Thinking about placebos, and healing. Thank you, Dad

 

Patients and doctors want to know which treatments “really work”. That is not too difficult when dealing with something mechanical, like fixing a broken bone, stopping bleeding or removing a stone. The problem comes when trying to relieve pain when it has no identifiable and fixable cause. Many patients with headaches or back pains – or stomach pains – are faced with a bewildering variety of treatments promoted by traditional and alternative therapists.

The gold standard scientific test of efficacy is the randomized controlled trial. Patients are assigned, with their consent, to receive the active treatment or a placebo (such as a “sugar pill”). They are “blinded” to the allocation (they don’t know whether they got the active or placebo pill), and followed to see if the clinical problem resolves more often in the patients receiving the active treatment.

Some may be surprised to know that this process has also been used to evaluate surgical treatments when they are controversial. Patients receive the active surgery or a “sham” procedure, which to them looks and feels identical. They get the anesthesia and skin incisions, but nothing more. The ethics and feasibility of such “sham surgery” studies are debated, but they do produce interesting results. A recent big study in patients with painful knees showed that merely looking in (with arthroscopy) was as effective as also mending the ligaments.

I have learned a lot about all this in recent years. If I have any readers (thank you), some will know that my medical career focused on a procedure called ERCP. We pass a flexible endoscope through the mouth down past the stomach to the “ampulla of Vater”, where the bile and pancreatic ducts drain their digestive juices. We can then pass instruments through the ampulla to detect diseases and to treat some of them. A good example is removing stones from the bile duct, a technique first described in 1974 from Germany and Japan. The stones are grasped and removed with a little basket after opening up the ampulla by cutting the surrounding sphincter muscle.

This cutting procedure, called sphincterotomy, is used very widely, and for many reasons. One is “sphincter of Oddi dysfunction” (SOD), a condition often suspected in patients with pain after having the gallbladder removed (cholecystectomy). The concept is that the ampullary sphincter muscle that controls the flow of bile does not relax, or goes into spasm. This results in back pressure in the duct, and attacks of pain. It is therefore logical to believe that the problem could be relieved by performing a sphincterotomy. We did a lot of those procedures. Many patients were happy, but not all, and some suffered complications, especially post-procedure pancreatitis.

More than 10 years ago we started a research project designed to find out if we could better predict which of those patients would respond to sphincterotomy, or not, in order to inform future practice. We thought it might be the precise nature of the pain, the patient’s psychosocial status or the pressure in the sphincter (we can measure that during ERCP).

For many reasons, simply looking into these and other factors in existing patients does not give clear answers. There are many biases, which is why we chose to introduce the placebo/sham element in a randomized trial.

With lots of care, patient education, institutional review board approval, and funding from the National Institutes of Health, we launched the EPISOD study (Evaluating Predictors and Interventions in SOD). This involved patients with “SOD type III”. They have pain post-cholecystectomy, but no objective evidence of biliary obstruction, such as elevated liver tests. All of the patents underwent the ERCP procedure, with measurement of the sphincter pressure. Then, 2/3 of the patients got the sphincterotomy, and the rest had no active treatment (sham). The patients and those caring for them afterwards, and the researchers, were all blinded to the intervention. No one knew which patients had had the active treatment. After one year we were very surprised to discover that the sham-treated patients did as well as those who had undergone sphincterotomy. Indeed, at 5 years, they were actually doing better!

Publication of these important results has hopefully changed practice (1). It is surely no longer appropriate to offer ERCP/sphincterotomy to those patients. We also wonder about the value of sphincterotomy in some other contexts, such as SOD type II, and idiopathic recurrent pancreatitis. Research is ongoing.

Having said all that, I come to my reason for venting today. Why on earth did the sham-treated patients do so well? Half of them had little or no pain 5 years after having “no treatment”.

I had always thought of placebos as inactive, with maybe only some temporary effect. Delving into the placebo literature revealed the extent of my ignorance, and made me think much more about the essence of “healing”. The literature is huge. I recommend reviewing papers by WB Jonas (2). It is abundantly clear that the results of any treatment, active or sham, is greatly influenced by the environment in which is given, by whom and how, and the patient’s expectations.

