Mayo recap of device for migraine prevention omits conflict of interest disclosure

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Cost is not mentioned.

According to the American Psychological Association:

A typical course of TMS therapy for depression involves 20 to 30 sessions, generally given in three to five treatments per week for four to six weeks. The full course of therapy with the pricey machines can cost $6,000 to $12,000.

This is consistent with other sources estimating the cost-per-session as approximately $400-500. Some (but not all) insurance plans cover TMS. Many insurance companies will require written justification from a physician for using TMS.

It’s unclear whether patients would need to buy or rent the machine, and at what cost.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The news release establishes in the first paragraph that TMS is “easy-to-use…noninvasive…safe,” but does not mention any side effects. These include worsening headaches, transient mood disturbances, and very rarely seizures. Importantly, given how new this treatment is, studies on potential long-term side effects are lacking at this time.

The procedure cannot be used in people who have metal in their head such as stents, aneurysm clips, metallic ear/eye devices, and bullet fragments.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This open label observational study has several important limitations that are not brought up in the brief news release.

First, there is no placebo (or sham device) with which to compare the results. Therefore, how much of a placebo effect occurred is unknown.

Second, beneficial outcomes relied upon self-assessment of pain. Such subjective reports are difficult to reproduce.

Third, there was missing information regarding patients’ overuse or underuse of pain medications during the 3-month study. How much pain medication was or was not used by subjects could alter the frequency and intensity of their headaches.

Fourth, the small sample group consisted mostly of Caucasian women, which may not generalize to the general population. The dropout rate reported in figure 2 of the paper also suggest a validity problem due to lack of information on why patients dropped out during the trial. Note that a number of patient volunteers didn’t have enough headaches to qualify for the end points (the outcomes that can be measured objectively to determine whether the intervention was beneficial). Thus, the treatment couldn’t really help them.

Finally, most of the subjects in this study had episodic migraines. Because response to the treatment was not subdivided by headache type, it’s unclear from the results if TMS is more or less beneficial depending on what type of migraine a patient has.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

This is a major weakness of the news release.

Not only is the funding for the study not mentioned (the study was supported by eNeura Inc.) but it’s also not mentioned that 5 of 13 authors have financial conflicts of interest with this manufacturer of portable TMS devices.

Furthermore, one of the lead authors is chairman of eNeura’s medical advisory board.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The lead author is quoted as saying:

For certain patients, treatment options for migraines, such as oral medications, are not effective, well-tolerated, or preferred.

Some context would have been helpful here. It would help readers to know that the treatment of migraines is usually dictated by which of the several types of migraine the patient has (ie. episodic, chronic, environmentally triggered, and with or without an aura), and whether the goal is preventing an attack or treating an ongoing attack.

TMS is a relative newcomer to a vast menu of treatment options for migraine.

It would have been helpful to state that there a large number of different treatments available for migraines including over-the-counter and prescription medications. Some are FDA approved and some are not. They include treatments for both acute symptoms of a migraine as well as preventing migraines from happening. There are also non-medication based treatments such as laying down in a darkened room and relaxation techniques. The use of preventive therapies for migraines is considered when the frequency is enough that focusing on the acute episode alone is not enough. This is something that patients decide, but is often considered if there are more than one attack per week. As noted, this study shows benefit, but it was not blinded and it doesn’t compare itself to other available treatments.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

It’s mentioned that the subjects in this study self-administered “pulses” each morning and evening, but readers are left wondering if this is done at a medical center or at home. If the former, do most hospitals and clinics have TMS machines? If done at home, how and where does one get a machine? Unclear.