Migraine Disability Assessment Scale Scores Research Articles

Reliability, validity, and responsiveness of the Arabic version of HIT-6 questionnaire in patients with migraine indicated for preventive therapy: A multi-center study.

The Headache Impact Test (HIT-6) is an important patient-reported outcome measure (PROM) in migraine prevention trials. This study aimed to (i) assess the reliability and validity of the Arabic version of HIT-6 in Arabic-speaking patients experiencing migraine, and (ii) evaluate the responsiveness of HIT-6 following migraine preventive therapy. In this prospective study, patients with migraine (n = 145) were requested to fill out a headache diary, the Arabic version of HIT-6, and Migraine Disability Assessment Scale (MIDAS) at two time points (baseline and 3 months after initiation of prophylactic treatment). Some respondents (n = 73) were requested to fill out HIT-6 again 1 week from the baseline for test-retest reliability. The intensity of migraine headache attacks was evaluated using the Visual Analogue Scale (VAS). An anchor-based method was used to establish the minimal important change (MIC) value and responsiveness of HIT-6. The total scores of HIT-6 were significantly correlated to a fair degree with MIDAS (r = 0.41), as well as VAS (r = 0.53), and monthly migraine days (r = 0.38) at the baseline while at the follow-up (after 3 months), the correlations were of moderate degree with MIDAS scores (r = 0.62) and monthly migraine days (r = 0.60; convergent validity). Reliability estimates of the Arabic HIT-6 were excellent (Cronbach's α = 0.91 at baseline and 0.89 at follow-up). The average measure interclass correlation coefficient (ICC) value for the test-retest reliability was 0.96 (95% confidence interval = 0.94-0.98, p < 0.001). The HIT-6 total score is sensitive to change, being significantly reduced after prophylactic treatment compared to before (effect size = 1.5, standardized response mean = 1.3). A reduction from baseline of 4.5 on HIT-6 showed the highest responsiveness to predict improvement with an area under the curve equal to 0.66, sensitivity of 80%, specificity of 45%, and significance at 0.021. Changes in the HIT-6 total score were positively correlated with changes in monthly migraine days (r = 0.40) and VAS scores (r = 0.69) but not with changes in the score of MIDAS (r = 0.07). The Arabic version of HIT-6 is valid, reliable, and sensitive to detect clinical changes following migraine prophylactic treatment with a MIC of 4.5 points.

Impact of headache frequency and preventive treatment failure on quality of life, disability, and direct and indirect costs among individuals with episodic migraine in the United States.

To evaluate unmet needs among individuals with episodic migraine (EM) in the United States (US). Data are limited on the impact of headache frequency (HF) and preventive treatment failure (TF) on the burden of migraine in the US. A retrospective, cross-sectional analysis of 2019 National Health and Wellness Survey (NHWS) data was conducted from an opt-in online survey that identified respondents (aged ≥18 years) in the US with self-reported physician-diagnosed migraine. Participants were stratified by HF (low: 0-3 days/month; moderate-to-high: 4-14 days/month) and prior preventive TF (preventive naive; 0-1 TF; ≥2 TFs). Comparisons were conducted between preventive TF groups using multivariable regression models controlling for patient demographic and health characteristics. Among individuals with moderate-to-high frequency EM, the NHWS identified 397 with ≥2 TFs, 334 with 0-1 TF, and 356 as preventive naive. The 36-item Short-Form Health Survey (version 2) Physical Component Summary scores were significantly lower among those with ≥2 TFs, at a mean (standard error [SE]) of 41.4 [0.8] versus the preventive-naive 46.8 [0.9] and 0-1 TF 44.5 [0.9] groups; p < 0.001 for both). Migraine Disability Assessment Scale scores were significantly higher in the ≥2 TFs, at a mean (SE) of 37.7 (3.9) versus preventive-naive 26.8 (2.9) (p < 0.001) and 0-1 TF 30.1 (3.3) (p = 0.011) groups. The percentages of time that respondents experienced absenteeism (mean [SE] 21.6% [5.5%] vs. 13.4% [3.6%]; p = 0.022), presenteeism (mean [SE] 55.0% [8.3%] vs. 40.8% [6.5%]; p = 0.015), overall work impairment (mean [SE] 59.4% [5.6%] vs. 45.0% [4.4%]; p < 0.001), and activity impairment (mean [SE] 56.8% [1.0%] vs. 44.4% [0.9%]; p < 0.001) were significantly higher in the ≥2 TFs versus preventive-naive group. Emergency department visits (preventive-naive, p = 0.006; 0-1 TF, p = 0.008) and hospitalizations (p < 0.001 both) in the past 6 months were significantly higher in the ≥2 TFs group. Direct and indirect costs were significantly higher in the ≥2 TFs (mean [SE] $24,026 [3460]; $22,074 [20]) versus 0-1 TF ($10,897 [1636]; $17,965 [17]) and preventive-naive ($11,497 [1715]; $17,167 [17]) groups (p < 0.001 for all). Results were similar in the low-frequency EM group. In this NHWS analysis, individuals with more prior preventive TFs experienced significantly higher humanistic and economic burden regardless of HF.

Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.

Long-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized controlled trial (RCT). We aimed to assess real-world evidence (RWE), long-term effectiveness, tolerability, and safety of fremanezumab in people with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with > 3 treatment failures and various comorbidities. A 48-week, prospective, multicenter (n = 26), cohort study assessed fremanezumab's effectiveness, safety, and tolerability in consecutive adults with HFEM or CM with > 3 treatment failures. Primary endpoint was variation from baseline in monthly migraine days (MMD) in HFEM and monthly headache days (MHD) in CM at weeks45-48. Secondary endpoints were changes in monthly analgesic medications, Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), and the Migraine Disability Assessment Scale (MIDAS) scores and ≥ 50%, ≥ 75%, and 100% responder rates. Of 533 participants who had received ≥ 1 fremanezumab dose, 130 were treated for ≥ 48weeks and considered for effectiveness analysis. No participant missed any treatment dosage every other consecutive month during the 12-month period. fremanezumab significantly (p < 0.001) reduced both MMD (- 6.4) in HFEM and MHD (- 14.5) in CM. Secondary endpoints: a significant reduction (p < 0.001) was observed in monthly analgesic medications (HFEM -6.0; CM -16.5), NRS (HFEM -3.4; CM -3.4), HIT-6 (HFEM -16.9; CM -17.9) and MIDAS score (HFEM -50.4; CM -76.6). The ≥ 50%, ≥ 75%, and 100% response rates to fremanezumab were 75.5%, 36.7%, and 2% in HFEM and 71.6%, 44.4%, and 3.7% in CM. Corresponding response rates were 60.5%, 37.2%, and 2.3% in individuals with psychiatric comorbidities, 74.2%, 50%, and 4.8% in CM with medication overuse, and 60.9%, 39.1%, and 4.3% in CM with medication overuse and psychiatric comorbidities. Mild and transient treatment-emergent adverse events occurred in 7.8% of the participants. No subject discontinued the treatment for any reason. This RWE study documents that long-term fremanezumab treatment is highly effective and remarkably well tolerated in subjects with HFEM or CM with multiple (> 3) therapeutic failures, even in the presence of concomitant medication overuse, psychiatric comorbidities, or both. The effectiveness-to-tolerability ratio appears to be better in RWE than in RCTs.

The first interim analysis of Italian patients enrolled in the real-world, Pan-European, prospective, observational, phase 4 PEARL study of fremanezumab effectiveness

IntroductionIn 2020, the Italian Medicines Agency (AIFA) approved the reimbursement of calcitonin gene-related peptide (CGRP) pathway monoclonal antibodies (mAbs), including fremanezumab, in patients with a Migraine Disability Assessment Scale (MIDAS) score ≥ 11, with prescription renewals for up to 12 months in patients with ≥ 50% reduction in MIDAS score at Months 3 and 6. In this sub-analysis of the Pan-European Real Life (PEARL) study, we provide real-world data on fremanezumab use in Italian routine clinical practice (EUPAS35111).MethodsThis first interim analysis for Italy was conducted when 300 enrolled adult patients with episodic or chronic migraine (EM, CM) completed 6 months of treatment with fremanezumab. The primary endpoint is the proportion of patients achieving ≥ 50% reduction in monthly migraine days (MMD) across the 6 months post-fremanezumab initiation. Secondary endpoints include: proportion of patients achieving ≥ 50% reduction in MIDAS score at Months 3 and 6, and mean change from baseline across Months 1–6 in MMD and headache-related disability. Safety was assessed through adverse events (AEs) reported.ResultsOf 354 patients enrolled at Italian centers, 318 (EM, 35.5%, CM, 64.5%) were included in the effectiveness analysis. Of patients with available data, 109 (61.2%) achieved the primary endpoint. 61.0% and 65.1% achieved ≥ 50% reduction in MMDs at Months 3 and 6, respectively; 79.9% and 81.0% experienced ≥ 50% reduction in MIDAS at the same timepoints.ConclusionFremanezumab was effective and well-tolerated over the first 6 months of treatment, with approximately 80% of patients meeting Italian criteria for treatment continuation at Months 3 and 6.

