The efficacy and safety of ciclesonide was assessed in this randomized, placebo-controlled study in patients with persistent asthma (randomized n=360) maintained on low to moderate doses of inhaled corticosteroids. Patients were randomized to receive ciclesonide 80 or 320 microg (ex-actuator doses, equivalent to 100 and 400 microg ex-valve, respectively) or placebo once daily in the morning via metered-dose inhaler for 12 weeks. Morning peak expiratory flow was maintained throughout the treatment period in patients treated with ciclesonide and decreased significantly in patients treated with placebo (P=0.0003). Ciclesonide (80 and 320 microg) significantly increased forced expiratory volume in 1s from baseline (0.13 and 0.19 L increases, respectively; P<0.01); improvements were superior versus placebo (P=0.0044 for 80 microg ciclesonide; P<0.0001 for 320 microg ciclesonide). The probability of losing efficacy decreased in a dose-dependent manner (55% for placebo, 38% for ciclesonide 80 microg, 23% for ciclesonide 320 microg). Asthma symptom scores and rescue medication use were unchanged with ciclesonide and significantly worsened with placebo. The incidence of adverse events was comparable in all treatment groups and no cortisol suppression was observed. Therefore, ciclesonide 80 and 320 microg administered once daily was a safe and effective maintenance treatment for patients with persistent asthma.
Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.
INTRODUÇÃO: A partir da criação do Sistema Único de Saúde (SUS) e das novas Diretrizes Curriculares Nacionais (DCN) para a graduação em Medicina, algumas escolas de Medicina têm procurado integrar o treinamento médico dos alunos aos serviços públicos de saúde. OBJETIVO: Identificar na literatura experiências de treinamento de alunos de Medicina no SUS. MÉTODOS: Artigos publicados entre janeiro de 2002 e dezembro de 2012 foram selecionados de buscas realizadas nos bancos de dados Scielo, PubMed e Biblioteca Virtual em Saúde (BVS), usando-se os termos "educação médica", "graduação em Medicina" e "Sistema Único de Saúde". Os autores avaliaram a elegibilidade dos artigos. RESULTADOS: Foram incluídos e categorizados 31 artigos. As experiências práticas no SUS foram associadas a currículos integrados, currículos tradicionais, a currículos tradicionais em fase de adequação às novas DCN e a práticas médicas inseridas em projetos extracurriculares. CONCLUSÃO: A literatura revisada desenha um cenário positivo para o treinamento de alunos de Medicina no SUS, destacando a integração entre docentes e profissionais de saúde como um caminho para a formação médica atual.
A Universidade Federal de São Carlos (UFSCar) implantou seu curso de Medicina em 2006, com currículo baseado em competências e aprendizado prático integrado ao SUS. O objetivo deste trabalho é apresentar uma pesquisa com docentes e graduandos da Primeira Turma da Medicina-UFSCar, realizada por meio da metodologia da História Oral de Vida. As narrativas indicam que o currículo favoreceu o desenvolvimento de competências como: capacidade de busca, pensamento crítico-reflexivo e autogerenciamento do aprendizado, apesar de relatos sobre deficiências em infraestrutura. A prática integrada ao SUS, especialmente nas Unidades de Saúde da Família, aprimorou as dimensões intelectivas, relacionais e afetivas do cuidado, favorecendo a autonomia profissional.
