The placebo effect or the placebo response

Placebo Effect (Doctor Who)

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Evidence-based medicine for all it’s ugly by products, is here to stay.  This means that any therapies/medicines/approaches to helping patients with illness must be proven by outcomes in a controlled and documented manner.  That means just simply saying, ‘see it works’ will not cut it.  Since 1993, when the Cochrane Collaboration was formed and recommended that all studies be conducted as full ‘ Randomized Control Studies’, evidence-based medicine has dominated Western thinking.  Those who have promoted that we treat patients the same way as we have always done without properly conducting trials when possible are of course not happy with this type of medicine.  Those who promote ‘complimenary and alternative medicine or CAM‘ are also not too happy, as many state that the effectiveness of that type of therapy is based on hundreds of years of experience. However, many supporters of CAM have been conducting randomized control trials to address these concerns about real efficacies.  So far, no CAM therapies have been proven effective after these trials are done.

So this is where placebos come in to play.  A placebo is an agent that is given to a patient that does NOT contain the active ingredient or ‘device’ being tested in the experimental arm.  So, if for asthma medication treatment study that could be the inhaled drug albuterol as the experimental agent and inhaled air as a placebo.  A placebo is designed to act as a type of control.  However, it is not a true control as if it is inhaled (even air) it may be perceived to provide some benefit by the patient.  A true control would be non-intervention or nothing.  So inhaled albuterol, inhaled air as a placebo and nothing as a true negative control is a great example of a randomized control trial design.  The patient does not know which one he/she is given (the placebo or albuterol) but will know if they are in the nothing treatment arm. 

This is actually a true study designed to look at the placebo effect.  This particular study published in the New England Journal of Medicine and compared the effects of inhaled asthma drug, placebo, acupuncture, and no treatment conditions.  The interesting thing is that when all of these were compared the placebo, the acupuncture and even the no treatment conditions all showed strong subjective responses.  This means that when patients were asked how these treatments made them feel about their asthma, they were very positive in their answers.  The drug was slightly higher at about 50% subjective responses while the acupuncture and placebo were both at about 45%, not much lower.  The lowest response came from those with no intervention; 21% of those folks felt that no treatment made them feel much better.  Seems good right?  Wow, seems like we can avoid expensive drugs and just take inhaled air or go see an acupuncturist right?

No, it turns out that the second set of data is what really makes people stand up and take notice.  When you actually measure the amount of air that gets in through the lungs (by an accepted lung air measuring medical device) the data looks completely different. When they actually measure physiologic response; ONLY the inhaled drug works well and gives a measurable response.  Whereas all three other treatment (or lack of it) gave the same low response.  So, the body really does react to the drug and only very little to the non drugs (or the placebo effect). There was actually no difference in physiologic or objective responses between the non-intervention or the placebo or acupuncture.  They were the same.  The body derives zero benefit from these as compared to no treatment.  

So, not to trash the CAM believers in any way…this is only one study on Asthma and not the definitive study on all other indications where traditional chinese medicine or other CAMs may have some effects (positive not negative).  But, this is fairly drastic news for those who propose that the placebo effect may explain how CAM works…as the placebo effect (in this case) is a fallacy.  It also underscores something else very important….that is, subjective responses (I feel, he feel, she feels) are very dangerous and recording them may not be the best measurement when looking at medications and treatments.  This is a big issue now?  Do we look at objective or subjective measurements?  For evidence-based medicine, the answer is clearly objective outcomes. 

Thank you for reading…Dr. G Cancer Made Simple  

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