Depression, Anxiety, and Pain Catastrophizing in Migraine Patients

Aim: In this study, we aimed to evaluate the relationship between anxiety, depression, and pain catastrophizing in individuals with and without migraine. Method: Data of the study was collected using the socio-demographic data form, Beck Depression Scale (BDI), Beck Anxiety Scale (BAI), Pain Catastrophizing Scale (PCS), Migraine Disability Assessment Scale (MIDAS), and Visual Analogue Scale (VAS). Results: Of the 183 patients, 80 were migraine patients and 103 were the control group. The BDI, BAI, and PCS scores were found to be higher in the migraine patients compared to the control group. The migraine patients were found to have "moderate" depression, "mild" anxiety, and "moderate" disability. There was a positive correlation between BDI, BAI, PCS, MIDAS, and VAS scores in the migraine patients. According to the total BDI and BAI scores of the migraine patients, the PCS total score and the PCS subscales "helplessness", " magnification", and "rumination" scores were higher in the patients with depression or anxiety. Conclusions: It was found that the migraine patients had "moderate" depression and "mild" anxiety, and their pain catastrophizing level increased with increasing depression and anxiety severity.

Positive Establishment of a Digital Working Alliance with a Prescription Digital Therapeutic in Patients with Migraine (P11-12.004)

<h3>Objective:</h3> Obtain evidence for a digital working alliance (DWA) between participants with migraine and an investigational precursor of a prescription digital therapeutic (PDT). <h3>Background:</h3> Recommended migraine treatments including cognitive behavioral therapy, biofeedback, and muscle relaxation are underutilized. PDTs can standardize such approaches to migraine treatment and overcome utilization barriers including provider availability and cost. A therapeutic alliance, which identifies patient goals, builds rapport, and establishes patient commitment to treatment, is a critical factor in successful face-to-face treatments. A digital working alliance (DWA), akin to the therapeutic alliance, is likely to be necessary in an effective PDT. Development of an effective DWA has not been assessed in participants with migraine. <h3>Design/Methods:</h3> Single-center, exploratory, single-arm, 2-week study of a precursor version of a PDT in individuals (18–64yrs) with physician-diagnosed migraine (N=60). Participants were asked to complete a lesson each day. DWA was interpreted on a 7-item Likert scale (Mobile Agnew Relationship Measure [mARM]) at end of treatment. <h3>Results:</h3> Correlating with real-world prevalence, Participants were majority female (90%) with a median age (IQR) of 38 years (34, 49). Most (73.3%) had episodic migraine and reported a median (IQR) Migraine Disability Assessment Scale score of 32.5 (18, 45.3). Participants completed a median (IQR) of 14 (13, 14) lessons and a total of 204 therapeutic skill modules. The median (IQR) overall mARM score was 5.9 (5.4, 6.2). <h3>Conclusions:</h3> This is the first study to report that participants with severe migraine related disability form a positive DWA with a PDT. Consistent with this, most participants completed a majority of daily lessons and therapeutic skill modules available to them. This evidence supports further development of PDTs for migraine and is a first step towards refinement and assessment in randomized controlled trials to evaluate clinical efficacy and safety in migraine. <b>Disclosure:</b> Dr. Snipes has received personal compensation for serving as an employee of Click Therapeutics. Dr. Snipes has received publishing royalties from a publication relating to health care. Dr. Kuka has received personal compensation for serving as an employee of Click Therapeutics. Miss Besedina has received personal compensation for serving as an employee of Click Therapeutics Inc.. Laura Taraboanta has received personal compensation for serving as an employee of Click Therapeutics. Laura Taraboanta has stock in Click Therapeutics. Mr. Hare has received personal compensation for serving as an employee of Click Therapeutics, Inc.. Dr. Gupta has received personal compensation for serving as an employee of Click Therapeutics. Dr. Lakhan has received personal compensation for serving as an employee of Zogenix, Fern Health, Thriveworks, The Learning Corp, Click Therapeutics. Dr. Lakhan has received personal compensation in the range of $500,000-$999,999 for serving as a Consultant for Shaheen Lakhan, MD. Dr. Lakhan has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurocrine, Fern Health, Lin Health. Dr. Lakhan has received personal compensation in the range of $500,000-$999,999 for serving as an officer or member of the Board of Directors for Click Therapeutics, SpineThera. Dr. Lakhan has stock in Zogenix, NeuroSport, Click Therapeutics, SpineThera.

