Results of a double-blind, randomized study to evaluate the efficacy and safety of Antibiophilus® in patients with radiation-induced diarrhoea

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Background and aimsGastrointestinal toxicity is frequently observed during radiotherapy for malignancies in the abdomen and pelvis. This study was performed to determine the efficacy and tolerability of Lactobacillus rhamnosus (Antibiophilus®) in comparison to placebo in a double-blind trial design. Its aim was to determine any clinically relevant difference between Antibiophilus® and placebo in terms of efficacy in patients suffering from mild to moderate diarrhoea induced by radiation therapy.MethodsThe study was performed in two radiotherapy units in Hungary; the results are based on the data for 206 recruited patients.ResultsBased on statistical analysis, Antibiophilus® patients showed superiority with respect to the number of bowel movements (P< 0.10) and faeces consistency ratings by the investigators (P< 0.05) at the study end. Statistical analysis of the patients’ self-ratings with regard to diarrhoea grade and faeces consistency showed a statistically highly significant treatment-by-time interaction (P< 0.001) which was supported by the evidence of tendencies or P values below the nominal 5% level in the second half of this study.ConclusionsOverall, there was a highly favourable benefit/risk ratio in favour of Antibiophilus®.

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