The acronyms are getting bigger. LIPUS (Low Intensity Pulsed
Ultrasound) therapy is commonly used to heal fractures faster, or to get them
to heal when they have not. It is a machine that straps on to the limb and is
worn for minutes or hours each day, for a few weeks or months. Just like the
techniques in my recent posts, it costs several thousand dollars and people
assume that if it costs that much and is high-tech, it must be working. Lets
cut to the chase.
Again, I am concentrating on the scientific evidence. Like
many other treatments, there is abundant scientific evidence that it does
amazing things to cell in a dish, and even mice and sheep, but the list of
treatments that work well in lab animals and cells but have no effect in humans
is too long to mention. To help me find the real (human) evidence, one of the
companies has helpfully listed the evidence for me under a tab named “Here’s
the proof” on their patient-targeting website, enticingly named
“healmybone.com”.
There are two claims: that it heals bones that have not
healed after a long time (non-union) and that it makes fresh fractures heal
faster. Scientific clinical studies (randomised trials in humans) are limited,
but they are there.
For the treatment of fresh (acute) fractures, it makes the
bone heal faster on X-ray. We now that new bone formation around fractures is
stimulated by movement. The ultrasound shakes up the bone, and consequently more
bone is made around the fracture, so it kind of makes sense. However, in the
landmark papers from the 90’s on tibia (leg) and radius (wrist) fractures,
all of the fractures healed anyway. These two papers are similar. So similar
that they have cut and pasted whole sections from one to the other, and the
authors in both studies received benefits from the sale of the device, and
several authors were employees of the company that made the device. And several
of the authors appeared on both studies. Even the authors that wrote the review on this topic
had conflicts of interest.
I don’t mind if the employees wrote the study, particularly
as the two landmark studies were good studies, using concealed placebo devices,
which is the best way to test these things. As long as there is verification
from and independent study (where the authors are not receiving benefits form
the manufacturer), everything is fine. However, a similar study from
non-conflicted authors in Sweden found no statistically significant difference
between the treatment groups (the placebo groups actually healed a little
quicker).
Interestingly, there are no studies comparing LIPUS to
placebo for the treatment of non-union (which surprised me, as I actually
thought there was good evidence out there for the use of LIPUS in non-unions).
In short, this expensive treatment is only supported by
studies that were sponsored by the manufacturer and written by employees and doctors
who benefit from the sale of the device. Even in these studies, all of the
fractures healed anyway. And there is no good evidence for using it in
fractures that have not healed. My advice? Strap on a placebo, independent
research shows that it might work a little better.
Dr Skeptic
ReplyDeleteThanks for the blog, entertaining and enlightening - keep up the good work - a few comments regarding LIPUS
(1) Regarding the Swedish study you allude to, it is important to look at why it may have failed to demonstrate any benefit - it was a good study, conducted independently, randomized, placebo controlled - but the study group selected was a poor choice - young, hyper-fit professional football players? You would expect them to already heal faster than normal, how could you possibly demonstrate they would heal even faster?! In fact, in that study both the LIPUS group and the placebo group heal faster than you would normally expect - the message? If you are young and fit you are already going to heal rapidly and reliably - don't waste money and resources trying to get back on the field faster - even if your employer is keen to get you back in the game...
(2) The study group is all important, as are the outcome measures and the study design - each of these factors can very critically influence what your study may or may not show - it would be wise in this instance to select a study group where the frature is already at great risk of delayed healing or non union - choose a group like diabetics, smokers, the elderly, or a fracture pattern that is notoriously slow to heal like a segmental fracture or sub-trochanteric fractures - Steven Cook's paper demonstrates more rapid union with LIPUS in distal radius fractures when he specifically looked at smokers - just makes a lot more sense, you wouldn't test anti-hypertensives in young fit people either, you just won't show any benefit!
(3) It is very important for new products to be developed in concert with surgeons and clinicians, and some surgeons have consulting agreements with our industry partners in order to help maintain the integrity of the studies that are conducted - most consulting agreements are not designed to directly benefit the surgeons involved through the increased sales of a given product; to suggest surgeons or physicians always derive significant additional benefits from the actual sales of implants or devices is somewhat misleading - very good studies can of course be conducted by surgeons with consulting agreements with industry (although admittedly the manufacturer may choose to suppress a study with negative results in favour of one reflecting positively on their product) - I know you have addressed this elsewhere on your blog, but in my opinion having a relatioinship with industry does not completely invalidate the results of a well-designed study, and with this I am sure you agree!
Doc Bruce, thanks for your comment.
DeleteI agree that industry sponsorship does not invalidate the results, but the evidence points to it being a factor that might influence the results.
And your points about the individual studies mentioned are valid. This is the kind of critical thinking I am trying to invoke in the public and our medical colleagues.
You also mentioned smoking as a negative predictor for fracture healing. I think that is an area worthy of an upcoming blog.
Stay tuned.
Dr. Skeptic,
ReplyDeleteI would just like to ask if LIPUS is available now in the market and where can we buy this thing? And how much does this cost and where to purchased this ? And how effective is this?
As explained, there are no good tests of LIPUS for fracture healing, so I would not be recommending, buying or using it myself.
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