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1.
Trials ; 22(1): 109, 2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33522951

RESUMO

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.


Assuntos
/terapia , Homeopatia/métodos , Materia Medica/administração & dosagem , Atenção Primária à Saúde/métodos , Cloreto de Sódio na Dieta/administração & dosagem , Administração Oral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Brasil/epidemiologia , /virologia , Método Duplo-Cego , Feminino , Seguimentos , Homeopatia/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Resultado do Tratamento , Adulto Jovem
3.
Arch Immunol Ther Exp (Warsz) ; 68(1): 3, 2020 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-31965304

RESUMO

The effects of infection with Toxoplasma gondii vary from asymptomatic to the development of alterations in various organs (including the liver and kidneys) which may be irreversible, and lead to the death of the host. Whereas homeopathy is an alternative and effective method for treating various diseases, including those caused by protozoa, we questioned the effect of using Lycopodium clavatum in mice infected with T. gondii. One hundred male Swiss mice, 60 days old, were divided into four groups (n = 25/group): NIC (uninfected and untreated control), IC (infected and treated with un-dynamized 7% alcohol solution [vehicle]), G48 (infected and treated 48 h before infection and treated three more times; at 2, 4, and 6 days post-infection (dpi) with L. clavatum 200dH), and G72 (infected and treated for 3 consecutive days before infection with L. clavatum 200dH). In this study, physiological, histopathological, and immunological parameters were evaluated. The L. clavatum 200dH intensified renal damage in mice infected with T. gondii from 7 dpi, causing severe and progressive alterations during this period, such as various degrees of inflammation, edema, atrophy, and tubular cystic dilation, degenerated tubules with intra-cytoplasmic vacuoles and coalescing spots, severe vascular lesions, glomerulonephritis, and peri-glomerular congestion. In the G72 animals, which received L. clavatum 200dH, more severe cortex damage was observed (91.66-96.66%) as compared to the IC group (55-80%) and more renal corpuscle, and renal tubule injury was observed (80 ± 5 to 96.7% ± 2.89 of the total area) during all periods, as compared to the IC group (p < 0.05). Both groups presented high liver enzyme levels, and the highest values for AST were observable at 60 dpi. We observed significant increases of type I and III collagen, as well as high levels of TGF-ß1 in both organs of the treated animals, the main factor involved in fibrosis in areas damaged by the process. L. clavatum 200dH intensifies kidney and liver alterations in mice infected with T. gondii. Our results reinforce caution when indicating administration schemes and dosages for ultra-diluted drugs.


Assuntos
Glomerulonefrite/patologia , Hepatite/patologia , Homeopatia/efeitos adversos , Lycopodium/efeitos adversos , Toxoplasmose/tratamento farmacológico , Animais , Colágeno/metabolismo , Modelos Animais de Doenças , Fibrose , Glomerulonefrite/metabolismo , Glomerulonefrite/parasitologia , Hepatite/metabolismo , Hepatite/parasitologia , Masculino , Camundongos , Preparações de Plantas/efeitos adversos , Toxoplasma/patogenicidade , Toxoplasmose/patologia , Fator de Crescimento Transformador beta1/metabolismo
5.
Rev. cuba. estomatol ; 56(4): e2207, oct.-dez. 2019. graf
Artigo em Português | LILACS | ID: biblio-1093260

RESUMO

RESUMO Introdução: A lesão central de células gigantes é própria dos ossos gnáticos, sendo um tumor benigno não odontogênico. É uma lesão de crescimento predominantemente lento, bem circunscrito e assintomático, geralmente diagnosticada através de algum exame de rotina ou, em casos mais avançados, quando se começa a visualizar alguma alteração estético-anatômica ou através da queixa do paciente de algum desconforto localizado na região. Objetivo: Ilustrar um caso clínico de lesão central de células gigantes e sua resolução envolvendo momento cirúrgico e reabordagem que inclui a homeopatia na proposta terapêutica. Apresentação do caso: Paciente do sexo feminino, inicialmente com 4 anos de idade com uma lesão na região de pré-maxila. Após avaliação radiográfica, tomográfica, exames sanguíneos e biópsia incisional, foi realizada, em primeiro momento, a exérese da lesão sob anestesia geral, por curetagem com aplicação de solução de carnoy. Após proservação e surgimento de imagem radiopaca nos exames, deu-se início ao tratamento não invasivo com homeopatia e injeções de corticoide visando à redução e neoformação óssea em área sugestiva de tecido cicatricial. Conclusões: Abordagens mais conservadoras podem ser, em muitos casos, uma opção plausível que acaba por livrar o paciente de cirurgias mutilantes(AU)


