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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.

The objective of the study was to assess the efficacy and tolerability of sodium valproate (VPA) on chronic daily headache (CDH) in a prospective, double-blind, randomized, placebo-controlled trial. Seventy patients were included in the study. Twenty-nine had chronic migraine (CM) and 41 had chronic tension-type headache (CTTH). VPA and placebo were applied for 3 months to 40 and 30 patients, respectively. Visual analog scale (VAS) and pain frequency (PF) were used for evaluation. VPA decreased the maximum pain VAS levels (MaxVAS) and PF at the end of the study ( P  = 0.028 and P  = 0.000, respectively), but did not change general pain VAS (GnVAS) levels ( P  = 0.198). In CM patients, the decreases in MaxVAS, GnVAS and PF parameters were more in VPA treated patients ( P  = 0.006, P  = 0.03, and P  = 0.000, respectively). VPA treatment caused more reduction in PF than placebo in the CTTH subgroup ( P  = 0.000). VPA is effective in the prophylactic treatment of CDH by reducing MaxVAS levels and PF. It was more effective in CM than in CTTH.

To identify a treatment-responsive population for botulinum toxin type A (BoNTA) and to evaluate the safety and efficacy of 3 different doses of BoNTA as prophylactic treatment of chronic daily headache (CDH). A randomized, double-blind, placebo-controlled study of BoNTA in patients with CDH was conducted from July 6, 2001, through November 7, 2003, at 28 North American study centers. Eligible patients were injected with BoNTA at 225 U, 150 U, 75 U, or placebo and returned for additional masked treatments at day 90 and day 180. Patients were assessed every 30 days for 9 months. The primary efficacy end point was the mean change from baseline in the frequency of headache-free days at day 180 for the placebo nonresponder group. For this study, 702 patients were enrolled and randomized. The primary efficacy end point was not met. Mean improvements from baseline at day 180 of 6.0, 7.9, 7.9, and 8.0 headache-free days per month were observed in the placebo nonresponder group treated with BoNTA at 225 U, 150 U, 75 U, or placebo, respectively ( P=.44). An a priori-defined analysis of headache frequency revealed that BoNTA at 225 U or 150 U had significantly greater least squares mean changes from baseline than placebo at day 240 (-8.4, -8.6, and -6.4, respectively; P=.03 analysis of covariance). Only 27 of 702 patients (3.8%) withdrew from the study because of adverse events, which generally were transient and mild to moderate. Although the primary efficacy end point was not met, all groups responded to treatment. The 225 U and 150 U groups experienced a greater decrease in headache frequency than the placebo group at day 240. The placebo response was higher than expected. BoNTA was safe and well tolerated. Further study of BoNTA prophylactic treatment of CDH appears warranted.

Background Medication overuse headache (MOH) is a major clinical concern and a common health risk. Recent literature stressed the need to manage chronic headache by using integrated biobehavioral approaches. Few studies evaluated how biofeedback can be useful in MOH. The aim of the study is to evaluate in a randomized, controlled, single-blind trial the effects of biofeedback associated with traditional pharmacological therapy in the prophylactic treatment of MOH. Method Twenty-seven subjects were randomized to frontal electromyographic (EMG) biofeedback associated with prophylactic pharmacological therapy (Bfb Group) or to pharmacological treatment alone (Control Group). The primary outcome was to evaluate the number of patients that return episodic after treatment. Secondly we evaluate the effects of frontal EMG BFB on frequency of headache and analgesic intake. Changes in coping strategies and in EMG frontalis tension were also evaluated. ANOVA was performed on all the variables of interest. Results Our results indicate that at the end of treatment the number of patients that returned episodic in the Bfb group was significantly higher than in the Control group. Patients in the Bfb group differed from the Control group in headache frequency, amount of drug intake and active coping with pain. These outcomes were confirmed also after 4 months of follow-up. No significant effects were observed in EMG recordings. Conclusions Biofeedback added to traditional pharmacological therapy in the treatment of MOH is a promising approach for reducing headache frequency and analgesic intake. Modification of coping cognitions in the Bfb group, as an adjunct mechanism of self-regulation, needs more evaluations to understand the role of biofeedback in changing maladaptive psychophysiological responses.

