UNASSIGNED: This preliminary retrospective cohort study investigates the potential additive prophylactic effect of erenumab, a fully human monoclonal antibody that blocks the calcitonin gene-related peptide receptor, in combination with ongoing onabotulinumtoxin A (onaBoNT-A) treatment in patients suffering from chronic migraine.
UNASSIGNED: The study included 218 patients and investigated the effects of adding erenumab to the existing treatment regimen. The primary outcome was the MIDAS (Migraine Disability Assessment) score assessed 3 months after the introduction of erenumab.
UNASSIGNED: The results indicated a significant improvement of the MIDAS score, suggesting a reduction in migraine-related disability following the addition of erenumab to onaBoNT-A. In the inter group comparison, dual therapy showed a significantly greater reduction of the MIDAS when compared to a switch from onaBoNT-A to erenumab monotherapy, but not compared to initiation of onaBoNT-A monotherapy. It is hypothesized that the observed additive effects are due to the independent modes of action of erenumab and onabotulinumtoxin A.
UNASSIGNED: This study suggests that the combination of erenumab with onaBoNT-A may offer an improved approach for the treatment of chronic migraine in selected patients. However, the results highlight the need for prospective, controlled studies to validate these findings and determine the optimal combination of treatments tailored to the individual patient.

UNASSIGNED: Migraine has a negative impact on patients\' quality of life, with the frequency of attacks being associated with greater disability and poorer health status. Frequent migraine-type headaches require prophylactic treatment, which has so far been of limited effectiveness until advent of calcitonin gene-related peptide (CGRP) monoclonal antibody.
UNASSIGNED: A prospective analysis was conducted of data from 41 migraine patients who experienced 4 or more monthly migraine days (MMD) longer than three months. At the beginning of the study, treatment with monoclonal antibodies against CGRP (fremanezumab 225 mg or erenumab 70 or 140 g per month) was prescribed according to the indications. The effect of the medications was evaluated after 3-month period.
UNASSIGNED: The mean age of patients was 37.17 (±11.78) years. It was found that 17 patients (41.5%) had episodic migraine (EM) and 24 (58.5%) had chronic migraine (CM). Fremanezumab was prescribed to 26 patients (63.4%) and erenumab to 15 patients (36.6%); among the latter, 13 patients used 70 mg/month and 2 patients used 140 mg/month. Three months after treatment, CM changed to EM for 19 patients (79.2%), 27 patients (65.9%) had ≥50% reduction in the number of MMD and total migraine disability assessment (MIDAS) score was reduced by >50% in 31 patients (75.6%). Also, all areas of quality of life of patients were improved after 3 months continued treatment compared to baseline.
UNASSIGNED: For more than half the patients using fremanezumab or erenumab after 3-month period, MMD decreased by ≥50% and total MIDAS score by >50 points. All areas of quality of life were improved after prophylactic treatment of migraine.
UNASSIGNED: Migrena neigiamai veikia pacientų gyvenimo kokybę ir galvos skausmų dažnis yra susijęs su didesnia negalia ir blogesne sveikata. Esant dažnam migreniam galvos skausmui yra reikalingas profilaktinis gydymas, kurio efektyvumas, iki atsirandant biologinei terapijai, buvo ribotas.
UNASSIGNED: Perspektyviniame tyrime dalyvavo 41 migrena sergantys pacientai, kuriems pasireiškė 4 ir daugiau migreninių dienų per mėnesį (MDM) ilgiau kaip 3 mėnesius. Pacientams paskirti su kalcitonino genu susijusį baltymą ir jo receptorius veikiantys (angl. calcitonin gene-related peptide, CGRP) monokloniniai antikūnai (fremanezumabas 225 mg ar erenumabas 70 mg ar 140 mg per mėnesį). Gydymo efektyvumas įvertintas po 3 mėnesių.
UNASSIGNED: Pacientų amžiaus vidurkis buvo 37,17 (±11,78) metų. Nustatyta, kad epizodinę migreną (EM) turėjo 17 (41,5 proc.) pacientų, o lėtinę migreną (LM) – 24 (58,5 proc.) pacientai. Fremanezumabas paskirtas 26 (63,4 proc.), o erenumabas – 15 (36,6 proc.) pacientams; atitinkamai, 13 pacientų naudojo erenumabo 70 mg per mėnesį, o 2 pacientai – 140 mg per mėnesį. Po trijų mėnesių vartojant monokloninius antikūnus, LM pasikeitė į EM 19 (79,2 proc.) pacientų, ≥50 proc. MDM sumažėjo 27 (65,9 proc.) pacientams ir 31 (75,6 proc.) pacientui bendras migrenos įtakos veiklai (angl. migraine disability assessment scale, MIDAS) balas sumažėjo >50 proc. Visose srityse gyvenimo kokybės įvertinimas pagerėjo 3 mėnesius skiriant monokloninius antikūnus.
UNASSIGNED: Daugiau kaip pusei pacientų sumažėjo ≥50 proc. MDM ir >50 proc. MIDAS balai, gyvenimo kokybės įvertinimas visose srityse pagerėjo po 3 mėnesių skiriant gydymą monokloniniais antikūnais.

