Why placebo surgery is ethical, and necessary

The research discussed in my previous post on placebo surgery for Parkinson’s disease sparked a rush of publications debating the ethics of placebo surgery, even before the results were released. One of these articles (here) gives a good overview of the ethics of placebo (sham) surgery controls, using one of the Parkinson’s trials as its case in point. The authors give both sides of the argument, but I disagree with two important points; points that lead them to conclude that placebo surgery is not necessary.

Do shoulder fractures need surgery?

Fractures that occur at the upper end of the humerus near the shoulder (called humeral neck fractures) are common. They are often treated with surgery despite a lack of supporting evidence for this, particularly in older, osteoporotic patients. Now, thanks to a recent study from the UK, it is possible that most of these fractures don’t need surgery, even in young patients. This is big news, but will this research jump the gap from research into practice and influence the decision making of the end users – the patient and their surgeon?

Is back fusion surgery just a placebo?

It is possible that spine fusion surgery for back pain achieves its effectiveness through the placebo effect. I would like to make the case that it is not only possible, but also probable.

Evidence based medicine vs the Golden Rule

I am a big fan of evidence based medicine (EBM). Not the cookbook type (“do it this way or else”), but the idea that medicine is a science and therefore should be approached scientifically. We should use the principles of logic and rational thinking to reduce the errors that result from our often irrational, subjective “human” way of making decisions. Sometimes, however, we try to use EBM to justify something that doesn’t need scientific support – something that should be the default, and only changed if there is evidence against it. Something like the Golden Rule.

Placebo surgery #1: Surgery for angina

I will attempt to write a short note on every clinical study that has compared surgery to a placebo operation (sham surgery). The common thread is that while many patients improve after the real operation, many patients also improve after the sham operation, and in each example the real operation is no more effective than the sham surgery. This shows that when we see patients get better after we treat them, it is not necessarily due to the specific effect of our treatment. We (the doctors and the patients) perceive effectiveness by attributing cause and effect to the association we see. The difference between the perceived effect and the specific (real) effect is the placebo effect.

This study dates from 1959, and relates to a surgical procedure for angina that dates from 20 years before that: internal mammary artery ligation.

Does removing breast cancer affect survival?

Allow me to make an assertion: breast cancer survival is not influenced by surgical excision of the primary tumour. This goes against the prevailing wisdom that cancer is cured by removing it, but that kind of thinking is simplistic and at odds with much of the evidence. Lets walk through that evidence.

Invasion of the robots

In my institution, the surgeons are keen to get some government money to turn us into a robotic surgery centre. I fear they are doing it for the reputation and the referrals, but this would be cynical rather than skeptical (see upcoming blog on the difference). So I will simply say that they are not doing it to benefit the patients. They may think they are, but I am not aware of any evidence that patient-based outcomes are better with robotic surgery. I am however, aware of empirical evidence that robots cost a lot, because I have seen the bill.

It turns out that robotic surgery is yet another example of something that sounds good, with some research showing improvements in some aspects, but with the whole thing falling down when it comes to improving patient health.

SLAP in the face for shoulder surgery

I have always been sceptical of some shoulder procedures, and the increasing rate of shoulder surgery and the lack of high quality evidence worries me. I started a simple blog post about one particular operation (for “SLAP” lesions) and found a tale of research waste, bad science, overdiagnosis and overtreatment.

Knee arthroscopy in arthritis: an evidence-practice mismatch

Osteoarthritis, where the cartilage lining a joint gets worn down, is common (Australian data, UK data, US data). Most people will get it if they live long enough, and the knee joint is commonly affected. There is little that can be done to repair or reverse this process, and a related paper that covers many osteoarthritis treatments shows that most of the things we do (analgesics, anti-inflammatory medication, injections etc.) only provide temporary relief, and many of them hardly work at all. Treatment, if severe enough, often means a knee replacement.

Knee replacement surgery is major surgery so it is only reserved for those with severe osteoarthritis. So what do surgeons do with patients who have knee pain and mild or moderate arthritis? They often do an arthroscopy: a low risk, day-only procedure that pays well and seems to work some of the time. Hundreds of thousands are done in the US every year, and in my state the rate of arthroscopy is high and is rising.

The trouble is: it doesn’t work. Most patients still have pain, some get worse, and about 20% will end up having a knee replacement within 2 years anyway. Feel free to skip to the last paragraph for the Bottom Line, or read on for the details.

The magical “floating” kidney

I started writing this up as a “Lesson from History”, because floating kidney (or “nephroptosis”) was big in the late 19^th century, and I thought that the condition was no longer taken seriously. In researching this however, I found that surgery for this condition is having a resurgence thanks to laparoscopic (keyhole) surgery. To a man with a hammer, everything looks like a nail.