The World Health Organization (WHO) Intersectoral Global Action Plan on Epilepsy and Other Neurological Disorders was developed by WHO to address the worldwide challenges and gaps in provision of care and services for people with epilepsy and other neurological disorders and to ensure a comprehensive, coordinated response across sectors to the burden of neurologic diseases and to promote brain health across life-course. Headache disorders constitute the second most burdensome of all neurological diseases after stroke, but the first if young and midlife adults are taken into account. Despite the availability of a range of treatments, disability associated with headache disorders, and with migraine, remains very high. In addition, there are inequalities between high-income and low and middle income countries in access to medical care. In line with several brain health initiatives following the WHOiGAP resolution, herein we tailor the main pillars of the action plan to headache disorders: (1) raising policy prioritization and strengthen governance; (2) providing effective, timely and responsive diagnosis, treatment and care; (3) implementing strategies for promotion and prevention; (4) fostering research and innovation and strengthen information systems. Specific targets for future policy actions are proposed. The Global Action Plan triggered a revolution in neurology, not only by increasing public awareness of brain disorders and brain health but also by boosting the number of neurologists in training, raising research funding and making neurology a public health priority for policy makers. Reducing the burden of headache disorders will not only improve the quality of life and wellbeing of people with headache but also reduce the burden of neurological disorders increasing global brain health and, thus, global population health.

The management of medication overuse headache (MOH) is based essentially on the withdrawal of the overused drug(s). Drug withdrawal is performed according to widely differing protocols, both within and across countries; therefore, therapeutic recommendations for the acute phase of detoxification vary considerably among studies. Basically, the aims of MOH management are: (a) to withdraw the overused drug(s); (b) to alleviate withdrawal symptoms by means of a bridge therapy, which includes pharmacological and non-pharmacological support, designed to help the patient to tolerate the withdrawal process; (c) to prevent relapse. Today, there is extensive debate over the best strategies for achieving these goals and the different aspects of this debate are discussed in this review. The authors searched for the best available evidence relating to the following questions: should medication withdrawal be abrupt or gradual? Should patients receive replacement therapy? What are the most effective therapeutic programmes for controlling withdrawal symptoms? Should replacement therapy be administered routinely or as rescue therapy? Should preventive treatment be started before, during or after withdrawal? What are the most effective preventive treatments? Should patients be managed through inpatient or outpatient withdrawal programmes? What is the best approach to adopt in preventing relapses? Treatment of MOH is a difficult challenge, but may be very rewarding. Although there is still a lack of high-quality studies providing evidence-based answers to the many specific questions it raises, neurologists need to know that the combination of education with a rational use of selected therapeutic strategies may be beneficial to people with chronic headache and help to relieve their suffering.

Medication overuse and subsequent medication-overuse headache (MOH) is a growing problem worldwide. Epidemiological data suggest that up to 4% of the population overuse analgesics and other drugs for the treatment of pain conditions such as migraine and that about 1% of the general population in Europe, North America, and Asia have MOH. Recent clinical studies gave further insights in clinical and pharmacological features, such as critical monthly doses and frequencies. These features seem to vary significantly and depend on the primary headache disorder and the type of drug that is overused. Along with these findings the new international classification of headache disorders has now incorporated additional criteria and new headache entities that will facilitate the diagnosis of MOH. Withdrawal therapy is the only treatment for this disorder and clear restriction of monthly doses is the central requirement for successful prevention.