RESUMEN Introducción: La lesión central de células gigantes es propia de los huesos gnáticos, lo que constituye un tumor benigno no odontogénico. Es una lesión de crecimiento predominantemente lento, bien circunscrita y asintomática, generalmente diagnosticada a través de algún examen de rutina o en casos más avanzados cuando se empieza a visualizar alguna alteración estético-anatómica o el paciente que se queja de algún malestar localizado en la región. Objetivo: Presentar un caso clínico de lesión central de células gigantes y su resolución involucrando momento quirúrgico y reabordaje que incluye la homeopatía en la propuesta terapéutica. Presentación del caso: Paciente del sexo femenino, inicialmente con 4 años de edad con una lesión en la región de pre-maxila. Después de la evaluación radiográfica, tomográfica, exámenes sanguíneos y biópsia incisional con el diagnóstico, se realizó en un primer momento la exéresis de la lesión bajo anestesia general, por curetaje con aplicación de solución de carnoy. En los exámenes de acompañamiento, después de la aparición de imagen radiopaca, se inició el tratamiento no invasivo con homeopatía e inyecciones de corticoides para la reducción y neoformación ósea en el área sugestiva de tejido cicatricial. Conclusiones: Los enfoques más conservadores pueden ser, en muchos casos, una opción plausible que termina librando al paciente de cirugías de mutilación(AU)


ABSTRACT Introduction: Giant cell central lesion is characteristic of the gnathic bones, being a non-odontogenic benign tumor. Classified as a predominantly slow grotwh, well-circumscribed and asymptomatic lesion usually diagnosed through routine examination or in some and more advanced cases once it begins to create some aesthetic-anatomical alteration or when the patient starts complaining of some located discomfort in the region. Objective: To present a clinical case of central giant cell lesion and its resolution involving surgical approach and second management, which includes homeopathy as a therapeutic proposal. Case presentation: central giant cell lesion located in the premaxilla region in a 4 years old female patient. After radiographic, tomographic and blood exams evaluation, followed by incisional biopsy and diagnostic, leading to surgical approach to remove the entire lesion by curettage with Carnoy's solution application under general anesthesia. After appearance of radiopaque imaging in the proservation examinations, the non-invasive treatment by corticoid injection and homeopathy got started aiming the reduction of cicatricial tissue's suggestive area and neoformation of the bone. Conclusions : approaches that are more conservative can be, in many cases, a plausible option that ends up ridding the patient of mutilating surgeries(AU)


Assuntos
Humanos , Feminino , Pré-Escolar , Doenças Maxilares/cirurgia , Tumores de Células Gigantes/diagnóstico por imagem , Homeopatia/efeitos adversos
6.
BMJ Case Rep ; 12(5)2019 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-31142491

RESUMO

We present a teetotaler with compensated non-alcoholic fatty-liver-disease related cirrhosis who presented with acute worsening of his chronic liver disease. The acute event was not discernible even after extensive work up and finally a transjugular liver biopsy revealed features suggestive of severe alcoholic hepatitis. The patient and the family denied occult alcohol use when questioned over multiple times and finally, the culprit 'alcohol' was found to be the homoeopathy medicines that the patient was consuming over a month for treatment of Gilbert's syndrome. We retrieved and tested the homoeopathy drug for alcohol content and found an alarming 18% ethanol in the same, confirming our diagnosis.