An investigation of the effects of connective tissue massage in women with migraine: A controlled clinical trial

IntroductionTo investigate the effects of connective tissue massage (CTM) on pain characteristics, accompanying symptoms, medication usage, disability, sleep quality, psychological status, and quality of life in women with migraine. MethodThe study was designed as a prospective controlled clinical trial. Women were allocated into the CTM (CTM + education (Ed) program, n = 8) and control groups (only Ed program, n = 8). One session of Ed and 12 sessions of CTM were performed for 4 weeks. They filled out a headache diary, including pain characteristics, accompanying symptoms, and medication usage, for the pre-, during-, and after-treatment periods. Disability, sleep quality, psychological status, quality of life, and disability were evaluated with the Migraine Disability Assessment Scale, the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, and the Headache Impact Test-6, respectively. ResultsThe CTM group showed a significant change in pain, accompanying symptoms (except vomiting), medication usage, Headache Impact Test-6, and Disability with Migraine Disability Assessment Scale scores compared to the control group (p < 0.05). Only the CTM group showed a significant change over time in all parameters of the headache diary except vomiting (p < 0.05). Only Headache Impact Test-6 and Migraine Disability Assessment Scale scores improved in the CTM group (p < 0.05). DiscussionsCTM was superior for reducing pain characteristics, accompanying symptoms, medication usage, disability, and improving quality of life. Conclusion: CTM may be considered as a non-pharmacological and complementary therapy for migraine.

A Cross Sectional Observational Study to Assess Clinical Characteristics, Prescription Pattern and Health Related Quality of Life in Migraine Patients at Tertiary Care Teaching Hospital

Published on:August 2022Journal of Young Pharmacists, 2022; 14(3):314-321Original Article | doi:10.5530/jyp.2022.14.62 Authors: Rajesh Hadia1, Vidhi Kapadi1, Kushal Parekh1, Sunetra Naidu1, Sanjay Prakash2, Vikas Chandrakar1, Hemraj Singh Rajput1 1Department of Pharmacy Practice, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, INDIA. 2Department of Neurology, SBKS Medical Institute and Research Centre, Sumandeep Vidyapeeth (Deemed to be University), Vadodara, Gujarat, INDIA. Abstract: Objectives: The present study was focused on assessing the clinical characteristics which include the symptom profile, triggering factors, prescription pattern, headache-related disability, and its impact on patients’ HRQoL. Methods: A cross-sectional observational study was conducted from October 2019 to March 2020 at the Department of Neurology, Dhiraj General Hospital-Vadodara. The data was collected from the prescription prescribed by the respective neurologist and by filling a pre designed questionnaire. All patients who met the inclusion criteria enrolled in a study. Results: In this study, the incidence of migraine is higher in females (78%), than males (23%). The majority of patients were having a severe disability and severe impact on HRQoL with high MIDAS (Migraine Disability Assessment Scale) and HIT-6 (Headache Impact Test-6) scores in opposing MSQoL v2.1 [Migraine Specific Quality of Life (Version 2.1)] where the majority of patients gained less score showing poor quality of life. A higher MIDAS score was observed in chronic migraineurs than episodic migraineurs (32.42 ±18.65 and 30.15 ±18.93) while HIT-6 showed a comparable score (63.98 ±6 and 63.38 ±6.29). Unlike MIDAS and HIT-6, MSQoL v2.1 showed less scores in chronic migraineurs than episodic migraineurs (45.66 ±22.59 and 48.82 ±23.77) which depicts that chronic migraineurs had a poor health-related quality of life than the episodic migraineurs. Conclusion: To conclude, healthcare professionals routinely evaluate the quality of life and related disability to determine whether patients are receiving effective treatment and whether any additional treatment strategies are warranted to enhance QOL.Keywords: Migraine, Health-related quality of life, MIDAS, HIT-6, MSQoL v2.1.

Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A PostHoc Analysis.

IntroductionIn evaluating therapies for migraine prevention, emphasis is placed on frequency and less attention is paid to duration or severity. Total pain burden (TPB) combines frequency, duration, and severity of migraine headache, and has the potential to further characterize the benefit of preventive treatment using a single composite measure. TPB was previously used to characterize response to galcanezumab (GMB) in patients with migraine. In this post hoc analysis we assessed the impact of GMB in lowering TPB in patients who had previously not benefited from two to four categories of migraine preventive medication.MethodsCONQUER trial patients (N = 462), 18–75 years old who had previously not benefited from two to four categories of migraine preventive medication, were randomized (1:1) to monthly placebo or GMB 120 mg with 240 mg loading dose. For each patient, monthly TPB in severity-weighted hours was calculated by multiplying migraine headache duration (hours) by maximum severity for each migraine headache day, then summing these daily scores over the month for the monthly score. Changes from baseline in monthly TPB across months 1–3 were analyzed. Spearman correlations between TPB and scores on the Migraine-Specific Quality-of-Life Questionnaire (MSQ) total and Migraine Disability Assessment Scale (MIDAS) were assessed at baseline.ResultsMean (SD) baseline monthly TPB was 192.1 (158.3) and 188.2 (197.4) severity-weighted hours for GMB-treated and placebo-treated patients, respectively. Across the 3-month double-blind period, GMB-treated patients experienced significantly greater mean reductions from baseline in monthly TPB compared with placebo-treated patients, both for mean change (GMB − 82.7, placebo − 15.8, p < 0.001) and percentage change (GMB − 38.6%, placebo 9.4%, p < 0.001). Furthermore, baseline TPB correlated with MSQ score (r = − 0.39) and MIDAS score (r = 0.40), suggesting good association of TPB with functional and disability outcomes.ConclusionGMB reduced mean TPB in patients who had previously not benefited from two to four categories of migraine preventive medication.Trial RegistrationNCT03559257.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-022-02233-y.

Bariatric Surgery in Migraine patients: CGRP Level and Weight Loss.

Obesity makes migraine more prevalent and severe. Serum level of calcitonin gene-related peptide (CGRP) is associated with the severity of migraine attacks. Although the effect of weight and bariatric surgery has been studied on migraine, the role of CGRP in migraine remission after weight loss surgery needs more investigation. Patients with severe obesity who were bariatric surgery candidates and had been diagnosed with chronic migraine were included in this study. Weight, BMI, number of days with headache in the past 3months, and severity of headaches in 10-point Likert VAS, Migraine Disability Assessment Scale (MIDAS) and Migraine Specific Quality of life (MSQ) questionnaire scores, and serum CGRP levels were evaluated before and within 6-10months after surgery. Sixty patients with chronic migraine with severe obesity were included. Ninety-five percent of patients reported a significantly lower number of attacks (21 to 8, p < 0.001) and severity of headaches within 90-day (7.7 to 4.8, p < 0.001); MIDAS (64.4 to 25.5, p < 0.001) and MSQ scores (44.6 to 26.8, p < 0.001) and CGRP level (252.7 to 130.1, p < 0.001) were significantly reduced after surgery with a mean follow-up of 7.5months. Changes in MIDAS, MSQ, and CGRP were significantly associated with weight-related variables. Bariatric surgery decreases the frequency of migraine attacks, lessens the severity of headaches, and improves the quality of life and disability as well as CGRP plasma levels, suggesting CGRP as a possible etiology in the migraine-obesity link.

