Why did the sham-treated EPISOD study subjects do so well?

Post written by Peter B. Cotton, MD, FRCS, FRCP, from the Digestive Disease Center, Medical University of South Carolina, Charleston, South Carolina, USA.
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The EPISOD study showed that sphincterotomy was not helpful for patients with post-cholecystectomy pain and little or no evidence for biliary obstruction (“SOD type III”). The conclusion was surprising; especially to those protagonists who knew that they had many satisfied customers. Focusing on that aspect, it took a while for us to ask the next question: 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.”

The answer is simple. They did have “treatment,” but sphincterotomy was not the active part. 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 reading from Wayne Jonas (1). It is clear that the result 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” (2), 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 a surgeon called Green, who might have been thinking about referral to an ERCP expert 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.”

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 (before antibiotics). 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.

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, Professor Solly Marks, the grandfather of gastroenterology in South Africa. 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.

  1. Jonas WB, Crawford C, CollocaL, 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.
  2. How Healing Works: Get Well and Stay Well Using Your Hidden Power to Heal. Jonas WB 2018. Available at Amazon.com.

Read the full article online.

The information presented in Endoscopedia reflects the opinions of the authors and does not represent the position of the American Society for Gastrointestinal Endoscopy (ASGE). ASGE expressly disclaims any warranties or guarantees, expressed or implied, and is not liable for damages of any kind in connection with the material, information, or procedures set forth.

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