Treatment of medication overuse headache: Effect and predictors after 1 year—A randomized controlled trial

Abstract

Background Combined withdrawal and early preventive medication was the most effective treatment for medication overuse headache (MOH) within the first 6 months in a previous study, but results from a longer follow‐up period are lacking. Objective (1) To measure the efficacy at 1 year of three different treatment approaches to MOH; (2) to compare withdrawal and early preventives (W+P), preventives with potential withdrawal therapy after 6 months (P+pW), and withdrawal with delayed potential preventives (W+pP); and (3) to identify predictors of chronic headache after 1 year. Methods Patients with MOH and migraine and/or tension‐type headache were randomly assigned to one of the three outpatient treatments. Headache calendar and questionnaires were filled out. Primary outcome was a reduction in headache days/month after 1 year. Results Of 120 patients, 96 completed 1‐year follow‐up, and all were included in our analyses. Overall headache days/month were reduced from 24.6 (23.4–25.8) to 15.0 (13.0–17.0) (p < 0.0001), and only 11/96 patients (11%) relapsed. Reduction in monthly headache days was 10.3 days (95% CI: 6.7–13.9) in the W+P group, 10.8 days (95% CI: 7.6–14) in the P+pW group, and 7.9 days (95% CI: 5.1–10.7) in the W+pP group. No significant differences in treatment effect were seen between the three groups (p = 0.377). After 1 year, 39/96 (41%) had chronic headache. Predictors of chronic headache after 1 year were higher headache frequency (aOR 1.19; 1.09–1.31), more days with acute medication (aOR 1.11; 1.03–1.19), higher pain intensity (aOR 1.04; 1.01–1.08), and depression (aOR 4.7; 1.38–18.95), whereas higher self‐rated health (aOR 0.61; 0.36–0.97) and high caffeine consumption (aOR 0.40; 0.16–0.96) were predictors of a lower risk of chronic headache. No adverse events were reported. Conclusions All treatment strategies proved effective in treating MOH with a low relapse rate. The W+P strategy leads to the fastest effect, confirming earlier treatment recommendations. Identification of predictors for chronic headache may help identify more complex patients.

The role of caffeine in headache disorders

“…It is interesting to consider how caffeine as a component of combination analgesics may contribute to medication overuse, whereas regular dietary caffeine may not have the same effect. Perhaps consistent with this concept, high dietary caffeine use was associated with reduced chronic headache following withdrawal on a clinical trial of medication overuse headache [37].…”

Preventive CGRP-targeted therapies for chronic migraine with and without medication-overuse headache

“…In a head-to-head comparison of three differing treatment modalities, secondary endpoints indicated that drug withdrawal combined with prophylactic treatment may be more effective than either treatment alone, but the primary outcome (reduction in monthly headache days) was not reached (75). Evidence from other studies also suggested that adding preventive medication may be helpful (76,77). In contrast, in a large investigator-initiated randomized double-blind clinical trial (CHARM) assessing the benefit of onabotulinumtoxinA (BTX-A) for drug withdrawal in patients with CM and MOH, BTX-A did not afford any additional benefit over drug withdrawal alone (78).…”

Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study

“…Medication overuse was quantified based on protocol-defined post-baseline intervals, in which 12- and 24-week results (i.e., the number of days patients used acute migraine medication during these timepoints) were calculated by taking the averages of smaller, 4-week increments. Other study protocols have used benchmarks of 1 year [ 56 ], for instance, to quantify meaningful changes in medication overuse; these differences in study design reflect the overall challenge with quantifying (and thus treating) medication overuse [ 57 ]. However, PROMISE-2 was placebo-controlled for 6 months.…”