Assuntos
Abstinência de Álcool , Hepatite Alcoólica/etiologia , Homeopatia/efeitos adversos , Hepatopatia Gordurosa não Alcoólica/complicações , Adulto , Etanol/efeitos adversos , Etanol/análise , Doença de Gilbert/tratamento farmacológico , Hepatite Alcoólica/diagnóstico , Humanos , Hiperbilirrubinemia/tratamento farmacológico , Cirrose Hepática/complicações , Masculino , Materia Medica/efeitos adversos , Materia Medica/química , Obesidade/complicações
7.
PLoS One ; 14(5): e0216707, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31083699

RESUMO

OBJECTIVE: To compare the differences in the use of healthcare services: visits to the doctor and hospitalisation, performance of routine tests, and preventive influenza vaccination, between users and non-users of homeopathic products. METHODS: We used the microdata for adults over 15 years old from three waves of the Spanish National Health Survey, corresponding to the years 2011, 2014 and 2017. We proposed a comparative design of a quasi-experimental type, considering as the treatment group the respondents who said that they had used homeopathic products in the past two weeks; and another group, for control, comprising respondents who said that they had not used this type of products, but only conventional medicines, with observable characteristics similar to those of the treatment group. We used a model for rare events logistics regression (relogit) to estimate the probability of using homeopathy. From the propensity score and a vector of control variables, we used techniques of genetic matching to match individuals from the treatment group with similar individuals belonging to the control group. RESULTS: There are no statistically significant differences between users and non-users of homeopathy in visits to the general practitioner (P>|z| 0.387), to the specialist (P>|z| 0.52), in hospitalisations (P>|z| 0.592) or in the use of emergency services (P>|z| 0.109). Nor were there any statistically significant differences in the performance of routine tests, except for the faecal occult blood test, which is more prevalent in users of homeopathic products. 20.9% of users of homeopathy had done this test compared with 15.3% of non-users (P>|z| 0.022). There are also significant differences in vaccination against influenza with 12.6% of homeopathy users stating that they had been vaccinated in the last influenza campaign, against 21.0% of non-users (P>|z| <0.001). The health conditions which homeopathy users reported were constipation (OR: 1.65 CI: 1.16-2.36), malignant tumour (OR: 1.60 CI: 1.09-2.36) osteoporosis (OR: 1.49 CI: 1.05-2.10), varicose veins (OR: 1.35 CI: 1.05-1.74) and allergy (OR: 1.35 CI: 1.06-1.72). CONCLUSIONS: Differences in the use of healthcare resources between users and non-users of homeopathic products have not been found to be statistically significant in Spain. It has been shown that most homeopathic products are used as a complement to treatment with conventional medicine. Nevertheless, our results highlight some warning signs which should raise the attention of healthcare authorities. The use of these therapies in patients with malignant tumours and the rejection of vaccines are warning signs of a possible health hazard in the long term.


Assuntos
Assistência à Saúde/tendências , Homeopatia/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Adolescente , Adulto , Feminino , Inquéritos Epidemiológicos , Homeopatia/efeitos adversos , Humanos , Masculino , Materia Medica/efeitos adversos , Pessoa de Meia-Idade , Espanha
8.
Swiss Med Wkly ; 149: w20071, 2019 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-30994926

RESUMO

Arsenic is a toxicant that has no dose threshold below which exposures are not harmful. Here I report a curious association of chronic homeopathic arsenic ingestion with nonspecific symptoms in a Swiss teenager. For about 4 years she had taken globules of a freely purchasable homeopathic remedy containing inorganic arsenic (iAs), infinitesimally diluted to D6 (average arsenic content per single globule: 0.85 ± 0.08 ng). In the previous 7 months she had taken 20 to 50 globules daily (average 30 ng arsenic daily). She complained of nausea, stomach and abdominal cramps, diarrhoea and flatulence, headache, dizziness, anxiety, difficulty concentrating, insomnia, snoring, leg cramps and fatigue, loss of appetite, increased thirst and sweating, reduced diuresis, weight gain, paleness and coolness of both hands with a furry feeling of the hands, eczema of the hands, arms and legs, conjunctivitis and irregular menstruation. The physical and laboratory examinations showed a body mass index of 30 kg/m2, acne vulgaris, bilateral spotted leukonychia, eczema of hands, arms and legs, non-pitting oedema of the legs, elevated plasma alkaline phosphatase activity, folate deficiency and severe vitamin D3 insufficiency. The arsenic concentration in her blood was <0.013 µmol/l, and arsenic was undetectable in her scalp hair. The total iAs concentration was 116 nmol/l in the morning urine and 47 nmol/l in the afternoon urine. The urinary arsenic concentration decreased and the patient’s complaints improved upon interruption of the arsenic globules, vitamin D3, thiamine and folic acid supplementation, and symptomatic therapy. It is concluded that an avoidable toxicant such as inorganic arsenic, for which no scientific safe dose threshold exists, should be avoided and not be found in over-the-counter medications.


Assuntos
Intoxicação por Arsênico/etiologia , Arsenicais/efeitos adversos , Fármacos Gastrointestinais/efeitos adversos , Homeopatia/efeitos adversos , Adolescente , Feminino , Fármacos Gastrointestinais/química , Humanos
9.
Regul Toxicol Pharmacol ; 103: 253-273, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30771368

RESUMO

The considerable number of homeopathic medicinal products (HMP) on the German market and the staggering breadth of active substances of various origin along with the specific legal requirements of adequate safety principles posed the need to compile data on toxicologically evaluated raw materials. In line with the European regulatory framework, HMP applications must consider appropriate safety standards in analogy to conventional human medicinal products. This review presents an option for a systematic and scientifically substantiated approach for regulatory use. Furthermore, this paper provides a multitude of data for selected raw materials processed in HMP with up to now rather scarce knowledge and, thus, aims at filling data gaps on acceptable amounts per day (AAD). The inclusion of raw materials into the compilation was determined considering the frequencies of their occurrence in HMP in Germany along with the availability of appropriate safety assessments. This safety evaluation compilation represents a practical, fairly comprehensive and systematic set of more than 170 raw materials. It is designed to both effectively support regulatory decision making and to be recognized and exploited by applicants, stakeholders and the scientific community.


Assuntos
Homeopatia/efeitos adversos , Materia Medica/efeitos adversos , Alemanha , Humanos , Medição de Risco
10.
Cochrane Database Syst Rev ; 9: CD005974, 2018 09 09.
Artigo em Inglês | MEDLINE | ID: mdl-30196554

RESUMO

BACKGROUND: Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs annually. Although these infections are self-limiting, symptoms can be distressing. Many treatments are used to control symptoms and shorten illness duration. Most have minimal benefit and may lead to adverse effects. Oral homeopathic medicinal products could play a role in childhood ARTI management if evidence for effectiveness is established. OBJECTIVES: To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections in children. SEARCH METHODS: We searched CENTRAL (2017, Issue 11) including the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 27 November 2017), Embase (2010 to 27 November 2017), CINAHL (1981 to 27 November 2017), AMED (1985 to December 2014), CAMbase (searched 29 March 2018), British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov trials registers (29 March 2018), checked references, and contacted study authors to identify additional studies. SELECTION CRITERIA: Double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self-selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on URTI recovery, and four studies investigated the effect on preventing URTIs after one to three months of treatment, followed up for the remainder of the year. Two treatment and two prevention studies involved homeopaths individualising treatment. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products.We found several limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many had additional domains with unclear risk of bias. Three studies received funding from homeopathy manufacturers; one support from a non-government organisation; two government support; one was cosponsored by a university; and one did not report funding support.Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products; trials at uncertain and high risk of bias reported beneficial effects.We found low-quality evidence that non-individualised homeopathic medicinal products confer little preventive effect on ARTIs (OR 1.14, 95% CI 0.83 to 1.57). We found low-quality evidence from two individualised prevention studies that homeopathy has little impact on the need for antibiotic usage (N = 369) (OR 0.79, 95% CI 0.35 to 1.76). We also assessed adverse events, hospitalisation rates and length of stay, days off school (or work for parents), and quality of life, but were not able to pool data from any of these secondary outcomes.There is insufficient evidence from two pooled individualised treatment studies (N = 155) to determine the effect of homeopathy on short-term cure (OR 1.31 favouring placebo, 95% CI 0.09 to 19.54; very low-quality evidence) and long-term cure rates (OR 0.99, 95% CI 0.10 to 9.67; very low-quality evidence). Adverse events were reported inconsistently; however, serious events were not reported. One study found an increase in the occurrence of non-severe adverse events in the treatment group. AUTHORS' CONCLUSIONS: Pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on ARTI recurrence or cure rates in children. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, so conclusions about safety could not be drawn.