Hydroxocobalamin Treatment and Pediatric Migraine Disability Assessment Scale Scores

AbstractMigraine is a common neurologic disorder in children, especially in adolescents. It can affect the school performance, family, and social daily activities. The Pediatric Migraine Disability Assessment Scale (PedMIDAS) is commonly used in young patients. This study evaluated vitamin B12 deficiency in children with migraine and the effect of hydroxocobalamin treatment on PedMIDAS scores. The study group comprised patients with vitamin B12 deficiency and diagnosed migraine. The PedMIDAS questionnaire was conducted before and 3 months after hydroxocobalamin treatment. PedMIDAS scores were evaluated and compared before and after hydroxocobalamin treatment. The mean ± standard deviation of vitamin B12 level was 175.9 ± 21.3 pg/mL in children with migraine. The PedMIDAS scores were significantly lower after hydroxocobalamin treatment than before treatment (p &lt; 0.001). These results indicated that hydroxocobalamin made a positive contribution to the mitigation of migraine symptoms in children and that treating vitamin B12 deficiency could be a useful option.

Real-world assessment of the relationship between migraine-related disability and healthcare costs in the United States.

ObjectiveThe 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.BackgroundMigraine 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.MethodThis 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.ResultsAmong 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).ConclusionHigher 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.

Efficacy of Nutūl-i-Ḥār (Hot Irrigation), a Polyherbal Unani Formulation, in the Treatment of Shaqīqa-i-Muzmin (Chronic Migraine): An Open Single-Arm Exploratory Clinical Trial

Shaqīqa-i-Muzmin (chronic migraine) is a type of migraine that is usually caused by cold humours (bārid akhlāṭ), specifically by phlegm (balgham) and to lesser extent by black bile (sauda). The aim of this study was to evaluate the effect of Nutul-i-Ḥār (hot irrigation) in the treatment of chronic migraine. Nutul (irrigation) therapy is widely and successfully used in diseases of head as described in Unānī system of medicine. This open, single-arm, exploratory clinical study was conducted in 30 patients of chronic migraine selected by convenient sampling method. One litre decoction prepared with 12 g each of Astragalus hamosus L. (Iklilul malik), Matricaria chamomilla L. (Babuna), Artemisia absinthium L. (Afsanteen), Origanum vulgare L. (Marznjosh) and Trigonella foenum graecum L. (Hulba) was poured over painful side of head for 45 minutes on every alternate day for a period of 30 days (15 sittings). The patients, thereafter, were followed untill 90th day of the study for various outcome measures comprising headache intensity, headache frequency, Migraine Disability Assessment Scale (MIDAS), and rescue medication. The reduction in headache frequency, MIDAS score and use of rescue medication was significant (p &lt; 0.001) after the treatment. Reduction in headache intensity at 30th day, 60th day and 90th day was significant as compared with baseline values (p &lt; 0.001) but not statistically significant at 90th day with respect to 60th day (p &gt; 0.05). Statistical analysis was done using parametric (paired t-test) and non-parametric tests (Wilcoxan sign ranked test, Freidman with Dunn’s multiple comparison tests). Hot irrigation with medicated decoction was found effective in the treatment of chronic migraine.

A comparative study on the effectiveness of topiramate and propranolol in patients with migraine with aura

Background: Migraine is considered as one of the most common and disabling diseases of the nervous system that has a great impact on quality of life (QOL) and a little risk of neurologic complications such as stroke. Migraine aura is known to be the result of cortical spreading depression and is associated with higher risk of this complication. Thus, the present study was conducted with the aim to compare the effects of topiramate as an antiepileptic, and propranolol in patients with migraine with aura. Methods: The present randomized clinical trial was conducted on patients with migraine with aura referred to the neurology clinic of Golestan Hospital, Ahvaz, Iran, in the period of 2019-2020. The patients were randomized into two groups and received either topiramate or propranolol. The Migraine Disability Assessment Scale (MIDAS) score was evaluated before and at the end of three months after initiating the treatment. Results: Reduction in the MIDAS score in patients taking topiramate (-16.94) was greater than that in the propranolol group (-14.5), but this difference was not statistically significant (P > 0.005). No significant relationship was found between gender and changes in the MIDAS score after the treatment of both groups (P > 0.050). However, the changes in the MIDAS score were greater in younger patients, and this relationship was statistically significant (P < 0.050). Conclusion: There was no significant difference in the efficacy of topiramate and propranolol in patients with migraine with aura. No significant relationship was found between gender and changes in the MIDAS score after the treatment in both groups, but the reduction in the MIDAS scores was significantly higher in younger patients of both groups.

