Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children.

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.

Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children.

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.

Quantitative and Qualitative Pathogenetic Indices for Review of Data Derived from Homeopathic Pathogenetic Trials.

INTRODUCTION: Analysis of data derived from homeopathic pathogenetic trials (HPTs, homeopathic drug provings) has been a challenge. Most parts of the homeopathic pharmacopeia were sourced from Hahnemann's Materia Medica Pura (1825-1833), TF Allen's Encyclopedia (1874) and Constantine Hering's Materia Medica (1879-1891), well before randomised controlled trials were in use. As a result, such studies and their outcomes harbour a large risk of inclusion of unreliable symptoms. AIMS AND OBJECTIVE: The main purpose of this article is to introduce Quantitative and Qualitative Pathogenetic Indices to improve the method of analysis of symptoms. MATERIALS AND METHODS: The data from HPTs for human immunodeficiency virus nosode, hepatitis C nosode, capsaicin alkaloids (capsaicin and dihydrocapsaicin) and hydroquinone (HQ) were extracted and analysed in terms of novel Qualitative and Quantitative Pathogenetic Indices. Taken into the consideration were the qualitative aspect of a symptom (i.e. its intensity), and the quantitative aspect by calculating the number of symptoms per volunteer per day. The pathogenetic effects and data evaluation indices were calculated for each HPT. A comparison was made of symptoms of verum versus placebo provers in terms of their quantity and quality. RESULTS: Four HPTs involving 81 volunteers (56 on verum and 25 on placebo) generated 555 symptoms or pathogenetic effects (excluding run-in phase symptoms), of which 448 (81%) were reported by volunteers who were in the verum arm, and 107 (19%) were reported by volunteers on placebo. The overall mean incidence of pathogenetic effects for the four HPTs was thus 8 per verum prover and 4.28 per placebo prover. The corresponding mean Quantitative Pathogenetic Index was 0.23 symptoms per volunteer per day for the verum arm and 0.12 symptoms per volunteer per day for the placebo arm. The overall mean incidence of pathogenetic effects in the run-in phase was less. The overall mean Qualitative Pathogenetic Index (number of symptoms, of a given intensity, per volunteer per day) for the verum arm was 0.09 versus 0.05 for the placebo arm. CONCLUSION: The symptoms exhibited by volunteers in the verum arm were more numerous and more intense than those in the placebo arm. An innovative and logical method of reporting of symptoms and analysis has been introduced by the use of these pathogenetic indices, which can be used in future as measurement tools for analysis of data from HPTs.

Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms.

Use of placebo interventions in primary care in Poland.

OBJECTIVE: The aim of the study was to investigate the behavior, beliefs and attitudes of Polish primary care physicians concerning the use of placebo interventions. SUBJECTS AND METHODS: A total of 220 Polish primary care physicians (internists, specialists in family medicine and pediatricians) were asked to participate in a questionnaire survey and 171 agreed to do so. The questionnaire was a self-report of the behavior, beliefs and attitudes of physicians concerning the use of placebo interventions in clinical practice. The percentages are based on the actual number of respondents to each question. RESULTS: Of 169 respondents, 135 (80%) declared that they used or prescribed placebo interventions, with 20/169 (12%) doing so almost every day, 51/169 (30%) once a week and 44/169 (26%) once a month. The most common placebos used were vitamins (86/135, 66%) and homeopathy (73/135, 56%). Among the participants, 114/129 (84%) reported that the placebos were effective, with only 10/129 (8%) considering them rarely effective; 75/139 (54%) of the physicians considered placebo interventions to be effective only in patients with subjective symptoms, 116/139 (73%) indicated that individual traits of patients were decisive factors in the effectiveness of placebo interventions, and 103/159 (65%) thought that the expectations of patients were of importance. A total of 128/170 (75%) respondents thought that the mechanism of placebo effects was purely psychological. CONCLUSION: The use and prescription of placebo interventions seemed to be very common among Polish primary care physicians studied and they generally had positive attitudes towards their use and effectiveness.

Treating menopausal symptoms with a complex remedy or placebo: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy and safety of a complex remedy compared with placebo to treat menopausal symptoms. METHODS: A total of 102 peri- and postmenopausal women requiring treatment for menopausal symptoms were randomized to receive a complex anthroposophic remedy prepared in the homeopathic manner (Apis regina tota GL D4, Argentum metallicum D5, Ovaria bovis GL D4), 3 × 10 globuli daily (2 × 12 weeks) and placebo (12 weeks) in different orders of remedy (R) and placebo (P) (1: R/R/P, 2: P/R/R, 3: R/P/R). The primary endpoint was change in climacteric symptoms assessed by the Menopause Rating Scale II (MRS II) after 12 weeks. Secondary endpoints were changes of symptoms and safety throughout the study. RESULTS: Reduction of symptoms after 12 weeks did not differ between remedy and placebo (total score MRS II: -1.4, 95% confidence interval (CI) -2.8 to 0 vs. -2.3, 95% CI -4.4 to -0.3, p = 0.441) and had no clinical relevance (defined as reduction in MRS II ≥ -3.5). Comparison of secondary outcomes at 12 weeks between remedy and placebo or between groups after the 2nd or 3rd period compared to previous periods did not differ. Treatment with remedy for 24 consecutive weeks did not reach clinical relevance either. However, total reduction of symptoms after three periods in Group 1 (R/R/P) (-5.0, 95% CI -7.5 to -2.5) and Group 2 (P/R/R) (-5.9, 95% CI -8.7 to -3.1) reached clinical relevance whereas almost no decrease of symptoms after three periods was seen in Group 3 (R/P/R) (-0.5, 95% CI -2.9 to 1.9). CONCLUSIONS: Treatment with the complex remedy for 12 or 24 weeks did not result in clinically significant improvement of menopausal symptoms.

