Mindfulness and pharmacological prophylaxis after withdrawal from medication overuse in patients with Chronic Migraine: an effectiveness trial with a one-year follow-up

DOI: https://doi.org/10.1186/s10194-017-0728-z

Abstract-Summary We report the results of a study assessing a one-year course of patients’ status, with the hypothesis that the effectiveness of a mindfulness-based approach would be similar to that of conventional prophylactic treatments.

Patients with CM-MO (code 1.3 and 8.2 of the International Classification of Headache Disorders-3Beta) completed a withdrawal program in a day hospital setting.

4.8 Psycho-Behavioral Interventions

833

After withdrawal, patients were either treated with Prophylactic Medications

(Med-Group), or participated in a Mindfulness-based Training (MT-Group).

Headache diaries, the headache impact test (HIT-6), the migraine disability assessment (MIDAS), state and trait anxiety (STAI Y1-Y2), and the Beck Depression Inventory (BDI) were administered before withdrawal and at each follow-up (3, 6, 12 after withdrawal) to patients from both groups.

Data revealed a similar improvement over time in both groups for Headache Frequency (approximately 6–8 days reduction), use of Medication (approximately 7 intakes reduction), MIDAS, HIT-6 (but only for the MED-Group), and BDI; no changes on state and trait anxiety were found.

Both groups revealed significant and equivalent improvement with respect to what has become a classical endpoint in this area of research, i.e. 50% or more reduction of headaches compared to baseline, and the majority of patients in each condition no longer satisfied current criteria for CM.

Taken as a whole, our results suggest that the longitudinal course of patients in the MT-Group, that were not prescribed medical prophylaxis, was substantially similar to that of patients who were administered medical prophylaxis.

Extended: Patients with CM-MO present therapeutic challenges and require mul- tidisciplinary care, including pharmacological and non-pharmacological therapeu- tic approaches [618].

Taken as a whole, our results suggest that the longitudinal course of patients receiving Mindfulness-based treatment, and who were instructed to refrain from medical prophylaxis (which was verified by the dairy records participants main- tained throughout the study), was overall very similar to that for patients who were administered conventional medical prophylaxis, with few exceptions noted.

Background Chronic Migraine associated with Medication Overuse (CM-MO) is diagnosed when the intake of headache medications for headache episodes is greater than 15 days/month for simple analgesics, or exceeds 10 days/month for triptans, opioids, ergotamine or combinations of certain drugs [430].

The success with other pain conditions, however, has spurred researchers in the field of headache to increasingly turn their attention to mindfulness training as another viable alternative approach for supplementing patient care.

What is not clear is the ability of a mindfulness-based approach by itself to impact key primary as well as secondary migraine headache parameters, as well as promote reductions in consumption of acute medications.

We carefully monitored the clinical course of these patients after all had under- gone a structured withdrawal, with the hypothesis that the mindfulness-based approach would be similar in effectiveness when compared to conventional prophy- lactic treatment, for reducing headache frequency, consumption of acute medica- tions, headache impact, symptoms of depression, and of anxiety.

Methods Eligible patients were those diagnosed with CM-MO – i.e. code 1.3 and associated medication overuse, following the international criteria included in point 8.2 of the

834

4 Treatment

International Classification of Headache Disorder III edition, beta version (ICHD-3- beta) [430] – who presented consecutively for treatment at the Headache Centre of the Neurological Institute C.  Besta of Milan, Italy, between February 2014 and June 2015.

Prior to discharge from the day treatment program, patients were informed of the possibility to participate in a new clinical trial, in which they could receive “medica- tion alone” or “mindfulness training alone” (Med-Group or MT-Group).

Patients in both groups were encouraged to restrict use of acute medications to headaches judged to be very disabling, operationally defined as a pain intensity rated as 8 or greater on a 0–10 (no pain—pain as bad as it could be).

Results A similar percentage of patients were overusing triptans: 8 of 22 patients (36.4%) in the Med-Group and 6 of 22 patients (27.3%) in the MT-Group (χ 2(1) = 0.42, p = 0.52).

The 2 groups did differ with respect to overuse of NSAIDS: 22 of 22 (100%) for

Med-Group vs. 18 of 22 for MT-Group (χ 2(1) = 4.40, p = 0.04).

Pairwise comparisons, with Sidak correction, revealed no differences between

any time points for the MF-Group.

For the MED-Group the 3-month and 12-month values were significantly

reduced when compared to baseline.

For both of the clinical endpoints, there were no differences between patients in

the MT-Group and those in the Med-Group.

Discussion Our preliminary data show that both groups of patients, treated with only a single, non-combination intervention—conventional pharmacological approach only ver- sus a mindfulness-based approach only—revealed significant decreases in number of monthly headache days, monthly consumption of medication for acute headache management, MIDAS, and depressive symptoms up to 12-months follow-up.

The fact that positive effects (although not always reaching significant changes) were observed in our study for these varied measures in patients who received our brief mindfulness training alone (in the absence of prophylactic medications) sug- gests that mindfulness-based treatment may be comparable to standard pharmaco- logical prophylaxis as far as its global positive clinical improvement.

Considering that only 40% of patients in the MED-group received a therapy hav- ing some kind of mood-modulating effect, the finding that the impact on mood component was similar is in line with the previous report, and suggests that mindfulness- based treatments, combined with appropriate antidepressant therapy, might yield an increased impact on symptoms of depression.

Conclusions Our results provide initial support for the beneficial effect of Mindfulness-based treatment in the management of chronic migraine that is accompanied with medica- tion overuse, a headache form which represents a clinical challenge.

Our results further suggest that a Mindfulness-based treatment may be compa- rable to standard pharmacological prophylaxis with regard to relevant primary

4.9 Childhood and Adolescent

835

outcomes such as headaches frequency reduction and reduction in the consumption of acute medications.

Acknowledgement A machine generated summary based on the work of Grazzi, Licia; Sansone, Emanuela; Raggi, Alberto; D’Amico, Domenico; De Giorgio, Andrea; Leonardi, Matilde; De Torres, Laura; Salgado-García, Francisco; Andrasik, Frank. 2017 in The Journal of Headache and Pain.

4.9

Childhood and Adolescent

Machine generated keywords: child, pediatric, adolescent, child adolescent, child- hood, evaluation, group, magnesium, migraine child, history, lasmiditan, occipital nerve, occipital, without aura, study drug

Migraine in childhood: an organic, biobehavioral, or psychosomatic disorder?