Inadequate safety reporting in the publications of randomised clinical trials in irritable bowel syndrome: drug versus probiotic interventions

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van der Geest, A. M.Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the Netherlands (författare)

Inadequate safety reporting in the publications of randomised clinical trials in irritable bowel syndrome : drug versus probiotic interventions

Artikel/kapitelEngelska2022

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Wageningen Academic Publishers,2022
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LIBRIS-ID:oai:DiVA.org:oru-100585
https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-100585URI
https://doi.org/10.3920/BM2021.0124DOI

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Språk:engelska
Sammanfattning på:engelska

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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.

Ämnesord och genrebeteckningar

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Gastroenterologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Gastroenterology and Hepatology hsv//eng
Adverse events
burden to benefit ratio
safety profile

Biuppslag (personer, institutioner, konferenser, titlar ...)

Schukking, I.Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the Netherlands (författare)
Brummer, Robert Jan,1957-Örebro universitet,Institutionen för medicinska vetenskaper,Nutrition-Gut-Brain Interactions Research Centre(Swepub:oru)rnbr (författare)
Pieterse, H.University of Ghent, Heymans Institute of Pharmacology, Ghent, Belgium (författare)
van den Nieuwboer, M.Stichting Darmgezondheid, Ede, the Netherlands (författare)
van de Burgwal, L. H. M.Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the Netherlands (författare)
Larsen, O. F. A.Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the Netherlands (författare)
Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan, Amsterdam, the NetherlandsInstitutionen för medicinska vetenskaper (creator_code:org_t)

Sammanhörande titlar

Ingår i:Beneficial Microbes: Wageningen Academic Publishers13:3, s. 195-2041876-28831876-2891

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Av författaren/redakt...: van der Geest, A ...; Schukking, I.; Brummer, Robert ...; Pieterse, H.; van den Nieuwboe ...; van de Burgwal, ...; visa fler...; Larsen, O. F. A.; visa färre...

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