Table 4.
Clinical effects of H3-L6 vs L6 interventions in chronic headache patients.
| H3-L6 intervention (n = 33) Mean (95% CI) |
L6 intervention (n = 34) Mean (95% CI) |
Between-group difference Mean (95% CI) |
Between-group P-valued | |
|---|---|---|---|---|
| Headache Impact Test (HIT-6)a | ||||
| Baseline | 61.0 (59.5, 62.5) | 60.6 (58.7, 62.6) | ||
| Follow-up | 53.5 (50.8, 56.2) | 58.5 (56.3, 60.8) | −5.4 (−8.2, −2.6) | <0.001 |
| Pre- to postchange | −7.5 (−4.9, −10.2) | −2.1 (−0.99, −3.2) | ||
| P-value c | <0.001 | <0.001 | ||
| Headache Days per montha | ||||
| Baseline | 23.3 (20.9, 25.8) | 23.2 (20.2, 25.8) | ||
| Follow-up | 14.5 (10.8, 18.2) | 19.0 (15.4, 22.7) | −4.8 (−8.9, −0.7) | 0.02 |
| Pre- to postchange | −8.8 (−5.4, −12.2) | −4.0 (−1.45, −6.55) | ||
| P-valuec | <0.01 | <0.01 | ||
| Headache Hours per dayb | ||||
| Baseline | 10.2 (8.4, 12.3) | 9.8 (8.1, 11.8) | ||
| Follow-up | 5.6 (4.3, 7.3) | 8.6 (7.0, 10.6) | −45% (−53%, −9%) | 0.01 |
| Pre- to postchange | −44% (−49%, −39%) | −13% (−18%, −8%) | ||
| P-valuec | <0.001 | <0.001 | ||
|
|
||||
| Percent (95% CI) | Percent (95% CI) | Percent (95% CI) | ||
| Probability of experiencing a Severe Headache dayb | ||||
| Baseline | 66 (55, 77) | 68 (58, 79) | ||
| Follow-up | 38 (24, 52) | 61 (47, 73) | −23 (−42, −4.1) | 0.02 |
| Pre- to postchange | −28 (−44, −13) | −7.8 (−15, −1) | ||
| P-value c | 0.02 | 0.03 | ||
CI, confidence interval.
a
Measured at baseline and at intervention end. Last values of each randomized subject brought forward for “intent-to-treat” analysis.
b
Measured daily throughout 4-week preintervention and 12-week intervention phase. Hierarchical linear models used all available data for each randomized participant.
c
Indicates paired sample t-test.
d
Between-group difference P-values are based on analysis of covariance comparing postintervention values controlling for baseline values.