ResumoContexto: Não há estudos metodologicamente adequados sobre a eficácia da homeopatia na depressão. Relatos de casos clínicos são os primeiros degraus da evidência clínica, a caminho de estudos controlados. Objetivos: Relatar resultados preliminares do tratamento homeopático de pacientes com depressão no SUS de Jundiaí. Métodos: Revisão dos prontuários dos casos novos, atendidos entre março e dezembro de 2006. O diagnóstico foi confirmado por entrevista estruturada. Os pacientes receberam homeopatia individualizada e a evolução foi avaliada pela escala de Montgomery & Åsberg (MADRS). Resultados: Foram tratados 15 casos e observou-se resposta terapêutica (redução maior que 50% dos escores de depressão) em 14 pacientes (93%), após uma média de sete semanas de tratamento; um paciente apresentou piora clínica e foi encaminhado ao tratamento convencional. O escore média (± dp) na Escala de Avaliação de Depressão de Montgomery-Åsberg diminuiu de 24,9 (± 5,8) a 9,7 (± 8,2, p < ,0001) na segunda avaliação, resultados mantidos no decorrer da terceira e quarta consultas. Conclusões: Os resultados sugerem que a homeopatia pode ser uma alternativa terapêutica no tratamento da depressão, mas estudos randomizados e controlados são necessários para se testar a eficácia e segurança do tratamento homeopático dos transtornos depressivos.Adler U.C. et al. / Rev. Psiq. Clín 35 (2); 74-78, 2008 Palavras-chave: Homeopatia, depressão, SUS, relato de série de casos. AbstractBackground: Evidence for the efficacy of homeopathy for depression is limited due to lack of clinical trials of high quality. Case reports are the first steps of clinical evidence, towards controlled trials. Objectives: To report preliminary results of homeopathic treatment of depression in Jundiai's public health system, Sao Paulo. Methods: Review of the medical records of new patients, treated between March and December 2006. Their diagnosis was confirmed by a semi-structured interview. Patients received individualized homeopathy and their response was measured by the Montgomery & Åsberg depression scale (MADRS). Results: Fifteen patients were treated and response (more than 50% decrease of MADRS scores) was observed in 14 patients (93%), after an average of seven weeks of treatment; one patient had clinical worsening and was refered to conventional antidepressant therapy. The MADRS mean scores (± dp) decreased from 24.9 (± 5.8) to 9.7 (± 8.2, p < .0001) in the 2 nd evaluation, and these results signifcance were sustained through the 3 rd and 4 th assessments. Discussion: these results suggest that homeopathy may be an alternative therapeutics for depression, but randomized and controlled studies are needed to test the efficacy and safety of the homeopathic treatment of the depressive disorders.
Objectives To investigate the effectiveness and safety of homeopathic medicine Natrum muriaticum (LM2) for mild cases of COVID-19 in Primary Health Care. Trial design A randomized, two-armed (1:1), parallel, placebo-controlled, double-blind, clinical trial is being performed to test the following hypotheses: H0: homeopathic medicines = placebo (null hypothesis) vs. H1: homeopathic medicines ≠ placebo (alternative hypothesis) for mild cases of COVID-19 in Primary Care. Participants Setting: Primary Care of São Carlos – São Paulo – Brazil. One hundred participants aged 18 years or older, with Influenza-like symptoms and a positive RT-PCR for SARS-CoV-2. Willingness to give informed consent and to comply with the study procedures is also required. Exclusion criterium: severe acute respiratory syndrome. Intervention and comparator Homeopathy: 1 globule of Natrum muriaticum LM2 diluted in 20 mL of alcohol 30% and dispensed in a 30 ml bottle. Placebo: 20 mL of alcohol 30% dispensed in a 30 ml bottle. Posology: one drop taken orally every 4 hours (6 doses/day) while there is fever, cough, tiredness, or pain (headache, sore throat, muscle aches, chest pain, etc.) followed by one drop every 6 hours (4 doses/day) until the fourteenth day of use. The bottle of study medication should be submitted to 10 vigorous shakes (succussions) before each dose. Posology may be changed by telemedicine, with no break in blinding. Study medication should be maintained during home isolation. According to the Primary Care protocol, the home isolation period lasts until the 10th day after the appearance of the first symptom, or up to 72 hours without symptoms. Main outcomes The primary endpoint will be time to recovery, defined as the number of days elapsed before all COVID-19 Influenza-like symptoms are recorded as mild or absent during home isolation period. Secondary measures are recovery time for each COVID-19 symptom; score of the scale created for the study (COVID-Simile Scale); medicines used during follow-up; number of days of follow-up; number of visits to emergency services; number of hospitalizations; other symptoms and Adverse Events during home isolation period. Randomisation The study Statistician generated a block randomization list, using a 1:1 ratio of the two groups (denoted as A and B) and a web-based tool (http://www.random.org/lists). Blinding (masking) The clinical investigators, the statistician, the Primary Care teams, the study collaborators, and the participants will remain blinded from the identity of the two treatment groups until the end of the study. Numbers to be randomised (sample size) One hundred participants are planned to be randomized (1:1) to placebo (50) or homeopathy (50). Trial Status Protocol version/date May 21, 2020. Recruitment is ongoing. First participant was recruited/included on June 29,2020. Due to recruitment adaptations to Primary Care changes, the authors anticipate the trial will finish recruiting on April 10, 2021. Trial registration COVID-Simile Study was registered at the University Hospital Medical Information Network (UMIN - https://www.umin.ac.jp/ctr/index.htm) on June 1st, 2020, and the trial start date was June 15, 2020. Unique ID: UMIN000040602. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.
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