Homeopathic care for the prevention of upper respiratory tract infections in children: A pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls

doi:10.1016/j.ctim.2005.06.007

Complementary Therapies in Medicine

Volume 13, Issue 4, December 2005, Pages 231-238

https://doi.org/10.1016/j.ctim.2005.06.007 Get rights and content

Summary

Objective

To investigate whether individualised treatment by homeopaths is effective in preventing childhood upper respiratory tract infection (URTI).

Methods

Open, pragmatic, randomised parallel-group trial with waiting-list group as control. One hundred and sixty-nine children below the age of 10 years, recruited by post from children previously diagnosed with URTI, were randomly assigned to receive either pragmatic homeopathic care from one of five homeopaths for 12 weeks or to a waiting-list control using self-selected, conventional health care.

Result

There was a significant difference in median total symptom score in favour of homeopathic care (24 points) compared to the control group (44 points) (p = 0.026). The difference in the median number of days with URTI symptoms was statistically significant with 8 days in the homeopathic group and 13 days in the control group (p = 0.006). There was no statistical difference in the use of conventional medication or care between the two groups.

Conclusion

In this study, there was a clinically relevant effect of individualised homeopathic care in the prevention of URTI in children.

Introduction

There are published studies on the effect of homeopathic medicine and homeopathic care for upper respiratory tract infection (URTI),¹ but the main body of clinical research has been in adults and has used one homeopathic medicine or a combination of several, compared to placebo; only a few studies concern the effect of individualised homeopathic care or the specific effect of homeopathic medicines for children with URTI.2, 3, 4, 5

The lack of clinically relevant research in homeopathy has been emphasised.1, 6 There is a need for studies that explore pragmatically the effect of the everyday provision of homeopathic care in commonly treated conditions.

Homeopathy is frequently used for children.7, 8 In Germany, nearly a third of the patients in homeopathic medical practice are children.⁹ The proportion of homeopathic consultations in Norway involving children below the age of 10 years has increased from 10% in 1985 to 26% in 1998,¹⁰ with respiratory and skin complaints as the main diagnostic groups. Most of these children have recurrent complaints and use homeopathy as a preventative treatment. Therefore, more rigorous information about its clinical effectiveness and cost within this population group is essential in order for both health personnel and patients to make informed treatment decisions.

A Norwegian population study found that during 1 year, 4-year-old children with frequent colds and otitis media visited physicians ten times more frequently than all other children.¹¹ Children with upper respiratory tract infections are also frequent users of antibiotics,¹² despite some evidence of only modest clinical effect.¹³

The objective of this trial was to investigate whether individualised homeopathic care is effective in the prevention of URTI in children.

Section snippets

Design

This was an open, pragmatic, randomised parallel-group, controlled trial, performed according to the principles of the Helsinki Declaration.¹⁴ The regional committee for medical ethics recommended the study and it was registered with the Norwegian data inspectorate. The study was carried out in Trondheim, a city with 150,000 inhabitants in the middle of Norway.

Inclusion criteria

Children below 10 years of age who had been to a medical doctor for URTI; how often or the number of episodes were not criteria. URTI

Results

One hundred and ninety-three patients returned the informed consent and were eligible to participate. One hundred and sixty-nine of these returned the initial questionnaire and were randomised. Of these, 65 participated in the first period and 104 in the second. One hundred and thirty-four (79%) were recruited from the casualty department, 23 (14%) from the advertisement in the local newspaper and 12 (7%) from the leaflets distributed to the child's health clinics. A total of 27 (16%) patients

Discussion

Children receiving individualised homeopathic care had clinically relevant benefits relating to the prevention of URTI over a 12-week study period.

The strength of this study is that it is pragmatic, mirroring real life for parents of children with URTI and the treatment that they can expect if they consult a homeopath. This study was developed from information obtained from everyday homeopathic practice.¹⁰ Its methodological strengths include an adequate sample size and concealed randomisation.

