Vítor Oliveira, MD
Campinas - SP - Brazil
In this very short paper, I question whether we should keep considering clinical research that lacks control for lifestyle still valid and "evidence-based". Or should we push for all clinical research to be performed under ideal lifestyle conditions?
Keywords: clinical research, research control, research quality, research validation, evidence-based medicine, lifestyle medicine.
Since we now recognize lifestyle factors, such as food, environment, exercise, sleep and emotions, as the basis of health and many, if not all, health conditions are heavily influenced by lifestyle, should we consider clinical research not controlled for, at least, these main lifestyle factors still valid?
Take any randomized, double-blind, placebo controlled trial about some clinical intervention, for instance, a new drug. What would be the results if the analyzed patient pool had ideal lifestyle conditions? Wouldn't that profoundly modify the results? Placebo would be so worst than the drug? Or, actually, even the disease would need drug intervention? And how misguided could be the results if the pool had heterogeneous lifestyle between the intervention and the placebo group, even if they were randomized (since the overall pool was not controlled for lifestyle)?
Indeed, we can conclude that many, perhaps most clinical research lack lifestyle control and that lack puts their validity under serious questioning. It is as if we tested our cars always using tires with lower than ideal air pressure, wrong fuel and inadequate engine oil, because we never considered what were the correct technical specifications to use the machine. Research conditions are simply wrong.
Common present humans and their very bad lifestyle are suboptimal research subjects to generate reliable knowledge about the actual human body and its health, and even less to claim “evidence-based” knowledge. It seems to be only “evidence-based” science about poor lifestyle populations.
We need to correct and control all clinical research for lifestyle and doing this we will eventually find that many of those research are not necessary at all. We will save money, time and lives.
Why are trials controlled for the placebo effect? Because it really matters. The placebo effect, however, is only one small aspect of only one of the main lifestyle factors that hugely impact health (the emotional or mental one).
If we are so concerned to control trials for the placebo effect, we should also be concerned to control trials for all the other main lifestyle factors, such as nutrition, environment, exercise, sleep and other emotional factors.
The demand for placebo-controlled research is a clue for the necessity of broad lifestyle-controlled research in Medicine.
Oliveira, Vítor. “No control for lifestyle: Are almost all clinical research invalid?" Open Science Repository Medicine. Online.open-access (2017): e45011864.
Oliveira, Vítor. “No control for lifestyle: Are almost all clinical research invalid?” Open Science Repository Medicine Online.open-access (2017): e45011864.
Oliveira, Vítor. “No control for lifestyle: Are almost all clinical research invalid?” Open Science Repository Medicine Online, no. open-access (2017): e45011864. doi:10.7392/OPENACCESS.45011864.
Oliveira, V. (2017) ‘No control for lifestyle: Are almost all clinical research invalid?’, Open Science Repository Medicine. Open Science Repository, Online(open-access), p. e45011864. doi: 10.7392/OPENACCESS.45011864.
1. V. Oliveira, No control for lifestyle: Are almost all clinical research invalid?, Open Sci. Repos. Med. Online, e45011864 (2017).
1. Oliveira, V. No control for lifestyle: Are almost all clinical research invalid? Open Sci. Repos. Med. Online, e45011864 (2017).
Research registered in the DOI resolution system as: 10.7392/openaccess.45011864.