In 2006 my mom (then 78) suffered severe back pain, that was found to be a fracture from osteoporosis. She elected to undergo a “new” procedure called vertebroplasty – where a radiologist or orthopedic surgeon would introduce “bone cement” into the area of the fracture to shore it up.
I had heard about this from local radiologists who were telling me this was the way to treat fractures from osteoporosis and provided almost instant relief for patients.
She had no relief. Being hundreds of miles away I asked my radiologist friends who said sometimes a second procedure was needed, and so I asked my mom to go back. She refused – my parents don’t like going to doctors (they are now 90 and 86) and with a bit of Advil she felt better in a few weeks.
Three years later, in 2009, the New England Journal of Medicine published two randomized trials comparing vertebroplasty vs a sham surgery for patients who had osteoporotic fractures. Their conclusion found that vertebroplasty did not decrease pain or disability compared to those who received the “sham” surgery. One year later the American Academy of Orthopedic Surgeons issued a guideline against the use of vertebroplasty for patients like my mom that had osteoporotic fractures.
Sham surgery – that is, surgery that is one arm of a trial where a real surgery is compared against surgery where nothing is done other than anesthesia and incisions, has had an impact in medicine – although not completely.
A list of operations comparing “sham” surgery to real surgery and outcomes:
Arthroscopic knee surgery for “clean out” in osteoarthritis of the knee
-No difference between the sham surgery and the “clean out” leading to the recommendation to not perform arthroscopic knee surgery for these conditions
Arthroscopic knee surgery for torn meniscus repair
“In this seven-center randomized, controlled trial involving symptomatic patients 45 years of age or older with a meniscal tear and imaging evidence of mild-to-moderate knee osteoarthritis, there were no significant differences in the magnitude of improvement in functional status and pain after 6 and 12 months between patients assigned to arthroscopic partial meniscectomy with postoperative physical therapy and patients assigned to a standardized physical-therapy regimen.”
Transmyocardial laster treatment during cardiac catheterization procedures to improve blood flow to the heart
-No difference between the sham surgery and laser treatment.
Acupuncture trials for chronic pain disorders, migraine, tension headache, low back pain, osteoarthritis of the knee
-No different than real acupuncture from sham acupuncture
Placebo surgery for Parkinson’s disease for implantation of stem cells
-No difference in quality of life outcomes the same, 42% major adverse outcome in transplant group v 5% in sham group
Spinal Fusion for Chronic Low Back Pain
“Conclusions. Surgery may be more efficacious than unstructured nonsurgical care for chronic back pain but may not be more efficacious than structured cognitive-behavior therapy.”
What Is the Placebo Effect — It Is Not Mind Over Matter
What is the placebo effect? It is NOT mind over matter, it is not mind-body treatment, instead medicine describes the placebo effect as a positive change in health that is not attributed to the treatment. That change can be from spontaneous improvement, misdiagnosis, classical conditioning, subject expectancy, or the person simply regresses to the mean with their disease.
With any condition there is a tendency to improve or to worsen with a disease. There is a natural history to the disease, and we may not know – or differentiate – that particular disease from another. For example- all leukemias use to be lumped together, but now we know there are many different types- some of which can be cured with simple medication or surgery, but not all of them.
But is the placebo effect “powerful” – when looked at, not really. In May 2001 the New England Journal of Medicine looked at this – the article “Is the Placebo Powerless? An Analysis of Clinical Trials Comparing Placebo with No Treatment.” They “found little evidence in general that placebos had powerful clinical effects.”
Take my mother’s back pain. She could have concluded that over time the vertebroplasty worked, but the natural course of the disease is to improve. My mother, being wise and old, properly concluded it didn’t work and she would avoid going back to a doctor where she might end up worse than before.
Pain is subjective- and pain syndromes can improve or not on their own. Back pain may get better. To date there is not a single randomized study showing improvement with steroids in spite of patients who will swear that the injection helped them.
Knee pain from osteoarthritis – some of it will improve over time, some will not. Patients who experienced the “fake wash out” felt, for the most part, just as good months later as the patients who had the real thing.
