Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients.
BACKGROUND
Radiation-induced diarrhea is frequently observed during pelvic radiotherapy. This study was performed to determine the ability of a probiotic containing live lactobacillus acidophilus plus bifidobacterium bifidum to reduce the incidence of radiation-induced diarrhea in locally advanced cervical cancer patients.


METHODS
Patients who were undergoing pelvic radiotherapy concurrent with weekly cisplatin were randomly assigned to a study drug or placebo, in a double-blind study. Diarrhea was graded weekly according the Common Toxicity Criteria (CTC) system. Stool consistency and white and red blood cell count in stool were also assessed. The primary endpoint was to reduce the incidence of diarrhea, defined by a CTC grade 2 or more, and the need for anti-diarrheal medication.


RESULTS
A total of 63 patients were enrolled. Grade 2 -3 diarrhea was observed in 45% of the placebo group (n = 31) and 9% of the study drug group (n = 32) (p = 0.002). Anti-diarrheal medication use was significantly reduced in the placebo group (p = 0.03). The patients in the study drug group had a significantly improved stool consistency (p < 0.001).


CONCLUSIONS
Live lactobacillus acidophilus plus bifidobacterium bifidum reduced the incidence of radiation-induced diarrhea and the need for anti-diarrheal medication and had a significant benefits on stool consistency.
Chitapanarux
Imjai
I
Department of Radiology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. imjai@hotmail.com
Chitapanarux
Taned
T
Traisathit
Patrinee
P
Kudumpee
Sudkaneung
S
Tharavichitkul
Ekkasit
E
Lorvidhaya
Vicharn
V
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D001644:Bifidobacterium / Q000502:physiology*; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000532:radiotherapy; D003967:Diarrhea / Q000209:etiology* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D007779:Lactobacillus acidophilus / Q000502:physiology*; D008875:Middle Aged; D010386:Pelvic Neoplasms / Q000473:pathology / Q000532:radiotherapy; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use; D011446:Prospective Studies; D011832:Radiation Injuries / Q000209:etiology / Q000517:prevention & control; D011878:Radiotherapy / Q000009:adverse effects*; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D055815:Young Adult
D010919:Placebos
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