Wednesday, December 21, 2011

Questioning Controls in Sham Surgery

The article Why Fake It? How ‘Sham’ brain surgery could be killing off valuable therapies for Parkinson’s disease brought up differing viewpoints on sham surgery. Proponents of sham surgery claim that they are critical about discovering whether new treatments actually work or if the positive outcomes are based solely on placebo. While opponents of sham surgery argue that the sham surgeries are unnecessary and detrimental to advancing therapies.

From a researchers perspective a well-designed study includes several components, the most important being controls. Some people believe that controls should undergo the same treatment regimen the individuals actually receiving the therapy undergo except for the actual treatment because this is the best way to compare to see whether the treatment itself was useful. Others believe that controls should be individuals at a similar disease state who do not receive the treatment. The need for controls in a good research design is important and I believe that all three levels should be assessed. In the article several studies found that individuals that just underwent surgery without getting any of the actual treatment had the same outcome as those who did. I believe that finding is important to know, and can help researchers to further pinpoint what parts of a therapy are beneficial. The ultimate goal of different research trials is to benefit the patient and any information that highlights that should be further studied.

In terms of “Placebo-controlled studies causing the downfall of potentially valuable treatments”, I think that this can be combated if these studies are used to further pinpoint components that are beneficial in therapies rather than obstruct further research. If these studies were used to further explore what occurred in the study and how it could be improved on and eventually used in the actual treatment they could benefit patients in the long run.

From a patients perspective an effective treatment alleviates some of the symptoms of their disease. I found it interesting in the article that both proponents and opponents of sham surgery were more interested in its “scientific” validity than in how it actually affected patients, I think a broader perspective should be adapted in trials to better serve patients. This can be seen from the patient tracked throughout the article who said “I just don’t see how they can call it a placebo effect after ten years.” Outcomes from these studies could and should be used to help patients.

In the article the cost of sham surgery was brought up, I think this is a moot point. There is a need for many different types of controls and expense should not be an issue that obstructs scientific endeavors. Trials should be designed to include as many components as necessary to answer a question, and not just cut out critical parts of this process due to funds.

Additionally, the point of unblinding studies was presented in the article. It was interesting to see that in studies that were unblinded patients that were in the placebo control group had a bad outcome after being told. This was cited for several studies. In medicine and ethics in general the number one rule is do no harm and so it is interesting to see that with these patients this was not the case. As quoted in the paper, “We just don’t know what the psychological effects of unblinding are.” Thus I think it is important that these trials not be unblinded unless there is a benefit to the patient in doing so.

I think as neuroscientist we play an important role in this argument. It is up to us to design research studies that will answer questions that will benefit patients. When we cease to do this we do a disservice to the patients we are trying to help. So although it is important to focus in on a certain issue within a study, it is critical to always keep a broader focus to see what effects our research has on people’s lives. It is also important to understand what our goals are in a study as well as what our participant’s goals are, this will help in ensuring that we maximize both.

--Mfon Umoh
Emory Neuroscience Graduate Program


Want to cite this post?
Umoh, M. (2011). Questioning Controls in Sham Surgery. The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2011/12/questioning-controls-of-sham-surgery.html

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