On 6th of September, 2018, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) has released a report on external stimulation of the trigeminal nerve for the prevention and acute treatment of an episodic and chronic migraine.
The authors have systematically reviewed the literature in order to explore whether external trigeminal nerve stimulation (e-TNS, Cefaly® device), as a preventive or acute therapy, is more effective and safer than standard drug therapy or placebo, taking into consideration improvement in migraine episodes, satisfaction, side effects and quality of life (QoL).
The authors have performed the search for scientific literature on Medline, Embase, The Cochrane Library and CRD databases. Only prospective studies, published in German or English, were considered. In addition, a hand search of publications, as well as a search in the clinical trial registries was executed.
Two (2) studies met the inclusion criteria and were considered for the assessment of the clinical effectiveness, both being RCTs (one for the preventive use of e-TNS and one for the acute treatment use of e-TNS). The RCT that tested the prevention use of the method (n=34) demonstrated that the e-TNS was more effective than the placebo treatment in episodic migraine patients. The patients have had:
- 0.67 fewer migraine attacks per month
- 1.74 fewer migraine days per month
- 2.28 fewer headache days per month
- 4.24 fewer instances of acute drug intake per month
- +26.2% more response to the e-TNS treatment and
- +31.2% difference in satisfaction with the control group
The RCT that tested the acute treatment use of the e-TNS demonstrated that method caused more improvement in pain reduction than placebo treatment on a VAS scale (out of 11 points) at 1, 2 and 24 hours post-acute treatment (1.68, 1.02 and 1.08 more improvement points, respectively). However, it remains unclear if the improvement measured is clinically relevant because the results fluctuate around the lower end of the clinically meaningful benefit threshold.
Regarding the safety of the method, seven (7) studies were included: the two (2) abovementioned RCTs and five (5) prospective case series (three (3) for preventive, n=84; and two (2) for acute treatment, n=95). All studies demonstrated no serious adverse device effects. Two (2) preventive-use studies reported intolerance to paraesthesia in 34% of the patients, while one (1) study indicated that headache occurred in 8% of the patients and neck tension occurred in 4% of the patients. One (1) acute-use study demonstrated intolerance to paraesthesia in 12% of the patients, two (2) studies reported that 18% of the patients reported skin allergies, and 3.5% of the patients reported other side effects.
Since the sample is small and consists of highly selective patients (as compared to the substantial burden of disease that a migraine creates), the authors point out the necessity for RCTs of a larger scale and, currently, do not recommend this method to be included in the catalogue of benefits.
You can find the full article in English (with German summary) here.
Subscribe to our newsletter delivered every second week not to miss important reimbursement information.