A quantum-like model of homeopathy clinical trials: importance of in situ randomization and unblinding.
ABSTRACT The randomized controlled trial (RCT) is the 'gold standard' of modern clinical pharmacology. However, for many practitioners of homeopathy, blind RCTs are an inadequate research tool for testing complex therapies such as homeopathy.
Classical probabilities used in biological sciences and in medicine are only a special case of the generalized theory of probability used in quantum physics. I describe homeopathy trials using a quantum-like statistical model, a model inspired by quantum physics and taking into consideration superposition of states, non-commuting observables, probability interferences, contextuality, etc.
The negative effect of blinding on success of homeopathy trials and the 'smearing effect' ('specific' effects of homeopathy medicine occurring in the placebo group) are described by quantum-like probabilities without supplementary ad hoc hypotheses. The difference of positive outcome rates between placebo and homeopathy groups frequently vanish in centralized blind trials. The model proposed here suggests a way to circumvent such problems in masked homeopathy trials by incorporating in situ randomization/unblinding.
In this quantum-like model of homeopathy clinical trials, success in open-label setting and failure with centralized blind RCTs emerge logically from the formalism. This model suggests that significant differences between placebo and homeopathy in blind RCTs would be found more frequently if in situ randomization/unblinding was used.
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ABSTRACT: Introduction it is assumed that, as measured during randomised placebo-controlled trials, specific and non-specific effects of an intervention do not interact with each other, and are simultaneously observable. It is argued this assumption means the results of RCTs (particularly for complex interventions, such as homeopathy) are treated too simplistically. Purpose of study to examine if a complex intervention's specific effects and non-specific effects are complementary (in a sense derived and generalised from quantum theory), i.e., correlated sets of observables from an RCT, in which both are necessary to achieve a more complete understanding of the efficacy of an intervention. Methods building on earlier work, and based on the properties of Abelian and non-Abelian algebras, a mathematical argument is developed, which is used to examine the nature of the relationship between a complex intervention's specific effects and non-specific effects as observables from RCTs. Results the mathematical argument suggests that it is essentially incorrect to assume specific effects and non-specific effects of a complex intervention (as measured during an RCT of a complex intervention) can be separated into simultaneously measurable, non-interacting sets of observables. Conclusion this calls into question not only the legitimacy of conclusions drawn from RCTs, but also the blinded observational stance of the RCT protocol (which currently justifies - and is justified by - a reductionist approach to the efficacy of complex therapeutic interventions). Indeed, such RCTs might well be demonstrating a Heisenberg-type Uncertainty between the specific effects of the intervention and the non-specific effects of the consultation, as complementary observable parts making up a whole irreducible phenomenon: the therapeutic process.European Journal of Integrative Medicine 06/2014; 6(5). DOI:10.1016/j.eujim.2014.06.008 · 0.65 Impact Factor
Article: Local, entangled or both?Homeopathy: the journal of the Faculty of Homeopathy 04/2013; 102(2):85-6. DOI:10.1016/j.homp.2013.03.001 · 0.75 Impact Factor