Adverse side effects from pharmacological treatments cause people with migraine to delay or avoid taking medication. Exercise is effective, but the effect of environment is unknown. The purpose was to determine if a natural environment affects monthly migraine load. Sedentary individuals (8 female, 1 non-binary) who experienced migraines participated. Participants completed one month of exercise (3 x week, 30-min, 60-70% estimated HRmax) indoors as well as in a natural outdoor environment in a randomized counterbalanced order. Migraine load was determined using the Headache Impact Test (HIT-6) and Migraine Disability Assessment (MIDAS) at the beginning and end of each month. Data were analyzed using repeated measures ANOVA. No interactions were evident for HIT-6 (p = 0.80), MIDAS (p = 0.72), migraine days (p = 0.508), or pain intensity (p = 0.66). No main effects were noted. Compliance was greater in the outdoor environment, with more exercise sessions completed in nature (Indoor = 72%, Outdoor = 90%, p < 0.001). Exercise environment did not impact MIDAS or HIT-6 questionnaire results, number of migraine days, or pain intensity. While there was no reduction in migraine load, it is possible that other health benefits were experienced due to greater compliance in a natural environment.

UNASSIGNED: The aim of the study was to investigate the clinical profile, disease burden, quality of life, and treatment patterns of various headache subtypes.
UNASSIGNED: In this prospective observational study, 815 patients presenting with chief complaints of headache between January 2020 to September 2021 were registered. After a detailed history, clinical examination, and subtyping, they were assessed at baseline with well-validated scales for severity (Visual Analogue Scale-VAS), disability burden (Migraine Disability Assessment- MIDAS), Humanistic burden (Headache Impact Test-HIT-6), and quality of life (World health organization-quality of life-WHO-QoL-8) scores. After initiating adequate management, parameters were reassessed at 3 and 6 months.
UNASSIGNED: 549 (67.7%) patients had migraine (395-episodic migraine, 144-chronic migraine), 266 (32.2%) patients had tension-type headache (TTH). Loss of sleep, prolonged working hours, and stress were common triggers. Disease burden, severity, and poor life quality was quite high in migraine patients (76.5% with moderate to severe disability, 61.7% with severe headache at onset, and 72% with poor life quality). All parameters had statistically significant improvement with preventive medication and lifestyle changes.
UNASSIGNED: In our study, we found migraine was the most common primary headache followed by TTH. Migraine patients had more severity, disease burdens, and inferior quality of life at onset compared to other headaches. With early and proper diagnosis as well as preventive treatment (including lifestyle modifications), all parameters could be reversed positively in a brief time. This is the first study on headache burden and its effect on the quality of life in the north Indian population.

Resveratrol, a vasoactive phytoestrogen, has beneficial effects on cerebrovascular function. Previous research has shown that hormonal migraineurs have poorer cerebrovascular function than non-migraineur women. We aimed to investigate if resveratrol supplementation for three months could reduce the hormonal migraine burden index (HMBI: the number of days with menstrual migraine per month), reduce migraine-related disability and improve migraine-related quality of life. A randomised, double-blind, placebo-controlled, crossover, intervention trial was conducted in 62 hormonal migraineurs (mean age: 37.5 ± 0.8 years). Participants consumed 75 mg of resveratrol or matching placebo capsules twice daily for three months before crossing over to the other treatment arm. Participants completed a daily diary and the Headache Impact Test-6™, Migraine Disability Assessment and Migraine-Specific Quality of Life questionnaires at months 0, 3 and 6. The HMBI was the primary outcome and was calculated using data extracted from the participant\'s diary. No differences in the HMBI (p = 0.895), the Headache Impact Test-6™, the Migraine Disability Assessment and Migraine-Specific Quality of Life were found between the resveratrol and placebo treatments. Resveratrol supplementation for three months did not affect the HMBI, the migraine-related disability or quality of life measures in our cohort of hormonal migraineurs.

