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.

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)

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.

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)

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.