Headache Impact Test-6 Scores Research Articles

Correlation between depression level and headache severity: A study among medical students during the COVID-19 pandemic.

Headache is the most prevailing disorder and the third leading cause of disability worldwide. The prevalence of primary headaches has been reported to increase by 2-4 times in patients with psychiatric comorbidities, including depression. This study sought to assess the correlation between depression level and headache severity among medical students. To the best of our knowledge, this is the first study to evaluate the correlation between depression level and headache severity in Indonesia. A cross-sectional study was conducted among students of Airlangga University in 2021. To evaluate the level of depression and the severity of headache, Depression Anxiety Stress Scales (DASS-42) and Headache Impact Test 6 (HIT-6) were used, respectively. A set of validated questionnaires were used to assess students' demographic characteristics. A total of 82 medical students were included in this study and most of them were female (86.6%). The third-semester students represented the highest proportion (45.2%) of subjects. The mean age and body mass index (BMI) were 19.88 ± 1.03 and 22.55±4.44, respectively. The average DASS-42 score was 10.98±11.47 which indicated a mild depression level. The average HIT-6 score was 45.74±6.130 which revealed a mild impact. The data of Spearman correlation suggested that headache severity was significantly correlated with depression level (r=0.396, p<0.001). This study provides insights on the importance of stress management and depression prevention to decrease the risk of headache, and vice versa.

Visual photosensitivity threshold and objective photosensitivity luminance in healthy human eyes assessed using an automated ocular photosensitivity analyser: a step towards translation of a clinical tool for assessing photophobia.

To evaluate the visual photosensitivity threshold and objective photosensitivity luminance in healthy eyes, thereby providing a normative dataset that will lead to a better understanding of diseases causing photophobia. This was a prospective cross-sectional study. Emmetropes whose visual acuity was better than 0.18logMAR (6/9) with no other ocular abnormality were included. Headache Impact Test-6 and visual light sensitivity questionnaires were administered. Visual photosensitivity threshold was measured subjectively using the ocular photosensitivity analyser. Objective photosensitivity luminance was assessed manually by evaluating videos recorded using an infrared camera and noting the intensity of light at the first squeezing reflex. Seventy five normal subjects (age range, 7-71years) were included. Median age was 32.7years (inter-quartile range, 20.3-47.9years). Forty (53.3%) were males. Median Headache Impact Test score was 38 (inter-quartile range, 36-42) and visual light sensitivity questionnaire score was 11 (inter-quartile range, 8-15). Mean (standard deviation) right eye, left eye and binocular visual photosensitivity threshold was 3.34 (0.78), 3.33 (0.81) and 3.37 (0.78) loglux, respectively. There was a significant negative correlation of visual light sensitivity questionnaire scores with right eye, left eye and binocular visual photosensitivity thresholds, and positive correlation of age with binocular visual photosensitivity thresholds. Mean (standard deviation) right eye, left eye and binocular objective photosensitivity luminance was 3.25 (0.55), 3.35 (0.47) and 3.15 (0.52) loglux, respectively. Age was only positively correlated with binocular objective photosensitivity luminance, and there was no correlation between age and right eye or left eye objective photosensitivity luminance. The study characterised, for the first time, objective photosensitivity luminance and established normative data for both visual photosensitivity threshold and objective photosensitivity luminance. The data will help in understanding the pathophysiology of diseases causing photophobia, monitoring the disease progression and evaluating treatment modalities.

N95 vs Half-face Respirator Wear in Surgical Trainees: Physiologic and Psychological Effects of Prolonged Use.

ObjectivesAs specialists of the upper airway, otolaryngologists are at high risk for COVID-19 transmission. N95 and half-face respirator (HFR) masks are commonly worn, each with advantages in functionality and comfort. In this study, physiologic and psychological parameters of prolonged N95 vs HFR wear were compared.Study DesignProspective crossover cohort study.SettingSingle academic tertiary care hospital.MethodsA prospective crossover cohort study was performed. Healthy otolaryngology trainees and medical students (N = 23) participated and wore N95 and HFR masks continuously for 3 hours each on separate days. Various measures were analyzed: vitals, spirometry variables, scores on the State-Trait Anxiety Inventory and HIT-6 (Headache Impact Test–6), distress, and “difficulty being understood.”ResultsThe average age was 26.3 years (SD, 3.42). There were no significant differences in vital signs and spirometry variables between N95 and HFR wear. N95 wear was associated with decreases in oxygen saturation of approximately 1.09% more than with HFRs (95% CI, 0.105-2.077). State-Trait Anxiety Inventory scores increased more with HFR wear when compared with mean changes with N95 wear (95% CI, 1.350-8.741). There were no significant differences in HIT-6 scores or distress levels between masks. The proportions of participants reporting difficulty being understood was significantly higher with HFRs.ConclusionsOxygen saturation decreases with prolonged N95 wear, but anxiety and difficulty being understood are greater with HFR wear. Although HFRs have less resistance to gas exchange, N95 respirators may produce less anxiety and distress in clinical situations. Further studies are warranted to evaluate the clinical significance of these differences.Level of Evidence2.

