Homeopathy for Chronic Non-specific Low Back Pain: Study Protocol for a Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (The BIOVERT Trial).

BACKGROUND: Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra, have shown promise in alleviating CNSLBP. OBJECTIVES: Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration. METHODS: A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy-placebo or placebo-homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight. DISCUSSION: The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP. TRIAL REGISTRATION: UMIN Clinical Trials Registry - ID: UMIN000051957.

Homeopathy for Major Depressive Disorder: Protocol for N-of-1 Studies.

BACKGROUND: N-of-1 studies allow the formal assessment of a patient's treatment. A single participant receives different interventions the same number of times in a crossover, double-blind, randomized design. Using this methodology, we will investigate the effectiveness and safety of a standardized homeopathy protocol in treating 10 cases of major depression. METHODS: The method is described below: Design: crossover double-blind placebo-controlled randomized N-of-1 studies, with at most 28 weeks of duration per participant. PARTICIPANTS: women and men at age over 18 years with a diagnosis of a major depressive episode given by a psychiatrist, who have presented a therapeutic response, i.e., a reduction ≥50% of the baseline depressive symptoms, self-assessed by the Beck Depression Inventory - Second Edition (BDI-II), and sustained for at least 4 weeks during an open homeopathic treatment following the protocol of the sixth edition of the Organon, with or without concomitant use of psychotropic drugs. INTERVENTIONS: individualized homeopathy following the same protocol, one globule of the fifty-millesimal potency diluted in 20 mL of 30% alcohol; placebo - 20 mL of 30% alcohol, in the same posology as homeopathy. Crossover study: the participant will go through three consecutive treatment blocks, with two random and masked treatment periods (A or B), corresponding to homeopathy or placebo. Treatment periods will have 2, 4, and 8 weeks in the first, second, and third blocks, respectively. A clinically significant worsening (characterized by an augmentation in BDI-II inclusion score ≥30%) will result in the termination of study participation and resumption of the open treatment. PRIMARY MEASURE: progression of the depressive symptoms, self-assessed by the participant using the BDI-II scale at weeks 0, 2, 4, 8, 12, 16, 20, 24, 28 and analyzed throughout the study concerning homeopathy and placebo partitions. Secondary measures: score of the Clinical Global Impression Scale; mental and physical health scores assessed by the 12-Item Short-Form Health Survey; participant's blind preference for treatment A or B at each block; clinical worsening; and adverse events. DATA ANALYSIS: the participant, assistant physician, evaluator, and statistician will remain blinded for the study treatments until the completion of data analysis of each study. We will follow a 10-step procedure for analyzing N-of-1 observational data of each participant and conduct a meta-analysis of the combined results. DISCUSSION: We understand that each N-de-1 study will be a chapter with its teachings in a book of ten, allowing a broader view of the effectiveness of the homeopathy protocol of the sixth edition of the Organon in treating depression.Einzelpatienten- oder "n = 1"-Studien ermöglichen die formelle Beurteilung der Behandlung eines Patienten. Bei einem einzigen Teilnehmer werden verschiedene Maßnahmen in gleicher Zahl in einem doppelblinden, randomisierten Crossover-Design angewendet. Mit dieser Methode untersuchen wir die Wirksamkeit und Sicherheit eines standardisierten Homöopathie-Protokolls zur Behandlung von Major Depression in zehn Fällen.Aufbau der Studie: Doppelblinde, placebokontrollierte, randomisierte Einzelpatienten- oder "n = 1"-Studie von maximal 28 Wochen Dauer pro Teilnehmer. Teilnehmer: Frauen und Männer ab 18 Jahren mit durch einen Psychiater diagnostizierter Episode einer Major Depression und mit mindestens vier Wochen lang anhaltendem therapeutischem Ansprechen (in Form einer Reduktion der depressiven Symptome um ≥50% gegenüber Baseline laut Selbstbeurteilung mit dem Beck Depression Inventar, zweite Ausgabe [BDI-II]) unter einer offenen homöopathischen Behandlung gemäß dem Protokoll der sechsten Auflage des Organon, mit oder ohne gleichzeitige Anwendung von Psychopharmaka. Interventionen: Individualisierte Homöopathie gemäß demselben Protokoll, ein Globulus der Quinquaginta-Millesimal-Potenz, verdünnt in 20 mL 30%igem Alkohol; Placebo in Form von 20 mL 30%igem Alkohol, nach demselben Dosierungsschema wie die Homöopathie. Crossover-Studie: Der Teilnehmer durchläuft in zwei randomisierten und maskierten Behandlungszeiträumen (A oder B), die Homöopathie oder Placebo enstprechen, je drei aufeinanderfolgende Behandlungsblöcke. Innerhalb der Behandlungszeiträume umfassen der erste, zweite und dritte Block je zwei, vier beziehungsweise acht Wochen. Eine klinisch bedeutsame Verschlechterung (gekennzeichnet durch einen Anstieg des BDI-II-Scores um ≥30% gegenüber der Aufnahme) führt zum Abbruch der Studienteilnahme und zur Wiederaufnahme der offenen Behandlung. Primäre Messgröße: Verlauf der depressiven Symptome laut Selbstbeurteilung des Teilnehmers mit der BDI-II-Skala in Woche 0, 2, 4, 8, 12, 16, 20, 24, 28 und Auswertung im Verlauf der Studie nach Homöopathie-und Placebo-Abschnitten. Sekundäre Messgrößen: Score auf der Clinical Global Impression Scale; Scores für psychische und physische Gesundheit laut 12-Item Short-Form Health Survey; verblindete Teilnehmerpräferenz für Behandlung A oder B in jedem Block; klinische Ver-schlechterung und unerwünschte Ereignisse. Datenauswertung: Der Teilnehmer, behandelnde Arzt, Auswertende und Statistiker bleiben im Hinblick auf die Stu-dienbehandlungen verblindet, bis die Datenauswertung jeder Studie abgeschlossen ist. Wir werden in einem 10-schrittigen Vorgehen die "n = 1"-Beobachtungsdaten der einzelnen Teilnehmer auswerten und eine Metaanalyse der zusammengeführten Ergebnissee durchführen.Unserer Auffassung nach wird jede einzelne "n = 1"-Studie ein Kapitel mit eigenen Lehren innerhalb eines zehnteiligen Buches sein, welches eine umfassende Darstellung der Wirksamkeit des Homöopathie-Protokolls der sechsten Ausgabe des Organon zur Behandlung von Depressionen ermöglicht.

Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study).

BACKGROUND: Different homeopathic approaches have been used as supportive care for coronavirus disease 2019 (COVID-19) cases, but none has been tested in a clinical trial. OBJECTIVES: To investigate the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: A randomized, double-blind, two-armed, parallel, single-center, placebo-controlled clinical trial was conducted from June 2020 to April 2021 in São-Carlos, Brazil. Participants aged > 18 years, with influenza-like symptoms and positive result from a real-time polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home-isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo. OUTCOME MEASURES: The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures. RESULTS: Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between two groups among participants who were reporting influenza-like symptoms at the beginning of monitoring (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group. CONCLUSION: Results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19. TRIAL REGISTRATION: UMIN Clinical Trials Registry ID: JPRN-UMIN000040602.

Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial.

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.

Double-blind evaluation of homeopathy on cocaine craving: a randomized controlled pilot study.

BACKGROUND: Brazil is among the nations with the greatest rates of annual cocaine usage. Pharmacological treatment of cocaine addiction is still limited, opening space for nonconventional interventions. Homeopathic Q-potencies of opium and Erythroxylum coca have been tested in the integrative treatment of cocaine craving among homeless addicts, but this setting had not proven feasible, due to insufficient recruitment. OBJECTIVE: This study investigates the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence (F14.2). The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). MAIN OUTCOME MEASURES: The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were reported in both groups. RESULTS: The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% (standard deviation (SD): 22.3%), compared to 29.8% (SD: 30.6%) in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients' appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group (P = 0.41). CONCLUSIONS: A psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention. TRIAL REGISTRATION: RBR-2xzcwz (http://www.ensaiosclinicos.gov.br).

