"Evidence submitted for health claims should normally include at least one adequately controlled experimental human study, but an adequately controlled observational human study might be sufficient in some circumstances.
If the body of evidence does not include at least one adequately controlled experimental human study, the ASA will usually need to be convinced that the data supplied is sufficiently compelling.
A convincing rationale would need to be provided as to why commissioning an experimental human study would be impractical.
‘Before and after’ studies with little or no control, studies without human subjects, self-assessment studies and anecdotal evidence are unlikely to be considered acceptable as sole support for a “new” claim relating to physiological or psychological action or function in humans.
On their own, outcome studies or audits may not be sufficient as a rigorous basis for claims as there is little way of controlling for bias or for other influences that may have a bearing on the results. In addition, the claims should be able to be applied across the population the evidence should therefore reflect the targeted consumer base, whether general or specific."To some alternative therapists (especially those who aren't familiar with scientific or medical terminology) the term 'adequately controlled' could mean something very different from its intended meaning here. The phrase could mean 'well run' or 'within expected limits' (as in 'her diabetes is adequately controlled' or 'his glucose levels are adequately controlled') or, as it means here, that an appropriate comparison was made between people getting the test treatment and people getting regular treatment or no treatment (the control group).
If people do misunderstand its meaning, how much of a problem in communication does it cause - if any?
The last paragraph in the quote does go some way to explaining how the term is being used but I'm not sure that its meaning is all that clear. Even 'outcome studies' might not mean much to everyone - after all you do a study... it has an outcome ;)
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