In my estimation, that’s the true cause for consternation, or it should be. Sham surgeries aren’t, at least in contemporary practice, a therapeutic device that we prescribe to patients. They almost exclusively exist as the back side of a randomized controlled trial (RCT); surgery is the yin, the sham is the yang. Double-blinded RCTs are the gold standard for determining whether or not a medical intervention actually works, and other branches of medicine are loathe to make a move without them. But in surgery, RCTs are few and far between. The meta-analysis I mentioned earlier found just 53 examples in the entire history of the specialty. This means that surgeons have missed the opportunity to rigorously test our methods, and consequently have been forced into an overreliance on anecdotes, tradition, and gut feeling.
Of course, there are a handful of good reasons why surgical research has developed this blind spot. RCTs, for instance, can be expensive, a pain to organize, and difficult to consent. The one hurdle that has been consistently insurmountable has been the question of whether it’s ethical to expose patients to a potentially harmful procedure in the name of research; after all, even sham surgeries are associated with a litany of unavoidable risks to the patient. Researchers haven’t found a consistent way to navigate this quandary.4
This, I think, is where the placebo effect can provide some unexpected value. The ethical balancing act of the RCT design has to consider both the potential harm and potential benefit to the patient. If sham surgeries can result in complications but aren’t also expected to make the patient feel better, then it’s difficult to see how they can be justified. But, as we’ve seen, that’s not at all the case. The (admittedly small) amount of data that we have shows a pretty clear benefit to sham surgeries. The placebo effect gives us the precise cover we need to ethically justify a dramatic expansion in prevalence of surgical RCTs. If we secure the knowledge that patients in both groups of a given trial are likely to benefit from their procedures, then RCTs could and should be installed as the gold standard in surgical research. It’s about time that surgery caught up to the rest of medicine.
A few weeks later, the patient comes back in for his first postoperative visit. Everything is going well: the incision is healing, he’s back at work, and most important, the pain that brought him to the operating room in the first place has vanished. He has no idea whether he got the real surgery or the sham, and it doesn’t even occur to him to ask. All he wants to say is “thank you.”
- Kwon R. Sham surgery: is it inherently unethical? The IDEAL Collaboration. http://www.ideal-collaboration.net/2013/06/845/. Published June 3, 2013. Accessed October 4, 2017.
- Beecher HK. Surgery as placebo: a quantitative study of bias. JAMA. 1961;176(13):1102-1107.
- Wartolowska K, Judge A, Hopewell S, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014;348:g3253.
- Tambone V, Sacchini D, Spagnolo AG, et al. A proposed road map for the ethical evaluation of sham (placebo) surgery. Ann Surg. 2017;265(4):658-661.