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.
The procedure involves blocking (ligating, or “tying-off”) an
artery that runs inside the chest, near the heart, in order to divert more
blood to the heart. The operation had everything going for it: biological
plausibility, support from animal experiments, and good results from series of
patients that had the procedure. Already, you have about as much evidence as
many of the surgical procedures performed today. And this was not considered an
experimental procedure; it was performed in many institutions across the USA.
The 1959 sham surgery experiment (link) involved surgery
on all of the participants, but half of them didn’t actually have the artery
ligated, and the patients were ‘blinded’ to the type of treatment they received.
Most patients in both groups felt better (in fact all patients in the study had improved exercise tolerance), but they
were no more likely to improve if they had the surgery than if they had the
sham surgery, showing that the treatment did not have a specific therapeutic
effect, only a perceived effect. Basically, the operation didn’t work. The
study was small (17 enrolled) which might make you think that it was not a powerful
enough study to detect the advantage of surgery, but I can counter that with
the observation that the patients in the placebo group actually did better than the (real) surgical group
for most outcomes. A larger study may have been more conclusive about a
difference between the groups: it might have been able to show us that the
surgery was significantly harmful.
The good news is that the operation fell out of favour after
publication of this study. Similar results from trials of knee arthroscopy for
arthritis (link)
have not resulted in a similar decrease in rates of surgery (definitely not in
my country, anyway). It is amazing how long an operation can ‘linger’ after it
has been shown to be ineffective (see my blog on blood letting here).
We need to rely more on what the science tells us than on our gut feelings.
And if you think that surgery is much better for angina nowadays, I direct you to a previous blog post (here).
Placebo surgery #2: surgery for Parkinson's disease is here.
And if you think that surgery is much better for angina nowadays, I direct you to a previous blog post (here).
Placebo surgery #2: surgery for Parkinson's disease is here.
I read your blog post give me more information. Its very informative and effective post.
ReplyDeleteUndescended testis surgery India
There is more to this than just angina
ReplyDeletehttp://www.nytimes.com/1999/04/25/weekinreview/ideas-trends-sham-surgery-returns-as-a-research-tool.html