The objective of this study was to determine the associations among migraine disability assessment scores, healthcare resource utilization (HCRU; medical visits and pharmacy use) and direct medical costs among people with episodic migraine in a real-world setting.
Migraine is a public health concern associated with a substantial economic burden in the United States. However, the association between migraine disability and direct medical costs among people with migraine is unknown.
This retrospective, cohort study used claims and electronic health record data from the Decision Resources Group database. Adults with migraine with or without aura, defined by International Classification of Disease Revision 9 (ICD-9) or ICD Revision 10 (ICD-10) codes, and a completed Migraine Disability Assessment Scale (MIDAS) questionnaire from January 2016 to December 2018 were included (chronic migraine codes not included). The associations of MIDAS score with the cost of HCRU for the 6 months after MIDAS assessment were explored. Results were stratified by treatment setting.
Among 7662 included patients, MIDAS scores were distributed as: 3348 (43.7%; I, little/none), 1107 (14.4%; II, mild), 1225 (16.0%; III, moderate), 893 (11.7%; IVa, severe), and 1089 (14.2%; IVb, very severe). Worsening disability was associated with higher medical costs (adjusted from a multivariable model). In the primary care setting, healthcare visit costs were $206 (95% confidence interval: $144-294) for grade I and $631 ($384-1036) for grade IVb patients; corresponding pharmacy costs were $203 (grade I; $136-301) and $719 (grade IVb; $410-1259). For specialty care (e.g., neurologist), healthcare visits cost $509 ($411-629) for grade I and $885 ($634-1236) for grade IVb patients; corresponding pharmacy costs were $494 (grade I; $378-645) and $1020 (grade IVb; $643-1620).
Higher levels of migraine-related disability (MIDAS assessed) are associated with increased HCRU costs among Americans with episodic migraine. Migraine disability assessment could be useful in the development, testing, and prescription of cost-effective treatments for people with high migraine-related disability.

OBJECTIVE: Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine.
METHODS: CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18-65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed.
RESULTS: A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: -33.58 ± 2.11 (GMB 120 mg) and -32.67 ± 2.04 (GMB 240 mg).
CONCLUSIONS: Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

OBJECTIVE: To assess the impact of a migraine management program offered as a complimentary service by a company within its corporate well-being program.
BACKGROUND: Migraine imposes a substantial burden on patients, families, employers, and societies. As migraine primarily affects working-age adults, this has important implications for both employees and employers. Workplace educational and well-being programs positively contribute to employees\' productivity, reduce costs related to absenteeism, and improve the quality of life of the employees living with migraine.
METHODS: This was a non-interventional cohort study, which followed employees and their family members over time. Participants received 1 telemedicine consultation to determine migraine diagnosis or a high probability of having migraine and 6 sessions of individualized telecoaching from a specialized nurse via a specially developed smartphone application to optimize their migraine management leveraging all appropriate medical and lifestyle options. Participants were evaluated during the program and at 3 months after completion through a series of validated questionnaires including Migraine Disability Assessment (MIDAS), Patient Activation Measure (PAM), and satisfaction with the services offered. A cost analysis was also performed to determine the economic benefit of the program considering the number of completers, dropouts, their associated program costs, MIDAS data, average salary of a Swiss employee in the pharma sector, and working days per year.
RESULTS: Of the 141 participants enrolled in the program, 79 completed 6-month and 42 completed 9-month assessments. The total MIDAS scores (mean, standard deviation [SD]) significantly improved from baseline by 54% at Month 6 (15.0 [13.6] vs 6.9 [8.2]; mean [SD] reduction: 8.1 [12.9], 95% confidence interval [CI]: 5.6-10.6; P < .0001) and by 64% at Month 9 (15.4 [14.7] vs 5.6 [6.0]; mean [SD] reduction: 9.8 [14.0], 95% CI: 6.6-13.0; P < .0001). The PAM scores also significantly improved from baseline by 8% at Month 6 (63.8 [10.9] vs 69.6 [12.8]; mean [SD] increase: 5.8 [12.8], 95% CI: 3.2-8.4; P = .003) and 11% at Month 9 (63.5 [10.7] vs 71.3 [12.2]; mean [SD] increase: 7.8 [11.0], 95% CI: 4.3-11.2; P = .003). At Month 6, common coaching lessons and respective action plans focused on progressive muscle relaxation, sleep, hydration, nutrition, general disease education, and stress management. The exit survey showed that the majority of the participants who completed the program had a meaningful and sustained improvement in their overall health and reported a high level of satisfaction with the program. The cost analysis revealed that on average participants gained 10.8 (95% CI: 9.3-12.3) working days/year that were previously lost due to migraine, resulting in a positive return on investment (ROI) of 490% (95% CI: 410%-570%), indicating a higher magnitude of savings that could be achieved by the implementation of such program. In addition to ROI and work productivity gained, participants also gained on average 13.6 (95% CI: 9.9-17.3) migraine-free days/year for their private and social life.
CONCLUSIONS: The employer-sponsored disease management program provided a better understanding of migraine, promoted methods and approaches to improve management by combining medical and lifestyle options leading to significant improvements in migraine symptoms that sustained beyond the intervention, supporting prolonged effectiveness of such programs. The program also provided a high ROI to the employer, supporting that the systematic inclusion of such programs into corporate well-being initiatives can be of significant benefit not only to the impacted individuals but to the employers as well.