Assuntos
Homeopatia/métodos , Infecções Respiratórias/terapia , Doença Aguda , Administração Oral , Antibacterianos/uso terapêutico , Criança , Pré-Escolar , Homeopatia/efeitos adversos , Humanos , Lactente , Análise de Intenção de Tratamento , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Apoio à Pesquisa como Assunto , Infecções Respiratórias/prevenção & controle
11.
Cochrane Database Syst Rev ; 4: CD005974, 2018 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-29630715

RESUMO

BACKGROUND: Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs each year. Although these infections are self limiting, the symptoms can be distressing. Many treatments are used to control symptoms and shorten the duration of illness. They often have minimal benefit and may lead to adverse effects. Oral homeopathic medicinal products could play a role in the treatment of ARTIs for children if evidence for effectiveness is established. OBJECTIVES: To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat acute respiratory tract infections in children. SEARCH METHODS: We searched CENTRAL (2017, Issue 11), which contains the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 27 November 2017), Embase (2010 to 27 November 2017), CINAHL (1981 to 27 November 2017), AMED (1985 to December 2014), CAMbase (searched 29 March 2018), British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov trials registers (29 March 2018), checked references, and contacted study authors to identify additional studies. SELECTION CRITERIA: Double-blind, randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included eight RCTs of 1562 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for upper respiratory tract infections (URTIs). Four treatment studies examined the effect on recovery from URTIs, and four studies investigated the effect on preventing URTIs after one to three months of treatment and followed up for the remainder of the year. Two treatment and two prevention studies involved homeopaths individualising treatment for children. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products.We found several key limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many had additional domains with unclear risk of bias. Three studies received funding from homeopathy manufacturers; one reported support from a non-government organisation; two received government support; one was cosponsored by a university; and one did not report funding support.Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products; trials at uncertain and high risk of bias reported beneficial effects.We found low-quality evidence that non-individualised homeopathic medicinal products confer little preventive effect on ARTIs (OR 1.14, 95% CI 0.83 to 1.57). We found low-quality evidence from two individualised prevention studies that homeopathy has little impact on the need for antibiotic usage (N = 369) (OR 0.79, 95% CI 0.35 to 1.76). We also assessed adverse events, hospitalisation rates and length of stay, days off school (or work for parents), and quality of life, but were not able to pool data from any of these secondary outcomes.There is insufficient evidence from two pooled individualised treatment studies (N = 155) to determine the effect of homeopathy on short-term cure (OR 1.31, 95% CI 0.09 to 19.54; very low-quality evidence) and long-term cure rates (OR 1.01, 95% CI 0.10 to 9.96; very low-quality evidence). Adverse events were reported inconsistently; however, serious events were not reported. One study found an increase in the occurrence of non-severe adverse events in the treatment group. AUTHORS' CONCLUSIONS: Pooling of two prevention and two treatment studies did not show any benefit of homeopathic medicinal products compared to placebo on recurrence of ARTI or cure rates in children. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, so conclusions about safety could not be drawn.


Assuntos
Homeopatia/métodos , Infecções Respiratórias/terapia , Doença Aguda , Antibacterianos/uso terapêutico , Criança , Homeopatia/efeitos adversos , Humanos , Análise de Intenção de Tratamento , Placebos/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Apoio à Pesquisa como Assunto , Infecções Respiratórias/prevenção & controle
12.
Trials ; 18(1): 299, 2017 06 30.
Artigo em Inglês | MEDLINE | ID: mdl-28666463

RESUMO

BACKGROUND: Despite controversy regarding homeopathy, some patients consult homeopaths for depression. Evidence is required to determine whether this is an effective, acceptable and safe intervention for these patients. METHODS: A pragmatic trial using the "cohort multiple randomised controlled trial" design was used to test the effectiveness of adjunctive treatment by homeopaths compared to usual care alone, over a period of 12 months in patients with self-reported depression. One third of patients were randomly selected for an offer of treatment provided by a homeopath. The primary outcome measure was the Patient Health Questionnaire (PHQ-9) at 6 months. Secondary outcomes included depression scores at 12 months; and the Generalised Anxiety Disorder (GAD-7) outcome at 6 and 12 months. RESULTS: The trial over-recruited by 17% with a total of 566 patients. Forty percent took up the offer and received treatment. An intention-to-treat analysis of the offer group at 6 months reported a 1.4-point lower mean depression score than the no offer group (95% CI 0.2, 2.5, p = 0.019), with a small standardized treatment effect size (d = 0.30). Using instrumental variables analysis, a moderate treatment effect size in favour of those treated was found (d = 0.57) with a between group difference of 2.6 points (95% CI 0.5, 4.7, p = 0.018). Results were maintained at 12 months. Secondary analyses showed similar results. Similar results were found for anxiety (GAD-7). No evidence suggested any important risk involved with the intervention. CONCLUSION: This trial provides preliminary support for both the acceptability and the effectiveness of treatment by a homeopath for patients with self-reported depression. Our results provide support for further pragmatic research to provide more precise estimates of treatment effect. TRIAL REGISTRATION: ISRCTN registry, ISRCTN02484593 . Registered on 7 January 2013.


Assuntos
Depressão/terapia , Homeopatia/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos Clínicos , Depressão/diagnóstico , Depressão/psicologia , Inglaterra , Feminino , Homeopatia/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Questionário de Saúde do Paciente , Dados Preliminares , Escalas de Graduação Psiquiátrica , Projetos de Pesquisa , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
13.
J Evid Based Complementary Altern Med ; 22(2): 251-259, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27215693

RESUMO

Indian patients' preference for integrated homoeopathy services remains underresearched. Two earlier surveys revealed favorable attitude toward and satisfaction from integrated services. The objectives of this study were to examine knowledge, attitudes, and practice of homoeopathy and to evaluate preference toward its integration into secondary-level health care. A cross-sectional survey was conducted during May to October 2015 among 659 adult patients visiting randomly selected secondary-level conventional health care setups in Kolkata, Mumbai, Kottayam, and New Delhi (India) using a self-administered 24-item questionnaire in 4 local vernaculars (Bengali, Marathi, Malayalam, and Hindi). Knowledge and practice scores were compromised; attitude scores toward integration and legal regulation were high. Respondents were uncertain regarding side effects of homoeopathy and concurrent use and interactions with conventional medicines. A total of 82.40% (95% confidence interval = 79.23, 85.19) of the participants were in favor of integrating homoeopathy services. Preference was significantly higher in Delhi and lower in Kottayam. Probable strategic measures for further development of integrated models are discussed.


Assuntos
Atitude do Pessoal de Saúde , Prestação Integrada de Cuidados de Saúde , Homeopatia , Preferência do Paciente/estatística & dados numéricos , Adulto , Atitude Frente a Saúde , Estudos Transversais , Prestação Integrada de Cuidados de Saúde/métodos , Prestação Integrada de Cuidados de Saúde/normas , Feminino , Homeopatia/efeitos adversos , Homeopatia/métodos , Homeopatia/psicologia , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Determinação de Necessidades de Cuidados de Saúde , Melhoria de Qualidade , Inquéritos e Questionários
15.
Med Clin North Am ; 100(5): 1089-99, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27542428

RESUMO

Dietary supplements are commonly used by patients as part of their medical care plan. Often clinicians may not be aware of their use, because patients do not always consider these to be medications. All clinicians need to continually ask patients about their use of dietary supplements when collecting a medication history. Dietary supplements and prescription medications often share similar enzymatic pathways for their metabolism. These interactions may lead to severe adverse reactions. This article reviews available evidence for a variety of dietary supplements in select disease categories.


Assuntos
Doenças Cardiovasculares/prevenção & controle , Suplementos Nutricionais , Interações Medicamentosas , Fitoterapia , Preparações de Plantas , Depressão/prevenção & controle , Diabetes Mellitus/prevenção & controle , Suplementos Nutricionais/efeitos adversos , Homeopatia/efeitos adversos , Humanos , Hipersensibilidade/prevenção & controle , Masculino , Medicamentos sem Prescrição/efeitos adversos , Obesidade/prevenção & controle , Fitoterapia/efeitos adversos , Preparações de Plantas/efeitos adversos , Medicamentos sob Prescrição , Hiperplasia Prostática/prevenção & controle , Infecções Respiratórias/prevenção & controle , Infecções Urinárias/prevenção & controle
16.
Complement Ther Med ; 26: 146-63, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-27261996

RESUMO

OBJECTIVES: Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed. DESIGN AND SETTING: Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis. RESULTS: A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high. CONCLUSION: Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.


