First evidence of Beauvais' hypothesis in a plant model.

INTRODUCTION: Beauvais presented the application of a so-called 'quantum-like model of homeopathy' by introducing the idea of a type of randomization/unblinding which he called 'in situ'. He predicted that randomized studies based on this type of randomization/unblinding lead to more pronounced effects in placebo controlled randomized homeopathic trials. We designed an experiment regarding wheat germination and stalk length to investigate Beauvais' idea of 'in situ randomization/unblinding' using a homeopathic dilution of sulphur (LM VI) as compared to placebo as well as to water. AIM AND METHOD: The primary aim of this double-blind randomized controlled experiment was to investigate whether there are differences of 'in situ randomization/unblinding' vs 'central randomization/unblinding' with respect to the effect of a homeopathic substance compared to placebo. The secondary aim of our study was to examine possible differences between the sulphur and the placebo group in the 'in situ' arm regarding germination and/or stalk growth of wheat seedlings measured after a seven days exposure. Wheat was treated either with sulphur LM VI, placebo, or water. The wheat grains were placed on glass lids and treatment was performed following the 'in situ randomization/unblinding' as well as 'central randomization/unblinding' method. Germination was measured and classified into three categories. RESULTS: Under 'in situ' randomization/unblinding the odds of a seed not to germinate is 40% lower if treated with sulphur compared to placebo (p=0.004). In contrast, these odds are practically equal in the 'central' meta-group (OR=1.01, p=0.954). Under 'in situ' randomization/unblinding the odds of a seed to germinate with a length ≥1mm is practically equal if treated with sulphur or with placebo (OR=0.96, p=0.717). In contrast, these odds are 21% higher under sulphur compared to placebo in the 'central' meta-group (OR=1.21, p=0.062). In summary, we found a sulphur effect that is significantly different between 'in situ' and 'central' randomization/unblinding relating to all three stages of germination.

Identifiability of Components of Complex Interventions Using Factorial Designs.

OBJECTIVE: The aim of this contribution is to demonstrate how the component structure of a complex intervention (CI) can be efficiently exploited for study design and statistical analysis by using concepts of factorial designs. Many studies on CIs in complementary and alternative medicine exhibit the structure of factorial designs, where all possible combinations of the levels of two or more treatments occur together. In this contribution, the treatment arms of CI studies are explicitly viewed as factorial combinations of their components. Experimental design offers the general concept of identifiability of effects, that is, unique estimability of the components' effects from the observed data. For factorial designs, a simple cross table representation of the treatment arms can show the components or sums or interactions of components that are identifiable within a given study design. The question of identifiability arises particularly if some combinations of components are not observed (e.g., individualized homeopathic prescription without consultation). Study designs from published homeopathy studies are used for demonstration. CONCLUSIONS: CI studies should explicitly use an intervention's factorial component structure if it is inherent in the treatment arms being compared. In this way, investigators can avoid study designs from which the effects of interest cannot be uniquely estimated and improve the interpretation of estimated effects.

Re-analysis of survival data of cancer patients utilizing additive homeopathy.

In this short communication we present a re-analysis of homeopathic patient data in comparison to control patient data from the same Outpatient´s Unit "Homeopathy in malignant diseases" of the Medical University of Vienna. In this analysis we took account of a probable immortal time bias. For patients suffering from advanced stages of cancer and surviving the first 6 or 12 months after diagnosis, respectively, the results show that utilizing homeopathy gives a statistically significant (p<0.001) advantage over control patients regarding survival time. In conclusion, bearing in mind all limitations, the results of this retrospective study suggest that patients with advanced stages of cancer might benefit from additional homeopathic treatment until a survival time of up to 12 months after diagnosis.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial.

OBJECTIVES: The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. DESIGN: In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. MAIN OUTCOME MEASURES: The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. RESULTS: 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. CONCLUSION: Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy.