Complete withdrawal is the most effective approach to reduce disability in patients with medication-overuse headache: A randomized controlled open-label trial

Abstract

Background Medication-overuse headache leads to high disability and decreased quality of life, and the best approach for withdrawal has been debated. Aim To compare change in disability and quality of life between two withdrawal programs. Methods We randomized medication-overuse headache patients to program A (two months without acute analgesics or migraine medications) or program B (two months with acute medications restricted to two days/week) in a prospective, outpatient study. At 6 and 12 months, we measured disability and headache burden by the Headache Under-Response to Treatment index (HURT). We estimated quality of life by EUROHIS-QOL 8-item at 2-, 6-, and 12-month follow-up. Primary endpoint was disability change at 12 months. Results We included 72 medication-overuse headache patients with primary migraine and/or tension-type headache. Fifty nine completed withdrawal and 54 completed 12-month follow-up. At 12-month follow-up, 41 patients completed HURT and 38 completed EUROHIS-QOL 8-item. Disability reduction was 25% in program-A and 7% in program-B ( p = 0.027). Headache-burden reduction was 33% in program-A and 3% in program-B ( p = 0.005). Quality of life was increased by 8% in both programs without significant difference between the programs ( p = 0.30). At 2-month follow-up, quality of life increased significantly more in program-A than program-B ( p = 0.006). Conclusion Both withdrawal programs reduced disability and increased quality of life. Withdrawal without acute medication was the most effective in reducing disability in medication-overuse headache patients. Trial registration Clinicaltrials.gov (NCT02903329).

Dependence‐like behaviour in patients treated for medication overuse headache: A prospective open‐label randomized controlled trial

“…(2011), MOH was consistently shown to be associated with a lower QoL score compared to healthy controls, episodic headache, and most importantly chronic daily headache without medication overuse. It has subsequently been shown that quality of life improved after withdrawal (Nielsen et al., 2019). In our study, we saw an improvement in perceived overall quality of life and health in all three arms which is in line with the last‐mentioned study.…”

The Many Faces of Medication‐Overuse Headache in Clinical Practice

“…A recent randomized trial in the outpatient setting by the Danish Headache Center provided evidence that abrupt withdrawal of all acute treatments was more effective in reducing disability and more feasible for patients than gradual withdrawal, while both programs resulted in reduced disability and increased QoL 96,97 …”

No efficacy of transcranial direct current stimulation on chronic migraine with medication overuse: A double blind, randomised clinical trial

“…At the end of the recruitment for the RCT, we started the open-label trial in which participants were assigned to standardised acute drug withdrawal. This arm was added to provide a pragmatic, non-parallel comparison with acute drug withdrawal, which is considered the most effective treatment of CM with MO (18). The reason why it was not added as one further arm of the double-blind part of the study is because results would have been biased by the lack of any active or sham tDCS procedure, and therefore would have not been comparable.…”