Assuntos
Homeopatia/efeitos adversos , Humanos , Segurança do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco
17.
Dermatol Online J ; 21(11)2015 Nov 18.
Artigo em Inglês | MEDLINE | ID: mdl-26632933

RESUMO

INTRODUCTION: Chromhidrosis is a rare sweat gland disorder characterized by the excretion of colored sweat. It can be classified as apocrine, true eccrine, and pseudochromhidrosis. Amongst the different types of chromhidrosis, green chromhidrosis is extremely rare. We describe herein a case of blue green chromhidrosis induced by ingestion of homeopathic medicine. CASE REPORT: A middle aged man presented to us with blue green discoloration of hands and feet. There was a preceding history of ingestion of homeopathic medication. Histopathology from the involved skin showed greenish particles within eccrine glands. Initial blood copper level was high which returned to normal level after discontinuation of the homeopathic medicine. Spectrophotometry revealed high copper content of the green sweat. CONCLUSION: Our case emphasizes the importance of considering any type of ingested medicine, including homeopathic medicine, as a probable cause of chromhidrosis.


Assuntos
Homeopatia/efeitos adversos , Transtornos da Pigmentação/etiologia , Transtornos da Pigmentação/patologia , Doenças das Glândulas Sudoríparas/etiologia , Doenças das Glândulas Sudoríparas/patologia , Grupo com Ancestrais do Continente Asiático , Cobre/análise , Humanos , Masculino , Pessoa de Meia-Idade , Suor/química
18.
Complement Ther Med ; 23(4): 535-43, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-26275646

RESUMO

UNLABELLED: The registration of adverse events is important to identify treatment that might impose risk to patients. Homeopathic aggravation, a concept unique for homeopathy may impose a particular risk, as it is tolerant towards a worsening of the patients' symptoms. The aim of this study was to explore the classification of patient reported reactions as homeopathic aggravations or adverse drug reactions. DESIGN AND SETTING: In a cross sectional survey, patients were asked to register any reactions they had experienced 14 days after taking homeopathic remedies. Worsening of symptoms was classified as homeopathic aggravation if it was (i) an increase of the patients' existing symptoms (ii) and/or a feeling of well-being that emerged 1-3 days after taking the remedy (iii) and/or headache and/or fatigue accompanying these symptoms. RESULTS: A total of 26% of the participants reported worsening of symptoms. One third was classified as adverse events. Half of these were graded as minor and the other half as moderate according to the Common Terminology Criteria for Adverse Events. Two thirds were classified as homeopathic aggravations. Of these, 73% were classified as minor and 27% as moderate, giving a tendency towards milder severity for those classified as homeopathic aggravations (p=0.065). CONCLUSION: Patients reported a substantial part of the short-term reactions after taking homeopathic remedy as a worsening of symptoms. These reactions were classified as mild and moderate. Hence, the risk connected to homeopathic treatment is minor. More studies are needed to confirm the existence of homeopathic aggravation and how to classify the concept in a clinically meaningful way.


Assuntos
Homeopatia/efeitos adversos , Homeopatia/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Medição de Risco , Inquéritos e Questionários , Adulto Jovem
20.
BMJ Case Rep ; 20152015 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-26038386

RESUMO

Oscillococcinum is an alternative medicine prepared by serial dilution of wild duck heart and liver extracts. This preparation has been labelled as a 'non drowsy, homoeopathic medicine' that 'reduces the duration and severity of flu and flu-like symptoms'. Clinical evidence exists to support this claim and the product has not previously been reported to cause any serious adverse drug reactions. We bring to light, however, a case of angioedema in our patient who was using oscillococcinum for flu-like symptoms. Consumers must therefore exercise caution at the outset of allergy symptoms.


Assuntos
Angioedema/induzido quimicamente , Homeopatia/efeitos adversos , Adulto , Angioedema/tratamento farmacológico , Animais , Patos , Humanos , Influenza Humana/tratamento farmacológico , Masculino , Extratos de Tecidos/efeitos adversos , Resultado do Tratamento
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