Can we all agree that a placebo should be a physiological inert substance?
Please, take a moment to ponder this question. By sharing this common belief we face a harsh reality, and must admit the throne we have placed Evidence Based Medicine (EBM) has problems, or perhaps the more modern term, “issues”.
And yet so many clinical trials are not using proper language. If we want to compare drugs, treatments, or food constituents against other drugs, treatments, or food constituents then that is a different study; not a placebo study. This might come as a huge surprise, but clinical trial after clinical trial repeatedly is touting their study as a placebo controlled trial and yet in the actual study the placebo used is an active chemical compound! The most recent example of this comes from a New England Journal of Medicine paper out of Italy looking at omega-3 fish oil vs. placebo to determine if the cumulative rate of death, non-fatal myocardial infarction (MI), or non-fatal stroke would be different between the two treatments.
What was there placebo?
…not a placebo
They chose olive oil because it is a physiologically inert substance that has no cardio-protective effects known to this date. WAIT!
OOPS? Olive oil just happens to have a TON of data to support it’s efficacy for cardio-protection. In fact the NEJM just published a study on the Mediterranean diet which had either 1 L of olive oil added to it or walnuts and showed that compared to the other diet, a 3% absolute risk reduction or 33% relative risk reduction in heart disease. So again, I ask if we are trying to determine if fish-oil is helpful vs. placebo, why are we not using placebo? I understand that masking patients from the treatment would be difficult but either we truly do a placebo study or we should say that it didn’t really matter if we use fish-oil or olive oil.
A quote from the recent fish oil study, “by the end of the trial the overall cardiovascular risk profile had improved in both groups.”
In fact a recent meta-analysis from JAMA on omega-3 supplementation shows that when olive oil is the “placebo” fish oil doesn’t perform better.
I continue to question excessive use of PUFA. Should they be in our diet? Absolutely. But how much? Here’s a good answer:
“JERF” -Sean Croxton from Underground wellness