Failure of Preventive Treatments in Migraine: An Observational Retrospective Study in a Tertiary Headache Center

Abstract

BACKGROUND: Despite the criteria of acute migraine treatment and prevention have been well described, there are still unmet needs, for a general underuse and low benefit of preventive treatments. The aim of the present study was to observe retrospectively the short term effect of preventive treatment in a cohort of migraine patients come at a tertiary headache center, using data from an electronic medical record.

METHODS: This was an observational retrospective cohort study on data collected in a tertiary headache center. Data were extracted from an electronic dataset collected between January 2009 to December 2019. Main selection criteria were age 18-75, diagnosis of migraine without aura(MO), with aura (MA) and chronic migraine (CM), a control visit after three months from the first access, prescription of preventive treatment with level of evidence 1 as reported by Italian guidelines. As primary outcome measure we considered the change of frequency of headache at follow up, as second outcomes disability scores, intensity of headache, allodynia; as predictive factors age, migraine duration, sex and headache frequency, allodynia, anxiety and depression at baseline; comorbidity with fibromyalgia.

FINDINGS: Among 6430 patients screened,2800 met the selection, 1800 returned to follow up, 550 withdrawn for adverse events, 1100 were introduced into analysis. One hundred thirty four had a frequency reduction of 50% or more. Flunarizine was used in less severe migraine, with a better effect as compared to other drugs (odds ratio 1.48; p 0.022). Low headache frequency and absent or mild allodynia predicted a better outcome.

INTERPRETATION: The mild effect of preventive drugs on migraine features and the number of patients lost to follow up or dropped out for adverse events confirm that in severely and chronic sufferers the first line preventive approach could delay a more focused therapeutic approach.

FUNDING STATEMENT: The study was entirely supported by internal funds, provided by Bari Aldo Moro University.

DECLARATION OF INTERESTS: Marina de Tommaso received remuneration for scientific contributions from: Allergan, Novartis, Teva; Marina de Tommaso and Marianna Delussi do not declare conflict of interest.

ETHICS APPROVAL STATEMENT: The local Ethic Committee of Policlinico General Hospital approved the use of electronic database, and patients signed an informed consent about the inclusion of their data and use for scientific purposes.