Conditions: Headache
Keywords: Medication-overuse headache preventative medication controls follow-up randomized abrupt withdrawal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
It is a common belief that patients with MOH rarely respond of preventative medications whilst overusing acute medications. However, no randomized trial has been done previously to prove such statement. Based on some clinical experiences, our hypothesis are patients with probably MOH may benefit from use of preventive medications better than treatment with abrupt withdrawal or no specific treatment.

Detailed description:
This randomized multi-centre study started January 2004, and patients with probably MOH have been included from five different University hospitals in Norway. The last patient was included November 9th 2006, final inclusion date was December 31th 2006. At this time a total of 64 patients with probable MOH according to the International Classification of Headache Disorders, 2nd Edition (2004) were included.

The included patients were randomized to one out of three possible options:

1. Abrupt withdrawal of the acute medication(s) they have been overusing. After 3 month: use of preventative medication (best choice)in those who need such treatment, 12 month follow-up.
2. Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
3. No specific treatment (controls), 5 month follow-up.

Arms:
arm 1: Use of preventive drugs from the start without abrupt withdrawal arm 2: Device: Abrupt withdrawal. Standard out-patients detoxication program including telephone call after 2 weeks and rescue medicine up to 2 days/week arm 3: Active control: No instruction for abrupt withdrawal or prophylactic treatment. The controls finished the study period after 5 months observation, and were then offered the optimal type of treatment

Interventions: intervention 1: Betablockers or other preventive drugs based on primary headache type
Intervention descriptions: intervention 1: Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)

Protocol document: