Steve Novella started the science-based medicine movement, if movement it is, in part because evidence-based medicine was inadequate to analyze the claims of pseudo-medicines.
The positive results of most pseudo-medicines are a result of bias and poor methodology, not a real effect. But evidence-based medicine was not equipped to counter the false results of pseudo-medical studies with zero prior plausibility.
This is most evident in the Cochrane reviews, which apply their meta-analytical methodologies to the fantastical interventions of acupuncture, homeopathy as if they had meaning.
Science-based medicine is a needed antidote to the subversion of evidence-based medicine. Given the growth of integrative medicine programs in the US, I suspect the antidote is not popular.
I am starting to wonder if we need science-based ethics. What brought this to mind was
It is one thing to do studies on adults who at least have the ability for informed consent, even it the study is entirely based on fantasy. I would think that if the underlying concept of an intervention is, well, wackaloon, it would be hard to justify it in adults. But given the popularity of so many pseudo-medicines, studies need to be done to evaluate efficacy. As if negative studies will have any effect on the practice of pseudo-medical providers.
But given there is no reason what-so-ever to think that acupuncture would have any effect on any process in a child, much less a newborn and colic, it is hard to understand how a clinical trial could occur in children.
I can see where a true believer would want to try acupuncture in a child. But what IRB, whose responsibility it is to protect patients and ensure that there is a
A study should be designed in a way that will get an understandable answer to the valuable research question. This includes considering whether the question researchers are asking is answerable, whether the research methods are valid and feasible, and whether the study is designed with a clear scientific objective and using accepted principles, methods, and reliable practices. It is also important that statistical plans be of sufficient power to definitively test the objective, for example, and for data analysis. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose
would allow newborns to be stuck with needles to test the fantastical theories of acupuncture?
I think this every time I see a badly done clinical trial for pseudo-medicines, but when I see acupuncture or homeopathy being evaluated on children in clinical trials, I think the IRB is seriously broken.
We need science-based ethics applied to IRB’s. No child should be subjected to therapies that have no basis in known reality. If the prior plausibility is essentially zero, the study should not be approved. Studies in adults of pseudo-medicine should only be approved if they are methodologically designed to be definitive, rather than the hodgepodge of badly done biased studies that define the world of pseudo-medicine.
In 2015 we have a good understanding of the human body in health and disease. That understanding needs to be applied by IRB's.