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.
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like