Feb 02 2012

American Headache Society Recommends Placebos for Migraine

This is yet another installment in my series on how so-called “alternative” medicine thrives under a double standard – a bizarro world where the rules of science and logic are suspended in favor of uncritical promotion. The American Headache Society (AHS) just sent out a press release endorsing acupuncture for migraine headaches. They write:

Mt. Royal, NJ (February 1, 2012) – When it comes to treating migraine, so-called “sham” acupuncture (where needles are inserted only to a superficial depth in the skin and not in specific sites) and traditional acupuncture where needles are inserted in specific sites, both are effective, according to the American Headache Society (AHS).

Citing publicity surrounding a recent Canadian study comparing the effectiveness of the two types of acupuncture, David W. Dodick, MD, AHS president, said both types of acupuncture, particularly when electrical stimulation is involved, may work to release endorphins that are important in controlling signals of pain and inflammation.

“How much of a benefit sham acupuncture can have on the release of these chemicals is unclear,” he said. “This suggests the benefits of treatment may not depend on the exact technique of acupuncture and needle positioning.”

Studies show that sham acupuncture is as effective as true acupuncture, and Dr. Dodick concludes from this that both work. The proper scientific interpretation of this result is that the treatment (acupuncture) is no different than placebo (sham acupuncture) and therefore has only a placebo effect. Only in CAM world can you take a negative result and then spin it into a positive result like this. Science is all about controlling for variables, and when you control for the variable of acupuncture (inserting needles into acupuncture points) it does not work.

Notice how he also muddies the variables further by mentioning electrical stimulation. Sure – acupuncture really works when you combine it with another modality (transdermal electrical stimulation) that may have some pain benefit by itself. That is like saying – acupuncture really works when you inject morphine through the needles.

The press release goes on:

There is ample evidence supporting the value of acupuncture in migraine treatment, Dr. Dodick noted, including four studies that compared acupuncture to standard migraine preventive medications. Acupuncture was found to be at least as effective and produced fewer side effects. Further, he noted that a randomized clinical trial study published in November comparing acupuncture to topiramate in chronic migraine prevention showed that acupuncture was more effective than topiramate. Topiramate is an anticonvulsant often used in epilepsy.

Let’s take a close look at this study. There were two treatment groups – acupuncture and topiramate. There was no sham acupuncture group, and no placebo medicine group. This means the study was not blinded – given the large documented placebo effect for subjective symptoms and for invasive procedures, this study is worthless. All it is demonstrating is something that is well known – sticking needles in someone has a larger placebo effect than giving them a pill.

Further, the topiramate was titrated up to only 100mg per day. While this dose may have an effect in some patients, other studies (and clinical experience) indicate that some patients need to titrate up to 200mg per day to get an effect. So the topiramate arm was underdosed to some degree, a classic way to show equivalency for a non-effective treatment, compare it to a non-effective dose of another treatment and then claim it works just as well. But worse, the treatment phase was only 8 weeks.  About this Dr. Dodick says:

“Further, the long-lasting effects of acupuncture, given that subjects continued to experience a reduction in migraine frequency two months after treatment, is also noteworthy and not a point to be ignored,” he said.

Two months, however, is nothing when you are talking about migraine prophylaxis. It can take that long for the topiramate to start working. So you should start counting headache frequency after a two month initial treatment period – not during this phase. Other studies showing efficacy in topiramate are 3-12 months long. This is another way to use a gimped comparison group to make the treatment group seem more effective.

Here is a more recent study of acupuncture in migraine that the press release did not discuss. It concludes:

Acupuncture tested appeared to have a clinically minor effect on migraine prophylaxis compared with sham acupuncture.

This also was not a great study. It was single blind only, and also used electrical stimulation. But at least they included a sham acupuncture group, and (you guessed it) no difference between the sham acupuncture group and the two other acupuncture groups. In other words – acupuncture does not work. There were minor difference in the secondary outcomes only, considered not clinically significant by the researchers, and within the noise level of such studies.

Conclusion

Placing needles into acupuncture points (in other words – acupuncture)  has no benefit for migraine, or for any pain or other medical outcome.  Proponents, however, have no problem breaking the rules of science and logic to claim that it does. They rely upon poorly designed studies that are not properly blinded or well controlled, or interpret negative studies as positive. They ignore the well-established facts established for placebo (such as the fact that needling has a larger placebo effect than pills), as well as experimenter and subject bias.

It is astounding that these basic principles of science-based medicine are completely ignored in order to take a promotional tone in favor of acupuncture.

46 responses so far