS. Together, these two studies provide a first assessment regarding the feasibility to determine a burden to benefit ratio for both probiotic and drug interventions in IBS. RCTs including participants (>18 years old) with IBS and comparing probiotic or drugs interventions with control groups were identified by a systematic search of MEDLINE (January 2015 - Jan 2021). Reported safety profiles in drug studies were completer and more detailed as compared with studies on probiotics. Several inconsistencies in safety reporting were identified between and within drug and probiotic studies, such as: didn't report on safety; only reported adverse reactions (ARs) or adverse events (AEs) with a certain severity; didn't report the total number of AEs; didn't split in the control- or experimental arm; didn't specify AEs; and used different thresholds for 'common' AEs. Hence, it is difficult to compare safety data from drug and probiotic RCTs across and between different studies. On the current approaches to safety reporting, we could not establish an unambiguous safety profile for neither probiotic and drug interventions in IBS. These shortcomings hamper a critical comparison of the burden to benefit ratio for IBS intervention.

Place, publisher, year, edition, pages
Wageningen Academic Publishers, 2022. Vol. 13, no 3, p. 195-204
Keywords [en]
Adverse events, burden to benefit ratio, safety profile
National Category
Gastroenterology and Hepatology
Identifiers
URN: urn:nbn:se:oru:diva-100585DOI: 10.3920/BM2021.0124ISI: 000837954700003PubMedID: 35848114Scopus ID: 2-s2.0-85135597400OAI: oai:DiVA.org:oru-100585DiVA, id: diva2:1687288
Available from: 2022-08-15 Created: 2022-08-15 Last updated: 2022-08-29Bibliographically approved

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