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.

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

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.

Biological Actions, Electrical Conductance and Silicon-Containing Microparticles of Arsenicum Album Prepared in Plastic and Glass Vials.

INTRODUCTION: According to the "silica hypothesis" formulated to explain homeopathy, the information of starting materials would be transferred to cells by silica nanoparticles detached from the glassware walls by serial dilution and agitation through epitaxy. We compared the biological activity, electrical current and silicon microparticle content (by means of scanning electron microscopy/energy-dispersive X-ray spectroscopy) of high dilutions (HDs) of arsenic prepared in plastic and glass vials to investigate the role of silica in their biological effects in vitro. MATERIALS AND METHODS: Co-cultures of macrophages and yeast (Saccharomyces cerevisiae) were treated with different HDs of arsenic prepared in plastic and glass vials. Macrophage morphology, phagocytosis index, nitric oxide (NO), and cytokine production were evaluated. RESULTS: Measurable amounts of silicon microparticles were detected only in the HDs prepared in glass vials, but ultra-centrifugation eliminated them. Specific and non-specific results were observed. Non-specific pro-inflammatory effects were seen in all dilutions prepared in plastic vials, including elevation of pro-inflammatory cytokines, NO and macrophage phagocytic index. Only the 200th centesimal dilution of arsenic produced specific decrease in interleukin-6 production in macrophages, and it was independent of the vial type or the presence of microparticles of silica in the medicine samples. The nature of the vials had an impact on the electric flow in the respective fluids. CONCLUSION: The non-specific, pro-inflammatory effects might be attributed to organic residuals detached from the vials' plastic walls during manipulation. Instead, specific silica-independent effects of the homeopathic medicine can be attributed to the decrease of interleukin-6 after treatment with the 200th centesimal dilution of arsenic.

Homeopatia: formas de preparação dos medicamentos / Homeopathy: ways to prepare the medicine

A partir das colocações feitas pelo Dr. Pedro Mintz, em artigo intitulado "Dinamização em pressão ou vácuo relativo" (Revista de Homeopatia 172:26), gostaríamos de discutir alguns pontos. A busca de novas formas e novos caminhos para se obter o que Hahnemann classificou como cura é elogiável sob todos os aspectos. São muitos os caminhos que hoje se pesquisam, tendo o autor colocado mais um que, certamente, merecerá um estudo criterioso para se chegar às soluções que ele busca.

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).

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

INTRODUCTION: Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma. OBJECTIVE: The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol (Organon.modus) on perennial asthma in adolescents. METHODS: Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit. RESULTS: Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% (p = 0.05). Few Adverse Events were reported. CONCLUSIONS: This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol. CLINICAL TRIAL REGISTRATION: RBR-6XTS8Z.

Organoterápicos a partir de tecidos de carneiro: relato etnográfico e preparação / Organotherapy medicines from sheep: ethnographic report and preparation

Organoterápicos (OT) são medicamentos diluídos e agitados, produzidos a partir de órgãos de animais saudáveis e utilizados como complemento ao tratamento homeopático ou convencional. As matérias-primas (matrizes) disponíveis no país não ofereciam rastreabilidade ou informações como a origem do material preparado. Este artigo apresenta um relato etnográfico e descreve a produção de matrizes de OTs a partir de tecidos de carneiro nas proporções (escalas) decimal, centesimal e cinquenta milesimal. Foram obtidos 70 diferentes órgãos, partes de órgãos e algumas composições, com informações completas sobre a origem e rastreabilidade. (AU)

Organotherapy (OT) employs serially diluted and agitated medicines prepared with organs of healthy animals as adjuvant to homeopathic or conventional treatment. The starting-substances for OT available in Brazil have no traceability and there is no information as to their origin. In the present article we present an ethnographic report of organ collection and preparation of 70 new OT medicines from sheep tissue in the decimal, centesimal and 50 milesimal scales which meet all traceability requirements. (AU)

Organoterápicos a partir de tecidos de carneiro: relato etnográfico e preparação / Organotherapy medicines from sheep: ethnographic report and preparation

Organoterápicos (OT) são medicamentos diluídos e agitados, produzidos a partir de órgãos de animais saudáveis e utilizados como complemento ao tratamento homeopático ou convencional. As matérias-primas (matrizes) disponíveis no país não ofereciam rastreabilidade ou informações como a origem do material preparado. Este artigo apresenta um relato etnográfico e descreve a produção de matrizes de OTs a partir de tecidos de carneiro nas proporções (escalas) decimal, centesimal e cinquenta milesimal. Foram obtidos 70 diferentes órgãos, partes de órgãos e algumas composições, com informações completas sobre a origem e rastreabilidade...

