Experts slam AGA and 60 Minutes claims that probiotics are ‘unregulated’ and ‘ineffective’

A new study helps to explain how nerve cells sense the microbes in the gut and how they coordinate their function with other tissues in the digestive tract.

New guidelines released by the American Gastroenterological Association (AGA) stated that for most digestive conditions there is not enough evidence to support the use of probiotics and claimed that the probiotics market is ‘largely unregulated’. (Read our full coverage).

Meanwhile a segment aired on US television show 60 Minutes titled released a segment titled “Do Probiotics Actually Do Anything?” suggested that probiotics are largely ineffective.

AGA guidance

In its guidelines document, the AGA wrote that the probiotic industry is ‘largely unregulated’ and asserts that “marketing of product is often geared directly at consumers without providing direct and consistent proof of effectiveness.”

The AGA said that after reviewing the literature currently available using the GRADE method, that there is not enough evidence that support the use of probiotics for the majority of digestive conditions, including Crohn’s disease, ulcerative colitis, irritable bowel syndrome (IBS), and Clostridioides difficile (C. difficile) infections.

“Patients taking probiotics for Crohn’s, ulcerative colitis or IBS should consider stopping,” commented Grace L. Su, MD, Division of Gastroenterology and Hepatology, University of Michigan, who led the panel on new guidelines. “The supplements can be costly and there isn’t enough evidence to prove a benefit or confirm lack of harm.”

While the guidelines did not back probiotics for the treatment of C. difficile, the AGA document did support use of certain probiotic formulations for the prevention of C. difficile infection in adults and children taking antibiotics. It also backed the use of probiotics for the prevention of necrotizing enterocolitis in preterm, low birthweight infants, and for the management of pouchitis – a complication of inflammatory bowel disease.

The AGA, however, did not include a recommendation for antibiotic-associated diarrhoea in its guidelines.

Responding to the AGA publication, the International Probiotics Association (IPA) said it welcomed AGA analysis of the role of specific probiotics in the management of digestive disorders, and particularly welcomed the strain-specific approach taken in the development of the guidelines – which looked at probiotic interventions individually and did not group different probiotic strains and combinations of strains into one meta-analysis.

The association added, however, that it is important to remember that the AGA has looked at probiotics through the lens of pharmaceuticals.

Food, not pharmaceuticals

“This classification is incorrect and out of scope: probiotics may be foods or supplements according to the FDA, unless they come with a drug registration,” noted the IPA. “For the most part, probiotics have not gone through pharmaceutical evaluation processes. As such, probiotics do not make medicinal claims; to treat, cure or prevent disease, unlike drugs.”

“Probiotics are generally not prescribed as an exclusive therapy in disease management, but most often suggested as part of the diet or as an adjunct to standard treatment,” the association added.

The US National Products Association also hit back at the AGA guidelines, suggesting that they ‘ignore the bulk of scientific evidence’ on the benefits of probiotics.

“The guidelines also falsely claim that the natural products industry is unregulated, despite being over seen by not one but two federal agencies to protect consumers from false advertising and bad actors,” noted NPA.

“Probiotics are among the most popular supplement products, primarily because consumers trust their safety and the important role they play in supporting their health,” added Sibyl Swift, NPA’s SVP for Scientific and Regulatory Affairs at NPA.

60 minutes causes confusion

Meanwhile, US television show 60 Minutes released a segment titled ‘Do Probiotics Actually Do Anything?’ which earned backlash from experts including the IPA and Council for Responsible Nutrition (CRN) after ending with the notion that probiotic supplements are useless.

While the section recognised the importance of the microbiome, and of the potential for improving health by altering the microbiome, it’s conclusion dismissed the efficacy of probiotics and raised doubts about the safety of probiotic supplements.

The 60 Minutes segment included comments from multiple researchers including Dr Frank Greer at the University of Wisconsin, Dr Dan Merenstein at Georgetown University, Dr Patricia Hibberd of Boston University, Eran Segal and Eran Elinav from the Weizmann Institute of Science, and Dr Jeff Gordon or Washington University.

Responding to broadcast, the IPA said the segment did not provide balance and created confusion for consumers – a sentiment echoed by Andrea Wong, PhD, senior vice president, scientific & regulatory affairs, at the Council for Responsible Nutrition (CRN).

IPA added that despite the segment being ‘well-intended’ it does not make the job easier for consumers trying to make sense of the data behind probiotics.

“The consumer will need more balanced sources of information to be able to make an informed choice,” an IPA statement said.

“In the US, probiotics may be foods or supplements according to the Food and Drug Administration (FDA), unless they come with a drug registration. However, the program did not reflect all of these factors and creates confusion and misimpressions in consumers by failing to present balanced information,” added the IPA.

Wong commented that probiotic use is supported both by a long history of safe use and rigorous clinical trial data.

“CRN underscores those beneficial effects and the safety of these products,” she said. “But unfortunately, the recent news segment highlights the developing nature of the science and the lack of scientific certainty with regard to their beneficial health effects.​”

‘No benefit’ claim countered

During the segment an interaction between host Dr Jon LaPook and Dr Patricia Hibberd suggests that the science behind probiotics is ‘chaos’, with Hibberd suggesting that despite a multi-billion dollar industry around probiotic supplements there is no convincing evidence for their beneficial effects in terms of reducing diarrhoea from antibiotics, aiding irritable bowl syndrome (IBS) or decreasing allergies.

IPA reacted by noting that multiple independent clinical organizations and research studies, including the WGO (Guarner et al., 2017) and the recently published AGA guidelines (Su et al., 2020) recommend specific probiotics for conditions including antibiotic‐associated diarrhoea and IBS.

It added that a 2019 Cochrane Review concluded that there was a protective effect of probiotics preventing antibiotic-associated diarrhoea, while a 2016 meta-analysis of clinical data suggested probiotics were associated with a 22% reduction in allergies.

Within the segment, Merenstein immediately counters the suggestions by Hibberd:

“I think the data is there,” he notes. “I recommend probiotics mainly for people who are on antibiotics and for people with irritable bowel disease.”