The Ultimate Placebo

The Short Version

• According to Dr. Ian Harris, many of today’s surgeries are no better than sham surgeries or conservative treatment when considering long term outcomes.
• Interventions supported by biologically plausible mechanisms, non-clinical evidence, and anecdotal evidence may be tempting, but we may be fooling ourselves.
• ALL of our outcomes are influenced by the “true” physiological aspects of the intervention, the psychosocial context in which the intervention is delivered, and the natural course of the problem.  
• Consider all of these factors when treating, and when a patient gets better, do not assume it was due to your intervention alone.  

A Thought-Provoking Question From A Patient

During my last week of my last affiliation (yay), a patient asked me a question about a chiropractic treatment she heard about.

“Did you ever hear of a chiropractic treatment where the chiropractor just touches you…..yadda yadda yadda chiropractic nonsense…..and you feel better?”

“That sounds great, DEFINITELY try it…” is what I wanted to say with a small but clear hint of sarcasm.  I ended up dropping the ever-so-subtle hint, and said something to the effect of “I have heard of some things like that, I would try it and see if it helps, but don’t waste your time if it doesn’t.”  Definitely a more diplomatic answer, but the question got me thinking.  It isn’t much different than what we do, considering I was massaging her neck when she asked.  It is extremely easy to critique another profession’s practices, but it is much harder to critique your own.

“It is difficult to get a man to understand something, when his salary depends on his not understanding it.”

-Upton Sinclair   

This brings me to Dr. Ian Harris, orthopedic surgeon from Australia and author of a highly recommended book, Surgery, The Ultimate Placebo.  

Surgeries That Don’t Make The Cut

In his book, Harris makes the case that many of today’s surgeries are not well supported by the gold standard of research; randomized-controlled trials, and much of the improvement seen after surgery is likely due to other factors besides the surgery itself.  If you are a physical therapist, and presumably you are if you are reading a physical therapy blog, this is a must-read for two reasons.  First, it highlights the problems with modern surgery and how conservative care (i.e. US) may lead to the same benefits with less complications.  Second, it provides an example of how to critique one’s own profession from the humble standpoint of reason, logic, evidence, and science, in general.  Many of the ideas brought up in this book are relevant to any critically-minded physical therapist.

A few of the ideas are worth unpacking a bit here, but you NEED to read this book in its entirety.  One big idea Harris discusses is what he terms “the wobbly tripod of surgical evidence.”  Many surgeons justify their choice for surgical intervention balancing atop this precarious bit of mental scaffolding, consisting of:

1. biologically plausible mechanism
2. related evidence from non-clinically relevant research
3. personal experience and observation of patients getting better

(p. 220-222, 2016)

The problem with this, as Harris suggests, is that as humans we are quick to make the logical fallacy of assuming cause and effect when there may or may not be a link.  Something makes sense to us, we have somewhat relevant evidence, and we have anecdotal evidence.  Bing, bang, boom, everything we do is awesome, it all works, no need to look any further, right?  The patients get better, that is all there is to it. Unfortunately, when many surgeries such as spinal fusions, knee arthroscopy, acromioplasty, fracture surgeries, and a long list of others, both orthopedic and non-orthopedic, are compared to sham surgery or conservative treatment in randomized, blinded trials, the long-term outcomes that patients care about like pain and quality of life are no different (Harris, 2016).  These surgeries do help people, just not better than fake ones.  Why are surgeons still doing these surgeries then?  Harris humbly and admirably explores these reasons at length in the remainder of the book and makes the case for doing far less surgeries.   

What We Can Learn From The Rogue Surgeon

One important thing we can pick up is that maybe surgical intervention should be recommended less often.  Harris points out that many patients do just as well with conservative care and you can avoid the risks of surgery.  But that is not the subject of this post.  The more important thing we can learn is how to be more critical of our own profession.

We need to take a look at ourselves and see if we are balancing very carefully on that wobbly tripod.  I suspect that many interventions we do are being bolstered by biologically plausible mechanisms, non-clinically relevant research, and anecdotal evidence instead of placebo-controlled, blinded studies.  Off the top of my head, things like dry needling, ultrasound, foam rolling, trigger point release, some manual therapies, and laser treatments come to mind.  I am not saying that these things don’t help people or that we should stop doing them until we study them, only that they may “work” in a way that may be different than what we think and the results may be much more short-term than we’d like.  When our outcomes are things that are largely subjective, like pain, perceived disability, etc, we have to be much more considerate of how placebo can influence a patient.  

The thing we really want to know is:

Did our treatment work?

