Highly diluted medication reduces parasitemia and improves experimental infection evolution by <it>Trypanosoma cruzi</it>

<p>Abstract</p> <p>Background</p> <p>There is no published information about the use of different protocols to administer a highly diluted medication.</p> <p>Evaluate the effect of different protocols for treatment with biotherapic <it>T. cruzi</it> 17 dH (BIOT_{<it>Tc</it>17dH}) on clinical/parasitological evolution of mice infected with <it>T. cruzi-Y</it> strain.</p> <p>Methods</p> <p>A blind, randomized controlled trial was performed twice, using 60 28-day-old male Swiss mice infected with <it>T. cruzi-Y</it> strain, in five treatment groups: CI <it>-</it> treated with a 7% ethanol-water solution, diluted in water (10 μL/mL) <it>ad libitum</it>; <it>BIOT</it>_<it>PI</it> - treated with BIOT_{<it>Tc</it>17dH} in water (10 μL/mL) <it>ad libitum</it> during a period that started on the day of infection; <it>BIOT</it>_<it>4DI</it> - treated with BIOT_{<it>Tc</it>17dH} in water (10 μL/mL) <it>ad libitum</it> beginning on the 4^th day of infection; <it>BIOT</it>_{<it>4-5–6</it>} - treated with BIOT_{<it>Tc</it>17dH} by gavage (0.2 mL/ animal/day) on the 4^th, 5^th and 6^th days after infection; <it>BIOT</it>_{<it>7-8–9</it>} - treated with BIOT_{<it>Tc</it>17dH} by gavage (0.2 mL/ animal/day) on the 7^th, 8^th and 9^th days after infection. We evaluated: parasitemia; total parasitemia (P_total); maximum peak of parasites; prepatent period (PPP) - time from infection to detection of the parasite in blood; patent period (PP) - period when the parasitemia can be detected in blood; clinical aspects; and mortality.</p> <p>Results</p> <p>Parasitological parameters in the BIOT_PI and mainly in the BIOT_4PI group showed better evolution of the infection compared to the control group (CI), with lower P_total, lower maximum peak of parasites, higher PPP, lower PP and longer survival times. These animals showed stable body temperature and higher weight gain and water consumption, with more animals having normal-appearing fur for longer periods. In contrast, groups BIOT_4-5–6 and BIOT_7-8–9 showed worse evolution of the infection compared to the control group, considering both parasitological and clinical parameters. The correlation analysis combined with the other data from this study indicated that the prepatent period is the best parameter to evaluate the effect of a medication in this model.</p> <p>Conclusions</p> <p>The BIOT_4DI group showed the best clinical and parasitological evolution, with lower parasitemia and a trend toward lower mortality and a longer survival period. The prepatent period was the best parameter to evaluate the effect of a medication in this model.</p

Implementation of a Brazilian Cardioprotective Nutritional (BALANCE) Program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicenter trial

Background: Appropriate dietary recommendations represent a key part of secondary prevention in cardiovascular disease (CVD). We evaluated the effectiveness of the implementation of a nutritional program on quality of diet, cardiovascular events, and death in patients with established CVD. Methods: In this open-label, multicenter trial conducted in 35 sites in Brazil, we randomly assigned (1:1) patients aged 45 years or older to receive either the BALANCE Program (experimental group) or conventional nutrition advice (control group). The BALANCE Program included a unique nutritional education strategy to implement recommendations from guidelines, adapted to the use of affordable and regional foods. Adherence to diet was evaluated by the modified Alternative Healthy Eating Index. The primary end point was a composite of all-cause mortality, cardiovascular death, cardiac arrest, myocardial infarction, stroke, myocardial revascularization, amputation, or hospitalization for unstable angina. Secondary end points included biochemical and anthropometric data, and blood pressure levels. Results: From March 5, 2013, to Abril 7, 2015, a total of 2534 eligible patients were randomly assigned to either the BALANCE Program group (n = 1,266) or the control group (n = 1,268) and were followed up for a median of 3.5 years. In total, 235 (9.3%) participants had been lost to follow-up. After 3 years of follow-up, mean modified Alternative Healthy Eating Index (scale 0-70) was only slightly higher in the BALANCE group versus the control group (26.2 ± 8.4 vs 24.7 ± 8.6, P <.01), mainly due to a 0.5-serving/d greater intake of fruits and of vegetables in the BALANCE group. Primary end point events occurred in 236 participants (18.8%) in the BALANCE group and in 207 participants (16.4%) in the control group (hazard ratio, 1.15; 95% CI 0.95-1.38; P =.15). Secondary end points did not differ between groups after follow-up. Conclusions: The BALANCE Program only slightly improved adherence to a healthy diet in patients with established CVD and had no significant effect on the incidence of cardiovascular events or death. © 2019 The Author