Escola médica e Sistema Único de Saúde (SUS): criação do curso de medicina da Universidade Federal de São Carlos, SP, Brasil (UFSCar) sob perspectiva de docentes e estudantes / Medical schools and Brazilian National Health System (SUS): Implantation of the Federal University of São Carlos (UFSCar) medical school from the perspective of teachers and students / Escuela médica y Sistema Brasileño de Salud (SUS): creación de la escuela de medicina de la Universidad Federal de São Carlos, SP, Brasil (UFSCar) bajo la perspectiva de docentes y alumnos

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.(AU)

Universidade Federal de Sao Carlos (UFSCar) launched in 2006 the UFSCar Medical School, with constructivist, competency curriculum and practice based learning, interweaved in the SUS structure. The objective of the present study is to analyze the perceptions of teachers and students from the first group of graduates about their experience usingthe methodology called Life Oral History. Despite reports of infrastructure deficiencies, the narratives suggest that the curriculum favored the development of competencies such as search capability, critical and reflective thinking and self-managed learning. The fact of having practice integrated into the SUS, especially within the Family Health Units, improved intellective, relational and affective dimensions of patient care, favoring professional autonomy.(AU)

La Universidad Federal de São Carlos (UFSCar) implantó su curso de Medicina en 2006, con un currículo basado en competencia y aprendizaje práctico integrado al SUS. El objetivo de este trabajo es presentar una encuesta con docentes y alumnos de graduación de la Primera Promoción de Medicina-UFSCar, realizada por medio de la Metodología de la Historia Oral de Vida. Las narrativas indican que el currículum favoreció el desarrollo de competencias tales como: capacidad de búsqueda, pensamiento crítico-reflexivo y auto-gestión del aprendizaje, a pesar de relatos sobre deficiencias en infraestructura. La práctica integrada al SUS, especialmente en las Unidades de Salud de la Familia, perfeccionó las dimensiones intelectivas, relacionales y afectivas del cuidado, favoreciendo la autonomía profesional.(AU)

Formação médica e serviço único de saúde: propostas e práticas descritas na literatura especializada / Medical education and the brazilian unified health system: proposals and practices from specialized literature

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.

INTRODUCTION: Since the creation of the Unified Health System (SUS) and the new National Curriculum Guidelines (DCN) for undergraduate courses in Medicine, some Medical Schools in Brazil have been trying to integrate medical training with public health services. OBJECTIVE: To identify in the literature experiences of undergraduate medical training within the SUS. METHODS: Articles published between January 2002 and December 2012 were selected from searches of the Scielo, PubMed and Virtual Health Library (BVS) databases, using the terms "medical education", "undergraduate medical education" and "Unified Health System". The reviewers assessed the eligibility of the articles. RESULTS: Thirty-one articles were included and categorized. Practical experiences in the SUS were associated with integrated curricula, traditional curricula, with traditional curricula in the process of being adapted to the new DCN and with extracurricular projects. CONCLUSION: The reviewed literature paints a positive picture for undergraduate medical training in the Unified Health System, emphasizing integration between medical educators and health professionals as a pathway for current medical training.

Homeopathic potencies of Opium in alcohol dependence: exploratory open-label study / Potências homeopáticas de Opium na dependência do álcool: estudo exploratório e aberto / Potencias homeopáticas de Opium en alcoholismo: estudio exploratorio abierto

The conventional pharmacological options for the treatment of alcoholism are limited, which led to the search for solutions in alternative or complementary medicine (CAM). Homeopathy is a CAM modality recognized as medical specialty in Brazil. According to the clinical experience of the early homeopaths, Opium was used to treat patients with alcohol dependence. Aim: to perform a preliminary assessment of the effectiveness and tolerability of fifty-millesimal potencies of Opium in the treatment of alcohol-dependent patients. Methods: exploratory, prospective, open-label trial, with pre-treatment measures as control. Confidence intervals were used to estimate the magnitude of the clinical differences. Results: a total of 14 patients were included, from which 12 were evaluated (intention to treat analysis - ITT). There was a significant reduction in the average daily alcohol consumption (-29.37 units of alcohol/day; 95% CI=10.63; 48.11) and in the severity of alcohol dependence, measured by the mean score of the Short Alcohol Dependence Data questionnaire (-10.17; 95% CI= 4.12; 16.22). No serious adverse events were reported. Randomized controlled studies with larger samples are needed.

