Eficácia de simbióticos na redução de sintomas de Proctite Actínica aguda : estudo clínico, duplo cego, randomizado e placebo-controlado

Abstract

symptoms of proctitis may appear during radiotherapy of pelvic tumors and persist for years bringing discomfort and limitations to patients. AIM: to evaluate if the daily intake of synbiotics interferes in the intensity of acute radiation proctitis symptoms and in quality of life during the initial phase of radiotherapy in patients with prostate cancer. METHODS: Twenty patients who underwent three-dimensional conformal radiation therapy (3D-CRT) for treatment of prostate cancer were randomized to use a synbiotic product containing Lactobacillus reuteri 108 cfu and 4.3 g of soluble fiber (Fibermais Flora, Nestle Brazil Ltda) or placebo (once daily in the week prior to the start of radiotherapy and 2 times a day after that). Patients were interviewed before starting radiotherapy and followed during the first 4 weeks of treatment, weekly responding to the questionnaire EORTC QLQ-PRT23. Thus, scores were higher or lower according to the extent to which each symptom or problem appeared. The main outcome variables were: the sum of the complete score of the EORTC QLQ-PRT23 questionnaire (issues related to gastrointestinal symptoms and quality of life), the sum score of questions that were only about gastrointestinal symptoms, the maximum number that the patient had to evacuate in a 24 hours period and the intensity of tenesmus and blood in stool. RESULTS: The demographic and clinical characteristics, radiation doses and irradiated rectal volume were similar in both groups (p>0.05). The complete questionnaire score (median and range) was higher in the 2nd (23 [21-30] vs. 26,5 [22-34]); p=0.05) e 3rd (23 [21-32] vs. 27,5 [24-33]); p<0.01) week in the placebo group. In comparison among groups by ANOVA for repeated measures, the score was higher in the placebo group (p = 0.027) than in the synbiotic group. In those questions only about gastrointestinal symptoms, the score of the placebo group in both the 2nd (19.5 [16-25]) and 3rd (19 [17-24]) weeks, were greater than the synbiotic group (week 2: 16.5 [15-20], p = 0:03, and 3rd week: 17 [15- 23], p <0.01). Comparing repeated measures the placebo group had higher scores than the synbiotic group (p=0.02). There were no differences between the groups regarding the number of evacuations and the presence of blood in stool. In the 3rd week, the tenesmus was more intense in the placebo group (p=0.01). When comparing repeated measurements, the intensity of tenesmus was higher in the placebo group than in the synbiotic group (p=0,006). CONCLUSIONS: The analysis of the results allows to conclude that the use of synbiotics reduces symptoms of acute radiation proctitis and improves quality of life in patients undergoing radiotherapy for prostate cancer.