In his marvelous book “How healing works” (3), Jonas describes patients recovering from various severe disabilities after treatments which had no discoverable effectiveness, and records the similarities in these phenomena across cultures and religions. He quotes an orthopedic surgeon called Green, who might have been thinking about referral to an ERCP expert like me when comparing surgeons with shamans, when stating: “Shamanistic healing measures include: journeying to a healing place, fasting, wearing ritual garb, ingesting psychotropic substances, anointment with purifying liquid, an encounter with a masked healer, and inhaling stupefactive vapors. These steps are followed by a central ritual activity that may include extracorporeal, surface, and penetrative components. Postoperative ritual activities reinforce the suggestive value of the healing. These experiences increase a patient’s suggestibility, thereby enhancing the likelihood of a favorable outcome”.

So, it is clear that the performance is all-important, how treatments are “sold”. This is a slippery slope that charlatans travel with great profit. But it is also the essence of “doctoring”, how we interact with our patients, whatever the context. I learned much of that from my Dad, a country doctor, going with him on house calls a long time ago. I watched him sit with patients and their families, hold their hands, listen quietly, and offer comfort and reassurance. He had very little else to offer in the 1940s. That was before antibiotics.

All of this makes me wonder about my own practice. How much of the (apparent) success of my thousands of ERCP procedures was due to the clever procedures, and how much to my Dad’s teaching?

I conclude with a favorite quote from another mentor, Solly Marks, the grandfather of gastroenterology in Cape town. After hearing me pontificate about my procedures, he said “Peter, remember to deal with the whole patient, not just the hole in the patient”. How wise.

Thanks for sticking with me, if you have. Comments are welcome.

  1. Cotton PB, Durkalski V, Romagnuolo J, et al. A multicenter, randomized trial of endoscopic sphincterotomy for suspected sphincter of Oddi dysfunction in patients with pain after cholecystectomy – the EPISOD trial. JAMA 2014;311:2101-09.
  2. Jonas WB, Crawford C, Colloca L, et al. To what extent are surgery and invasive procedures effective beyond a placebo response? A systematic review with meta-analysis of randomized, sham controlled trials BMJ Open 2015;5:e009655.
  3. How Healing Works: Get Well and Stay Well Using Your Hidden Power to Heal. Jonas WB 2018. Available at Amazon.com

 

 

 

 

7 Responses to Thinking about placebos, and healing. Thank you, Dad

  1. Chips Reid says:

    Hi Cousin Peter;

    I thoroughly enjoyed reading about your findings ! What a revelation !

    I always enjoy your writings and especially learning more about you. I love how frank and honest you are in your stories.

    Love to you and Marion

    from your cousin,

    Chips

  2. Ann Procter says:

    HI, brother Peter,

    I too enjoyed your excursions into the placebo phenomenon and felt moved by your acknowledgement of Dad’s use of what in those days was called the “bedside manner”. The medicines and procedures were nowhere near so effective as now, unlikely to solve many health problems without that vital human connection. I too learned from visiting his patients with him, especially over Christmas and New Year 1948/9 when I was learning to drive and chauffeured him every day, and often in the surgery in our home over the years. I took that apprenticeship into healing in areas non-medical – although not shamanistic! – and there is no doubt at all in my mind that how we relate to patients/clients is vital to the success of any intervention. Sadly it is no longer given priority while reliance is put on drugs, surgery and wonderfully clever procedures, such as yours. Hope you can influence its widespread return to practice. Go well. lots of love Ann

  3. Brucie Harry says:

    Fascinating. The body intends desperately to heal itself, and yes it’s nice to know there is back-up in the Dr Cottons, both in treatments and in a human to human manner. I appreciate both of these abilities in you, Peter.

