Harms reporting inadequate in probiotics, prebiotics, synbiotics

Harms reporting is often lacking or inadequate in published reports of randomized controlled trials assessing probiotics, prebiotics and synbiotics, according to new research appearing in Annals of Internal Medicine.

“We believe that researchers must clearly describe the incidence and severity of [adverse events] related to probiotics, prebiotics and synbiotics, particularly when they are used to treat severe disease or are used by high-risk patients (such as preterm infants or persons who are receiving ventilation or are critically ill),” Ada Bafeta, PhD, University Descartes-Sorbonne Paris City, and colleagues wrote. “To facilitate decision making by all stakeholders, the different issues related to harms reporting from studies of these microorganisms must be identified before use of these interventions is expanded. Therefore, we performed a methodological, systematic review of all published randomized controlled trials assessing probiotics, prebiotics and synbiotics to examine how harms have been reported.”

The researchers reviewed 384 recently published randomized controlled and found that no harms-related data were reported for 28% of trials and 37% of trials did not report any safety results. Additionally, 80% of studies did not report the number of serious adverse events.

Among studies that reported safety results, reporting was frequently inadequate and often only used generic statements, inadequate metrics or only gave the global total number of adverse events. When reporting adverse events, 21% used some restrictions, 7% lumped grade, type and seriousness and just 5% provided only global statistical comparisons.

“The inadequacy in reporting harms-related results may lead to an inaccurate safety profile and erroneous decision making, with major consequences for patients,” researchers wrote. “For example, a generic statement, such as ‘well-tolerated,’ may be misinterpreted as a lack of [adverse events] reported for a trial, but the reader cannot determine whether no [adverse events] occurred in any participants, the [adverse events] were not measured or reported or both. Readers should be able to estimate the number of [adverse events], even if no events occur.” – by Jake Scott

Disclosure: The authors reported no relevant financial disclosures.