Guidance
3 Committee considerations
The evidence
3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 14 sources, which was discussed by the committee. The evidence included 2 randomised controlled trial, 3 case series and 1 observational survey for acute treatment of migraine. It included 4 randomised controlled trials, 2 case series, 1 observational survey and 1 Food and Drug Administration Manufacturer and User Facility Device Experience database adverse event report for prevention. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: reduced frequency, duration and severity of migraine episodes, reduced medication use and improved quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: pain, weakness, poststimulation headaches and worsening of migraine.
3.4 Twelve commentaries from people who have had this procedure and a submission from a patient organisation were discussed by the committee.
Committee comments
3.5 The committee noted that migraine is often a chronic condition with a detrimental effect on quality of life. It recognised that, for some people, there is a lack of effective prevention and treatment options.
3.6 The committee noted that many people having this procedure continued to take medications to treat or prevent migraine.
3.7 The committee was pleased to receive patient commentary and a submission from a patient organisation for this procedure. It noted that several people reported a negative experience of the procedure, including unpleasant side effects.
ISBN: 978-1-4731-4389-0