Organotherapy (OT) employs serially diluted and agitated medicines prepared with organs of healthy animals as adjuvant to homeopathic or conventional treatment. The starting-substances for OT available in Brazil have no traceability and there is no information as to their origin. In the present article we present an ethnographic report of organ collection and preparation of 70 new OT medicines from sheep tissue in the decimal, centesimal and 50 milesimal scales which meet all traceability requirements...

Proposta de padronização farmacotécnica para dispensação não farmacopeica de medicamentos homeopáticos em potências cinquenta-milesimais (LM) diluídas, em complexos e em glóbulos / Proposal for pharmacotechnical standardization of non-pharmacopeial preparation of homeopathic medicines in fifty-millesimal potencies (LM) with additional dilution, as complex or in globules

O preparo e a dispensação dos medicamentos homeopáticos, em nosso país, são realizados em farmácias com manipulação homeopática, fato que possibilita a perfeita adequação da prescrição às necessidades do paciente. O trabalho da classe farmacêutica homeopática levou à publicação de várias edições da Farmacopeia Homeopática Brasileira; com isto foi padronizada a manipulação desses medicamentos nas diversas farmácias do país. Com o tempo, porém, observamos que algumas necessidades não foram supridas. Com o objetivo de colaborar com a padronização dos medicamentos, neste trabalho propomos um procedimento para preparo e dispensação de medicamentos com o método cinquenta-milesimal diluídos (para pacientes mais sensíveis), sob a forma decomplexos e ainda em glóbulos. (AU)

In Brazil, homeopathic medicines are prepared and delivered by homeopathic pharmacies, which allows for exact fitting of the medicines to the patients’ needs. As a result of the cumulative work of homeopathic pharmacists, several editions of the Brazilian Homeopathic Pharmacopeia were published, resulting in nationwide standardization of the preparation of homeopathic medicines. That advance notwithstanding, clinical practice showed that some particular cases escaped the scope of the standards. To contribute to a more thorough standardization of the preparation of homeopathic medicines, in the present article we describe procedures for preparation and delivery of fifty-millesimal (LM) potencies with additional dilutions (for more sensitive patients), in complex formulas or globules. (AU)

Proposta de padronização farmacotécnica para dispensação não farmacopeica de medicamentos homeopáticos em potências cinquenta-milesimais (LM) diluídas, em complexos e em glóbulos / Proposal for pharmacotechnical standardization of non-pharmacopeial preparation of homeopathic medicines in fifty-millesimal potencies (LM) with additional dilution, as complex or in globules

O preparo e a dispensação dos medicamentos homeopáticos, em nosso país, são realizados em farmácias com manipulação homeopática, fato que possibilita a perfeita adequação da prescrição às necessidades do paciente. O trabalho da classe farmacêutica homeopática levou à publicação de várias edições da Farmacopeia Homeopática Brasileira; com isto foi padronizada a manipulação desses medicamentos nas diversas farmácias do país. Com o tempo, porém, observamos que algumas necessidades não foram supridas. Com o objetivo de colaborar com a padronização dos medicamentos, neste trabalho propomos um procedimento para preparo e dispensação de medicamentos com o método cinquenta-milesimal diluídos (para pacientes mais sensíveis), sob a forma decomplexos e ainda em glóbulos.

In Brazil, homeopathic medicines are prepared and delivered by homeopathic pharmacies, which allows for exact fitting of the medicines to the patients’ needs. As a result of the cumulative work of homeopathic pharmacists, several editions of the Brazilian Homeopathic Pharmacopeia were published, resulting in nationwide standardization of the preparation of homeopathic medicines. That advance notwithstanding, clinical practice showed that some particular cases escaped the scope of the standards. To contribute to a more thorough standardization of the preparation of homeopathic medicines, in the present article we describe procedures for preparation and delivery of fifty-millesimal (LM) potencies with additional dilutions (for more sensitive patients), in complex formulas or globules.

