lancet-header
Preprints with The Lancet is part of SSRN´s First Look, a place where journals and other research experts identify content of interest prior to publication. These preprint papers are not peer-reviewed. Authors have either opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet, or submitted directly via SSRN. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These papers should not be used for clinical decision making or reporting of research to a lay audience without indicating that this is preliminary research that has not been peer-reviewed. For more information see the Comment published in The Lancet, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com

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

69 Pages Posted: 25 Jun 2020

See all articles by Marina de Tommaso

Marina de Tommaso

Bari Aldo Moro University - Applied Neurophysiology and Pain Unit

Marianna Delussi

Bari Aldo Moro University, Basic Medical Sciences, Neuroscience and Sensory System Department, Applied Neurophysiology and Pain Unit

More...

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.

Keywords: migraine, preventive treatment, observational study, tertiary headache center

Suggested Citation

de Tommaso, Marina and Delussi, Marianna, Failure of Preventive Treatments in Migraine: An Observational Retrospective Study in a Tertiary Headache Center (3/31/2020). Available at SSRN: https://ssrn.com/abstract=3566240 or http://dx.doi.org/10.2139/ssrn.3566240

Marina De Tommaso (Contact Author)

Bari Aldo Moro University - Applied Neurophysiology and Pain Unit ( email )

Bari
Italy

Marianna Delussi

Bari Aldo Moro University, Basic Medical Sciences, Neuroscience and Sensory System Department, Applied Neurophysiology and Pain Unit

Click here to go to TheLancet.com

Paper statistics

Abstract Views
53
Downloads
5