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Medication-overuse headache (MOH) is a disabling condition, yet treatable. According to European guidelines and based on evidence, multidisciplinary detoxification is the first choice of treatment for MOH. However, consensus about the details in such detoxification programs is lacking. Contrary, other headache specialists believe more in treating chronic headache with medication overuse with single-therapy of prophylaxis and no withdrawal of acute medication, based on randomized controlled double-blinded placebo trial with prophylaxes. Only a single RCT has compared single-therapy with prophylaxis to detoxification. However there was no significant difference.
AIM:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detoxification and pharmacological prophylactic treatment | Active Comparator | Group A: Two months detoxification program combined with pharmacological prophylactic treatment from start. |
|
| Pharmacological prophylactic treatment | Active Comparator | Pharmacological prophylactic treatment from start without detoxification. |
|
| Detoxification | Active Comparator | Two months detoxification program with postponed pharmacological prophylactic treatment after ended detoxification. |
|
| Control group 1: Episodic migraine | No Intervention | ||
| Control group 2: Healthy volunteers | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Different well-known treatments | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in headache days per month in group A and C compared to group B. | Six months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in headache days per month |
| Two and 12 months follow-up and 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in DNA-profile between patients with MOH and controlgroups. | Baseline | |
| Difference in methylation levels and RNA sequence analysis in patients with MOH undergoing treatment compared to controls. | From baseline to 6 months follow-up |
Patients with medication-overuse headache:
Inclusion Criteria:
Exclusion Criteria:
Criteria for Control group 1 - Episodic migraineurs:
Criteria for Control group 2 - Healthy volunteers:
•≥ 2 days with headache in the past month at time of inclusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Headache Center | Glostrup Municipality | Copenhagen | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36786322 | Derived | Carlsen LN, Hansen CS, Kogelman LJA, Werge TM, Ullum H, Bybjerg-Grauholm J, Hansen TF, Jensen RH. DNA-methylation and immunological response in medication overuse headache. Cephalalgia. 2023 Mar;43(3):3331024221147482. doi: 10.1177/03331024221147482. | |
| 32453406 | Derived | Carlsen LN, Munksgaard SB, Nielsen M, Engelstoft IMS, Westergaard ML, Bendtsen L, Jensen RH. Comparison of 3 Treatment Strategies for Medication Overuse Headache: A Randomized Clinical Trial. JAMA Neurol. 2020 Sep 1;77(9):1069-1078. doi: 10.1001/jamaneurol.2020.1179. |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Reduction in days/month with use of analgesics and/or migraine medication. |
|
| Two, 6 and 12 months follow-up and 4 years |
| Responders based on reduction in headache days / month (percentage with more than 30%, 50% and 75%). |
| Two, 6 and 12 months follow-up and 4 years |
| Reduction in headache intensity. |
This outcome will be presented as 1) Total headache intensity per month, and as 2) Visual Analogue Scale (VAS). | Two, 6 and 12 months follow-up and 4 years |
| Descriptive report of self-reported adverse effects of treatments. |
| Two, 6 and 12 months follow-up |
| Changes in Headache Under-Response to Treatment (HURT)-score. |
| Two, 6 and 12 months follow-up |
| Drop-out rate. | One, 2, 4, 6, 9 and 12 months follow-up and 4 years |
| Changes in Hospital Anxiety and Depression Scale (HADS). |
| Six and 12 months follow-up |
| Changes in Quality of Life (QoL) score. |
| Six and 12 months follow-up |
| Changes in Severity of Dependence Score (SDS). |
| Six and 12 months follow-up |
| Changes in Perceived Stress Score (PSS). |
| Twelve months follow-up. |
| Patient's satisfaction questionnaire |
| Two, 6 and 12 months follow-up |
| Analysis of association between methylation levels and treatment outcome defined as 1) reduction in headache days per month at 6 months and 12 months and 2) percent of cured vs. percent of relapsers after 12 months. | At 6 and 12 months follow-up |