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The trial found no evidence of any clinically relevant benefit from the CHESS intervention across multiple outcomes at multiple time points, nor in any sensitivity or subgroup analyses.
Martin Underwood, MD
Findings from the CHESS randomized study indicated that a brief group education and self-management program does not increase the probability of improvement in headache-related quality of life (QOL) in patients with chronic migraine. Above all, these data highlight the need to identify more effective treatments for those living with, the sometimes disabling, symptoms of chronic migraine, or chronic tension type headache and episodic migraine.1
Led by Martin Underwood, MD, professor of neurology, University of Warwick, the CHESS intervention consisted of 2, 1-day group sessions 1 week apart followed by a 1-on-1 nurse interview and telephone support. The group sessions focused on education and self-management to promote behavior change, healthy living, understanding chronic headache, and learning strategies to manage life despite headache. Eligible patients coming into the study had at least 15 headache days per month for at least 3 months, with migraine or tension type headaches.
Nine of the 736-patient cohort had chronic tension type headache, so the main analyses were limited to the remaining 727 individuals with chronic migraine, or chronic tensions type headache and episodic migraine. Of these, 376 were allocated to the self-management intervention and 351 to usual care. At baseline, the mean Headache Impact Test-6 (HIT-6) scores were 64.5 (±5.5), with over half (53%) of the participants with probable anxiety (HADS anxiety score ≥11) and 22% had probably depression (HADS depression score ≥11).
In a post-hoc analysis of the ADVANCE trial, atogepant 30 and 60 mg produced significant improvements in outcomes on Migraine-Specific Quality of Life Questionnaire and Activity Impairment in Migraine-Diary domains.
After 12 months, primary outcome data on 586 participants with chronic migraine showed no between-group difference in HIT-6 (adjusted mean difference, –0.3; 95% CI, –1.23 to 0.67; P = .56). At 4 months only, there was a difference favoring the self-management program (adjusted mean difference, –1.0; 95% CI, –1.91 to –0.006; P = .049). The between-group difference over 12 months for the number of headache days was 0.2 (95% CI, –0.11 to 0.46; P = .234), for the duration of headache the estimated difference was 0.4 (95% CI, –0.47 to 1.28; P = .361) and for the headache severity the estimated difference was 0.2 (95% CI, –0.08 to 0.46; P = .163).
In terms of secondary outcomes, the self-management group demonstrated 1.5 (95% CI, 0.48-2.56; P = .004) more headache days over the previous 4 weeks at 4 months follow-up, but not at 8 and 12 months. Additionally, there were no differences in proportion of patients using acute medications at least 10 or 15 days in the previous 28 days at any follow-up, indicating no effect on medication overuse. In pre-planned analyses for anxiety, depression, and headache severity, there was no evidence of subgroup effects seen from either intervention.
The CHESS intervention generated incremental adjusted costs of $383 (95% CI, $252-$539) and incremental adjusted quality-adjusted life years (QALYS) of 0.031 (95% CI, –0.005 to 0.063). Overall, the incremental net monetary benefit was $506 (95% CI, $536-$550), with probability that the intervention is cost-effective approaching 0.83 if the cost-effectiveness threshold is $28,600 per QALY gained. In terms of safety, there were 7 adverse events in the study, 1 in the standard arm and 6 in the self-management arm. There was 1 serious event in the standard care arm pertaining to a death from an unrelated cause.