Contexto: as opções farmacológicas convencionais para o tratamento do alcoolismo ainda são limitadas, contribuindo para a busca de soluções na medicina alternativa ou complementar (CAM). A homeopatia é uma modalidade de CAM reconhecida como especialidade médica no Brasil. Na experiência clínica dos primeiros homeopatas, Opium era usado no tratamento de pacientes com dependência do álcool. Objetivo: avaliação preliminar da efetividade e da tolerabilidade de dinamizações homeopáticas de Opium no tratamento de pacientes dependentes do álcool. Métodos: estudo exploratório, prospectivo e aberto, com medidas pré-tratamento como controle. Intervalos de confiança foram utillizados para se estimar a magnitude das diferenças clínicas. Resultados: 14 pacientes foram incluídos e 12 avaliados (análise segundo a intenção de tratar- ITT). Houve uma redução clinicamente significativa no consumo médio diário de álcool (-29,37 unidades de álcool/dia, 95% CI=10,63; 48,11) e na severidade da dependência do álcool, medida pelo escore médio do questionário Short Alcohol Dependence Data (-10,17 pontos 95% CI= 4,12; 16,22). Não foram relatados ou observados eventos adversos graves. Os resultados justificam estudos maiores, randomizados e controlados.

Homeopathic potencies of Opium in alcohol dependence: exploratory open-label study / Potências homeopáticas de Opium na dependência do álcool:estudo exploratório e aberto / Potencias homeopáticas de Opium en alcoholismo:estudio exploratorio abierto

The conventional pharmacological options for the treatment of alcoholism are limited, which led to the search for solutions in alternative or complementary medicine (CAM). Homeopathy is a CAM modality recognized as medical specialty in Brazil. According to the clinical experience of the early homeopaths, Opium was used to treat patients with alcohol dependence. Aim: to perform a preliminary assessment of the effectiveness and tolerability of fifty-millesimal potencies of Opium in the treatment of alcohol-dependent patients. Methods: exploratory, prospective, open-label trial, with pre-treatment measures as control. Confidence intervals were used to estimate the magnitude of the clinical differences. Results: a total of 14 patients were included, from which 12 were evaluated (intention to treat analysis - ITT). There was a significant reduction in the average daily alcohol consumption (-29.37 units of alcohol/day; 95% CI=10.63; 48.11) and in the severity of alcohol dependence, measured by the mean score of the Short Alcohol Dependence Data questionnaire (-10.17; 95% CI= 4.12; 16.22). No serious adverse events were reported. Randomized controlled studies with larger samples are needed.(AU)

Contexto: as opções farmacológicas convencionais para o tratamento do alcoolismo ainda são limitadas, contribuindo para a busca de soluções na medicina alternativa ou complementar (CAM). A homeopatia é uma modalidade de CAM reconhecida como especialidade médica no Brasil. Na experiência clínica dos primeiros homeopatas, Opium era usado no tratamento de pacientes com dependência do álcool. Objetivo: avaliação preliminar da efetividade e da tolerabilidade de dinamizações homeopáticas de Opium no tratamento de pacientes dependentes do álcool. Métodos: estudo exploratório, prospectivo e aberto, com medidas pré-tratamento como controle. Intervalos de confiança foram utillizados para se estimar a magnitude das diferenças clínicas. Resultados: 14 pacientes foram incluídos e 12 avaliados (análise segundo a intenção de tratar- ITT). Houve uma redução clinicamente significativa no consumo médio diário de álcool (-29,37 unidades de álcool/dia, 95% CI=10,63; 48,11) e na severidade da dependência do álcool, medida pelo escore médio do questionário Short Alcohol Dependence Data (-10,17 pontos 95% CI= 4,12; 16,22). Não foram relatados ou observados eventos adversos graves. Os resultados justificam estudos maiores, randomizados e controlados.(AU)

