4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 A multicentre double-blind randomised controlled trial (RCT) of 67 patients with migraine compared transcutaneous supraorbital neurostimulation (tSNS; n=34) against sham treatment (n=33). In the intention-to-treat analysis, there was a statistically significant decrease in the mean number of migraine days between baseline and 3 months after treatment in the tSNS group (6.94±3.04 to 4.88±3.46; p=0.023), but not in the sham group (6.54±2.61 to 6.22±2.99; p=0.608). The difference between the 2 groups was not statistically significant (p=0.054). A case series of 20 patients with migraine without aura reported a statistically significant decrease in the frequency of migraine days per month from 4.5±0.24 at baseline to 2.06±0.28 at 60‑day follow-up (p<0.001).

4.2 In the RCT of 67 patients the 50% responder rate (defined as the percentage of patients having a greater than 50% reduction in monthly migraine days) was statistically significantly higher in the tSNS group than in the sham group (38% [n=13] versus 12% [n=4]; p=0.023) in the intention‑to‑treat analysis. The percentage of patients with at least a 25% reduction (moderate improvement) in migraine days was also statistically significantly higher in the tSNS group than in the sham group (59% [n=20] versus 27% [n=9], p=0.014). The case series of 20 patients reported a 50% reduction in monthly migraine attacks and migraine days in 81% and 75% of patients respectively at 60‑day follow-up.

4.3 In the RCT of 67 patients (intention-to-treat analysis) the monthly migraine attack frequency was 4.37±1.87 at baseline and 3.55±2.94 at 3 months (p=0.058) in the tSNS group, and 4.04±1.52 at baseline and 3.89±1.89 at 3 months (p=0.516) in the sham group. The difference between the 2 groups was statistically significant (p=0.044).

4.4 In the RCT of 67 patients (intention-to-treat analysis) there was a statistically significant decrease in monthly days with any headache between baseline and 3 months after treatment in the tSNS group (7.78±4.00 to 5.27±3.55; p=0.011), but not in the sham group (6.72±2.63 to 6.49±3.20; p=0.674). The difference between the 2 groups was statistically significant (p=0.041).

4.5 In the RCT of 67 patients (intention-to-treat analysis) the mean headache severity per migraine day (on a 4‑point scale, 0 indicating no pain and 3 indicating severe pain prohibiting daily activities) was 1.96±0.46 at baseline and 1.8±0.60 at 3 months (p=0.131) in the tSNS group, and 1.78±0.41 at baseline and 1.73±0.53 at 3 months (p=0.443) in the sham group. The difference between the 2 groups was not statistically significant (p=0.301). In the case series of 20 patients there was a statistically significant reduction in average pain intensity (measured on a visual analogue scale from 0–10, 0 indicating no pain and 10 indicating severe pain) during migraine attacks, from 8.0±0.1 at baseline to 6.7±0.2 at 60‑day follow-up (p=0.002).

4.6 In the RCT of 67 patients (intention-to-treat analysis) there was a statistically significant decrease in the monthly intake of migraine drugs for acute attacks in the tSNS group (11.45±8.35 to 7.25±7.31; p=0.0057), but not in the sham group (9.24±4.75 to 9.28±5.69; p=0.822). The difference between the 2 groups was statistically significant (p=0.0072). In the case series of 20 patients, there was a statistically significant reduction in the use of rescue drugs from 5.6±0.4 medications at baseline to 2.2±0.3 at 60‑day follow‑up (p<0.001). Statistically significant reductions were also seen in the intake of non-steroidal anti-inflammatory drugs, from 3.2±0.6 medications at baseline to 1.3±0.4 at 60‑day follow‑up (p=0.02), and in triptans, from 2.4±0.7 medications at baseline to 0.9±0.3 at 60‑day follow‑up (p=0.04).

4.7 In the RCT of 67 patients the percentage of very or moderately satisfied patients was higher in the tSNS group (70%) than in the sham group (39%). The case series of 20 patients reported 100% satisfaction with tSNS treatment at 60‑day follow‑up.

4.8 The specialist advisers listed key efficacy outcomes as changes in monthly migraine days, migraine attacks, total headache days, headache load (severity multiplied by duration), headache‑free days and analgesic‑free days.

4.9 Twenty commentaries from patients who had experience of this procedure were received, which were discussed by the committee.

  • National Institute for Health and Care Excellence (NICE)