When sceptics claim that no positive trials of homeopathy exist, they are clearly mistaken. The truth is that there are plenty of them! But many, if not most are of such poor quality that it is safe to suspect they are false-positives. Here is a recent example of this type of scenario.
This new study investigated the clinical effectiveness of a homeopathic add-on therapy in children with upper respiratory tract infections (URTI). It was designed as a randomized, controlled, multi-national clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. IFC tablets contain a fixed combination of 6 homeopathic single substances (Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuanha D3, and Phosphorus D5). IFC was administered according to the following schedule: 8 tablets/day during the first 72 hours, 3 tablets/day during the following 96 hours. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).
A total of 261 paediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, their symptoms resolved significantly earlier, they had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less during the entire URTI episode.
Days until symptom resolution (WURSS-21 item 1) in both treatment groups.
The light grey (IFC-group) and dark grey (ST-group) lines are polynomial fit curves. The dashed line estimates the between-group difference in the number of days after which 50% of patients had symptom resolution.
Between-group differences (IFC − ST) with 95% confidence intervals in the proportion of patients without fever during the observational period.
A difference (%) greater than zero indicates a higher proportion without fever in the IFC-group. Day 1 = Baseline.
The authors concluded that IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use.
On the one hand, this study has many features of a rigorous trial. I am sure that homeopaths will praise its quality, sample size, clever statistical analyses, etc. etc. The trial will therefore be cited by enthusiasts as a poof for homeopathy’s effectiveness and for homeopaths’ laudable research efforts.
On the other hand, one only needs to apply a minimum of critical thinking to find that it has been designed such that it cannot possibly generate a negative result. In fact, the paper turns out to be much more of a marketing exercise than a research effort.
The homeopathic remedy was given as an add-on therapy according to a fairly tedious ritual. It is safe to assume that this ritual created expectations on the parents’ side. These expectations alone suffice to account for the small group differences which seemingly favour homeopathy. The study follows the infamous ‘A+B versus B’ design which (as we have discussed ad nauseam on this blog) is extremely likely to generate false positive findings.
Why do researchers nevertheless plan, conduct and publish such studies (in the case of the paper discussed here, they even published their findings twice! Their previous paper included a larger group of patients of all ages and concluded that the homeopathic treatment shortened URTI duration, reduced the use of symptomatic medication, and was well tolerated.)? The answer can be found, I think, in the small print at the end of the paper:
Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Robert van Haselen has received a consultancy fee from the Deutsche Homöopathie-Union. Manuela Thinesse-Mallwitz received a fee from the Deutsche Homöopathie-Union for coordinating the study. Vitaliy Maidannyk received a fee from the Deutsche Homöopathie-Union for coordinating the study. Stephen L. Buskin is a member of the Advisory Board of the Deutsche Homöopathie-Union. Stephan Weber received a fee from the Deutsche Homöopathie-Union for contributing to the study. Thomas Keller received a fee from the Deutsche Homöopathie-Union for contributing to the study. Julia Burkart is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid. Petra Klement is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid.
Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Deutsche Homöopathie-Union, Karlsruhe, Germany. Deutsche Homöopathie-Union manufactures the homeopathic medicinal product used in this study and provided the publication fee.
I REST MY CASE