Tennis elbow treatment: perception versus reality

For decades, surgeons have been reporting good results with surgery for tennis elbow. In a classic article from 1961, the late, great British surgeon RS Garden, reported that the results of surgery for tennis elbow were such that “no patient failed to benefit in some way from the operation”. Fifty years later in a review of 80 patients undergoing surgery for tennis elbow, 78 were reported to have improved. There are plenty of non-surgical treatments out there for tennis elbow (lateral epicondylitis) - all of them are reported as having good results, yet none of them are any better than placebo. Why then, did it take until now for a randomised trial to be done comparing real surgery with sham surgery?

Knee arthroscopy for "mechanical symptoms"

I have previously written about the (non) role of arthroscopy for osteoarthritis or degenerative meniscus tears in the knee (here, here and here). Surgeons have continued to operate, based on a belief that (now) centres on the presence of mechanical symptoms. An analysis of the recent sham surgery trial of arthroscopic partial meniscectomy (APM), which showed APM to be no better than sham for patients with meniscus tears without arthritis, has shown that this procedure is no better than sham surgery for patients with mechanical symptoms.

Stimulating spines

Spinal cord stimulators are small battery-powered devices that are implanted in the back and electrically stimulate the spinal cord to relieve chronic pain, often from failed spine surgery. These days they can be controlled remotely and can even do your step count. They are widely used and are very expensive. But we don’t know if they work or not – good evidence hasn’t been produced, and this problem doesn’t look like being corrected anytime soon. Why should it, when everybody is paying for the treatment now?

Are you getting your money’s worth from surgery?

There is a common belief that if something costs more, it must be better; that you get what you pay for. Recently, a friend of a friend (this is not sounding very scientific, but hear me out) went to see two spine surgeons about his neck pain. One surgeon advised against surgery. The other recommended a neck fusion, to be done in the private hospital with an out-of-pocket “gap” (the fee, above and beyond the health fund rebate) of $10,000. He is now considering drawing on his retirement fund to pay for the surgery. Considering that there are surgeons who will perform this operation for no “gap”, is this worth it? Is the price a reflection of quality?

Financial incentives and surgery rates

Recently, a reader asked me if financial incentives could be responsible for the findings referred to in previous posts, like practice variations and the persistence of some surgical procedures despite evidence of their ineffectiveness. We know that you can change physician behaviour by altering financial incentives (Cochrane review), but anyone who believes in Homo Economicus will tell you that. And there is also evidence that financial incentives lead to increased health care usage amongst primary care doctors (here), but what about the evidence for financial incentives influencing surgery rates?

Book review, of my book: Surgery, the ultimate placebo.

This will be a test of how unbiased I am. Writing a review of my own book (regardless of any bias) seems like shameless self-promotion, but what the hell, it's better than just saying "Hey, I wrote a book".

Lessons from history #11: Extra- to Intra-cranial Bypass Surgery

This story is about a procedure that made sense and had supporting evidence, became common practice, but was later discontinued because a high quality study showed it to be ineffective. The story of extra-cranial intra-cranial bypass surgery ticks all the boxes: overestimation of benefit, seduction by the theory, unrecognised bias in studies, and just plain ineffectiveness despite our best effort and beliefs.

The parachute analogy

“You don’t need a randomised trial to prove that parachutes work” is a common refrain from doctors who believe that their operation works, despite a lack of good scientific evidence from controlled trials. They see it as an argument-stopper, but it is actually an example of argument by analogy, and a poor one at that. And at least one surgeon has been burned by putting the parachute analogy in writing.

Achilles tendon ruptures: let the patient decide

As we age, our collagen loses its elasticity and our tendons weaken. A ruptured Achilles tendon (TA) is often the result. This is a common injury; patients are usually aged 30 – 50 and it normally occurs with a sudden push-off during sport. Now, the initial reaction when anything is torn is to repair it, and while this holds true for inanimate objects, living things are different – 4 billion years of evolution has made some headway in that regard. Many people do not appreciate that as surgeons, when something is broken, cut or torn, all we do is put the ends roughly together and it is nature that does all the healing; we just take the credit. Placing the torn ends of a ruptured TA together is easy: you just flex the ankle. And it turns out that if you do this, and gradually bring the ankle back to normal position over a few weeks, it heals fine – without surgery, and without the complications associated with surgery.

Placebo trials of surgery

In a recent systematic review of placebo trials of surgery (here) it was found that in half of the 53 trials found, surgery was not better than placebo treatment. And in the ones where it was better, the difference wasn’t great. This may not be big news to my readers, but this review was important because it highlighted many of the problems with surgery, namely that:
1) placebo studies are needed to determine the true effectiveness of surgical procedures, but …
2) surgery and associated devices are regulated less strictly than drugs, consequently …
3) surgery is often not subjected to placebo / sham studies, even though …
4) such studies are ethical and practical.