Background: Little is known about the effects of non-pharmacological interventions among medication-overuse headache (MOH) patients, although non-pharmacological approaches combined with pharmacological treatment are recommended. The objective was to evaluate the effect of an educational programme as an add-on to standard treatment.
Methods: Medication-overuse headache patients were randomized (1:1) in a single-centre setting to standard treatment with 12 weeks of education (I-group) versus standard treatment (C-group). The primary outcome was measurement of reduction in headache days/last month at 9 months' follow-up. Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity and patient satisfaction. The between-group differences were analysed using a mixed-effects model for repeated measurements with a between group factor (I-group vs. C-group) and a time factor (baseline, 4 and 9 months).
Results: Ninety-eight patients were randomized (I-group: n = 48, C-group: n = 50), with 40 and 39 patients completing the study, respectively. Intention-to-treat analyses showed that both groups experienced statistically significant reductions in headache days/last month (I-group: -4 ± 6 days (95% CI 2.47; 5.95), p < .001) versus C-group: -4 ± 9 days ([95% CI 1.53; 6.79], p = .003), but there were no significant differences between groups (mean ± SE):Δ: 0.7 days ([95% CI, -2.50; 3.93], p = .66). At follow-up, 85% from the I-group and 86% from C-group, no longer fulfilled the criteria for MOH.
Conclusion: The compliance rate was high, indicating that patients were motivated for receiving education, but we found no additional benefits of adding an educational programme to standard treatment. Future research focusing on the MOH complexity, group heterogeneity, duration and content of educational programmes is warranted.
Significance: Randomized controlled trials (RCTs) of non-pharmacological intervention such as patient educational programmes are of great importance, as this approach is common in the clinical practice. Medication-overuse headache (MOH) is a heterogenetic patient group, which must be taken into account when conducting RCTs of non-pharmacological interventions. An educational programme based on Motivational Interviewing is well-tolerated among MOH patients, however, no superior effects were found from adding the educational programme to standard treatment versus standard treatment alone.
Trial registration: ClinicalTrials.gov NCT02768233.
© 2019 European Pain Federation - EFIC®.