Behavioural intervention in medication overuse headache: A concealed double‐blind randomized controlled trial

European Journal of Neurology, vol. 29, pp. 1496–1504

Abstract

BACKGROUND AND PURPOSE: Medication overuse headache is a prevalent disorder, with a strong biobehavioural component. Hence, behavioural interventions might effectuate reduction of the overused medication. We assessed in a double-blind manner the efficacy of a behavioural intervention during medication withdrawal therapy. METHODS: In this concealed, double-blind, randomized controlled trial in medication overuse headache, conducted at the Leiden University Medical Centre, we compared the effect of maximal versus minimal behavioural intervention by a headache nurse during withdrawal therapy. Maximal intervention consisted of an intensive contact schedule, comprising education, motivational interviewing, and value-based activity planning during 12 weeks of withdrawal therapy. Minimal intervention consisted of a short contact only. Patients were unaware of the existence of these treatment arms, as the trial was concealed in another trial investigating botulinum toxin A. Endpoints were successful withdrawal and monthly days of acute medication use after the withdrawal period. RESULTS: We enrolled 179 patients (90 maximal, 89 minimal intervention). At Week 12, most patients achieved withdrawal in both groups (82/90 [93%] maximal intervention vs. 75/89 [86%] minimal intervention, odds ratio = 2.44, 95% confidence interval [CI] = 0.83-7.23, p = 0.107). At Week 24, patients in the maximal intervention group had fewer medication days (mean difference = -2.23, 95% CI = -3.76 to -0.70, p = 0.005). This difference receded over time. Change in monthly migraine days did not differ between groups (-6.75 vs. -6.22). CONCLUSIONS: This trial suggests modest benefit of behavioural intervention by a headache nurse during withdrawal therapy for medication overuse headache, to reduce acute medication use during and shortly after intervention, but extension seems warranted for a prolonged effect.

Authors 5

1. Judith A. Pijpers Aachen Department of Neurology Leiden University Medical Centre Leiden The Netherlands Department of Neurology, Leiden University Medical Centre

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Neurology Leiden University Medical Centre Leiden the Netherlands

   Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands

2. Dennis A. Kies Aachen Department of Neurology Leiden University Medical Centre Leiden The Netherlands Department of Radiology Leiden University Medical Centre Leiden the Netherlands Department of Neurology, Leiden University Medical Centre Department of Radiology, Leiden University Medical Center

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Neurology Leiden University Medical Centre Leiden the Netherlands

   Department of Radiology Leiden University Medical Centre Leiden the Netherlands

   Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands

   Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands

3. Erik W. van Zwet Aachen Department of Medical Statistics Leiden University Medical Centre Leiden The Netherlands Department of Medical Statistics

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Medical Statistics Leiden University Medical Centre Leiden the Netherlands

   Department of Medical Statistics, Leiden University Medical Centre, Leiden, the Netherlands

4. Frits Richard Rosendaal Aachen Department of Clinical Epidemiology Leiden University Medical Centre Leiden The Netherlands Department of Clinical Epidemiology

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Clinical Epidemiology Leiden University Medical Centre Leiden the Netherlands

   Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands

5. Gisela Marie Terwindt corresponding Aachen Department of Neurology Leiden University Medical Centre Leiden The Netherlands Department of Neurology, Leiden University Medical Centre

   Leiden University · Leiden University Medical Center

   Affiliation as printed

   Department of Neurology Leiden University Medical Centre Leiden the Netherlands

   Department of Neurology, Leiden University Medical Centre, Leiden, the Netherlands