This story describes a study, which found that a portable single-pulse trancranial magnetic stimulation (sTMS) device decreases progression of a migraine attack in some people. It provides some appropriate caveats about interpreting study results. But it could have been even stronger had it discussed adverse effects and costs.
This matters because this is a non-drug treatment for certain headaches that can be very disabling. It is important for the reader to understand whether this is a beneficial, safe, and cost-effective option because as a device, its regulation by the FDA is looser than that for medications. In the case of "new" devices therefore, reader beware!
No mention of cost was made in the report about this device. As medications exist for treatment of migraine during aura, the comparative cost is important. Speculation as to whether this device would be covered by insurance would have also been helpful.
The article does not give the reader a sense of how significant the pain relief or avoidance was. There was a significant improvement in rate of freedom from pain at two hours for the first treated episode (39% in the treatment arm versus 22% in the sham treatment arm), but about half the subjects in both arms thought their pain relief was fair to poor.
According to the study, 9 out of 99 (9%) of patients in the sham group reported at least one adverse event compared to 14 out of 102 (14%) in the sTMS group. Even though the authors suggest the adverse events were similar between the groups, the story should have reported this. Furthermore, we have no long-term information about problems associated with magnetic pulses in the brain, nor do we know about long-term effects on the primary endpoint, namely headache. Could they worsen over time?
The story did an adequate job describing the study and highlighting the rigorous design methods, namely that it was a randomized, sham-controlled, multicenter trial. But the story didn’t reveal whether the benefit was sustained for multiple headaches and repeated use of the device. A discussion of why about 2/3 of the originals subjects were not randomized or why another third dropped out after randomization seems like an important omission.
The story does point out that since this is an industry-sponsored trial, replicating the results with an independent trial is prudent.
Overall, the story could have zeroed in better on specific limitations and strengths of this report.
This story indicates that 35 million Americans have migraines and 20-30% of these people have aura-associated symptoms.
This story did at least include comments from the editorial writer who injected some cautionary notes into the discussion. And it did point out the conflicts of interest associated with the trial. This study was funded by Neurolieve, the company that makes the device used in the trial. Furthermore, the lead author of the study owns stock in this company.
The story states that "Drugs commonly used in the treatment of severe headaches are generally not considered effective in the aura phase of migraine attacks." In fact inexpensive drugs (such as nonsteroidals) or others, such as triptans, are effective in the aura phase. So we think the discussion of alternative options is incomplete.
The story makes it clear that this device is pending FDA approval and not yet available.
The story points out that a similar device has received FDA approval for the treatment of depression.
It does not appear that the story relied soley on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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