Conclusion

Child patients receiving homeopathic care experienced fewer days with URTI and fewer symptoms from the URTI, indicating that the whole package of individualised homeopathic care is beneficial in the prevention and treatment of URTI in children. The increase in the proportion of children visiting homeopaths in Norway may be a result of a lay knowledge about this beneficial effect.

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Cited by (42)

Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine
2023, Complementary Therapies in Medicine
Randomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking.
This paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy.
Identification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy.
Recommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented.
The formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.
How can one evaluate the clinical effectiveness of homeopathic therapy? Some thoughts about the report of the High Authority for Health
2019, Revue d'Homeopathie
The recent evaluation of the efficacy of homeopathic medicines by the French High Authority for Health (HAS) mainly focused on the medicine, yet homeopathy is a therapy which should be evaluated as a whole. After having described the main characteristics of this therapy, the examination of the results obtained in different clinical situations examined by the HAS enables clinical evaluation proposals to be put forward, with observational studies and clinical trials adapted to the therapy's key singularity: the individualisation of the treatment. The continued integration of homeopathic medicine in the French health system and its reimbursement is an essential condition for ensuring the development of research and patient safety.
How to evaluate the clinical efficacy of homeopathic therapy? About the French national health authority's report
2019, Revue d'Homeopathie
La récente évaluation de l’efficacité des médicaments homéopathiques par la Haute Autorité de Santé (HAS) a été essentiellement centrée sur le médicament alors que l’homéopathie constitue une thérapeutique qu’il est nécessaire d’évaluer dans son ensemble. Après avoir décrit les caractéristiques essentielles de cette thérapeutique, l’examen des résultats obtenus dans différentes situations cliniques examinées par la HAS permet de faire des propositions d’évaluation clinique, avec des études d’observation et des essais cliniques adaptés à la singularité essentielle de la thérapeutique : l’individualisation du traitement. La poursuite de l’intégration du médicament homéopathique dans le système de santé français et de son remboursement est une condition indispensable pour assurer le développement de la recherche et la sécurité des patients.
The recent evaluation of the efficacy of homeopathic medicines by the French national health authority (HAS) mainly focused on the medicine, yet homeopathy is a therapy which should be evaluated as a whole. After having described the main characteristics of this therapy, the examination of the results obtained in different clinical situations examined by the HAS enables clinical evaluation proposals to be put forward, with observational studies and clinical trials adapted to the therapy's key singularity: the individualisation of the treatment. The continued integration of homeopathic medicine in the French health system and its reimbursement is an essential condition for ensuring the development of research and patient safety.
Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials
2016, Complementary Therapies in Medicine
Citation Excerpt :
There was an inconsistent use of referring measures of adverse effects. Twenty-seven trials54–56,59,61,62,64,65,70–73,75–78,80–86,88,91 used the terminology adverse effects or adverse events. These trials assessed the symptoms as mild/moderate or severe, or serious or non-serious.
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.
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.
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, I² = 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.
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.
Outcome of homeopathic treatment in paediatric patients: An observational study from 1998 to 2008
2010, European Journal of Integrative Medicine
To study the socio-demographic features of the paediatric population treated at the Homeopathic Clinic – Hospital of Lucca (Italy), the observed diseases, the most commonly used remedies, outcome and follow-up of children, in particular with respiratory disease.
An observational longitudinal study was carried out on a total of 2141 patients consecutively examined from 1998 to 2008. We describe the characteristics of paediatric patients (<14 years): sex, age, whether or not they have already used conventional and/or homeopathic therapies, existing disease and follow-up. The outcome was assessed using the Glasgow Homeopathic Hospital Outcome Score (GHHOS).
