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Table 2 Sustained response at 24 and 48 h post-treatment

From: Consistent effects of non-invasive vagus nerve stimulation (nVNS) for the acute treatment of migraine: additional findings from the randomized, sham-controlled, double-blind PRESTO trial

 

Double-blind Period

Open-label Period

nVNS

Sham

P Value

nVNS

% (n/N)

(95% CI)

% (n/N)

(95% CI)

% (n/N)

(95% CI)

All Attacks

 Pain-free

  24 h

79.0 (71/93)

(67.9, 87.1)

83.7 (54/66)

(69.9, 91.9)

0.532a

80.8 (118/146)

(73.5, 86.6)

  48 h

65.7 (59/93)

(53.3, 76.3)

71.2 (46/66)

(56.5, 82.5)

0.537a

70.3 (102/146)

(61.6, 77.7)

 Pain relief

  24 h

80.9 (109/138)

(72.3, 87.3)

80.3 (78/99)

(69.4, 87.9)

0.916a

80.5 (185/230)

(74.5, 85.3)

  48 h

74.1 (99/138)

(64.0, 82.1)

72.1 (70/99)

(60.7, 81.3)

0.775a

71.9 (165/230)

(65.2, 77.7)

First Attack

 Pain-free

  24 h

75.0 (27/36)

(57.8, 87.9)

84.6 (22/26)

(65.1, 95.6)

0.359b

75.4 (46/61)

(62.7, 85.5)

  48 h

58.3 (21/36)

(40.8, 74.5)

69.2 (18/26)

(48.2, 85.7)

0.381b

65.6 (40/61)

(52.3, 77.3)

 Pain relief

  24 h

77.3 (58/75)

(66.2, 86.2)

79.3 (46/58)

(66.7, 88.8)

0.784b

78.8 (108/137)

(71.0, 85.3)

  48 h

69.3 (52/75)

(57.6, 79.5)

71.0 (41/58)

(57.3, 81.9)

0.866b

70.1 (96/137)

(61.7, 77.6)

  1. Abbreviations: CI Confidence interval, nVNS Non-invasive vagus nerve stimulation
  2. aGeneralized linear mixed effects regression models were used to estimate the proportion of successful responses, allowing for both subject-specific and population-averaged inferences in non-normally distributed data. bFrom chi-square test or Fisher exact test, as appropriate