The International Classification of Headache Disorders lists different subtypes of medication overuse headache (MOH), according to the medication overused. The aim of this study is to evaluate whether the different subtypes correspond to clinically distinguishable phenotypes in a large population.
This descriptive cross-sectional observational study included 660 patients with MOH referred to headache centers in Europe and Latin America as a part of the COMOESTAS project. Information about clinical features was collected with structured patient interviews and with self-administered questionnaires for measuring disability, anxiety, and depression.
Female/male ratio, body mass index, marital status, and level of education were similar among in subjects enrolled in the 5 centers. The mean age was higher among subjects overusing triptans (T-MOH) with respect to subjects overusing simple analgesic (A-MOH). Duration of headache before chronification was longer in T-MOH (19.2 ± 11.9 years) and in subjects overusing ergotamines (E-MOH, 17.8 ± 11.7 years) with respect to the A-MOH group (13.1 ± 10.9; P < .001 and P = .017, respectively) and in T-MOH with respect multiple drug classes (M-MOH, 14.9 ± 11.7; P = .030). Migraine Disability Assessment (MIDAS) score was significantly lower in E-MOH group (33.6 ± 41.6), while T-MOH group (56.8 ± 40.6) had a significant lower MIDAS score with respect to M-MOH (67.2 ± 62.5; P = .016 and P = .037, respectively). Prevalence of depression and anxiety was lower in patients overusing T with respect to other groups of patients (χ2  = 10.953, P = .027 and χ2  = 25.725, P < .001, respectively).
In this study on a large and very well characterized population of MOH, we describe the distinctive clinical characteristics of MOH subtypes. These findings contribute to more clearly define the clinical picture of a poorly delineated headache disorder. They also provide some insights in the possible trajectories leading to this highly disabling chronic headache, that is classified as a secondary form, but whose occurrence is entirely dependent on an underlying primary headache.

Introduction: Migraine is a disabling neurovascular disorder characterized by increasing levels of pro-inflammatory cytokines and oxidative stress biomarkers. Curcumin and coenzyme Q10 (CoQ10) can exert neuroprotective effects through modulation of inflammation and oxidative stress. The aim of the present study was to evaluate the combined effects of nano-curcumin and CoQ10 supplementation on migraine symptoms and quality of life in migraine patients.Methods: One-hundred men and women (mean age 32 years) with episodic migraine based on the International Headache Society (IHS) criteria participated in this study. The subjects were randomly divided into four groups as (1) combination of nano-curcumin (80 mg) plus CoQ10 (300 mg), (2) nano-curcumin (80 mg), (3) CoQ10 (300 mg) and (4) the control (nano-curcumin and CoQ10 placebo included oral paraffin oil) beside usual prophylactic drugs for 8 weeks. Frequency, severity, duration of headache attacks, the headache diary results (HDR) and headache disability based on migraine-specific questionnaires were assessed at the baseline and end of the study.Results: Ninety-one of 100 patients completed the study. The results showed a significant effect of nano-curcumin and CoQ10 supplementation on frequency, severity, duration of migraine attacks and HDR compared to other groups (All P < 0.001). Nano-curcumin and CoQ10 group also had better scores in migraine-specific questionnaires at the end of the study compared to other groups (All P < 0.001). There were no side effects reported by the participants.Conclusions: These findings suggest a possible synergistic effect of nano-curcumin and CoQ10 on clinical features of migraine.Trial registration number: IRCT2017080135444N1.