Validação do método de análise capilar preconizado por hugo platz para o controle de qualidade de tinturas-mães / Validation of Hugo Platz´s method of capillary analysis for quality control of mother tinctures

Um dos insumos mais utilizados na manufatura de medicamentos homeopáticos é a tintura-mãe. Um método aparentemente útil para o controle de qualidade das tinturas-mães é a análise capilar. Este método analítico, tornado público no início do século passado por Hugo Platz, caiu em desuso após o advento de técnicas cromatográficas mais modernas. Embora empregue técnicas simples e de baixo custo, não há estudos de validação da análise capilar. O presente ensaio teve por objetivo validar o método de análise capilar utilizado no controle de qualidade de tinturas-mãe. Para tanto foram obtidos os espectros capilares das tinturas-mãe de Aconitum napellus L., Strychnos nux vomica L. e Anemone pulsatilla L. provenientes de fornecedores nacionais qualificados pela Associação Brasileira de Farmacêuticos Homeopatas. Os atributos avaliados foram precisão, reprodutibilidade e seletividade. Os resultados alcançados recomendam a utilização do método de análise capilar, conforme proposto por Platz, nas análises qualitativas de tinturas-mãe.

Mother tinctures are one of the most common starting materials used in the elaboration of homeopathic medicines. Capillary analysis seems a useful method for quality control of mother tinctures. This method was publicized in the beginning of the 20th century by Hugo Platz to fell into disuse following the development of the modern chromatographic techniques. Despite the simple techniques involved, and the low cost of the overall method, no studies of validation have yet been performed of Platz´s capillary analysis. The present study sought to validate capillary analysis for quality control of mother tinctures. The capillary spectra of mother tinctures of Aconitum napellus L., Strychos nux vomica L. e Anemone pulsatilla L. provided by Brazilian suppliers certified by the Brazilian Association of Homeopathic Pharmacists were obtained. The attributes evaluated were accuracy, reproducibility and selectivity. The results allow recommending the use of capillary analysis as formulated by Platz for qualitative analysis of mother tinctures.

O risco sanitário e o medicamento homeopático / The health risk and the homeopathic medicine

Por sugestão do farmacêutico, Daniel Magano, o tema “Risco sanitário do medicamento homeopático” foi inserido no Congresso Brasileiro de Farmácia Homeopática da Associação Brasileira de Farmacêuticos Homeopatas (ABFH), realizado em outubro de 2013, junto com o Congresso de Farmácia do Conselho Regional de Farmácia do Estado de São Paulo (CRF-SP). O que no início causou certa estranheza, logo mostrou ser um assunto interessante para ser aprofundado e nos fazer pensar mais sobre o medicamento homeopático....Após a apresentação dos três palestrantes, seguiu-se uma discussão proveitosa, mostrando que os farmacêuticos estão capacitados, prontos e desejosos de contribuir para os diversos aspectos da regulamentação dos medicamentos homeopáticos de maneira séria, correta, justa, sem negligência e sem excessos, favorecendo os usuáriosda prática homeopática, que está garantida pela legislação brasileira. Trabalho a fazer!

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.

Certificados de qualidade para matrizes homeopáticas / Quality certificates for homeopathic matrices

Background: To produce homeopathic medicines, pharmacies need raw materials (mother tinctures and diluted-agitated solutions, named ?matrices?), provided by insumes suppliers. The ?matrices? are ultra high dilutions and can not be tested against Analysis Reports. Aims: to propose alternatives to the matrices Analysis Report; to contribute to the quality of homeopathic medicines and treatment. Method: search of information present in the documentation provided from 2 national and 3 European suppliers in order to develop criteria. Discussion: the needed concepts for compliance with the orders throughout their production process were presented. The control of information involved in the process allows to trace the production of matrices, providing an indication of the quality with which they were obtained. Each supplier gives different approach to issuing a document, calling it Certificate of Conformity Protocol Preparation, Manufacturing Certificate or Quality Certificate. Summarizing, it is a supplier's declaration, which involves the quality control of raw materials, packaging materials and of the process used, but not a report that enables customers to repeat the analysis. A model was proposed for a Certificate of Quality, with the minimum information needed to indicate to the pharmacies that there is a control of the process. This certificate shall contain statements about the process. Conclusion: Quality Certificate seems to be the best document to ensure the pharmacy that the matrix(AU)