Did it work the way we think it did?

…OR…

Is something else going on?

Presumably we want to know what things work AND why they work.  As Harris mentions, like many orthopedic surgeons, they see results, patients feel better, and there is no critical thinking past that.   However, there are other factors that a therapist should consider when evaluating what their treatments are doing.  

Placebo Trials In Physical Therapy

Marco Testa and Giacomo Rossettini, therapists from Italy, discuss these factors in their paper Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes.  A therapeutic outcome, it is argued, always has three components in play:

1. the specific effect of the treatment on a physiological level
2. the contextual effects of treatment on a psychosocial level
3. other sources of recovery or aggravation

(Testa, Rossettini, 2016, p. 7).  

Patients will get better from the treatment, the context in which the treatment was given, and other factors like the natural course of their condition.  The problem is that our estimates of the percentage each component contributes for a given patient’s outcomes may be imprecise.  We may be giving ourselves more credit than we deserve.  According to Testa and Rossettini, data from quantitative studies suggests that patient outcomes and satisfaction may be more influenced by:

• Professionalism, optimism, confidence, and positivity of the therapist
• Strong verbal and non-verbal communication, active listening, and display of empathy
• Patient-centeredness, personalization, and one-on-one time
• A calming, healing environment

(Testa, Rossettini, 2016, p. 6)

Is it possible that your outcomes are more influenced by these factors instead of the “treatment” itself?   Did you really correct their SI obliquity or did you provide a comforting, warm environment, where you told them you will fix their problem?   Does it matter long term if a patient’s C5 can extend appropriately on C6 or they can improve their lower trap MMT score to 4/5, or their multifidus can now kick in during a bird-dog? Or does it matter more that a patient feels safe, has a good relationship with you, and is encouraged to exercise and move as much as possible?

A quick literature search on PubMed did not reveal hundreds of slam dunk studies in favor of physical therapy over placebo treatments or minimal treatments like I was hoping.  The issues with designing placebo trials in physical therapy are discussed by Maddocks et.al.   Physical therapy treatments are complex and multifaceted, and designing a placebo trial is much more challenging than designing one for a drug trial.  I don’t expect researchers to be able to magically figure this out.  I am not suggesting you should be stopping any and all treatments until you read a good RCT and systematic review, but I am suggesting you consider the psychosocial factors and the natural course of a problem when deciding whether or not to give yourself a pat on the back.

You Need To Do Science!  

While there has been some pushback against the call for more evidence-informed decision making, (see the tongue-in-cheek Parachute Use to Prevent Death and Major Trauma Related to Gravitational Challenge: Systematic Review of Randomised Controlled trials; turns out there is no “evidence” for parachute use in the skydiving population) it is still important to be critical, skeptical, and rational when deciding what treatments work and what treatments do not.  It is easy to be influenced by authority figures, financial incentives, and your own biases.  If you want to believe your treatments work, you will find a way to do it.  Physical therapy, and science more broadly, should not be like that.  As Richard Feynman has said, you are the easiest person to fool when doing science.

“Science is, above all else, a reality-driven enterprise.  Every active investigator is inescapably aware of this.  It creates the pain as well as much of the delight of research.  Reality is the overseer at one’s shoulder, ready to rap one’s knuckles or to spring the trap into which one has been led by overconfidence, or by a too-complacent reliance on mere surmise.”

Paul R. Gross and Norman Levitt, Higher Superstition

Science may be painfully difficult to do, notoriously slow to catch up, and extremely arduous to translate into real world applications, but that’s what makes it successful.  What are you really doing with your patients? What actually helps people?  In order to gain respect, we need to have an idea of why and how our treatments work.  We cannot just assume what we do works, and works better than any other treatment, or we risk falling into the same hole that Dr. Ian Harris is trying to hoist his profession out of.  Don’t fool yourself.  

References

1. Gross, P. R., & Levitt, N. (1994). Higher superstition: The Academic Left And Its Quarrels With Science. Baltimore: Johns Hopkins University Press.
2. Harris, I. (2016). Surgery, The Ultimate Placebo: A Surgeon Cuts Through The Evidence. Sydney, Australia: New South Publishing.
3. Maddocks, M., et.al., G. (2016). Problematic Placebos In Physical Therapy Trials. Journal of Evaluation In Clinical Practice
4. Smith, G., & Pell, J. (2004). Parachute use to prevent death and major trauma related to gravitational challenge: Systematic review of randomised controlled trials. ACC Current Journal Review, 13(10), 12.
5. Testa, M., & Rossettini, G. (2016). Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Manual Therapy

 

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