Complete detoxification is the most effective treatment of medication-overuse headache: A randomized controlled open-label trial

Carlsen, Louise Ninett; Munksgaard, Signe Bruun; Jensen, Rigmor Højland; Bendtsen, Lars

doi:10.1177/0333102417737779

Cited by 85 publications

(101 citation statements)

References 32 publications

(54 reference statements)

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“…These results should be seen in the context of previously published results from the study (Carlsen et al, ). Both complete withdrawal and restricted intake reduced the number of headache days per month significantly from baseline to 6‐month and 12‐month follow‐up.…”

Section: Discussionsupporting

confidence: 87%

“…All participants signed informed consent. The study was registered at Clinicaltrials.gov (NCT02903329; Carlsen et al, 2018).…”

Section: Methodsmentioning

confidence: 99%

“…Outcome results on headache from the current study have previously been published (Carlsen et al, 2018).…”

Section: Study Populationmentioning

confidence: 98%

“…Both withdrawal programmes were effective in reducing headache and migraine days/month. However, withdrawal without analgesics or acute migraine medication was the most effective programme with a 46% reduction in headache days/month compared to 23% reduction in the restricted intake programme; 70% vs. 42% reverted to episodic headache, and migraine days/month were reduced by 7.2 compared to 3.6 in the restricted intake programme (Carlsen et al, ).…”

Section: Introductionmentioning

confidence: 99%

“…Restricted intake of acute headache medication during withdrawal is an often used approach to improve patient acceptance and relieve withdrawal symptoms (Ghiotto et al, 2009;Tassorelli et al, 2014;Trucco, Meineri, Ruiz, & Gionco, 2010). Current Danish guidelines recommend abrupt and complete stop of all acute analgesics and migraine medications in two months accompanied by rescue medication, patient education and close follow-up (Bendtsen et al, 2010;Carlsen, Munksgaard, Jensen, & Bendtsen, 2018;Zeeberg, Olesen, & Jensen, 2006). This is supported by recently published results from the current study, where we compared the effect of restricted intake of acute medication to maximally two days/week with complete stop of acute medication during the 2 months of withdrawal.…”

Section: Introductionmentioning

confidence: 99%

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Complete withdrawal is the most feasible treatment for medication‐overuse headache: A randomized controlled open‐label trial

Engelstoft

Carlsen

Munksgaard

et al. 2019

European Journal of Pain

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Background Complete stop of acute medication and/or migraine medication for treatment of medication‐overuse headache (MOH) has previously been reported more effective in reducing headache days and migraine days per month compared with restricted intake of acute medication. However, it is unknown whether complete stop or restricted intake is the most feasible treatment for patients. Objectives To investigate whether feasibility of withdrawal in MOH is different between complete stop of acute medication and restricted intake, and whether reductions in headache‐related medication dependence, anxiety and depression differ between the treatments. Methods Medication‐overuse headache patients were included in a prospective, open‐label, outpatient study and randomized to two months of withdrawal with either no analgesics or acute migraine medication (programme A) or acute medication restricted to 2 days/week (programme B). After 6 and 12 months, patients graded feasibility of withdrawal. Dependence was measured by Severity of Dependence Scale (SDS), while anxiety and depression were measured by Hospital Anxiety and Depression Scale (HADS). Results We included 72 MOH patients with primary migraine and/or tension‐type headache. Forty‐nine completed withdrawal and the SDS questionnaire at 12‐month follow‐up, and the feasibility of withdrawal was significantly higher in programme A compared to programme B (p < 0.001). At 12 months, the dependence was reduced by 44% in programme A compared to 26% in programme B (p = 0.053), while the anxiety score was reduced by 32% and 11%, respectively (p = 0.048). Conclusions Withdrawal with complete stop of acute medication was more feasible and most effective in reducing headache‐related anxiety compared with restricted intake. Significance A complete stop of all analgesics is the most effective treatment for MOH regarding reduction in headache days but has often been regarded as too challenging for patients. However, in this study, complete stop appears to be more feasible compared with restricted intake of analgesics seen from the patients’ perspective.

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Section: Discussionsupporting

confidence: 87%

“…All participants signed informed consent. The study was registered at Clinicaltrials.gov (NCT02903329; Carlsen et al, 2018).…”

Section: Methodsmentioning

confidence: 99%

“…Outcome results on headache from the current study have previously been published (Carlsen et al, 2018).…”

Section: Study Populationmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Complete withdrawal is the most feasible treatment for medication‐overuse headache: A randomized controlled open‐label trial

Engelstoft

Carlsen

Munksgaard

et al. 2019

European Journal of Pain

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Comparison of 3 Treatment Strategies for Medication Overuse Headache

