Patient-Centered Treatment of Chronic Migraine With Medication Overuse: A Prospective, Randomized, Pragmatic Clinical Trial.

BACKGROUND AND OBJECTIVES: Overuse of symptomatic (i.e., acute) medications is common among those with chronic migraine. It is associated with developing frequent headaches, medication side effects, and reduced quality of life. The optimal treatment strategy for patients who have chronic migraine with medication overuse (CMMO) has long been debated. The study objective was to determine whether migraine preventive therapy without switching or limiting the frequency of the overused medication was noninferior to migraine preventive therapy with switching from the overused medication to an alternative medication that could be used on ≤2 d/wk. METHODS: The Medication Overuse Treatment Strategy (MOTS) trial was an open-label, pragmatic clinical trial, randomizing adult participants 1:1 to migraine preventive medication and (1) switching from the overused medication to an alternative used ≤2 d/wk or (2) continuation of the overused medication with no maximum limit. Participants were enrolled between February 2017 and December 2020 from 34 clinics in the United States, including headache specialty, general neurology, and primary care clinics. The primary outcome was moderate to severe headache day frequency during weeks 9 to 12 and subsequently during weeks 1 to 2 after randomization. RESULTS: Seven hundred twenty participants were randomized; average age was 44 (SD 13) years; and 87.5% were female. At baseline, participants averaged 22.5 (SD 5.1) headache days over 4 weeks, including 12.8 (SD 6.7) moderate to severe headache days and 21.4 (SD 5.8) days of symptomatic medication use. Migraine preventive medication without switching of the overused medication was not inferior to preventive medication with switching for moderate to severe headache day frequency during weeks 9 to 12 (switching 9.3 [SD 7.2] vs no switching 9.1 [SD 6.8]; p = 0.75, 95% CI -1.0 to 1.3). The treatment strategies also provided similar outcomes during the first 2 weeks (switching 6.6 [SD 3.7] moderate to severe headaches days vs no switching 6.4 [SD 3.6]; p = 0.57, 95% CI -0.4 to 0.7). DISCUSSION: When reduction in moderate to severe headache days was used as the outcome of interest for the management of CMMO, migraine preventive medication without switching or limiting symptomatic medication is not inferior to migraine preventive medication with switching to a different symptomatic medication with a maximum limit of 2 treatment days per week. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov identifier NCT02764320. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that, for patients who have CMMO, migraine preventive medication without switching or limiting the overused medication is noninferior to migraine preventive medication with switching and limiting symptomatic medication.

Determinants of pain interference and headache impact in patients who have chronic migraine with medication overuse: Results from the MOTS trial.

OBJECTIVE: "Pain interference" and "headache impact" refer to negative consequences that pain and headache have on one's life. This study investigated determinants of these negative impacts in a large patient cohort who have chronic migraine with medication overuse. METHODS: Six hundred and eleven adults were enrolled from 34 headache, neurology, and primary care clinics. Negative consequences of chronic migraine with medication overuse were determined using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference 6b questionnaire and the Headache Impact Test 6. Relationships between PROMIS-6b and Headache Impact Test 6 scores with demographics, headache characteristics, medication use, anxiety symptoms, and depression symptoms were assessed with linear regression. Elastic Net regression was used to develop a multiple regression model. RESULTS: PROMIS-6b T-Scores averaged 65.2 (SD 5.4) and Headache Impact Test 6 scores averaged 65.0 (SD 5.3), indicating severe negative consequences of chronic migraine with medication overuse. Chronic migraine with medication overuse interfered with enjoyment of life, concentration, daily activities, doing tasks away from home, and socializing. Depression symptom severity had the strongest relationship with pain interference and headache impact. Moderate-to-severe headache frequency, headache intensity, and anxiety symptoms were also associated with pain interference and headache impact. CONCLUSIONS: Chronic migraine with medication overuse is associated with substantial negative consequences, the extent of which is most strongly related to depression symptoms.

