Treatment of withdrawal headache in patients with medication overuse headache: a pilot study

DOI: https://doi.org/10.1186/s10194- 017- 0763- 9

Abstract-Summary Drug withdrawal still remains the key element in the treatment of Medication Overuse Headache (MOH), but there is no consensus about the withdrawal procedure.

The aim of this study was to evaluate the effectiveness of methylprednisolone or

paracetamol in the treatment of withdrawal headache in MOH.

MOH patients, unresponsive to a 3 months prophylaxis, underwent withdrawal

therapy on an inpatient basis.

Overused medications were abruptly stopped and methylprednisolone 500 mg

i.v (A) or paracetamol 4 g i.v. (B) or placebo i.v. (C) were given daily for 5 days.

Withdrawal headache on the 5th day was absent in 21.0% of group A, in 31.6%

of group B and in 12.5% of group C without significant differences.

Withdrawal headache intensity decreased significantly after withdrawal without

differences among the groups.

Rregardless of withdrawal treatment, 52% MOH patients reverted to an episodic

migraine and 62% had no more medication overuse after 3 months.

This study suggests that in a population of severe MOH patients, withdrawal headache decreased significantly in the first 5 days of withdrawal regardless of the treatment used.

Extended: MOH patients, unresponsive to education on the nature of the disease, simple advice to reduce the intake of medication and a prophylaxis in a three-month run-in period, underwent withdrawal therapy on an inpatient basis of 5 days.

Overused medications were suddenly stopped and patients were randomized (1:1:1) to methylprednisolone (group A) or paracetamol (acetaminophen) (group B) or placebo (group C) for 5 days.

Background According to EFNS guidelines, treatment of MOH patients should include: patient’s education on the nature of the disease, on risk factors and on treatment options;

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withdrawal including rescue medication; preventive treatment and a multimodal approach including psychological support, if necessary [620].

Previous studies have shown that simple information about MOH may be suffi- cient for some treatment-naïve patients to stop medication overuse on their own [619–622].

MOH subjects who fail withdrawal after simple advice or are complicated by a long duration of disease, multiple overuse, comorbidity or history of unsuccessful treatments have been scarcely studied [623].

A study showed that 49% of patients who failed to withdraw from medication overuse after simple advice, had a successful outcome after a structured detoxifica- tion program and close follow-up [624].

We aimed to perform a pilot study in order to evaluate the efficacy of methyl-

prednisolone or paracetamol on withdrawal headache in MOH patients.

Methods MOH patients, unresponsive to education on the nature of the disease, simple advice to reduce the intake of medication and a prophylaxis in a three-month run-in period, underwent withdrawal therapy on an inpatient basis of 5 days.

Overused medications were suddenly stopped and patients were randomized (1:1:1) to methylprednisolone (group A) or paracetamol (acetaminophen) (group B) or placebo (group C) for 5 days.

In the treatment of withdrawal headache in patients with MOH (absence of head-

ache at the fifth day of withdrawal).

Secondary endpoints were: headache intensity and associated withdrawal symp- toms each day of treatment, number of rescue medications needed during hospital- ization, efficacy of detoxification on headache frequency and medication overuse at follow-up (1 and 3 months after inpatient withdrawal).

We performed repeated measures ANOVA to compare headache intensity per day among groups (within-subjects variable time: headache intensity on days 1–2–3-4-5; among subjects variable group: A vs. B vs. C; and interaction between days and treatment groups).

Results No differences in prophylactic medications were found among the three groups.

Participants randomized to group C showed an increased headache duration (hours/day) when compared to those randomized to others groups (p = 0.0230): an ANOVA post hoc test showed that this statistical significance was attributable to the difference between B vs. C group (p = 0.042).

Three patients (2 females and 1 male) randomized to C group dropped out during

the 3rd day of hospitalization.

After the hospitalization one patient randomized to group C was lost at 1 month

follow-up.

After the 3 months of follow-up, 28 (52.8%) participants still presented an epi- sodic migraine: 9 (50.0%) randomized to group A, 8 (42.1%) to B and 11 (68.7%) to C without significant differences.

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Discussion This study suggests that in a population of severe MOH patients, withdrawal head- ache decreased significantly in the first 5 days of withdrawal regardless of the treat- ment used to relieve withdrawal symptoms.

Pageler and co-authors in a small randomized, placebo controlled, double blind study, reported that prednisone 100 mg given orally once a day for the first 5 days of inpatient withdrawal treatment reduced significantly the total number of hours with severe or moderate headache within the first 72 and 120 h [625].

Bøe and colleagues performed a randomized, double blind, placebo controlled study in order to verify whether oral prednisolone reduced headache intensity dur- ing the first 6 days after medication withdrawal.

This was a multicentre double blind, placebo controlled, randomized study involving 96 MOH patients with migraine or episodic tension type headache as primary headache.

Conclusions Education on medication overuse and drug withdrawal still remain the key elements in the treatment of medication overuse headache.

Our study suggest that Methylprednisolone and Paracetamol may be useful in reducing the intensity of rebound headache during the second day of withdrawal, but they are not superior to placebo at the end of the detoxification program.

Acknowledgement A machine generated summary based on the work of Cevoli, Sabina; Giannini, Giulia; Favoni, Valentina; Terlizzi, Rossana; Sancisi, Elisa; Nicodemo, Marianna; Zanigni, Stefano; Bacchi Reggiani, Maria Letizia; Pierangeli, Giulia; Cortelli, Pietro. 2017 in The Journal of Headache and Pain.

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8. Rossi P, Di Lorenzo C, Faroni J, et al. Advice alone vs. structured detoxification programmes for medication overuse headache: a prospective, randomized, open-label trial in transformed migraine patients with low medical needs. Cephalalgia. 2006;26:1097–105. https://doi. org/10.1111/j.1468- 2982.2006.01175.x.

9. Munksgaard SB, Jensen RH. Medication overuse headache. Headache. 2014;54:1251–7.

10. Munksgaard SB, Bendtsen L, Jensen RH. Detoxification of medication-overuse headache by a multidisciplinary treatment program is highly effective: a comparison of two consecutive treatment methods in an open-label design. Cephalalgia. 2012;32:834–44.

11. Pageler L, Katsarava Z, Diener HC, et al. Prednisone vs. placebo in withdrawal therapy fol-

lowing medication overuse headache. Cephalalgia. 2008;28:152–6.

Chapter 4 Treatment

Introduction A disease intrinsically jeopardized as migraine needs multiple management approaches in the treatment process. Thinking that the drug alone, albeit innovative, efficient, safe, can play the role of gold player can sometimes lead to error. The pharmacological management should include integration and compliance in special situations such as emergency, pregnancy, age. Therephore, it is necessary to have a holistic vision of the treatment where psychobehavioral support, and in particular cases neuromodulatory and complementary alternative medicine, can be not a sub- stitute but an integrative part of it.

Machine-Generated Summaries 1. Treatment

Machine generated keywords: emergency, erenumab, cgrp, pregnancy, behav- ioral, lasmiditan, stimulation, dose, emergency department, placebo, galcane- zumab, monthly, department, woman, triptan.

4.1

Acute Treatment

Machine generated keywords: lasmiditan, rimegepant, triptan, ubrogepant, placebo, httagentityendreceptor, postdose, dose, cgrp, acute treatment, acute therapy, sumat- riptan, freedom, tablet, participant.

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Recent Advances in Pharmacotherapy for Episodic Migraine