- Describe your topic.
- The impact of antibiotic associated diarrhea (AAD) and Clostridium difficile infection (CDI) on healthcare is significant. It is estimated that 20-35% of patients who use antibiotics experience AAD, and 1-2% of all patients who use antibiotics test positive for CDI. In the United States, 453,000 cases of CDI occurred in 2013, and resulted in 29,300 deaths. The monetary costs are substantial, and are estimated at $3,427-$9,960 per CDI patient. AAD also drives poor medication compliance and the overuse of broad spectrum antibiotics. The prevention of AAD may lead to significant improvements in patient outcomes and lower costs of care. Many physicians commonly recommend probiotics for the prevention AAD. A Cochrane review of probiotics for the prevention of pediatric AAD found 16 studies (3,432 participants) that met the inclusion criteria.1 The authors concluded that probiotics were effective in preventing AAD [incidence of AAD in the probiotic group was 8%, compared to 22% in the control group (1,474 participants); relative risk 0.40; 95% confidence interval, 0.29 to 0.55]. A review of probiotics for prevention of AAD in all age groups included 82 clinical trials (11,811 participants) and found a 42% decrease in AAD when probiotics were used (relative risk, 0.58; 95% confidence interval, 0.50 to 0.68).2 More basic microbiome research and clinical trials have been published since these reviews.3-11 Evidence supporting the use of probiotics along with antibiotics in the prevention of AAD is important; there is also compelling evidence to support the administration of probiotics along with antibiotics in the prevention of CDI. A Cochrane review and meta-analysis of 23 randomized controlled trials (4,213 patients) and found a 64% relative risk reduction in the probiotic group versus placebo. This resulted in a low number-needed-to-treat of 28. One hospital in Canada provided a probiotic to all adult inpatients (44,835 inpatients) on antibiotics over a 10-year period. The CDI rate declined from 18.0 cases per 10,000 patient-days to 2.3 cases per 10,000 patient-days.12 Importantly, no Lactobacillus bacteremia was detected. They reported an average savings of $2,661 per patient. Thus, we request that AHRQ examine the role for prophylaxis probiotics in the prevention of AAD and CDI. There are no current, effective comparators in traditional medicine for the prevention of AAD and CDI. Treatments for CDI exist, but all have multiple adverse events associated with their usage.
- Describe why this topic is important.
- Probiotics are stocked in many hospital pharmacies and are often used by physicians for the prevention or management of AAD. A CDC study led by Yi et al. (2016) conducted a survey of 145 U.S. hospitals and concluded, “a sizable and growing number of inpatients received probiotics as part of their care.”13 Abe et al. (2013) surveyed academic hospitals and found that 86.8% of hospital pharmacies stocked a probiotic, but that the choice of probiotic products stocked was not evidence-based.14 Fifty-nine percent of physicians recommend probiotic supplements (AccentHealth Survey, 2014). Additionally, the Pharmacy Letter of July 2015 recommended probiotics for AAD, stating the NNT was 12 for probiotics for AAD and 29 for probiotics for CDI. We believe that the evidence exists to support efficacious probiotics to be stocked in all hospital formularies. Further, efficacious probiotics should be available to accompany ambulatory antibiotic usage. Currently, it appears that while some clinicians recommend probiotics, they are not being used in an evidence-based manner, this could change with an authoritative review by the EPC.
- Tell us why you are suggesting this topic.
- As discussed earlier, physicians, pharmacists and consumers are using probiotics for prevention of AAD and CDI, but there is a need for an evidence-based approach for such use.
- Target Date.
- Describe what you are doing currently and what you are hoping will change because of a new evidence report.
- A definitive, evidence-based report, such as the EPC’s conduct, would likely result in many national organizations revising or clarifying their recommendations about probiotic usage with antibiotics. Physicians are very interested in this topic -- just this year I was invited to give a CME talk to discuss evidence-based probiotic use in the clinic at the AAFP National Conference and a live webinar for Medscape. However, there is great variation in how probiotics are used clinically and practice seldom reflects the current research. There are enough studies that we believe the EPC review can help dictate how to best implement prophylactic probiotic usage.
- How will you or your group use the information from a new evidence report?
- I believe there is a genuine interest in probiotic usage for AAD and that many groups will listen to the EPC’s recommendations.
- How would you or your group plan to disseminate information from the report? Who would you plan to disseminate it to?
- I am Vice President of the, non-paid academic board of directors, for the International Scientific Association of Probiotics and Prebiotics. Our organization includes many clinical physicians from a variety of specialties and we would all work with our national organizations to disseminate the information. Both the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) and The World Gastroenterology Organization have recommended probiotics for a variety of indications and I am confident would appreciate a more authoritative review.
- Do you know of organizations that could use an evidence report to change clinical practice? Are you a part of, or have you been in contact with, any organizations that might implement the research findings of an evidence report?
- I have had email discussions with the Chair of the Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). He stated, “Whether a recommendation should be made for probiotics and, if so, what it should/could look like, was certainly a topic of intense discussion amongst the writing group. I think many of the writing group acknowledged a signal for some efficacy in prevention, but if and how that could translate into a recommendation and the strength of evidence for a such recommendation remains less clear.” It seems that the IDSA and AAFP, among others, would appreciate some clarification about when and how specific strains of probiotics should be used.
- Information About You: (optional)
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- Provide a description of your role or perspective.
- I am a clinician, researcher, father of 4 (one of which has ulcerative colitis and is on a probiotic at the recommendation of hi
- If you are you making a suggestion on behalf of an organization, please state the name of the organization.
- Please tell us how you heard about the Effective Health Care Program.
- I was part of a review when I was a fellow at Johns Hopkins.
