Showing posts with label placebo-controlled trials. Show all posts
Showing posts with label placebo-controlled trials. Show all posts

The US will try treating opioid addiction with fake medicine

If you can't afford to offer real medical care, why not offer fake medicine? The U.S. Medicare system is about to give this strategy a try, for treating back pain.

Last week, Medicare announced that it wants to start paying for studies of acupuncture as a treatment for low back pain, as reported by the Washington Post and Stat. The government's reason, according to Secretary of Health and Human Services Alex Azar, was that we need this option to help solve opioid addiction:
“Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.”
If you break down HHS Secretary Azar's statement, it's mostly correct. Yes, treating opioid addition should explore all methods for treating chronic pain. And yes, this program will provide "new" options, even though the option in question is nonsense.

But (3) no, studying acupuncture will not expand our scientific understanding of "alternative approaches" to pain. Why not? Because thousands of studies have already been done, and the verdict was in, long ago, that acupuncture is nothing more than an elaborate placebo.

The problem is, acupuncture proponents never give up. Every time a study shows that acupuncture fails (and this has happened, repeatedly), they claim it wasn't done properly or make another excuse. I've even seen proponents argue that studies in which acupuncture failed were in fact successes, because acupuncture and placebo treatments both outperformed the "no treatment" option.

(Aside: we use placebo treatments because we've known for decades that any treatment, even a sugar pill, may show a benefit as compared to no treatment at all. Acupuncture research has created placebos by using fake needles that don't actually pierce the skin, or by placing needles in random places rather than the so-called acupuncture points. Scientifically speaking, if a treatment doesn't outperform a placebo, then the treatment is a failure.)

To make matters worse, the new HHS program will fund "pragmatic" clinical trials rather than the usual, gold-standard randomized trials (RCTs). Without going into details, let's just say that pragmatic trials are much less well-controlled than RCTs, allowing more room for mistakes and misinterpretation. This is a bad idea even when the intervention being studied is legitimate. It's an even worse idea here, where trials have shown, over and over, that acupuncture doesn't work.

Secretary Azar might be confused because the acupuncture industry has managed to get hundreds of studies published, many of them positive–but most of them are poorly designed, and who has time to read all that bad science? (The rare well-designed studies always show that acupuncture doesn't work.) Acupuncturists have even created pseudoscientific journals devoted entirely to acupuncture, as I wrote about in 2017. Some of these journals are published by respected scientific publishers, but they are still little more than fake journals.

Not surprisingly, with entire journals trying to fill each issue with acupuncture articles, last week's Medicare announcement noted that
"the agency [CMS] recognizes that the evidence base for acupuncture has grown in recent years". 
No, it hasn't. What has grown is the number of articles. Adding more garbage to a pile doesn't make it smell better.

For those who aren't familiar with the claims of acupuncture, let's do a very quick summary: acupuncturists stick needles in a person's body at specific points in order to manipulate a mystical life force that they call "qi" (proounced "chee"). This idea is "a pre-scientific superstition" that has no basis in medicine, physiology or biology, and has never had any good scientific evidence to support it.  Acupuncturists don't even agree on where the acupuncture points are, which should make it impossible to do a scientific study. It's not at all surprising that acupuncture doesn't work; indeed, if it did work, modern medicine would have to seriously examine what mechanism could possibly explain it.

But wait, argue proponents, what about all the wise traditional doctors in China who developed acupuncture over thousands of years? Well, it turns out that acupuncture wasn't popular in China until the mid-20th century, when Chairman Mao pulled a fast one on his population because he couldn't supply enough real medical care. Mao didn't use acupuncture himself and apparently didn't believe in it. I highly recommend this expose of Mao's scam, by Alan Levinovitz in Slate.

So rather than spend millions of dollars on yet another study of acupuncture for pain, I have a better suggestion for HHS: invest the funds in basic biomedical research, which has had a flat budget for more than a decade now. As long as it goes through proper peer review, almost any research will be far better than wasting the money on acupuncture.

Now, I'm not naive enough to think that Medicare will take my advice, but I can tell them right now what their new "pragmatic" trials will reveal. Acupuncturists will happily take the money, treat people suffering from back pain, and report that some of them experienced reductions in pain. Some of the patients will invariably agree, because back pain comes and goes, and it's hard to know why it went away.

Then the acupuncturists will say, "look, it works! Now please cover acupuncture for all Medicare patients." Then we'll spend more tax dollars on pseudoscience, and patients will be in just as much pain as ever. If Medicare falls for this (and I fear they will), then Chairman Mao will have fooled the U.S. government, just as he fooled many of his own people half a century ago.

Falling 300 feet and living to tell about it


How far can a human being fall and survive?  Normally, not very far.  People usually survive falls from a height of 20-25 feet (6-8 meters), but above that, things get very deadly very fast.  A study done in Paris in 2005 looked at 287 victims of falls, and found that falls from 8 stories (30 meters) or higher were 100% fatal.

How about 300 feet? Last fall, a remarkable case report appeared in an little-noticed journal, the Scandinavian Journal of Trauma, Resuscitation, and Emergency Medicine. The article begins with this astonishing sentence:
"We report the case of a 28-year old rock climber who survived an 'unsurvivable' injury consisting of a vertical free fall from 300 feet onto a solid rock surface."
This is no ordinary case report.  The accident happened when a 28-year-old woman and her boyfriend, both experienced rock climbers, were climbing in the Rocky Mountains in Colorado.  Both were wearing helmets.  The woman took the lead on the final pitch of a 300-foot (90-meter) climb.  At the very top, after securing the rope, her climbing harness failed.  She fell 200 feet straight down, hit a flat rock surface, then fell another 100 feet.  Her boyfriend climbed down as rapidly as he could, and found her at the bottom, alive.  This appears to be the highest vertical free fall onto a hard surface that a human has been documented to survive.

The list of the climber's injuries, described in detail in the article, is frighteningly long.  The article shows a picture of her, awake and off the respirator, on her 4th day in the hospital.  (The patient agreed to have her case published along with her photo.)  Despite her extensive injuries, including paralysis of both legs, she otherwise recovered remarkably well and "was transferred to her local community regional spinal cord rehabilitation center out-of-state at 2½ months after injury in excellent conditions."

The authors of the article focused on this question: if you fall a very, very long distance, how should you land?  The authors of the study concluded that a critical factor in the climber's survival was that she landed feet first.  As they wrote: " a fall on both feet represents the 'ideal' body to impact surface position with regard to survival from vertical falls."  Landing feet first allows the lower body to absorb most of the deceleration force, as they illustrated in the figure reproduced here.

This case reminds me of a famous paper from BMJ back in 2003: "Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials."  In that paper, G.C.S. Smith and J.P. Pell complained that no one has ever done a properly controlled experiment to determine if parachutes really work.
"We were unable to identify any randomised controlled trials of parachute intervention," they wrote.
They argued that "an adverse outcome after free fall is by no means inevitable," a point that the current study would seem to support.  However, I can't agree with Smith and Pell's conclusion: "We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute."