Avoiding Treatment Effect Overestimation in Medication-Overuse Headache

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A period of observation after an educational session may be important to confirm medication-overuse headache (MOH) diagnoses.

A period of observation after an educational session may be important to confirm medication-overuse headache (MOH) diagnoses in order to avoid overestimation of treatment efficacy, according to a recent study published in the European Journal of Neurology.

In both inpatient and outpatient detoxification programs, educational intervention and advice regarding medication overuse known as “simple advice” has been demonstrated effective for individuals with uncomplicated medication overuse headaches (simple patient Type 1). Complex or type 2 patients who don’t respond as well to this approach and have a history of relapse following withdrawal tend to have comorbidities such as anxiety or substance use disorder.

The current study sought to assess the differences between the patients who respond well to simple advice and those who don’t, and to examine the amount and type of drugs overused by patients who don’t respond.

This study was an ancillary part of the multicenter placebo-controlled Sodium Valproate in the Treatment of Medication Overuse Headache (SAMOHA) study. Before enrollment, patients were evaluated using a headache diary and/or meticulous interviews to determine the intensity and frequency of migraine attacks over the previous 3 months, as well as the type, frequency, and dosage of medications used. The SAMOHA protocol enrolled patients who could be diagnosed with medication overuse headache from this information, who were between the ages of 18 and 65, who did not have a history of alcohol or illicit drug abuse over the past 2 years, who were not pregnant or lactating, and who were not taking headache prevention medications in the month before enrollment or concomitant therapies like anticoagulants, neuroleptics, tricyclic antidepressants, or antiepileptic drugs.

The SAMOHA study began with a 4-week observational period to establish baseline, wherein patients kept a headache diary describing the intensity and frequency of migraines and the characteristics of drug intake. If the diagnosis could be confirmed from this observational period, and inclusion criteria were still met, patients continued to the placebo-controlled study. The current study evaluated the data from this observational period.

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Of the total 130 patients who were initially enrolled, 88 (67.7%) qualified to continue. The 42 (32.3%) who no longer qualified had fewer years of chronic migraine history and were significantly younger. These results indicate that an observational period is necessary to confirm the diagnosis of medication overuse headache. In addition, early diagnosis will lead to a higher rate of remission, as patients who are younger and have fewer years of chronic migraine respond better to simple advice.

The study found that early management with simple advice remains highly effective even with the presence of comorbidities and regardless of what type of analgesic is used for pain relief.

Investigators conclude that the study findings “further support the critical role of the general practitioner as well as the pharmacist in guiding the attack management and in the educational process to avoid MOH or in its early diagnosis.”

Please refer to original reference for full list of disclosures.


Corbelli I, Sarchielli P, Eusebi P, Cupini LM, Caproni S, Calabresi P; for SAMOHA Study Group. Early management of medication‐overuse headache patients: results from a multicentric clinical study[published online March 25, 2018]. Eur J Neurol. doi:10.1111/ene.13632.