Skip to main navigation
Skip notifications
Access to POEMs and Essential Evidence Plus will no longer be included in CMA membership as of Dec. 1, 2023.
Search
Noninvasive vagus nerve stimulation more effective than sham therapy for migraine attacks (PRESTO)
Clinical Question
Is noninvasive vagus nerve stimulation more effective than sham therapy in terminating migraine attacks?
Bottom line
In this study, a noninvasive vagus nerve stimulator was more effective than sham therapy in terminating acute migraines by 2 hours, but the difference was not statistically significant. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
This industry-sponsored study enrolled 285 patients with 3 to 8 migraines per month in the preceding 6 months. The study had 3 four-week phases: an inactive run-in period, a double-blind period (the focus of this paper), and an open-label period. Active run-in periods typically weed out patients not able to adhere to the study protocol and those with short-term side effects of treatment, and they generally stack the deck in favor of the intervention. Inactive run-in periods typically weed out the patients not likely to adhere to the study protocol and may not reflect adherence among patients that we see in primary care. Anyway, after the run-in period (13% of the patients did not proceed) the patients were randomized to receive active vagus nerve stimulation (n = 120) or sham vagus nerve stimulation (n = 123). The vagus nerve stimulator is a handheld doohickey that looks like a cross between a Taser and one of those injectors you see on Star Trek. You apply it for 2 minutes to the lateral aspect of both sides of the neck within 20 minutes of the onset of a migraine. A second administration can be repeated after 15 minutes. This 2-step process can be repeated in 2 hours. The sham device delivered a palpable signal that does not actually stimulate the vagus or cause muscle contraction. More than 90% of the patients had migraine without aura and more than 75% were women. The primary outcome, complete relief after 2 hours, occurred more frequently in the active treatment group (30.4%) than in the sham treatment group (19.7%). Although this difference corresponds to a number needed to treat of 12, the difference is not statistically significant. The study had more than 90% power to detect a 20% difference, corresponding to a number needed to treat of 5. The authors report statistically significant improvements on intermediate intervals, but the 2-hour outcome is the standard outcome set by the International Headache Society. How much does it cost? I was unable to find pricing information on the manufacturer's website. A blog, the Daily Headache, reports the device costs $600 per device, that the patient co-pay is $500, and that the device needs to be replaced every month (www.thedailyheadache.com/tag/gammacore). The Daily Mail reports that the device costs �250 in the United Kingdom (~ $320 US; www.dailymail.co.uk/health/article-2956189/Jolt-electricity-fights-migraines-helps-lose-weight.html).
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
This is totally misleading - a finding that says a treatment shows an improvement but is not statistically significant - means the opposite! This conclusion should say there is NO improvement with this treatment more than sham.
Terrific reviewer!
SI-16 runs along the posterior border of the SCM at the level of the larynx. This stimulates the cervical plexus. Along with GB-34, the vagus gets modulated, leading to migraine resolution. There is a huge over lap of myofascial trigger points in migraines
Thanks to the reviewer who correctly observed the problems with run-in intervals. Results cannot be duplicated in the general setting. Kind of like the mileage figures published for new cars in lab settings with air conditioner dismantled.
The expense is disgraceful. This is a "money-maker at the expense of the poor patient. Migraine is a horrible disease for the victim, often not realized by others who put it in the "anxiety" category, which may be part of it but it is still a very painful , debilitating problem with hard to control triggers and poor treatments options. (I do not suffer this so am not "self-biased").
One of the more amusing POEMS I have read in a while
I use injections of 1 mL of 5% mannitol around the involved trigeminal nerve branches (generally supratrochlear, supraorbital, lacrimal) as well as a long the preauricular temporal nerve, which I treat with 3 mL of the solution below the earlobe and 1 mL along its course where it is tender to palpation. This takes approximately 5 minutes and it never fails to relieve a headache. For occipital headaches, I use the same solution to follow the course of the greater and lesser occipital nerves.
good poem
" Industry sponsored" , need I say more. Think of the Purdue sponsored opiate crisis, also "industry sponsored'.
bla bla bla