Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE - Coalition V): A double-blind, multicentre, randomised, controlled trial.

Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.

LED phototherapy to prevent mucositis: a case report.

OBJECTIVE: The purpose of this case report was to evaluate the efficacy of phototherapy using light-emitting diodes (LEDs) to prevent oral mucositis in a Hodgkin's disease patient treated with the ABVD (doxorubicin [Adriamycin], bleomycin, vinblastine, and dacarbazine) chemotherapy regimen. BACKGROUND DATA: Mucositis is a common dose-limiting complication of cancer treatment, and if severe it can lead to alterations in treatment planning or suspension of cancer therapy, with serious consequences for tumor response and survival. Therefore, low-power lasers and more recently LEDs, have been used for oral mucositis prevention and management, with good results. MATERIALS AND METHODS: In this study, a 34-year-old man received intraoral irradiation with an infrared LED array (880 nm, 3.6 J/cm2, 74 mW) for five consecutive days, starting on chemotherapy day 1. In each chemotherapy cycle, he received the ABVD protocol on days 1 and 15, and received LED treatment for 5 d during each cycle. To analyze the results, the World Health Organization (WHO) scale was used to grade his mucositis, and a visual analogue scale (VAS) was used for pain evaluation, on days 1, 3, 7, 10, and 13 post-chemotherapy. RESULTS: The results showed that the patient did not develop oral mucositis during the five chemotherapy cycles, and he had no pain symptoms. CONCLUSION: LED therapy was a safe and effective method for preventing oral mucositis in this case report. However, further randomized studies with more patients are needed to prove the efficacy of this method.

Value of real time three-dimensional echocardiography in patients with hypertrophic cardiomyopathy: comparison with two-dimensional echocardiography and magnetic resonance imaging.

UNLABELLED: Real time three-dimensional echocardiography (RT3DE) has been demonstrated to be an accurate technique to quantify left ventricular (LV) volumes and function in different patient populations. We sought to determine the value of RT3DE for evaluating patients with hypertrophic cardiomyopathy (HCM), in comparison with cardiac magnetic resonance imaging (MRI). METHODS: We studied 20 consecutive patients with HCM who underwent two-dimensional echocardiography (2DE), RT3DE, and MRI. Parameters analyzed by echocardiography and MRI included: wall thickness, LV volumes, ejection fraction (LVEF), mass, geometric index, and dyssynchrony index. Statistical analysis was performed by Lin agreement coefficient, Pearson linear correlation and Bland-Altman model. RESULTS: There was excellent agreement between 2DE and RT3DE (Rc = 0.92), 2DE and MRI (Rc = 0.85), and RT3DE and MRI (Rc = 0.90) for linear measurements. Agreement indexes for LV end-diastolic and end-systolic volumes were Rc = 0.91 and Rc = 0.91 between 2DE and RT3DE, Rc = 0.94 and Rc = 0.95 between RT3DE and MRI, and Rc = 0.89 and Rc = 0.88 between 2DE and MRI, respectively. Satisfactory agreement was observed between 2DE and RT3DE (Rc = 0.75), RT3DE and MRI (Rc = 0.83), and 2DE and MRI (Rc = 0.73) for determining LVEF, with a mild underestimation of LVEF by 2DE, and smaller variability between RT3DE and MRI. Regarding LV mass, excellent agreement was observed between RT3DE and MRI (Rc = 0.96), with bias of-6.3 g (limits of concordance = 42.22 to-54.73 g). CONCLUSION: In patients with HCM, RT3DE demonstrated superior performance than 2DE for the evaluation of myocardial hypertrophy, LV volumes, LVEF, and LV mass.

Trimetazidine to reverse ischemia in patients with class I or II angina: a randomized, double-blind, placebo-controlled dobutamine-atropine stress echocardiography study.

AIMS: We sought to evaluate the effects of trimetazidine on ischemia induced by dobutamine-atropine stress echocardiography in patients with class I or class II angina. METHODS: In a randomized, double-blind, placebo-controlled study, 66 patients with proved coronary disease were subjected to dobutamine-atropine stress echocardiography. Ischemia was proved in 56 patients who were included in the study and who had been on standard maintenance medications (propranolol, aspirin and statin). They were randomized to placebo or trimetazidine, 20 mg three times daily for a 12-week period, when dobutamine-atropine stress echocardiography was repeated. RESULTS: Fifty-two patients (56.53+/-8.9 years old) completed the study. No differences were seen between groups at entry. Thirty patients had class I and 26 class II angina. At the end of the study, 42 had class I and 14 class II angina (P=0.01), owing to patients being in the trimetazidine arm. We did not observe any differences between groups either for onset time of ventricular ischemic dysfunction, or for wall-motion score index. Comparing variation at peak using the delta wall-motion score index, we observed no differences, but only a trend toward reduction favoring trimetazidine (P=0.09). CONCLUSION: We did not detect a significant anti-ischemic effect of trimetazidine in patients with mild angina, but there was a clear improvement in angina class.

Trimetazidine to reverse ischemia in patients with class I or II angina: a randomized, double-blind, placebo-controlled dobutamine–atropine stress echocardiography study / Trimetazidine to reverse ischemia in patients with class I or II angina: a randomized, double-blind, placebo-controlled dobutamine–atropine stress echocardiography study

Aims We sought to evaluate the effects of trimetazidine on ischemia induced by dobutamine–atropine stress echocardiography in patients with class I or class II angina. Methods In a randomized, double-blind, placebocontrolled study, 66 patients with proved coronary disease were subjected to dobutamine–atropine stress echocardiography. Ischemia was proved in 56 patients who were included in the study and who had been on standard maintenance medications (propranolol, aspirin and statin). They were randomized to placebo or trimetazidine, 20mg three times daily for a 12-week period, when dobutamine–atropine stress echocardiography was repeated. Results Fifty-two patients (56.53 ±8.9 years old) completed the study. No differences were seen between groups at entry. Thirty patients had class I and 26 class II angina. At the end of the study, 42 had class I and 14 class II angina (P =0.01), owing to patients being in the trimetazidine arm. We did not observe any differences between groups either for onset time of ventricular ischemic dysfunction, or for wall-motion score index.

Valor da ecocardiografia tridimensional em tempo real em portadores de cardiomiopatia hipertrófica. Comparação com a ecocardiografia bidimensional e a ressonância magnética cardiovascular / Value of real-time three dimensional echocardiography in patients with hypertrophic cardiomyopathy. Comparison with two-dimensional echocardiography and magnetic resonance imaging

Avaliar o valor da ecocardiografia tridimensional em tempo real em 20 pacientes com cardiomiopatia hipertrófica em comparação a ecocardiografia bidimensional utilizando como padrão de referência a ressonância magnética cardiovascular. Foram comparadas entre as 3 modalidades a espessura das paredes, massa, volumes e função sistólica ventricular esquerda. A análise estatística pelo modelo de Bland-Altman e coeficiente de concordância de Lin foi demonstrada superioridade da ecocardiografia tridimensional em tempo real.

To evaluate the value of real time three dimensional echocardiography in 20 patients with hypertrophic cardiomyophaty in comparison with two dimensional echocardiography using cardiovascular magnetic resonance imaging as a gold standard. Left ventricular wall thickness, mass, volumes and systolic function were compared within the three modalities. Using the Bland-Altman analysis as well as Lin’s concordance coefficient we demonstrated superiority of real time three dimensional echocardiography.