Sham good!

The results of a really interesting clinical trial were just reported at the annual meeting of the American College of Cardiology and simultaneously published online before print by the New England Journal of Medicine .

The trial, SIMPLICITY-HTN3, was designed to test the efficacy of renal artery denervation by radiofrequency (RF) ablation in the treatment of medication resistant hypertension. For those of you unfamiliar with the technique, it utilizes catheters similar to those used in intra-cardiac ablations by cardiac electrophysiologists. In this case, the ablation catheters are positioned in the renal arteries, and deliver RF energy through the arterial wall to the nexus of nerves in the surrounding tissue. In early reports of the technique, this “catheter based sympathectomy” led to stunning reductions in systolic blood pressure, and cardiologists were jumping on the bandwagon to do the procedure.

Cooler heads prevailed, and the recent trial was designed to address several methodologic limitations of the earlier reports. For me, the most interesting difference was the inclusion of a blinded control group, which was “treated” with a sham procedure. The sham included insertion of catheters into the renal arteries, along with renal artery angiography, but no ablation. The patients were all sedated, and the duration of the procedures was adjusted so that neither the patient nor family members could tell what had been done. The effectiveness of the blinding efforts was confirmed with patient questionnaires.

The results? No significant difference in the blood pressure at 6 months between the ablation and the control groups:
Sham Good Image

Here’s the really interesting part. There was no difference, not because the ablation failed to lower BP, but because the sham procedure lowered BP just as much as the “real” intervention. Once again we are reminded of the power of patients’ believing that they had undergone a therapeutic procedure.

I believe that tapping in to the strength of patients’ beliefs is one of the “unmeasurable” things that separate great doctors from technically proficient ones. Great doctors develop a therapeutic bond, characterized by mutual respect and trust. That trust leads to faith in the prescribed course of action, which leads to better results.  Every “medicine-man” or shaman knew that to be the case. We should remember it too.

What do you think?

3 thoughts on “Sham good!

  1. I don’t mean to laugh. This is actually quite sad. It raises questions about why the psychological doesn’t work with BP medication to begin with? Do the prescribing doctors raise doubts about the effectiveness of BP meds? Do the side-effects of BP meds cause the patient to loose ‘faith’ in their effectiveness? Are we, as a society, brainwashed into believing that only the costliest and most invasive procedures are effective? Do the TV ads for new ‘miracle’ cure drugs influence how we react to an older and effective med or treatment? It’s possible that the subjects feel more about caring for themselves, because they are so special to receive this cutting edge treatment.

    This shows that it’s possible that a caring doctor that listens a little bit could be medicine in itself.

    1. Perhaps it is the deep rooted beliefs of both the patient and the doctor that activates the self-cure (placebo effect) and that a quasi-surgical procedure is more believable than a pill for effecting change. The study raises interesting questions regarding the reliance on a ‘higher power” embodied by skilled and caring physicians, medications and procedures rather than the potential power of patients to heal themselves.

      1. personally, I practice self-hypnotism to control pain. Some doctors seem skeptical-and maybe scared of the unknown. I have some doctors that are excited and treat me well. It does give me problems with some ER staffs, as I’m able to go in calm, and my pain pretty much under control. It went well with military care, as they ran lab work to see if I got an opioid somewhere. The lab work was clean, but they put on front of my chart that I don’t feel pain below level 5, so I was treated well.

        These younger doctors don’t understand that. My dentist has been taking care of me since the early 90s. Last summer he showed me my X-Rays. My teeth filled themselves-did their own root canal. He says that I’m the only person that he met that this has happened to. My lower front teeth are about half way done. I live in a small rural state, so there is a man in another area, whose teeth are doing their own root canal. My wisdom teeth took care of themselves too-dissolved or something-but they’re gone on their own.

        I certainly wish that I could do something about my thyroid and Surfer’s Ear. I’ve had many doctors that had healing hands-some didn’t have a good bedside manner. It was that something was there, and I could relax with them, trust them.

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