Discussion
migraine-associated, days/month, ’ percentage reduction, CM, headache, migraine, migrainous headaches, disability
MIGRAINE, DISEASE, ADVERSE EVENTS, MIGRAINE HEADACHES
The results of this phase-III single-blind RCT, demonstrated that a mindfulness-based protocol added-on to TaU for the treatment of CM associated to MOH produced a superior and statistically significant reduction in headache frequency, total drug intake and NSAIDs intake compared to baseline compared to TaU alone. Patients allocated to the TaU + MIND group also achieved more frequently a meaningful reduction in headache impact, as defined by a reduction ≥ 6 points in HIT-6 score, and outperformed those in the TaU group with regard to LPT, indirect, direct healthcare, and total costs throughout the study. Finally, they showed better QoL and disability scores (as measured by the MIDAS) at 12 months only.Mindfulness gained considerable attention for migraine management and some reviews have been carried out [The MIND-CM study is, to date, one of the largest on behavioral treatments, and the largest on mindfulness in patients with migrainous headaches. Patients allocated in the TaU + MIND group achieved more frequently, than those receiving TaU only, 50% or more headache frequency reduction (78.4% vs. 48.3%): such a result was superior to our hypotheses, which accounted for a 20% higher rate, and is corroborated by the time by group analyses on headache impact, LPT, medications intake, and cost.A delta of approximately 3.5 days/month between the two groups was found on headache frequency, being the reduction by around 30 days for patients in TaU and 40 in those in TaU + MIND. The mean headache days’ percentage reduction was comprised between 59% and 64% among patients in the TaU + MIND group. This result is wider compared to that of previous investigations, which often found either no [The clinical improvement was corroborated by some improvement in disability (as measured by the MIDAS) and in QoL at 12 months only, along with a higher rate of achievement of clinical meaningful HIT-6 score reduction, and by a superior overall LPT improvement. Improvements in disability and QoL were not systematically retrieved in previous studies contrasting mindfulness treatment participants to controls [Of specific interest is the superior outcome of patients in the TaU + MIND group on LPT, reduced intake of symptomatic medications and disease cost, all of which have not been systematically investigated before. Our mindfulness-based protocol produced a sizeable LPT reduction, which moved from 20 to 7 days-equivalent per trimester (the average reduction being 60–66%), which is similar to what was observed on headache frequency, and superior to that of patients allocated to TaU. The greater improvement in LPT is clearly connected to the superior improvement in indirect cost, which represents the largest part of migraine-associated costs [Additionally, patients in the TaU + MIND group outperformed those in TaU for medication intake, and specifically NSAIDs, reduction. This is of relevance, considering medication overuse role in migraine chronification [Considering the unpredictable course of migraine headaches, and the difficulties connected to their occurrence, addressing patients’ perception of these difficulties and increasing their ability to handle them is of core relevance. We hypothesize that this enhanced ability led to the reduction in medication intake and to an improved patients’ ability to work, both of which were linked to the superior reduction in disease costs, whose difference was 690€ at 6 months and 850€ at 12 months. Despite a cost-efficacy analysis is out of the scope of this work, it seems there is room enough to compensate for the cost of a regular implementation of the mindfulness protocol herein proposed.Some limitations need to be considered. First, the study was based in a single center with patients with very severe CM and MOH who attended a structured withdrawal at a specialty headache center: this partially limits the generalizability of our results. Second, COVID-19 pandemic partly disrupted our RCT. In fact, most of the drop outs from the TaU + MIND group were registered in the first trimester due to the development of COVID-19 or to the restrictions in mobility and in access to hospitals. Moreover, we had to switch to tele-visits instead of in-person visits. Third, we did not systematically report adverse events due to mindfulness practice. Behavioral treatments are deemed to be free from side effects [