Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly?
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up.|
- Our primary outcome measures were the change, compared to the baseline period, in headache days. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Our secondary outcome measures were: (i) change in days with analgesics use per month, (ii) change in "headache index (HI)", (iii) change in sick leave days per month, iv) change in anxiety and depression, v) change in SF-12. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Use of preventive drugs from the start without abrupt withdrawal
Drug: Betablockers or other preventive drugs
Several preventive drugs based on each individual
No Intervention: 2
Device: Abrupt withdrawal
No Intervention: 3
Active control: No instruction for abrupt withdrawal or prophylactic treatment
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:
- 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.
- Start with preventative medication (best choice) directly without abrupt withdrawal, 12 month follow-up.
- No specific treatment (controls), 5 month follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159588
|Trondheim, Norway, 7006|
|Study Chair:||Knut Hagen, MD; PhD,||Dept. of Neurology, St. Olavs University Hospital, Trondheim, Norway|