Page 97 - The clinical aspects and management of chronic migraine Judith Anne Pijpers
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Outcome measures and analysis
The predefined outcome measures were successful withdrawal after 12 weeks and monthly days with use of acute headache medication after the withdrawal period. Successful withdrawal was defined as intake of acute medication on ≤2 days/month. Change in monthly days of acute medication use was assessed at timepoints 12, 24, 36 and 48 weeks. Since the intervention aims to enhance medication withdrawal and focusses on medication-related behavior, all outcomes of this study were medication-use related. A previous retrospective study by our group indicated that intervention by a headache nurse increases withdrawal adherence, but does not directly influences migraine attack frequency.13 Descriptives are reported as means ± standard deviations or numbers with proportions, and differences between groups are shown with 95% confidence intervals. Multivariate regression models were fit adjusting for age, gender, baseline medication days, drug treatment allocation, depression and anxiety (based on the Hospital Anxiety and Depression Scale (HADS))20. For the repeated measures model unstructured covariance matrixes were used. Analyses were (modified) intention-to-treat, including patients who provided at least one outcome measurement, performed in SPSS 23.0 (SPSS Inc., Chicago, Ill).
Data availability
Anonymized data can be made available upon request to the corresponding author.
Results
Of 179 MOH patients, 90 were allocated to receive maximal intensive behavioral intervention and 89 patients to minimal intervention during the first 12 weeks of withdrawal therapy. Patients in the two treatment arms did not differ in sex, age, headache characteristics, medication use, and psychiatric comorbidity (Table 1). Follow-up was complete for 98% (n=175) after 12 weeks and 82% (n=147) after 48 weeks, with similar numbers of dropouts in both groups (Figure 2). Most patients (88%) were accurately treated according to the protocol of the allocated treatment (maximal intervention n=82 (91%), minimal intervention n=75 (84%)).
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Behavioural intervention: a double blind RCT
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