Headache
Conditions
Keywords
Medication-overuse headache, preventative medication, controls, follow-up, randomized, abrupt withdrawal
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.
Interventions
DRUGBetablockers or other preventive drugs based on primary headache type
Several preventive drugs based on each individual regarding type of original headache type (i.e angiotensin II blockers, betablockers, valproate, tricyclic antidepressants or gabapentin)
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* fulfill 8.2.7 probably medication-overuse headache according to the International Classification of Headache Disorders, 2th Edition (2004)
Exclusion criteria
* No benefit of all available preventative medications * no benefit of abrupt withdrawal lasting more than 3 weeks of acute medication that has been overused * cluster headache * chronic paroxysmal hemicrania * hemicrania continua, pregnancy * use of pain killers for other reasons than headache * other reasons for chronic daily headache than medication-overuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Days | 5 month | Change in Headache days per month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache Index | 5-month follow-up | Headache index (HI) per month calculated by the sum of products of headache days /month combined with mean daily hours with headache and mean daily headache severity on days with headache. High HI reflect high headache burden |
Countries
Norway
Participant flow
Recruitment details
64 randomized, 3 excluded not fulfilling the inclusion criteria after the baseline period
Participants by arm
| Arm | Count |
|---|---|
| Preventive Drugs From the Start Preventive medication started day 1 without explicit advice of withdrawal of overused medication | 19 |
| Abrupt Withdrawal Standard out-patient detoxication program | 22 |
| Controls Did not get a new preventive medication or direct advice to stop use of analgesics | 20 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 5 Month Follow-up | Withdrawal by Subject | 2 | 4 | 2 |
Baseline characteristics
| Characteristic | Preventive Drugs From the Start | Abrupt Withdrawal | Controls | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 22 Participants | 20 Participants | 61 Participants |
| Age, Continuous | 41.6 years STANDARD_DEVIATION 10 | 42.1 years STANDARD_DEVIATION 9 | 38.7 years STANDARD_DEVIATION 11 | 40.9 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 11 Participants | 14 Participants | 11 Participants | 36 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 9 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 1 / 17 | 3 / 20 | 1 / 19 |
| serious Total, serious adverse events | 0 / 17 | 0 / 20 | 0 / 19 |
Outcome results
Primary
Headache Days
Change in Headache days per month
Time frame: 5 month
Population: Headache diary information available
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prophylaxis From the Start | Headache Days | 7.2 days/month |
| Abrupt Withdrawal | Headache Days | 4.2 days/month |
| Controls | Headache Days | 1.6 days/month |
Comparison: Kruskal-Wallis testp-value: 0.056Kruskal-Wallis
Secondary
Headache Index
Headache index (HI) per month calculated by the sum of products of headache days /month combined with mean daily hours with headache and mean daily headache severity on days with headache. High HI reflect high headache burden
Time frame: 5-month follow-up
Population: Headache diary information available
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prophylaxis From the Start | Headache Index | 169 headache index per month |
| Abrupt Withdrawal | Headache Index | 371 headache index per month |
| Controls | Headache Index | 302 headache index per month |
Comparison: Kruskal-Wallis testp-value: 0.012t-test, 2 sided