Optimism Bias, the Placebo Effect and Snake Oil
On July 30th 2018, the US Food & Drug Administration issued a Safety Communication regarding the safety of energy based devices in vaginal rejuvenation. The FDA explicitly states that the energy devices were neither cleared nor approved for the treatment of symptoms of menopause such as vaginal laxity, dryness, painful intercourse, painful urination, or decreased sexual sensation. The communique emphasizes that the safety and effectiveness of energy based treatments in treating vaginal symptoms has not been established and in some cases may be harmful.
In stark contrast to the recent advisory issued by the FDA, energy based devices from well established brands claim to address a variety of common female maladies including urinary incontinence. What is more concerning is that some vendors have targeted breast cancer patients in order to promote the notion that some side-effects of chemotherapy may be treatable with energy-based vaginal rejuvenation.
To further confound matters, I have personally met many credible clients and physicians who offer frank testimonials to the benefits of vaginal rejuvenation by both LASER and radiofrequency. How then is it possible that a treatment with no proven clinical efficacy is believed to be beneficial by some physicians and patients?
The answer resides in our intrinsic human bias which guides us toward seeing the best of things. That is we want some treatments to work so badly that we see positive outcomes when none exist. It is for this reason we use tools such as statistical analysis to conduct objective analysis in order to arrive at the correct answers. The field of statistics has identified several phenomena that could lead us to believe in outcomes that are not true, including errors in study designs and a variety of observer biases.
Optimism bias is simply our human nature to view things more positively than they actually are. For example, when asked to recall high school academic performances and social popularity, virtually all respondents report a better academic performance and better appearance than the reality.
Another well established bias is the Placebo Effect. That is to say the very act of undergoing a treatment leads us to believe some “cure” may result. The salutary effects of a sugar pill on one’s health cannot be underestimated. In fact it has been determined to be so powerful that upto 40% of subjects respond positively to sham treatments. In some studies of antidepressants, placebos outperformed the very medicines used for the treatment of psychiatric symptoms!
Finally — the term snake oil comes to us from Chinese rail workers of the Transcontinental Railways. These workers relied on an oil, alleged to have been extracted from the the Chinese water snake (Enhydris chinensis), to relieve muscle and joint pains. In reality, the oil was simply a mixture of vegetable oil and camphor. The healing potion was hawked by unscrupulous carpetbaggers who came to personify fraudulent claims and the term “snake oil” has since become a part of the modern lexicon.
Unfortunately in modern aesthetics — the triad of Optimism Bias; the Placebo Effect; and Snake Oil is alive and kicking. This is evidenced by the recent FDA Safety Communication on vaginal rejuvenation with energy devices.
It is always best to discuss treatments with a qualified professional, with the requisite knowledge and training, in order to evaluate the efficacy of a given treatment. It is challenging to know what is best for you and how best to budget for aesthetic treatments when faced with media blitzes and marketing campaigns on the newest and next best thing. A treatment backed by a slick marketing campaign and (paid) celebrity endorsements does not mean it will deliver the promised results.
At the Reddy Aesthetic Institute, we are pleased to explore the evidence, when available, for any questions clients may have regarding the safety and effectiveness of a newly touted treatment. Despite the FDAs best efforts and intentions, the enduring refrain of caveat emptor must still be the rule of the day.
Please consult with your Board Certified Plastic Surgeon or Board Certified Dermatologist when considering a new cosmetic/aesthetic treatment.
Dr. Pravin Reddy is a Board Certified Plastic and Reconstructive Surgeon. Dr. Reddy has performed numerous reconstructive surgeries for gynecologic cancers. As an Adjunct Faculty at the Georgia Institute of Technology, he continues to pursue research in healthcare technologies.
P. Pravin Reddy, MD is a Board Certified Plastic & Reconstructive Surgeon and a member of the American Society of Plastic Surgeons.