Introdução: Para produzir medicamentos homeopáticos as farmácias necessitam de matérias primas (tinturas-mãe e matrizes), fornecidas por laboratório de insumos. As matrizes são soluções ultra diluídas e não podem ser testadas segundo Laudos de Análise.Int J High Dilution Res 2011; 10(36):224-225Proceedings of the XXV GIRI Symposium and VIII CBFH; 2011 Sep 04-07; Foz do Iguaçu (Brazil)225Objetivos: propor alternativas para o Laudo de Análises de matrizes; contribuir para a qualidade dos medicamentos e do tratamento homeopático. Método: pesquisa de informações provenientes da documentação de 2 fornecedores nacionais e 3 europeus para desenvolvimento de critérios. Discussão: foram abordados conceitos necessários para o atendimento do pedido ao longo de todo o processo. O controle das informações envolvidas no processo possibilita rastrear a produção das matrizes, fornecendo um indicativo da qualidade com que estas foram obtidas. Cada fornecedor dá enfoque diferente para o documento que emite, chamando de Certificado de Conformidade, Protocolo de Preparo, Certificado de Manufatura ou Certificado de Qualidade. Em resumo, é uma declaração do fornecedor, que envolve o controle de qualidade de matérias primas, do material de embalagem e do processo utilizado, mas não de um laudo que possibilita ao cliente refazer a análise. Foi proposto um modelo de Certificado de Qualidade, com as informações mínimas necessárias que indiquem à farmácia que há um controle de processo. Neste certificado devem constar declarações sobre o processo. Conclusão: o Certificado de Qualidade parece ser o melhor documento para assegurar à farmácia que a matriz adquirida apresenta características compatíveis com a manipulação de um medicamento homeopático de qualidade.(AU)

Estabilidade microbiológica de medicamentos homeopáticos veiculados em água purificada / Microbiological stability of homeopathic medicines using purified water as vehicle

Background: Homeopathic medicines are prepared in homeopathic pharmacies. This leads to freedom of prescription but requires more knowledge of the clinicians to achieve the best results. Preparations made of purified water receive a validity of 24 hours, but there are prescriptions for up to 30 days. This contradiction raises tensions among physicians, pharmacists and patients. Aims: to evaluate the increase in microbiological contamination in homeopathic medicines using purified water as vehicle compared with the microbiological stability of purified water. Contribute to the quality of homeopathic medicine and treatment. Methodology: daily microbiological analysis for one week to assess the growth of heterotrophic bacteria, Pseudomonas, yeasts and molds. The reference used was the USP 32/NF 27 and the Brazilian Pharmacopoeia 5th edition. Results: there was a higher growth of microorganisms on the medicine, compared with purified water. From the 2nd day on, this growth has been beyond the legal limits. Discussion: medicines for oral use are not sterile preparations, but they must remain stable during its shelf life. Our results indicate that contamination occurs from the earliest days of use. This shows the need to change the prescription in relation of the vehicle, to ensure hygiene and avoid potential contamination of the patient. It is necessary to prevent conflict of information between pharmacists and patients, and the contradiction of the doctor's advice, besides the potential risk of responsibility to be attributed to the pharmacy. It is necessary to promote a discussion between pharmacists and clinicians, to spread this information for those that prescribe. Conclusion: there was an increased of microbiological contamination of the medicines dispensed in purified water, which harms the quality of homeopathic medicine and homeopathic treatment.(AU)

Introdução: Medicamentos homeopáticos são manipulados em farmácias com manipulação homeopática. Isto leva a liberdade de prescrição, porém exige mais conhecimento por parte dos clínicos, para atingir os melhores resultados. Preparações em água purificada recebem validade de 24 horas, mas existem prescrições para tomar o medicamento durante 30 dias. Esta contradição gera tensões entre médicos, farmacêuticos e pacientes. Objetivos: avaliar o aumento da carga microbiana em medicamentos homeopáticos veiculados em água purificada, em comparação com a estabilidade microbiológica da água purificada. Contribuir com a qualidade do medicamento e do tratamento homeopático. Metodologia: análises microbiológicas diárias durante uma semana para avaliação do incremento de bactérias heterotróficas, Pseudomonas, bolores e leveduras. A referência utilizada foi a USP 32/NF 27 e a Farmacopeia Brasileira 5ª edição. Resultados: houve um maior crescimento de microorganismos no medicamento, quando comparado com a água purificada. Este crescimento foi além dos limites permitidos na legislação a partir do 2º dia. Discussão: os medicamentos para uso oral não são estéreis, porém devem manter-se estáveis durante seu prazo de validade. Nossos resultados indicam que a contaminação ocorre desde os primeiros dias de uso. Isto mostra a necessidade de alterar a prescrição médica em relação ao veículo, para garantir a higiene e evitar a potencial contaminação do paciente. É necessário prevenir o conflito de informações entre farmacêuticos e pacientes, e a contradição da indicação do médico, além de potencial risco da responsabilidade de medicamento contaminado recair sobre a farmácia. É necessário promover uma discussão entre farmacêuticos e clínicos, para que estas informações sejam divulgadas para a classe prescritora. Conclusões: houve aumento da carga microbiana dos medicamentos dispensados em(AU)