  4. Mike ANDERSON says:

    Very enlightening and honest. Nowadays if all the blood tests are normal the secretary tells you everything is alright so presumably nothing is wrong. Seldom does anyone examine properly as in years past, that in itself can be reassuring. Doctors are discouraged from putting an arm around or holding the hand of an elderly bereaved patient.

    An old patient of mine came to see me quite frequently after her husband had died. Understandably she was unhappy and had almost given up. I knew she was quite a good painter once so I said I do not want to see her until she had started to paint again. I knew her quite well even so I was worried that I might have been too harsh. However, after a few weeks she came back carrying a plastic bag in which was a painting of Stone Henge. She had not signed it because she did not think it was good enough. She cheered up and without any medication was living life again. I still have that unsigned paining on the wall to remind me of her. Your father was right!

    • Peter Cotton says:

      Wise words from another country physician. Thank you Mike (and for your golf lessons many years ago). Your lovely painting story is so typical of anecdotes in Jonas’s book “How healing works”, encouraging patients to re-embrace some activity they valued to regain their own self-worth.
      And your comment about examining patients reminds me of advice given by George Day, a doctor in charge of a TB sanatorium where a family member resided for a while.
      He talked about “the therapeutic examination”, examining the patient not primarily to seek problems, but mainly to reassure. He stated “A therapeutic overhaul is the reverse of the ordinary physical examination in that one is seeking good rather than evil things, glad tidings and not bad news. Every system is impressively examined and gets an honourable mention whenever possible. “Your kidneys are behaving like perfect little gentlemen”, “That’s a good strong heart you’ve got. It will last out your time”, “Your x-rays showed a flawless pair of lungs, what’s more, they work”. In contrast, we often hear patients saying “he didn’t even examine me”.

      All of which reminds me why I became a specialist. Although perhaps more glamorous and certainly rewarding in many ways, it is very much easier to become an expert in a small area than to be able to deal effectively, and confidently, with the “whole patient”.

  5. Ann Procter says:

    sister Ann again:
    re Dr George Day:
    I was your family member who spent two years under his care in Mundesley Sanatorium. The London G.P. who diagnosed TB rampant in both my lungs when I was 19 said I’d about 3 months to live (I am now 86). I feel I owe my ongoing life as much, if not more, to Dr George Day’s care of me as a whole person, very much including psychological aspects, than to the interminable bed rest, drugs and procedures he prescribed.
    Some time later a surprisingly innovative article by him was published in The Lancet, THE prestigious medical journal, about the power of the doctor’s position making it likely he could cast “spells” simply by how he related with the patient. I wish I could find my copy! He was explaining how a doctor could give patients the impression that he valued them as individuals and had faith in their ability to get well i.e.a white spell, or, by contrast, a black one by in some way indicating difficulty and doom. eg. the GP ! Over the years I have heard a large number of black spell scenarios from my psychotherapy and healing clients, and put a lot of effort into transmuting them.
    Thank you, Dr George, from my heart.

  6. Steve Schutz says:

    Thank you for this, Peter. Words of wisdom. As you know, I trained under you and others at Duke University Medical Center about 25 years ago. My first job after training was as a Staff Gastroenterologist with the US Air Force at a hospital in San Antonio, Tx. Everything was so different, but what I remember most was the sense from patients and families that, because it was a military facility, they probably weren’t getting first rate care.

    At Duke, I always felt like I couldn’t lose: if there was a complication, patients would believe, “If we were at our home hospital this would have been worse”. And if a procedure was unsuccessful they’d say something like, “Well, it just can’t be done, and thank you for trying”.

    Meanwhile at the Air Force hospital everything was the opposite. If we did a difficult procedure well and there was a good outcome, the feeling from patients and their families was, “It’s about time you guys did something right”, while any complication seemed to bring a sigh that meant, “of course there’s a complication, isn’t there always?” I frequently felt like I couldn’t win. The secret is to have a better Shamanistic center I guess.

    This whole area is fascinating, and I really appreciate the discussion of it here. Twenty five years later I’m still learning from Peter Cotton.

Leave a reply