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Open Access Study protocol

Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

Espen Saxhaug Kristoffersen, Jørund Straand, Jūratė Saltytė Benth, Michael Bjørn Russell and Christofer Lundqvist*

BMC Neurology 2012, 12:70  doi:10.1186/1471-2377-12-70

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Authors reply to Dr Soumaoro Ibrahima

Espen Saxhaug Kristoffersen   (2013-07-17 15:49)  University of Oslo

Dear Dr Soumaoro Ibrahima,

Thank you for your comment and concern about the correct diagnosis of
medication overuse in our study protocol. Firstly, we will use exactly
the criteria you referred to regarding number of headache days ie.
regular overuse (15 days or more per month) over more than 3 months and,
though it is not specified in the criteria how many days per week this
requires, from our previous sample we know that the large majority of
MOH patients in our population are well above this and have few days
without headache. Secondly, as you will see from the protocol, number of
days will be addressed both through meticulous interview (which will
also address the regularity) and through self-reported headache diary.

In other words, I see "bunching of treatment days" as much less of a
problem than your comment may suggest though I agree with you that it is
important to be sure that the patients are really overusing their
medication "regularly over at least 3 months" (most in our population
have many years of overuse).

Kind regards,

Espen Saxhaug Kristoffersen (first author)

Competing interests

I am the first author of this article

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Medication Overuse Headache (MOH) definition

Ibrahima Soumaoro   (2013-03-10 13:28)  Allergan

According to SD Silberstein et al. Cephalalgia 2005; 25:460��465 (Revision-of-criteria-8.2-MOH) and ICDH-IIR, the diagnosis criteria for MOH are the following:

A Headache present on �� 15 days/month fulfilling criteria C and D.
B Regular overuse for > 3 months of one or more drugs that can be taken for acute and/or symptomatic treatment of headache.
C Headache has developed or markedly worsened during medication overuse.
D Headache resolves or reverts to its previous pattern within 2 months after discontinuation of overused medication.

Overuse is defined in terms of duration and treatment days per week. What is crucial is that treatment occurs both frequently and regularly, i.e. on 2 or more days each week. Bunching of treatment days with long periods without medication intake, practiced by some patients, is much less likely to cause medication-overuse headache and does not fulfill criterion B.

I'm concerned that majority of your sample might not fulfill the above definition criteria of MOH, especially in regard to the duration and treatment days per week (frequency and regularity of overuse).
I'm not sure if those subjects that were not frequent and not regular over users can be diagnosed as MOH. For example taking the medication only during the first 11 days of the month, or 5 days in the first week of the month and 6 days in the fourth week etc...
I will appreciate if you could provide me with explanation on how you controlled this in your sample and analysis?

Competing interests

Nothing to declare.

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