Estudo piloto comparativo dos efeitos de placebo e medicação homeopática sobre os níveis pressóricos de pacientes hipertensos / Pilot comparative study of the placebo effects and homoeopathic drugs, on the pressure levels of high blood pressure patients

Os autores realizaram um estudo piloto, na Associação Paulista de Homeopatia, para averiguar os efeitos de placebo e medicação homeopática sobe os níveis pressóricos de pacientes portadores de hipertensão arterial sistêmica idiopática. Foram estudados 19 pacientes em uso concomitante ou não de drogas hipotensoras, sendo 14 do sexo feminino, com idade média de 53 anos, e 5 do sexo masculino, com idade média de 44 anos. Fez-se uso do medicamento homeopático único, escolhido por totalidade sintomática característica, nas dinamizações 6C, 12C, 30C, 200C, em doses repetidas, 2 vezes ao dia, por 4 semanas cada. Todos os pacientes receberam previamente placebo por um período de 4 semanas (fase "washout"). Constatou-se efeito significativo da terapêutica homeopática, porém, dentro de uma dinamização individualizada para cada paciente, além da individualização do medicamento. Os autores finalmente fazem considerações para estudos futuros. (AU)

The authors performed a pilot study at the São Paulo Medical Homeopathic Association to investigate the effects of placebo and homeopathic treatment on the blood pressure of patients with idiopathic hypertension. We analyzed 19 patients concomitantly using or not antihypertensive agents, 14 females, with average age 53 years old, and 5 males, with average age 44 years old. One single homeopathic drug was selected as per the total set of characteristic symptoms, and prescribed in dilutions 6C, 12C, 30C and 200C, in repeated doses, twice per day, over 4 weeks each. All the patients previously received placebo over 4 weeks (washout). We found significant effect of homeopathic treatment, however, only for the best individual dilution, in addition to the individualization of the prescribed drugs. The authors finally make some considerations relative to future studies. (au)

Estudo dos efeitos de placebo X medicamento homeopático na totalidade sintomática característica em hipertensos / Pilot comparative study of the placebo effects and homoeopathic drugs, on the pressure levels of high blood pressure patients

Os autores realizaram um estudo piloto de investigação clínica, no ambulatório da Associação Paulista de Homeopatia, para verificar os efeitos de placebo e de medicamentos homeopáticos, escolhidos por totalidade sintomática característica individual, com um grupo de pacientes portadores de hipertensão arterial. Foi enfocada a capacidade de atuação do placebo e de dinamizações sucessivas de medicamento único, 6C, 12C, 30C e 200C, em doses repetidas, 2 vezes ao dia, na referida totalidade sintomatológica, considerando-se seu desaparecimento ou melhoria. Placebo e homeopatia foram fornecidos em frascos idênticos, a cada 4 semanas, começando pelo placebo, até atingir a 200C. Consultas de controle a cada 2 semanas. Concluise pela significância do medicamento homeopático, que não produziu praticamente agravações ou patogenesias, em doses repetidas. A partir da experiência, os autores sugeres condições melhores para feitura de trabalhos semelhantes, para uma melhor avaliação estatística. (AU)

Nineteen patients with idiopathic high blood pressure were subjected to treatment with placebo and homeopathic medicines. Their effects on the characteristic symptoms used to select the individual medication of each patients were analyzed. Statistically significant effect was found for the homeopathic drugs. No aggravation of pathogenetic symptoms practically occurred with doses taken twice daily. Based on their experience, the authors suggest how to improve studies in this field. (AU)

The context and meaning of placebos for complementary medicine.

Calls for placebo-controlled randomised trials in complementary and alternative medicine (CAM) are entirely reasonable. However, they present major methodological problems, particularly when we understand so little about the underlying biological mechanisms involved for many of these therapies. Designing a placebo in CAM is frequently dependent on unsubstantiated assumptions about the specificity of a particular CAM intervention. In this paper we address the development and application of placebos to clinical trials of homeopathy, acupuncture, kinesiology, Chinese herbal medicine and healing. Each therapy-based vignette is authored by a researcher from the Complementary and Integrated Medicine Research Unit at the University of Southampton who has specific expertise in the field. The essential research question within this review is; can we legitimately claim to have placebos for these particular CAM interventions? In some areas of CAM the debate has become very involved and sophisticated, for instance in acupuncture but for other areas, such as healing, our understanding of placebos is currently limited and very naïve. For instance, if acupuncture is not point specific, then many so-called 'placebo-controlled' acupuncture trials are both misconceived and misleading. We have addressed this debate in what we hope is a thoughtful and rigorous manner with a view to developing realistic, reliable and credible placebos for randomised controlled studies when and where possible. However, our conclusions suggest that we are some way from developing valid, credible and reliable placebos for most CAM therapies.

[Placebo action and alternative medicine]. / Placebowirkung und Alternativmedizin.

Experimental and clinical data concerning placebo effects on pain states and other subjective symptoms are summarized, and show that placebo treatment and psychotherapy are identical. The drugs used by anthroposophical physicians, homeopaths, phytotherapists and therapists attempting to "normalize" the intestinal bacterial flora are in fact pure or impure placebos. Since official medicine is well aware of the scientific basis and favourable results of placebo treatment in psychosomatic and self-limiting diseases, it does not appear necessary to integrate varieties of alternative medicine into graduate and postgraduate medical training.

More trials, fewer placebos, please

The argument that randomized placebo-controlled trials of homeopathy might usefully be replaced by observational studies, audit and quality-of life assessment is considered. Randomized equivalence and patient-preference trials are proposed as more... (AU)

Le placebo / The placebo

Si le recours a la technique du placebo n'est pas interessant pour "demontrer" l'homeopathie, il est essentiel pour faire la part de l'effet "consultation" de l'effet reel de nos traitements homeopathiques. Il permet de reveler... (AU)

Estudo comparativo dos efeitos placebo x medicamento homeopatico, na totalidade sintomatica caracteristica, em hipertensos / Comparative study of the placebo effects vs. homoeopathic drugs in the caracteristic symptomatical totality, in high blood pressure patients

Os autores realizaram um estudo piloto de investigacao clinica, no ambulatorio da Associacao Paulista de Homeopatia, para verificar os efeitos placebo e de medicamentos homeopaticos, escolhidos por tatalidade sintomatologica e caracteristica individual, com um grupo de pacientes portadores de hipertensao arterial. Foi enfocada a capacidade de atuacao do placebo e das dinamizacoes sucessivas de medicamento unico em C6, C12, C30 e C200, em doses repetidas, duas vezes ao dia, na referida totalidade sintomatologica, considerando-se oseu desaparecimento ou melhoria. Placebo e homeopatia foram fornecidos em frascos identicos, a cada 4 semanas, comecando pelo placebo, ate atingir C200. Consultas de controle a cada 2 semanas: Conclui-se pela significancia do medicamento homeopatico, que nao produziu, praticamente, agravacoes ou patogenesias, em doses repetidas. A partir da experiencia, os autores sugerem condicoes melhores para feitura de trabalhos semelhantes, para uma melhor avaliacao estatistica

Estudo piloto comparativo dos efeitos de Placebo e medicacao homeopatica, sobre os niveis pressoricos de pacientes hipertensos / Pilot comparative study of the placebo effects and homoeopathic drugs, on the pressure levels of high blood pressure patients

Os autores realizaram um estudo piloto, na Associacao Paulista de Homeopatia, para averiguar os efeitos de placebo e medicacao homeopatica sobre os niveis pressoricos de pacientes portadores de Hipertensao Arterial Sistemica Idiopatica. Foram estudados 19 pacientes em uso concomitante ou nao de drogas hipotensoras, sendo 14 do sexo feminino com idade media de 53 anos e 5 do sexo masculino com idade media de 44 anos. Fez-se uso de medicamento homeopaticounico, escolhido por totalidade sintomatica caracteristica, nas dinamizacoes C6,C12, C30, C200, em doses repetidas, duas vezes ao dia, por quatro semanas cada. Todos os pacientes receberam previamente placebo por um periodo de 4 semanas (fase "wash-out"). Constatou-se efeito significante da terapeutica homeopatica, porem dentro de uma dinamizacao individualizada para cada paciente, alem da individualizacao do medicamento. Os autores finalmente fazem consideracoes para futuros estudos

Efeito hipnótico de medicaçäo homeopática e do placebo: avaliaçäo pela técnica de duplo-cego e cruzamento / Hypnotic effect of homeopathic medication and placebo: evaluation by double-blind technic

Quarenta e quatro pacientes com isônia foram atendidos nos consultórios de médicos homeopatas e encaminhados ao Departamento de Psicobiologia para responderem a um questionário que avaliava parâmetros do sono: tempo de induçäo, manutençäo, sonhos e pesadelos, e despertar. Estes pacientes passaram a receber em esquema "duplo-cego" a medicaçäo homeopática ou do placebo, durante três meses, por seis vezes, com intervalos de 15 dias. Metade dos pacientes iniciou o tratamento com placebo e após o 45ª dia passou a tomar a medicaçäo homeopática, ocorrendo o inverso com a outra metade. Vinte e seis pacientes terminaram o tratamento, tendo havido melhora marcante da isônia em todos. Esta melhora independeu de medicaçäo ou do placebo e foi observada tanto pelos médicos homeopatas como pelo questionário de sono. Também näo houve distinçäo entre a melhora apresentada por pacientes que iniciaram o tratamento recebendo o medicamento e aqueles que iniciaram com o placebo