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Table 2 Results of primary and secondary treatment outcome measures

From: Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

 

Intention-t-treat analysis

Per protocol analysis

 

1 Hz (n = 22)

25 Hz (n = 24)

Group comparison

1 Hz (n = 17)

25 Hz (n = 22)

Group comparison

Change in headache days/28 days

−5.6 ± 5.0

−3.0 ± 5.3

F[42] = 2.94

−7.0 ± 4.6

−3.3 ± 5.4

F[35] = 4.82

(−5.9; −0.5)

(−8.5; −3.2)

p = 0.094

(−9.6; −4.1)

(−5.9; −0.4)

p  = 0.035

Responder (50 % reduction in headache days)

5 (22.7 %)

3 (12.5 %)

OR = 2.44

5 (29.4 %)

3 (13.6 %)

OR = 3.21

p = 0.29

p = 0.18

Change in headache intensity (NRS 0 – 10)

−0.1 ± 1.1 (n = 20)

0.2 ± 1.0

F[40] = 0.30

0.02 ± 1.2 (n = 15)

0.2 ± 1.0

F[33] = 0.28

(−0.2; 0.9)

(−0.4; 0.7)

p = 0.58

(−0.4; 0.8)

(−0.2; 0.9)

p = 0.60

Change in days with acute headache medication in 28 days

−2.0 ± 4.2

−1.3 ± 4.4

F[42] = 0.01

−2.7 ± 4.5

−1.6 ± 4.1

F[35] < 0.01

(−4.2; −0.3)

(−4.4; −0.3)

p = 0.91

(−4.7; −0.4)

(−4.7; −0.3)

p = 0.96

Change in MIDAS score

−18.7 ± 28.0

−21.8 ± 54.5

F[42] < 0.01

−24.2 ± 29.8

−26.5 ± 53.9

F[35] < 0.01

(−38.6; −0.9)

(−39.2; −0.8)

p = 0.98

(−43.2; −4.0)

(−42.1; −3.7)

p = 0.96

Change in HIT-6 score

−2.5 ± 6.8

−3.8 ± 5.5

F[42] = 0.12

−3.8 ± 7.1

−3.9 ± 5.69

F[35] = 0.01

(−6.7; −0.7)

(−7.3; −1.2)

p = 0.73

(−7.8; −1.1)

(−7.6; −1.0)

p = 0.93

  1. Change refers to change from the 4-week baseline period to the last 4 weeks of the 12-week treatment period. Means, SDs and 95 % confidence intervals are given. For the responder analysis, numbers of subjects and percent of the total group are given. Significant differences are marked in bold. Number of subjects is given in parentheses, where different from the total group. Primary outcome parameter: change in headache days/28 days
  2. MIDAS migraine disability assessment, HIT headache impact test, NRS numerical rating scale 0–10