07.23.18
A new review published in the Annals of Internal Medicine sought to examine how harms-related information was reported in publications of randomized controlled trials (RCTs) for probiotics, prebiotics, and synbiotics, and found correlating data to be significantly lacking.
Researched utilized RCTS assessing the safety or efficacy of at least one intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition.
In a review of 384 trials conducted in healthy volunteers, researchers found:
While the researchers were limited in their reported by only using English-language studies, they concluded that harms reporting in published reports of RCTs assessing these ingredients provided insufficient information. Furthermore, they suggested that they could not verify the safety of such ingredient without adequate data.
Industry Responds
Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, for the Council for Responsible Nutrition (CRN), said that while the review raised from legitimate concerns about the importance of including safety data in published RCT results, he believes“drawing any conclusions about the safety of probiotics, prebiotics, or synbiotics, based on this review, is misguided.”
Dr. MacKay said that as the authors themselves state, “the only conclusion that can be drawn from the review is that reporting of harms-related information in clinical trials of these products is lacking. An absence of harms data does not signify the presence of safety concerns; it simply means we need to be better at reporting this crucial information.”
CRN encouraged researchers to publish all relevant safety data to better inform the medical community when using probiotics for clinical conditions. “While a significant number of clinical trials on probiotics have not yielded any evidence of safety issues, the current literature is not well-equipped to confidently answer specific safety questions about using these products therapeutically in different patient populations,” he stated.
Probiotics and prebiotics have wide spread use in the food industry, Dr. MacKay noted, and suggested their safe application has been well-supported throughout their longstanding history. Products featuring probiotics and prebiotics are also subject to pre-market evaluation of safety by the U.S. Food and Drug Administration (FDA).“Under the law, dietary supplements containing these ingredients are accountable for manufacturing standards that include testing procedures, labeling and storage requirements, and other practices examined and enforced by regulatory agencies at both the federal and state levels,” explained Dr. MacKay.
The Natural Products Association (NPA) also stressed that FDA considers probiotics to be safe, and that robust adverse event reporting systems are in place to monitor the use of probiotic and prebiotic supplements.
“This so-called study is an absurd outlier compared to the overwhelming number of studies supporting the safety and efficacy of probiotics in modern medicine,” said Daniel Fabricant, PhD, president and CEO of NPA. “Consumers should always consult with their doctors or medical professionals before using probiotics, but to suggest that there are potentially widespread adverse events is just plain wrong. There are robust government reporting requirements to document adverse reactions when they do occur, but for the vast majority of people side effects are minimal and almost never exceed some slight discomfort. FDA considers probiotics to be safe and millions of Americans use them every day.”
NPA added that thousands of studies have supported the safe use and efficacy of probiotics for a range of treatments and patient populations, including:
Researched utilized RCTS assessing the safety or efficacy of at least one intervention involving probiotics, prebiotics, or synbiotics alone or in combination with another intervention compared with any control (such as a placebo or an antibiotic) for any clinical condition.
In a review of 384 trials conducted in healthy volunteers, researchers found:
- Trials most often evaluated probiotics (69%);
- No harms-related data were reported for 28% of trials;
- Safety results were not reported 37% of trials;
- The number of serious adverse events (SAEs) per study group was not given for 80% of trials.
While the researchers were limited in their reported by only using English-language studies, they concluded that harms reporting in published reports of RCTs assessing these ingredients provided insufficient information. Furthermore, they suggested that they could not verify the safety of such ingredient without adequate data.
Industry Responds
Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, for the Council for Responsible Nutrition (CRN), said that while the review raised from legitimate concerns about the importance of including safety data in published RCT results, he believes“drawing any conclusions about the safety of probiotics, prebiotics, or synbiotics, based on this review, is misguided.”
Dr. MacKay said that as the authors themselves state, “the only conclusion that can be drawn from the review is that reporting of harms-related information in clinical trials of these products is lacking. An absence of harms data does not signify the presence of safety concerns; it simply means we need to be better at reporting this crucial information.”
CRN encouraged researchers to publish all relevant safety data to better inform the medical community when using probiotics for clinical conditions. “While a significant number of clinical trials on probiotics have not yielded any evidence of safety issues, the current literature is not well-equipped to confidently answer specific safety questions about using these products therapeutically in different patient populations,” he stated.
Probiotics and prebiotics have wide spread use in the food industry, Dr. MacKay noted, and suggested their safe application has been well-supported throughout their longstanding history. Products featuring probiotics and prebiotics are also subject to pre-market evaluation of safety by the U.S. Food and Drug Administration (FDA).“Under the law, dietary supplements containing these ingredients are accountable for manufacturing standards that include testing procedures, labeling and storage requirements, and other practices examined and enforced by regulatory agencies at both the federal and state levels,” explained Dr. MacKay.
The Natural Products Association (NPA) also stressed that FDA considers probiotics to be safe, and that robust adverse event reporting systems are in place to monitor the use of probiotic and prebiotic supplements.
“This so-called study is an absurd outlier compared to the overwhelming number of studies supporting the safety and efficacy of probiotics in modern medicine,” said Daniel Fabricant, PhD, president and CEO of NPA. “Consumers should always consult with their doctors or medical professionals before using probiotics, but to suggest that there are potentially widespread adverse events is just plain wrong. There are robust government reporting requirements to document adverse reactions when they do occur, but for the vast majority of people side effects are minimal and almost never exceed some slight discomfort. FDA considers probiotics to be safe and millions of Americans use them every day.”
NPA added that thousands of studies have supported the safe use and efficacy of probiotics for a range of treatments and patient populations, including:
- Treating acute bowl infections; preventing antibiotic-associated diarrhea in healthy children; and preventing necrotizing enterocolitis, a devastating disease that affects bowls in premature infants.[1]
- Managing irritable bowel syndrome.[2]
- Improving not only gut health but liver health as well.[3]
- Reducing the severity of skin rashes in children and eliminate the need for topical corticosteroids to treat symptom flare-ups.[4]
- Reducing the likelihood of infection during antibiotic treatments, with no adverse events.[5]
