Page 101 - The clinical aspects and management of chronic migraine Judith Anne Pijpers
P. 101

Hitherto, evidence for non-pharmacological interventions in the treatment of MOH is mainly based on observational studies.13,14,21 For headache disorders in general, contradictory conclusions have been drawn on existing data. A recent Cochrane review indicated a lack of good-quality research on the efficacy of psychological interventions in migraine. A potentially higher response rate was suggested (risk rate for response 2.21, 95% CI 1.63-2.98), but based on trials with a high risk of bias.22 Meta-analyses using broader inclusion criteria, for instance a population with both migraine and tension-type headache, suggest efficacy of psychological treatment.3,23 Nevertheless, common ground in these studies is an urgency for high quality clinical trials, minimizing risk of bias.
Our study has the big advantage that it conceals the behavioral intervention within another trial, which is a new and unique design in headache trials and provided an adequately blinded control group. A potential risk of unblinding can be social interactions among trial patients, which may affect clinical and biological variables.5 Due to the intensive versus minimal behavioral intervention principle, the two treatment arms were unlikely to be revealed by incidental contact between patients. Furthermore, the patients were not even aware of the existence of this part of the study. Therefore, blinding was guaranteed, reducing bias by psychological mechanisms such as expectations and classical conditioning.4
Still, the concurrent drug trial might have influenced the results. The rates of successful withdrawal in our study are relatively high in both our groups (86 and 93%) as previous studies showed rates of 62-85%.13,14,19,24 As patients would only receive subsequent open label BTA in case of successful withdrawal, the drug trial may have contributed to the high withdrawal success rates in both groups during the first 12 weeks, narrowing the differences between groups. This likely explains that the groups after 12 weeks did not differ. However, the main problem with MOH is relapse into overuse of acute medication. Therefore, our aim was to restrict patients on acute medication after the acute withdrawal period. Our study clearly shows benefit of behavioral intervention with reduced use of headache medication in the period after the acute withdrawal period. As the behavioral therapy was only provided during the withdrawal period itself (first 12 weeks), this effect gradually diminished during the long term follow up period of almost one year, which we also expected as only limited care was provided by the treating physician with only once per three months a visit at our headache clinic.
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Behavioural intervention: a double blind RCT
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