Probiotics May Not Reduce Antibiotic-Associated Diarrhea in Elderly Inpatients

EBM Focus - Volume 8, Issue 44

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Reference: PLACIDE trial (Lancet 2013 Oct 12;382(9900):1249) (level 2 [mid-level] evidence)

Probiotic preparations have been widely investigated for prevention of antibiotic-associated diarrhea and Clostridium difficile diarrhea under the theory that augmenting the gut flora may restore pathogen resistance disrupted by antibiotic treatment. A recent Cochrane review (Cochrane Database Syst Rev 2013 May 31;(5):CD006095) provided moderate-quality evidence that probiotics were effective against antibiotic-associated diarrhea in children and adults. However, most of the 31 included trials had relatively small sample sizes and were conducted at single centers, and few individual trials showed significant risk reduction. Furthermore, few trials have specifically addressed the efficacy of probiotics in elderly patients. Now, the PLACIDE trial, a multicenter randomized trial, roughly the size of the entire population included in the Cochrane review, has evaluated the efficacy of a probiotic preparation in 2,981 elderly inpatients in England.

Hospitalized patients ≥ 65 years old (mean age 77 years) who were taking at least 1 oral or parenteral antibiotic were randomized to a probiotic preparation with Lactobacilli acidophilus plus Bifidobacteria bifidum orally once daily for 21 days vs. placebo and were followed for 8 weeks. All patients had taken antibiotics within 7 days or were about to start antibiotic treatment, and the indications for antibiotics were similar between groups (most common indications were respiratory, thoracic and mediastinal disorders, surgical and medical procedures, and renal and urinary disorders). Antibiotics given included penicillins in 72%, cephalosporins in 24%, and quinolones in 12%.

Adherence to the allocated treatment was low, with only about 53% of patients in each group taking all 21 doses. The incidence of antibiotic-associated diarrhea at 3 weeks was 10.8% with probiotics vs. 10.4% with placebo (not significant), and the incidence of C. difficile diarrhea was 0.8% vs. 1.2% (not significant). The median hospital stay in each group was 4 days. There were no significant differences in duration or severity of either antibiotic-associated diarrhea or C. difficile diarrhea, or in serious adverse events or quality of life.

For more information, see the Probiotics to prevent antibiotic-associated diarrhea topic in DynaMed.