Demers, M., Dagnault, A., & Desjardins, J. (2013). A randomized double-blind controlled trial: Impact of probiotics on diarrhea in patients treated with pelvic radiation. Clinical Nutrition (Edinburgh, Scotland), 33(5), 761–767.
To determine the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea in patients with pelvic cancer undergoing therapy, with a secondary objective to assess whether Bifilact® decreased or delayed the need for antidiarrheal medication, reduced intestinal pain, decreased hospitalization, lowered the interruption of radiotherapy treatments or doses of both radiotherapy and chemotherapy, and improved the overall well-being of patients during treatment
Patients were divided into three groups: prostatic cancers, gynecologic cancers without chemotherapy, and gynecologic or rectal cancers with chemotherapy. Then, using double-blind procedures, patients were block-randomized by blocks of two, four, or six patients according to random permutations. A second random block using a higher probiotic dosage was added after an interim analysis. New, random lists were generated for each stratum with a 3:1:1 ratio (higher dose, standard dose, placebo). Nutritional intervention was enacted with a diet teaching to control dietary lipids and providing recommendations on fiber and carbohydrate intake. Yogurt consumption was encouraged.
Prospective, single-center, placebo-controlled, randomized, double-blinded trial
229 patients were analyzed. For the primary endpoint among all groups, there was no difference in the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea. At the 60-day point, there were more patients without moderate and severe diarrhea in the standard-dose group (35%) compared with the placebo group (17%) (hazard ratio of 0.69, p = 0.04). The postsurgical group with patients taking the standard dose had fewer patients without very severe diarrhea compared to the placebo group (97% and 74%, respectively) (p = 0.03). While undergoing therapy, the average number of bowel movements per day during treatment was less than three soft stools (p = 0.80), and the median level of abdominal pain was < 1 based on the NCI scale (p = 0.23).
Bifilact®, when administered in standard doses to patients with pelvic cancer undergoing therapy, may reduce the risk of radiation-induced grades 2–4 diarrhea towards the end of the treatment. While receiving radiation therapy, a standard dose of probiotics may reduce radiation-induced grade 4 diarrhea in patients who had prior surgery.
Nurses may want to consider offering counseling and education regarding probiotics as a potential alternative approach to reducing radiation-induced diarrhea.