Headache characteristics and burden from chronic migraine with medication overuse headache: Cross-sectional observations from the Medication Overuse Treatment Strategy trial.

OBJECTIVE: To describe headache characteristics, medication use, disability, and quality of life in a large patient cohort from the United States who have chronic migraine (CM) and medication overuse headache (MOH). METHODS: In all, 610 adult patients were enrolled into the Medication Overuse Treatment Strategy trial from 34 healthcare clinics, including headache specialty, general neurology, and primary care clinics. Descriptive statistics characterize baseline demographics, headache characteristics, medication use, disability (Headache Impact Test 6 [HIT-6] and Migraine Functional Impact Questionnaire [MFIQ]), pain interference (PROMIS Pain Interference), and quality of life (EQ-5D-5L). Relationships with headache frequency were assessed. RESULTS: Mean age was 45 years (SD 13) and 531/608 (87.3%) were females. Mean headache days per 30 was 24.3 (SD 5.5), including 13.6 (SD 7.1) with moderate to severe headache. Daily headaches were reported by 36.1% (219/607) of patients. Acute headache medications were used on 21.5 (SD 7.5) per 30 days. The most commonly overused medications were simple analgesics (378/607, 62% of patients), combination analgesics (246/607, 41%), and triptans (128/607, 21%). HIT-6, MFIQ, PROMIS Pain Interference, and EQ-5D-5L scores demonstrated substantial negative impact from CM with MOH on patient functioning and quality of life. Higher headache frequency was associated with more moderate-severe headache days, more frequent acute headache medication use, greater headache-related disability, and lower quality of life. Only 272/606 (44.9%) were taking migraine preventive medication. CONCLUSIONS: CM with MOH is associated with a large burden on patients in the United States. Higher headache frequency is associated with greater impact on functioning, pain interference, and quality of life.

Non-pharmacological and pharmacological prevention of episodic migraine and chronic daily headache.

Episodic Migraine and Chronic Daily Headache are common disorders affecting millions of Americans, with a significantly disproportionate affect on women. West Virginia, due to its high obesity rates and lower socioeconomic status, is likely more heavily affected by these conditions. Prevention of episodic migraine goes well beyond the limited scope of medications and includes many areas which physicians need to be knowledgeable, including lifestyle modifications, trigger avoidance, and relaxation therapies. The prevention of progression of episodic headaches to chronic headaches includes a number of options, possibly most importantly the prevention of medication overuse from either over-the-counter or prescription medications. Despite limited evidence based pharmacologic options for the prevention of headaches, there are many safe and effective mechanisms in which physicians can help their patients limit the burden of migraine and prevent the progression toward chronic daily headache.

Naming migraine and those who have it.

Medical language has implications for both public perception of and institutional responses to illness. A consensus panel of physicians, academics, advocates, and patients with diverse experiences and knowledge about migraine considered 3 questions: (1) What is migraine: an illness, disease, syndrome, condition, disorder, or susceptibility? (2) What ought we call someone with migraine? (3) What should we not call someone with migraine? Although consensus was not reached, the responses were summarized and analyzed quantitatively and qualitatively. Panelists participated in writing and editing the paper. The panelists agreed that "migraine," not "migraine headache," was generally preferable, that migraine met the dictionary definition for each candidate moniker, terms with psychiatric valence should be avoided, and "sufferer" should be avoided except in very limited circumstances. Overall, while there was no consensus, "disease" was the preferred term in the most situations, and illness the least preferred. Panelists disagreed strongly whether one ought to use the term "migraineur" at all or if "person with migraine" was preferable. Panelists drew upon a variety of principles when considering language choices, including the extent to which candidate monikers could be defended using biomedical evidence, the cultural meaning of the proposed term, and the context within which the term would be used. Panelists strove to balance the need for terms to describe the best science on migraine, with the desire to choose language that would emphasize the credibility of migraine. The wide range of symptoms of migraine and its diverse effects may require considerable elasticity of language.