Mindfulness and pharmacological prophylaxis after withdrawal from medication overuse in patients with Chronic Migraine: an effectiveness trial with a one-year follow-up.
BACKGROUND
Chronic Migraine (CM) is a disabling condition, worsened when associated with Medication Overuse (MO). Mindfulness is an emerging technique, effective in different pain conditions, but it has yet to be explored for CM-MO. 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.


METHODS
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. After withdrawal, patients were either treated with Prophylactic Medications (Med-Group), or participated in a Mindfulness-based Training (MT-Group). MT consisted of 6 weekly sessions of guided mindfulness, with patients invited to practice 7-10 min per day. 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. Outcome variables were analyzed in separate two-way mixed ANOVAs (Group: Mindfulness vs. Pharmacology x Time: Baseline, 3-, 6-, vs. 12-month follow-up).


RESULTS
A total of 44 patients participated in the study, with the average age being 44.5, average headache frequency/month was 20.5, and average monthly medication intake was 18.4 pills. 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.


CONCLUSIONS
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.
Neurological Institute "C. Besta" IRCCS Foundation, Headache and Neuroalgology Unit, Via Celoria 11, 20133, Milan, Italy. licia.grazzi@istituto-besta.it.
Licia
L
Grazzi
Neurological Institute "C. Besta" IRCCS Foundation, Neurology, Public Health and Disability Unit, Milan, Italy.
Emanuela
E
Sansone
Neurological Institute "C. Besta" IRCCS Foundation, Neurology, Public Health and Disability Unit, Milan, Italy.
Alberto
A
Raggi
Neurological Institute "C. Besta" IRCCS Foundation, Headache and Neuroalgology Unit, Via Celoria 11, 20133, Milan, Italy.
Domenico
D
D'Amico
eCampus University, Faculty of Psychology, Novedrate, Italy.
Andrea
A
De Giorgio
Neurological Institute "C. Besta" IRCCS Foundation, Neurology, Public Health and Disability Unit, Milan, Italy.
Matilde
M
Leonardi
Neurological Institute "C. Besta" IRCCS Foundation, Neurology, Public Health and Disability Unit, Milan, Italy.
Laura
L
De Torres
Department of Psychology, Univeristy of Memphis, Memphis, TN, USA.
Francisco
F
Salgado-García
Department of Psychology, Univeristy of Memphis, Memphis, TN, USA.
Frank
F
Andrasik
D000328:Adult; D000359:Aftercare; D002908:Chronic Disease; D005260:Female; D005500:Follow-Up Studies; D051271:Headache Disorders, Secondary / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy*; D064866:Mindfulness / Q000379:methods*; D016896:Treatment Outcome
Chronic migraine; Medication overuse; Mindfulness; Pharmacological prophylaxis