Experiências e impactos do aprendizado em Homeopatia: relatos de médicos egressos do Curso de Especialização em Homeopatia da FMJ / Experiences and impacts of Learning Homeopathy: reports by medical graduates of a specialization course in homeopathy

Nas últimas décadas, a insatisfação com o cuidado médico contribuiu para a valorização de formações médicas mais abrangentes e humanizadas e para a busca das medicinas complementares e alternativas (CAM) como opções de tratamento. Desde 2003, o Curso de Pós-Graduação em Homeopatia da Faculdade de Medicina de Jundiaí (PGH-FMJ) oferece o ensino da Homeopatia para médicos, integrando-a à medicina convencional. Este estudo analisa as experiências de aprendizado em Homeopatia dos egressos das duas primeiras turmas do Curso de Especialização em Homeopatia da PGH-FMJ, totalizando 14 participantes. A metodologia compreendeu questionários de múltipla escolha, entrevistas não estruturadas e a técnica de História Oral. Os resultados revelaram que os egressos adquiriram competências para o exercício da especialidade, com ganhos nas dimensões afetivas, intelectivas e de atitude, maior satisfação profissional e pessoal, e melhora na relação médico-paciente.

In recent decades, dissatisfaction with medical care has led to greater appreciation of a more comprehensive and humanistic medical education and to the search for other treatment options among complementary and alternative medicines (CAM). Since 2003, the Jundiaí School of Medicine offers graduate education in homeopathy (PGH-FMJ) for medical doctors, combining homeopathy and conventional medicine. The aim of this paper was to analyze the learning experiences of graduate students from the two first classes at the PGH-FMJ, with a total of 14 participants. The methodology included multiple-choice questionnaires, non-structured interviews, and the oral history technique. The results showed that the learning of homeopathy at the Jundiaí School of Medicine developed specific professional skills and led to new humanistic, affective, intellectual, and attitudinal insights among participants, as well as to greater professional and personal satisfaction and an improved physician-patient relationship.

From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal potencies

Background: 20 years ago we began to standardize the procedures of preparation and use of fifty-millesimal dilutions (LM or Q) according to indications in the 6th edition of Hahnemann?s Organon. Aim: to describe the main stages in standardization as well as our teaching and research experience on Organon 6th edition. Results: with the use of standardized LM dilutions we observed a lower incidence of homeopathic aggravation than with our earlier experience with non standardized preparations. Organon.modus, a clinical-pharmaceutical protocol derived from the standardization was adequate for the teaching of homeopathy at Faculty of Medicine of Jundiai (São Paulo), the first Brazilian medical school with a graduate course on homeopathy. A randomized double-blind trial comparing individualized homeopathic medicines prescribed in LM dilutions and fluoxetine showed the former not be inferior to the latter in the treatment of moderate-to-severe depression. Conclusion: protocol Organon.modus showed to be adequate to graduate-level teaching of homeopathy and efficient in a controlled clinical trials, favoring its use as common denominator between the art of healing and medical science.

Experiências e impactos do aprendizado emHomeopatia: relatos de médicos egressos doCurso de Especialização em Homeopatia daFMJ / Experiences and Impacts of Learning Homeopathy: reports by medical graduates of a specialization course in homeopathy

Nas últimas décadas, a insatisfação com o cuidado médico contribuiu para a valorização de formações médicas mais abrangentes e humanizadas e para a busca das medicinas complementares e alternativas (CAM) como opções de tratamento. Desde 2003, o Curso de Pós-Graduação em Homeopatia da Faculdade de Medicina de Jundiaí (PGH-FMJ) oferece o ensino da Homeopatia para médicos, integrando-a à medicina convencional. Este estudo analisa as experiências de aprendizado em Homeopatia dos egressos das duas primeiras turmas do Curso de Especialização em Homeopatia da PGH-FMJ, totalizando 14 participantes. A metodologia compreendeu questionários de múltipla escolha, entrevistas não estruturadas e a técnica de História Oral. Os resultados revelaram que os egressos adquiriram competências para o exercício da especialidade, com ganhos nas dimensões afetivas, intelectivas e de atitude, maior satisfação profissional e pessoal, e melhora na relação médico-paciente.(AU)