Paediatric patients were 551 (mean age 5.9 years), representing 25.7% of all patients. Respiratory diseases were present in 337 children, of whom 168 came to at least one follow-up visit. Respiratory infections (337 cases; 61%), followed by dermatological (88 cases; 16%), psychological (45; 8%) and digestive (40; 7%) disorders were the most frequently observed diseases; 68% of children with respiratory disease showed a strong improvement or attained a resolution of their problems.
The likelihood of considerable improvement or resolution of symptoms is significantly higher in patients with problems in the upper respiratory tract (OR: 4.2, 95% CI: 1.6–11.4) and in patients with follow-up of at least 12 months. Therefore, type of disease and follow-up duration were the variables that most strongly affected the probability of success of homeopathic treatment.
The results seem to confirm that homeopathic medicine produces a positive therapeutic response particularly in children presenting respiratory diseases.
Placebo effect sizes in homeopathic compared to conventional drugs - a systematic review of randomised controlled trials
2010, Revista Medica de Homeopatia
Se ha propuesto que el fracaso frecuente de los ensayos clínicos aleatorizados (ECA) y controlados con placebo en el campo de la homeopatía clásica (individualizada) se debe a que el efecto placebo es notablemente mayor que en la medicina convencional.
Comparar el efecto placebo observado en ensayos clínicos de medicamentos homeopáticos y en ensayos clínicos de medicamentos convencionales.
Se llevó a cabo un análisis sistemático de las publicaciones científicas sobre ECA doble ciego controlados con placebo de homeopatía clásica. Se estableció una correspondencia entre cada ensayo y 3 ECA doble ciego controlados con placebo de medicina convencional (principalmente intervenciones farmacológicas) sobre el mismo diagnóstico. Los criterios para establecer la correspondencia incluyeron la gravedad de los síntomas, el criterio de valoración elegido y la duración del tratamiento. El resultado se expresa como porcentaje de cambio de las puntuaciones de los síntomas entre el inicio y el final del tratamiento en el grupo de placebo. Se identificaron los ECA de homeopatía clásica. Diez de ellos se excluyeron debido a la imposibilidad de extraer datos relevantes o a que no fue posible localizar 3 ensayos convencionales correspondientes.
En los 13 grupos de ensayos correspondientes, el efecto placebo en el ensayo homeopático fue mayor que el efecto placebo medio en los ensayos convencionales, y en 12 de los grupos fue menor (p = 0,39). Por otra parte, ninguno de los análisis de subgrupos mostró diferencias significativas.
El efecto placebo en los ECA de homeopatía clásica no parece ser mayor que en los ensayos de medicina convencional.
It has been proposed that the frequent failure of placebo controlled randomised clinical trials (RCT) in the field of classic homeopathy (individualised) is due to the placebo effect being notably greater in conventional medicine.
To compare the placebo effect observed in clinical trials on homeopathic drugs and in clinical trials on conventional drugs.
A systematic review of scientific publications on classic homeopathy placebo controlled, double-blind RCTs. A relationship was established between each trial and 3 conventional medicine placebo controlled, double-blind RCTs (mainly pharmacological interventions) on the same diagnosis. The criteria to establish a relationship included, the severity of the symptoms, the chosen assessment criteria, and the duration of the treatment. The results are expressed as percentage change in the scores of the symptoms between the start and end of treatment in the placebo group. Classic homeopathy RCTs were identified. Ten of them were excluded due to it being impossible to extract the relevant data or it was not possible to find 3 corresponding conventional trials.
In the 13 corresponding trial groups, the placebo effect in the homeopathic trial was greater than the mean placebo effect in conventional trials, and it was less in 12 of the groups (P = 0.39). On the other hand, there were no significant differences in the analysis of the sub-groups.
The placebo effect in classic homeopathy RCTs does not seem to be greater than that in conventional medicine clinical trials.

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^☆: Sources of support: Norwegian Research Council.

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Homeopathic care for the prevention of upper respiratory tract infections in children: A pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls☆

Summary

Objective

Methods

Result

Conclusion

Introduction

Section snippets

Design

Inclusion criteria

Results

Discussion

Conclusion

Lancet

Homeopathy

Homeopathy

A randomized comparison of homoeopathic and standard care for the treatment of glue ear in children

Complement Ther Med

The homoeopathic treatment of otitis media in children—comparisons with conventional therapy

Int J Clin Pharmacol Ther

Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial

Pediatr Infect Dis J

Prevalence of complementary/alternative medicine for children: a systematic review

Eur J Pediatr

Use of unconventional medicine in children in Italy

Eur J Pediatr