Pilot Study of Amitriptyline in the Prophylactic Treatment of Medication-Overuse Headache: A 1-Year Follow-Up

OBJECTIVE: This study aims to evaluate the long-term efficacy of low-dose amitriptyline combined with abrupt withdrawal in outpatients of medication-overuse headache (MOH) in an open-label design. METHODS: We evaluated the effectiveness of early introduction of low-dose amitriptyline combined with abrupt withdrawal in outpatients with MOH over a 1-year observational period. The primary outcome measures were the reduction in number of headache days and days with use of acute headache medication after 3 months and after 12 months. A number of secondary outcome measures, as well as safety and tolerability, were assessed. The responders were defined as patients with ≥50% reduction in headache frequency from baseline and being without medication overuse. RESULTS: Thirty-three patients completed the study. Significant reductions in headache frequency and medication consumption were observed at both months 3 and 12, compared to baseline (P < 0.05 for all). Neither the primary nor the secondary endpoints differed significantly between months 3 and 12. At the 12-month follow-up, 58% of the patients were considered as responders (N = 19); 73% remained cured of MOH (N = 24); 64% had reverted to episodic headaches (N = 21); 27% had relapsed into MOH (N = 9). CONCLUSION: Given these results, early introduction of low-dose amitriptyline combined with abrupt withdrawal could be considered as a choice for patients with MOH.