et al. 2020

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IMPORTANCE Medication overuse headache (MOH) is a disabling, globally prevalent disorder representing a well-known and debated clinical problem. Evidence for the most effective treatment strategy is needed.OBJECTIVE To compare 3 treatment strategies for MOH. DESIGN, SETTING, AND PARTICIPANTSThis open-label, randomized clinical trial with 6 months of follow-up was conducted in the tertiary sector at the Danish Headache Center, Glostrup, from October 25, 2016, to June 28, 2019. Of 483 patients with MOH referred during the inclusion period, 195 met the criteria consisting of migraine and/or tension-type headache, 18 years or older, eligibility for outpatient treatment, no severe physical or psychiatric disorder, no other addiction, and not pregnant or breastfeeding. Of these, 75 refused participation and 120 were included. Data were analyzed from July 3 to September 6, 2019.INTERVENTIONS Random assignment (1:1:1 allocation) to 1 of the 3 outpatient treatments consisting of (1) withdrawal plus preventive treatment, (2) preventive treatment without withdrawal, or (3) withdrawal with optional preventive treatment 2 months after withdrawal. MAIN OUTCOMES AND MEASURESThe primary outcome was change in headache days per month after 6 months. Predefined secondary outcomes were change in monthly migraine days, use of short-term medication, pain intensity, number of responders, patients with remission to episodic headache, and cured MOH. RESULTSOf 120 patients, 102 (mean [SD] age, 43.9 [11.8] years; 81 women [79.4%]) completed the 6-month follow-up. Headache days per month were reduced by 12.3 (95% CI, 9.3-15.3) in the withdrawal plus preventive group, by 9.9 (95% CI, 7.2-12.6) in the preventive group, and by 8.5 (95% CI, 5.6-11.5) in the withdrawal group (P = .20). No difference was found in reduction of migraine days per month, use of short-term medication, or headache intensity. In the withdrawal plus preventive group, 23 of 31 patients (74.2%) reverted to episodic headache, compared with 21 of 35 (60.0%) in the preventive group and 15 of 36 (41.7%) in the withdrawal group (P = .03). Moreover, 30 of 31 patients (96.8%) in the withdrawal plus preventive group were cured of MOH, compared with 26 of 35 (74.3%) in the preventive group and 32 of 36 (88.9%) in the withdrawal group (P = .03). These findings corresponded to a 30% (relative risk, 1.3; 95% CI, 1.1-1.6) increased chance of MOH cure in the withdrawal plus preventive group compared with the preventive group (P = .03).CONCLUSION AND RELEVANCE All 3 treatment strategies were effective, but based on these findings, withdrawal therapy combined with preventive medication from the start of withdrawal is recommended as treatment for MOH.

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Efficacy and Safety of Erenumab for Nonopioid Medication Overuse Headache in Chronic Migraine

Tepper,

Dodick,

Lanteri-Minet

et al. 2024

JAMA Neurol

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ImportancePatients with chronic migraine and medication overuse headaches (CM-MOH) represent a particularly burdened subpopulation. This trial provides first, to our knowledge, American Academy of Neurology class I evidence for a preventive therapy in CM-MOH.ObjectiveTo assess erenumab efficacy and safety in patients with nonopioid CM-MOH.Design, Settings, and ParticipantsThis randomized, double-blind, parallel-group, placebo-controlled trial took place at 67 centers in North America, Europe, and Australia from October 7, 2019, to November 2, 2022. This report reflects the primary analysis conducted in January 2023, using a database snapshot from December 1, 2022, which contains the complete dataset of the double-blind treatment period (DBTP). Participants included adults with CM-MOH who had 1 or more preventive treatment failure(s). There were 992 participants screened and 620 participants enrolled (584 in nonopioid cohort and 36 in opioid cohort)InterventionsErenumab, 70 mg, 140 mg, or placebo, once monthly for 24 weeks.Main Outcomes and MeasuresThe primary end point was MOH remission at month 6. Secondary end points included change from baseline in mean monthly acute headache medication days (AHMD) at month 6 and sustained MOH remission throughout the DBTP. Safety end points were adverse events and changes in vital signs.ResultsThe primary analysis population included 584 participants in the nonopioid-treated cohort with a mean age of 44 years and 482 participants were female (82.5%). Baseline demographics and disease characteristics were balanced across groups. At month 6, 134 participants in the erenumab, 140 mg group (69.1%) (odds ratio [OR], 2.01; 95% CI, 1.33-3.05; P &lt; .001 vs placebo) and 117 in the erenumab, 70 mg group (60.3%) (OR, 1.37; 95% CI, 0.92-2.05; P = .13 vs placebo) achieved MOH remission vs 102 participants in the placebo group (52.6%). AHMD use was also reduced in the erenumab groups vs placebo. Least squares mean (standard error) change from baseline in average monthly AHMD was –9.4 (0.4) days in the erenumab, 140 mg group (difference from placebo, –2.7; 95% CI, –3.9 to –1.6; P &lt; .001) and –7.8 (0.4) days in the erenumab, 70 mg group (difference from placebo, –1.2; 95% CI, –2.4 to –0.1; P = .03), vs –6.6 (0.4) days in the placebo group. MOH remission throughout the DBTP was sustained in 119 participants (61.3%,) 96 participants (49.5%), and 73 participants (37.6%) in the erenumab, 140 mg, 70 mg, and placebo groups, respectively. Adverse events were consistent with the known safety profile of erenumab. Treatment-emergent adverse events incidence in the combined erenumab group was 66.8% (259 participants; constipation 15.2% (59 participants) and COVID-19 13.9% (54 participants) were most common.Conclusions and RelevanceIn this study, monthly, 140 mg, erenumab injections safely and effectively achieved MOH remission in patients with nonopioid CM-MOH within 6 months.Trial RegistrationClinicalTrials.gov Identifier: NCT03971071

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Complete detoxification is the most effective treatment of medication-overuse headache: A randomized controlled open-label trial

Cited by 85 publications

References 32 publications

Complete withdrawal is the most feasible treatment for medication‐overuse headache: A randomized controlled open‐label trial

Complete withdrawal is the most feasible treatment for medication‐overuse headache: A randomized controlled open‐label trial

Comparison of 3 Treatment Strategies for Medication Overuse Headache

Efficacy and Safety of Erenumab for Nonopioid Medication Overuse Headache in Chronic Migraine

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