Table 3.
Secondary efficacy measures for baseline and after one single BTA treatment of SPG. Per protocol analysis (n = 7).
| Baseline | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | |
|---|---|---|---|---|---|---|---|
| Mean intensity/ attack ± SD (p value) | 3.50 ± 1.05 | 2.66 ± 1.10 (0.043) | 2.56 ± 1.08 (0.043) | 2.44 ± 1.31 (0.043) | 2.46 ± 1.46 (0.043) | 2.38 ± 1.43 (0.028) | 2.56 ± 1.19 (0.043) |
| Mean durationa ± SD (p value) | 1345 ± 793 | 422 ± 691 (0.12) | 528 ± 740 (0.12) | 550 ± 882 (0.12) | 511 ± 792 (0.12) | 666 ± 969 (0.25) | 724 ± 888 (0.50) |
| Mean durationa per attack ± SD (p value) | 35.6 ± 24.8 | 26.0 ± 35.0 (0.25) | 30.5 ± 43.9 (0.60) | 31.0 ± 45.1 (0.89) | 32.1 ± 47.2 (0.69) | 35.6 ± 47.4 (0.89) | 36.2 ± 47.5 (0.89) |
| Days without attacks ± SD (p value) | 4.2 ± 5.9 | 14.6 ± 10.6 (0.046) | 14.3 ± 11.2 (0.075) | 13.6 ± 10.1 (0.063) | 12.3 ± 10.9 (0.12) | 11.7 ± 11.8 (0.25) | 12.1 ± 11.6 (0.23) |
| Headache severity indexb ± SD (p value) | 10.4 ± 14. | 0.98 ± 1.21 (0.075) | 3.60 ± 7.78 (0.075) | 1.78 ± 2.77 (0.12) | 1.51 ± 1.42 (0.17) | 3.38 ± 3.83 (0.46) | 4.25 ± 6.04 (0.46) |
| Mean number of attacks, intensity 3 or 4c ± SD (p value) | 50 ± 38 | 13 ± 16 (0.028) | 11 ± 11 (0.028) | 10 ± 8 (0.043) | 17 ± 20 (0.028) | 18 ± 23 (0.063) | 19 ± 21 (0.042) |
| Triptan doses ± SD (p value) | 91 ± 49 | 35 ± 25 (0.068) | 56 ± 64 (0.068) | 40 ± 37 (0.068) | 42 ± 23 (0.14) | 52 ± 42 (0.14) | 60 ± 54 (0.14) |
| HIT-6 ± SD (p value) | 65.1 ± 2.73 | 51.9 ± 7.76 (0.018) | 56.9 ± 8.86 (0.063) | 54.1 ± 12.2 (0.075) |
P value for each month compared to baseline. BTA: onabotulinumtoxinA; SPG: sphenopalatine ganglion; HIT-6: Headache Impact Test-6.
a
In minutes.
b
Duration (min) × intensity × frequency, 106.
c
Categorical intensity scale: Grade 1; mild, grade 2; moderate, grade 3; severe, grade 4; unbearable.