Background In adults, intravenous (IV) dihydroergotamine (DHE) has been shown to be effective at improving medium term outcomes in patients with chronic headache disorders. The IV formulation is utilized given its superior bioavailability. We aim to assess the safety and effectiveness of repetitive IV DHE infusions paired with an adjustment of a preventive treatment strategy within children and youth with chronic headache disorders. Methods A retrospective chart review was conducted of children and youth diagnosed with a chronic headache disorder who were admitted for DHE from January 2014 – October 2020. Patients completed a 5-day, standardized protocol. A new preventive was started one week after discharge. Data were collected from pre- and post-admission clinic notes. Safety and tolerability were assessed. Results were evaluated using descriptive statistics and compared with paired t -tests. Results One hundred and eighty-seven patients were included for review. Sixty-eight percent (127) had chronic migraine (CM), 20% (37) new daily persistent headache (NDPH) and 12% (23) persistent headache attributed to head trauma (PHHT). The median (range) age was 16 years (7–21), and median (range) number of previous preventive trials was 4 (0–21). At follow-up, patients with CM had a significant decrease in headache days per month from 28.6 to 26.3 days (95% CI -4.1 to -1.3) p  < 0.001, baseline headache intensity decreased from 5.9/10 to 5.3/10 (95% CI -1.3 to -0.1) p  = 0.006, number of severe headache days per month decreased from 11.5 to 7.9 days (95% CI -6.5 to -2.3), p  < 0.001, and monthly days of acute medication use from 12.1 to 9.8 days (95% CI -4.5 to -0.7) p  = 0.002. In patients with NDPH there were significant decreases in baseline headache intensity from 6.4/10 to 5.3/10 (95% CI -1.7 to -0.3) p  = 0.005 and monthly days of acute medication usage from 9.2 days to 5.9 days (95% CI -7.8 to -0.1) p  = 0.043. Patients with PHHT had a significant decrease in headache days per month from 29 to 24 days (95% CI -9.4 to -0.7) p  = 0.031. The most common side effects were nausea (85%) and mild leg cramping (60%). Conclusion Repetitive DHE infusions followed by preventive treatment adjustment was well tolerated and significantly reduced headache frequency, baseline intensity, number of severe days and/or acute medication usage in children and youth with refractory headache disorders.

Purpose of Review Management of chronic daily headaches (CDH) remains challenging due to the limited efficacy of standard prophylactic pharmacological measures. Several studies have reported that repetitive transcranial magnetic stimulation (rTMS) can effectively treat chronic headaches. The objective was to determine the utility of rTMS for immediate post-treatment and sustained CDH prophylaxis. Recent Findings All procedures were conducted per PRISMA guidelines. PubMed, Scopus, Web of Science, and ProQuest databases were searched for controlled clinical trials that have tested the efficacy of rTMS on populations with CDH. DerSimonian-Laird random-effects meta-analyses were performed using the ‘meta’ package in R to examine the post- vs. pre-rTMS changes in standardized headache intensity and frequency compared to sham-control conditions. Thirteen trials were included with a combined study population of N = 538 patients with CDH (rTMS, N = 284; Sham, N = 254). Patients exposed to rTMS had significantly reduced standardized CDH intensity and frequency in the immediate post-treatment period (Hedges’ g = -1.16 [-1.89, -0.43], p = 0.002 and Δ = -5.07 [-10.05, -0.11], p = 0.045 respectively). However, these effects were sustained marginally in the follow-up period (Hedges’ g = -0.43 [-0.76, -0.09], p = 0.012 and Δ = -3.33 [-5.52, -1.14], p = 0.003). Significant between-study heterogeneity was observed, at least partially driven by variations in rTMS protocols. Summary Despite the observed clinically meaningful and statistically significant benefits in the immediate post-treatment period, the prophylactic effects of rTMS on CDH do not seem to sustain with discontinuation. Thus, the cost-effectiveness of the routine use of rTMS for CDH prophylaxis remains questionable. Registration Protocol preregistered in PROSPERO International Prospective Register of Systematic Reviews (CRD42021250100)

Background Chronic headache (headache ≥ 15 days/month for at least 3 months) affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH) can be identified by using the Severity of Dependence Scale (SDS). A “brief intervention” scheme (BI) has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI) scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT) of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication withdrawal method. To our knowledge this is the first RCT of structured non-pharmacological MOH treatment in primary care. Results may hold the potential of offering an instrument for treating MOH patients in the general population by GPs. Trial registration ClinicalTrials.gov identifier: NCT01314768