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.
Background Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. Findings Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates. Comments There is neither a rational basis nor scientific evidence for assigning a short (3–5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.
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