Comparison of 3 Treatment Strategies for Medication Overuse Headache

Abstract

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.

The impact of COVID-19 pandemic on headache symptoms and drug withdrawal among patients with medication overuse headache: a cross-sectional study

“…During the pandemic, we found few MOH patients experiencing improved headache days and intensity compared with pre-pandemic period. These results differ from the findings of several published studies conducted in MOH patients under non-COVID-19 condition [ 14 , 17 , 31 , 32 ], which found significant decrease in headache days and intensity per month in most MOH patients with regular prophylactic medications. The inconsistency is probably due mainly to the difficulty of accessing to regular prophylactic medications during the pandemic on basis of our analysis.…”

Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine

“…However, while some studies report high “cure” rates with complete cessation of acute medications, most patients require the addition of preventive treatment to successfully stop or reduce the overused medication(s) (22). In a head-to-head comparison of three differing treatment modalities, data from several secondary endpoints indicated that withdrawal of acute medication combined with prophylactic treatment was more effective than either treatment alone (9). The data from this post hoc analysis indicate patients with medication overuse, who were not weaned off or instructed to limit the use of acute medications, responded to galcanezumab equally as well as patients without medication overuse.…”

“…In addition, a systematic review of different treatment strategies for medication overuse headache concluded that adding preventive medication to the withdrawal of overused medications led to better improvements than early discontinuation alone (8). More recently, a randomized clinical trial that directly compared treatment modalities found withdrawal of acute medication in combination with initiating preventive medication constituted a more effective treatment for medication overuse headache than either approach alone (9).…”

Reference programme: diagnosis and treatment of headache disorders and facial pain. Danish Headache Society, 3rd edition, 2020

“…The headache pattern becomes clearer during withdrawal, and a correct diagnosis would help find the best treatment option for preventive medication; 2) It seemed that some patients did not need preventives after withdrawal. However, a recently Danish study has reported that early start of preventive medication simultaneously with start of withdrawal therapy is more effective in treating MOH, compared to a strategy where preventive treatment is postponed to after withdrawal [57]. This may be due to fewer patients starting preventive medication when assigned to the last-mentioned strategy.…”

“…However, a recently Danish study has reported that early start of preventive medication simultaneously with start of withdrawal therapy is more effective in treating MOH, compared to a strategy where preventive treatment is postponed to after withdrawal [ 57 ]. This may be due to fewer patients starting preventive medication when assigned to the last-mentioned strategy.…”