If placebo effect were “real” then we would see objective rather than subjective results. For example: if you give a sugar pill and blood sugar decreases . That is a measurable response – as opposed to a subjective response “ my pain is better.”
Complementary and Alternative Medicine (CAM) – or as Dr. Mark Crislip – Supplements, Complementary and Alternative Medicine (SCAM)
When you peddle hope in a bottle, the natural course of most diseases tend to improve and there will always be room for those to take advantage. The role of modern medicine is to use scientific analysis to prevent becoming a peddler of false hope. People who make their money selling acupuncture, chiropractic, homeopathy, chelation therapy, HcG therapy, reiki, hypnosis, and others make their living peddling hope and the list of individuals who have been harmed by peddling hope instead of science is long and contains a list of prominent individuals.
Back to Sham Surgery and Ethics
The four pillars of modern medical ethics are autonomy, nonmaleficence, beneficence, and justice. So how does sham surgery stack up with these pillars?
Autonomy: this involves a well informed patient who makes a decision to become a part of the trial. The patient will know that there may be no benefit to the operation, but with all sham operations the patient is given the opportunity to get the “real” operation if it is proven that the real operation works.
Nonmaleficence: or that we are not to use our skill and knowledge to harm a patient is more problematic. We are not to place our patients in to deliberate harm, or risk for a treatment that does not work. However, there is a caveat here- that the risk associated with the procedure does not constitute a violation of this principle. The difference lies in treatment of a patient versus the voluntary act of participating in a trial for which there is an expected outcome. There are ethical principles involving research of people that have been defined through the Helsinki and other accords. In this case the use of a trial would be to define if a surgery would have a benefit to persons or not – and if the “greater good” to determine that is overwhelming.
Beneficense: determined by the patient- while it is, as a physician, our duty to act in the best interest of the patient – for the comfort of the patient and the well-being of the patient, the ultimate judge of this is the patient. You will notice in places where physicians are “evaluated” that the most common complaints are that they felt the physician was not acting in their best interest – be that the time spent waiting for the physician, the charges that the physician did, or the time that the physician spent with the patient. It is the physician’s goal to ease pain and suffering and not to cause it- although surgeons have to cause pain and suffering in order to cure it later.
Justice: there is a distribution of costs and benefits to the potential research subjects – and it is fair to all.
The questions raised are this- is there a benefit to doing sham surgery? Clearly there is. No surgeon would want to subject a patient to a procedure for which there is no benefit. Humans are naturally subject to confirmation bias, and surgeons are no different about this. We see patients after operations improve and tend to remember them, and tend to file that into our brains as proof- when in fact it is anecdotal to our experience. However, our confirmation bias inhibits us from science – after the study about vertebroplasties it still took the Academy of Orthopedics a year to comment about the topic. In spite of showing certain operations have no benefit, surgeons will still preform them – because in “their hands” they have seen positive results. That is confirmation bias – and what every person who practices CAM or SCAM relies upon.
REFERENCES WORTH READING
Sham procedures and the ethics of clinical trials. J R Soc Med. Dec 2004; 97(12): 576–578. Miller FG and Kaptchuk TJ
Randomized Surgical Trials and “Sham” Surgery: Relevance to Modern Orthopaedics and Minimally Invasive Surgery.Iowa Orthop J. 2006; 26: 107–111. Wolf BR and Buckwalter JA.
Systematic Review of Randomized Trials Comparing Lumbar Fusion Surgery to Nonoperative Care for Treatment of Chronic Back Pain
Mirza, Sohail K. MD, MPH*†‡; Deyo, Richard A. MD, MPH*†§∥ Spine:1 April 2007 – Volume 32 – Issue 7 – pp 816-823
Do doctors pay attention to negative randomized clinical trials? by David Gorski in the blog Science-Based Medicine
Acupuncture Doesn’t Work by Steven Novella in the blog Science-Based Medicine
Why placebo surgery is ethical, and necessary in the blog Doctor Skeptic
placebo effect in the blog skepdic.com – a great review about the placebo effect with references .
