Mean subjective rating across time points
Baseline | Active phase | Placebo phase | P value | |||
4 weeks | 12 weeks | 4 weeks | 12 weeks | |||
HIT-6 | 60.8±8.77 | 59.2±8.56 | 57.9±8.64 | 55.8±9.49 | 58.1±9.22 | 0.65 |
PRI | 16.2±10.6 | 12.6±8.8 | 14.3±12.5 | 13.1±10.6 | 14.8±10.1 | 0.81 |
PPI-VAS | 56.9±26.7 | 41.9±26.6 | 44.6±27.1 | 46.9±28.8 | 53.9±29.9 | 0.33 |
SFMcGill(III) | 2.93±1.28 | 2.25±1.11 | 2.12±1.24 | 2.48±1.39 | 2.58±1.33 | 0.19 |
ESS | 7.55±4.82 | 6.65±4.61 | 6.85±4.53 | 7.15±4.83 | 7.42±4.80 | 0.92 |
ESS, Epworth Sleepiness Scale; HIT-6, Headache Impact Test-6; PPI-VAS, present pain intensity Visual Analogue Scale; PRI, Pain Rating Index; SFMcGill(III), Short Form McGill overall intensity of pain experience .