In recent decades, dissatisfaction with medical care has led to greater appreciation of a morecomprehensive and humanistic medical education and to the search for other treatment optionsamong complementary and alternative medicines (CAM). Since 2003, the Jundiaí School of Medicineoffers graduate education in homeopathy (PGH-FMJ) formedical doctors, combining homeopathyand conventionalmedicine. The aim of this paperwas to analyze the learning experiencesof graduate students fromthe twofirst classes at the PGH-FMJ, with a total of 14 participants. Themethodology included multiple-choice questionnaires, non-structured interviews, and the oralhistory technique. The results showed that the learning of homeopathy at the Jundiaí School ofMedicine developed specific professional skills and led to new humanistic, affective, intellectual,and attitudinal insights among participants, as well as to greater professional and personal satisfactionand an improved physician-patient relationship.(AU)

From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal potencies / Da padronização farmacêutica à pesquisa clínica: 20 anos de experiência com potências cinquenta-milesimais

Background: 20 years ago we began to standardize the procedures of preparation and use of fifty-millesimal dilutions (LM or Q) according to indications in the 6th edition of Hahnemann’s Organon. Aim: to describe the main stages in standardization as well as our teaching and research experience on Organon 6th edition. Results: with the use of standardized LM dilutions we observed a lower incidence of homeopathic aggravation than with our earlier experience with non standardized preparations. Organon.modus, a clinical-pharmaceutical protocol derived from the standardization was adequate for the teaching of homeopathy at Faculty of Medicine of Jundiai (São Paulo), the first Brazilian medical school with a graduate course on homeopathy. A randomized double-blind trial comparing individualized homeopathic medicines prescribed in LM dilutions and fluoxetine showed the former not be inferior to the latter in the treatment of moderate-to-severe depression. Conclusion: protocol Organon.modus showed to be adequate to graduate-level teaching of homeopathy and efficient in a controlled clinical trials, favoring its use as common denominator between the art of healing and medical science.(AU)

Introdução: Iniciamos há 20 anos, uma padronização dos procedimentos para o preparo e uso das potências cinquenta-milesimais (LM ou Q) de acordo com a 6ª edição do Organon. Objetivo: Relatar as principais etapas dessa padronização e nossa experiência com o ensino e a pesquisa usando os princípios essenciais da a 6ª edição do Organon. Resultados: Observamos uma menor incidência de agravações homeopáticas com o uso de medicamentos padronizados, em relação à nossa experiência anterior com potências LM não padronizadas. O protocolo clínico-farmacêutico, que aqui denominamos Organon.modus, mostrou-se adequado ao ensino da Homeopatia na Faculdade de Medicina de Jundiaí, primeira escola de Medicina no Brasil a oferecer uma especialização em Homeopatia para médicos. Potências LM individualizadas não foram inferiores ao antidepressivo fluoxetina no tratamento de pacientes com depressão moderada a grave em um estudo randomizado e duplo-cego. Conclusão: O protocolo Organon.modus mostrou-se adequado ao ensino acadêmico da Homeopatia e eficaz em um estudo clínico controlado, resultados que favorecem seu uso como denominador comum entre a arte de curar e a ciência médica.(AU)

Tratamento homeopático da depressão: relato de série de casos / Homeopathic treatment of depression: series of case report

CONTEXTO: 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. OBJETIOS: 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 por cento dos escores de depressão) em 14 pacientes (93 por cento), 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.

BACKGROUND: 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 percent decrease of MADRS scores) was observed in 14 patients (93 percent), 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 2nd evaluation, and these results signifcance were sustained through the 3rd and 4th 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.

Tratamento homeopático da depressão: relato de série de casos / Homeopathic treatment of depression: series of case report

CONTEXTO: 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. OBJETIOS: 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 por cento dos escores de depressão) em 14 pacientes (93 por cento), 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.(AU)

BACKGROUND: 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 percent decrease of MADRS scores) was observed in 14 patients (93 percent), 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 2nd evaluation, and these results signifcance were sustained through the 3rd and 4th 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.(AU)