The Efficacy of Greater Occipital Nerve Block in Patients With Chronic Migraine

Aim : In chronic migraines(CM), the rate of benefiting from medical treatment is relatively low, and it is known that patients use analgesics extensively. Greater occipital nerve (GON) block, have been started to be used in chronic migraine patients who were refractory to treatment. In this study, we aimed to evaluate the headache attack frequency, analgesic use, VAS (Visual Analog Scale) and MIDAS (Migraine Disability Assessment Scale) scores in the 3-month follow-up of patients we had performed a GON block in our clinic for chronic migraine refractory to medical treatment. Materials and Methods: A total of 120 CM patients were included in the study. The number of analgesics used, the number of days with pain, and the VAS and MIDAS scores were recorded before the GON block and at one and three months of treatment. Results: There was a statistically significant (p&amp;lt;0.001*) reduction in the number of days with pain, analgesic use, and the VAS and MIDAS scores in the first and third months compared to the pre-treatment baseline values in patients who had undergone a GON block. No significant differences between the first and third months. Conclusion: After the GON block, we noted a significant reduction of headaches and improved quality of life in patients who had been experiencing severe headaches despite medical treatment. The GON block has an exceptionally high benefit rate, might be considered as a treatment option before migraines gain chronicity, patients are not exposed to an excessive medical burden and increased treatment costs.

Patient-Reported Outcomes for Migraine in the US and Europe: Burden Associated with Multiple Preventive Treatment Failures.

PurposeTo evaluate patient-reported outcomes (PROs) among patients with migraine, including those who were preventive-naïve and preventive-treated.MethodsThis was a point-in-time, real-world study of patients with migraine in the US and EU5 (France, Germany, Spain, Italy, and UK) and their physicians using data from the Adelphi Migraine Disease Specific Programme (DSP™). Physicians completed patient record forms (PRFs) for the next nine consulting patients with migraine plus a tenth patient, who did not need to be consecutive, for whom prior preventive migraine treatments had failed at least once, in order to achieve oversampling of such patients. Patients were given self-completion (PSC) forms that included the Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ), Migraine Disability Assessment Scale (MIDAS), and Work Productivity and Activity Impairment (WPAI) questionnaire. Populations of interest included preventive-naïve and preventive-treated patients defined by the number of treatment lines (1–2 or 3+ preventive regimens). Continuous variables were compared using t-test or ANOVA if normally distributed and Mann–Whitney if not. Chi-squared was used for categorical variables.ResultsDuring August–December 2017, 615 physicians (359 PCPs, 256 neurologists) completed PRFs for 5785 patients (71% female; mean age 40 (±14) years; 65% in full- or part-time employment). Of these, 2798 completed a PSC (preventive-naïve/1–2/3+ preventive lines, n=1707/1034/57). Preventive-treated patients had a greater patient-reported burden across multiple measures versus preventive-naïve patients. Preventive-treated patients had lower MSQ scores indicating greater functional impairment, higher MIDAS scores indicating greater migraine-associated disability, and higher WPAI scores indicating greater overall work and activity impairment than preventive-naïve patients. The magnitude of difference was greatest for the 3+ preventive-treatments cohort. Patterns were similar in the US and EU5.ConclusionAmong patients with migraine who are preventive-treated, including those with multiple lines of therapy, there remain considerable unmet needs in terms of restoring patient function.

The effectiveness of propranolol, flunarizine, amitriptyline and botulinum toxin in vestibular migraine complaints and prophylaxis: a non-randomized controlled study

