Article type
Year
Abstract
Background: Migraine is a very common disease, approximately 15% of people are affected globally. Current available preventive antimigraine drugs have limited efficacy and have unpleasant adverse effect or contraindications. Due to these limitations, patients need safe and effective non-pharmacological therapy. The external trigeminal nerve stimulation (e-TNS) is reported effective for pain relief and patient satisfaction.
Objectives: This study aimed to evaluate the effectiveness and safety of e-TNS for preventive treatment of migraine.
Methods: We searched Medline, EMBASE, Cochrane library and Korean database, including KoreaMed, RISS, KISS, KISTI, KMBASE on 18 March 2019. The risk of bias was assessed by SIGN methodology checklist.
Results: Of the total 1,299 articles retrieved according to the literature search strategy, the final 9 articles were selected according to the selection and exclusion criteria. The effectiveness was assessed for the parameters of migraine symptomatic improvement, including the changes in migraine duration, pain intensity, drug intake and frequency of migraine attack, based on 8 articles. In a study comparing e-TNS and Flunarizine (a migraine preventive drug), changes in the number of migraine days and the intakes of acute migraine medications decreased similarly, but were not statistically significant, and the pain intensity measured with VAS-10 was significantly greater decreased in Flunarizine group (p = 0.01). Compared with the sham control, the e-TNS group had a significantly reduction in migraine days (p = 0.023), acute migraine medication intake (p = 0.0072) and frequency of migraine attacks (p = 0.044). In the single-arm studies, most studies reported that it had an effect on symptom improvement significantly after using e-TNS. Safety was assessed for procedure-related side effects based on 5 articles. The reported side effects included paresthesia, arousal and sleep disorder, skin rash or pressure feeling in the area of electrode attachment. The most frequently reported side effect was local paresthesia in 5 studies, and the rate was reported as 1.34-34.39%.
Conclusions: The effectiveness may be expected if e-TNS is used as a treatment alternative in patients with adverse effects or contraindications to migraine drugs. However, this doesn't have sufficient evidence to verify the effectiveness, there should be more study results from RCTs compared with the sham control are needed. And the safety is acceptable since the the selected articles reported only mild side effects and a technology based on similar principle is already in use for other indications. The New Health Technology Assessment Committee deliberated that e-TNS is safety, but further research is required to verify the effectiveness.
Patient or healthcare consumer involvement: This study was performed with two researchers independently and subcommittee of 7 members (neurologists, neurosurgeons, anesthesiologist, psychiatrist, and pediatrician). This conclusion will help migraine patients and clinicians to make clinical decisions.
Objectives: This study aimed to evaluate the effectiveness and safety of e-TNS for preventive treatment of migraine.
Methods: We searched Medline, EMBASE, Cochrane library and Korean database, including KoreaMed, RISS, KISS, KISTI, KMBASE on 18 March 2019. The risk of bias was assessed by SIGN methodology checklist.
Results: Of the total 1,299 articles retrieved according to the literature search strategy, the final 9 articles were selected according to the selection and exclusion criteria. The effectiveness was assessed for the parameters of migraine symptomatic improvement, including the changes in migraine duration, pain intensity, drug intake and frequency of migraine attack, based on 8 articles. In a study comparing e-TNS and Flunarizine (a migraine preventive drug), changes in the number of migraine days and the intakes of acute migraine medications decreased similarly, but were not statistically significant, and the pain intensity measured with VAS-10 was significantly greater decreased in Flunarizine group (p = 0.01). Compared with the sham control, the e-TNS group had a significantly reduction in migraine days (p = 0.023), acute migraine medication intake (p = 0.0072) and frequency of migraine attacks (p = 0.044). In the single-arm studies, most studies reported that it had an effect on symptom improvement significantly after using e-TNS. Safety was assessed for procedure-related side effects based on 5 articles. The reported side effects included paresthesia, arousal and sleep disorder, skin rash or pressure feeling in the area of electrode attachment. The most frequently reported side effect was local paresthesia in 5 studies, and the rate was reported as 1.34-34.39%.
Conclusions: The effectiveness may be expected if e-TNS is used as a treatment alternative in patients with adverse effects or contraindications to migraine drugs. However, this doesn't have sufficient evidence to verify the effectiveness, there should be more study results from RCTs compared with the sham control are needed. And the safety is acceptable since the the selected articles reported only mild side effects and a technology based on similar principle is already in use for other indications. The New Health Technology Assessment Committee deliberated that e-TNS is safety, but further research is required to verify the effectiveness.
Patient or healthcare consumer involvement: This study was performed with two researchers independently and subcommittee of 7 members (neurologists, neurosurgeons, anesthesiologist, psychiatrist, and pediatrician). This conclusion will help migraine patients and clinicians to make clinical decisions.