IntroductionVestibular migraine is the most common cause of spontaneous episodic vertigo in adult patients and the second most common cause of vertigo in patients of all ages. ObjectiveTo assess the effectiveness of oral medication type (propranolol, flunarizine, and amitriptyline) and botulinum toxin A application on vestibular symptoms, headache severity and attack frequency for vestibular migraine patients. MethodsSixty patients with vestibular migraine were enrolled. Thirty patients received botulinum toxin A treatment (B+ group) in addition to the oral medication, whereas 30 patients received only oral medication (B− group). Headache severity was evaluated with Migraine Disability Assessment Scale and vertigo severity was evaluated with Dizziness Handicap Inventory scale. Vestibular migraine attack frequencies in the last three months were also evaluated. ResultsThere was a statistically significant decrement in mean Dizziness Handicap Inventory scores, Migraine Disability Assessment Scale scores and vertigo attack frequencies after treatment for all patients, B+ and B− group patients (p<0.001 for all). The mean Migraine Disability Assessment Scale score gains (p<0.001) and vertigo attack frequency gains (p= 0.003) were significantly higher in the B+ patients than B− patients. ConclusionsBoth B+ and B− group patients exhibited significant improvement in vestibular migraine attack frequencies, Dizziness Handicap Inventory score and Migraine Disability Assessment Scale score values. However, botulinum toxin A application had a more pronounced effect for Migraine Disability Assessment Scale score gain and vestibular migraine attack frequency values, but not for Dizziness Handicap Inventory score gain values. Thus, botulinum toxin A application should be considered for vestibular migraine patients whose headache severity degrees are more profound. The oral medication type (propranolol, flunarizine or amitriptyline) did not differ in influencing the vestibular migraine attack frequency, Dizziness Handicap Inventory score gain and Migraine Disability Assessment Scale score gain values.

Degree of compliance with treatment at three months in migraine patients

Adherence to oral preventive treatment (OPT) in migraine is often compromised. The aim was to determine the degree of adherence to OPT in migraine patients at three months. We conducted a multicentre observational study of patients diagnosed with episodic or chronic migraine (criteria of the International Headache Classification, third edition) in whom OPT was initiated. Demographic data (age, gender, educational level, marital status) and disease data (number of attacks, Headache Impact Test-6 and Migraine Disability Assessment Scale scores) were collected. At three months, the Morisky-Green scale was administered, which differentiates levels of adherence: excellent (0), moderate (1-2) and low (3-4). Altogether 100 patients participated in the study: 87% women aged 42 ± 13 years, 14% with chronic migraine; 53.2% of them were beginning their first OPT. Beta-blockers were initiated in 23.2%, tricyclic antidepressants in 35.4%, flunarizine in 21.2%, neuromodulators in 19.2% and antihypertensives in 1%. Severe disability was observed in 56%, and the impact was very severe in 79.5%. Adhesion at three months was excellent in 41.8%, moderate in 28.6% and low in 29.6%. The most frequent reason for discontinuing was the occurrence of adverse effects (44%). A significant relationship was found between excellent adherence and being single (p = 0.046), and between low adherence and adverse effects (p = 0.009). No significant differences were found between the OPT used and the degree of adherence or the other variables studied. Although our results are better than those published in the literature, we consider that therapeutic adherence in our setting is low and educating our patients in this regard is a priority.

Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.

Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting. This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was achangein Migraine Disability Assessment Scale (MIDAS) scores or a changein headache days. Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7±12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2±0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3±0.6). For the first 6weeks, participants practiced PMR 2-4days/week. Mean per session duration was 11.1±8.3minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P=.100) corresponding to a small-moderate mean effect size (Cohen's d=0.38). Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.

Impact of 24-Hour On-Call Shifts on Headache in Medical Residents: A Cohort Study.

During 24-hour on-call shifts medical residents are exposed to diverse circumstances such as sleep deprivation and stress. Our aim is to assess the effect of 24-hour on-call shifts on medical residents' headache-related disability. The Migraine Disability Assessment Scale (MIDAS), the Headache Impact Test (HIT-6), the Pittsburgh Sleep Quality Index (PSQI), and the Hospital Anxiety and Depression Scale (HADS) questionnaires were administered to medical residents who had never performed on-call shifts at baseline and 6 months after beginning 24-hour on-call shifts. Scores were compared. About 66 medical residents completed this study. About 21.2% (n=14) had history of migraine, 42.4% (n=28) had a history of tension-type headache (TTH) and 12.1% (n=8) had a history of both migraine and TTH. Among medical residents with migraine, the median MIDAS score was significantly higher after starting 24-hour on-call shifts than at a baseline (4.0 vs 8.0; Wilcoxon, P=.001), meaning that, on average, disability increased from little or no disability, to moderate disability. No difference in HIT-6 scores was found. The median score of PSQI and HADS was higher at 6 months (PSQI: 7.0 vs 8.0; P=.003), (HADS: 5.0 vs 8.0; P<.001) for the general group. In medical residents with migraine, migraine-related disability increased after starting 24-hour on-call shifts. We also found a worsening in depression and anxiety symptoms and self-reported sleep quality in medical residents with and without headache history.