Long-term (48weeks) effectiveness, safety, and tolerability of erenumab in the prevention of high-frequency episodic and chronic migraine in a real world: Results of the EARLY 2 study.

To evaluate the long-term effectiveness, safety, and tolerability of erenumab in a real-world migraine population, looking for putative predictors of responsiveness. Erenumab proved to be effective, safe, and well tolerated in the prevention of episodic migraine (EM) and chronic migraine (CM) in long-term extension studies of double-blind, placebo-controlled trials in patients with no more than two (EM) or three (CM) prior preventive treatment failures. A 48-week, multicenter, longitudinal cohort real-life study was conducted at 15headache centers across eight Italian regions between December 20, 2018 and July 31, 2020. We considered all consecutive patients with high-frequency episodic migraine (HFEM) or CM aged 18-65years. Each patient was treated with erenumab 70mg, administered monthly. The dose was switched to 140mg in nonresponders and in responders who had become nonresponders for at least 4weeks. Change in monthly migraine days (MMDs) or monthly headache days (MHDs) at Weeks 45-48 compared with baseline was the primary efficacy endpoint. Secondary endpoints encompassed variation in monthly analgesic intake, achievement of a ≥50%, ≥75%, or 100% reduction in migraine or headache days, and any change in the Visual Analogue Scale (VAS) and Headache Impact Test-6 scores (HIT-6) during the same time interval. A total of 242 patients with migraine received at least one dose of erenumab 70mg and were considered for safety analysis, whereas 221 received a monthly erenumab dose for ≥48weeks and were included in the effectiveness and safety analysis set. All patients had previously been treated unsuccessfully with ≥3migraine-preventive medication classes. From baseline to Weeks 45-48, erenumab treatment reduced MMD by 4.3±5.3(mean±SD) in patients with HFEM, and MHD by 12.8±8.9 (mean±SD) in subjects with CM. VAS and HIT-6scores were decreased by 1.8±1.9 (mean±SD) and 12.3±11 (mean±SD) in HFEM, and by 3.0±2.2 (mean±SD) and 13.1±11.2 (mean±SD) in CM. Median monthly analgesic intake passed from 11.0 (interquartile range [IQR] 10.0-13.0) to 5 (IQR 2.0-8.0) in HFEM and from 20.0 (IQR 15.0-30.0) to 6.0 (IQR 3.8-10.0) in CM. The ≥50% responders were 56.1% (32/57) in HFEM and 75.6% (124/164) in CM; ≥75% responders were 31.6% (18/57) and 44.5% (73/164); and 100% responders were 8.8% (5/57) and 1.2% (2/164), respectively. At Week 48, 83.6% (137/164) of patients with CM had reverted to EM. Erenumab was safe and well tolerated. Responsiveness to erenumab was positively associated with cutaneous allodynia (OR: 5.44, 95% CI: 1.52-19.41; p=0.009) in HFEM. In patients with CM, ≥50% responsiveness was positively associated with male sex (OR: 2.99, 95% CI: 1.03-8.7; p=0.044) and baseline migraine frequency (OR: 1.12, 95% CI: 1.05-1.20; p=0.001) and negatively associated with psychiatric comorbidities (OR: 0.37, 95% CI: 0.15-0.87; p=0.023) and prior treatment failures (OR: 0.77, 95% CI: 0.64-0.92; p=0.004). Long-term (48-week) erenumab treatment provides sustained effectiveness, safety, and tolerability in real-life patients with HFEM or CM with ≥3 prior preventive treatment failures. The dose of 140mg was required in most patients along the study and should be taken into consideration as the starting dose. Allodynia (in HFEM), male sex, and baseline migraine frequency (in CM) might represent positive responsiveness predictors. Conversely, psychiatric comorbidities and multiple prior preventive treatment failures could be negative predictors in patients with CM.

Reference Values for the Headache Impact Test-6 Questionnaire

ObjectiveTo determine reference values for the Headache Impact Test-6 (HIT-6) in a young, physically active cohort and to examine the influence of sex, concussion history, headache history, and competitive sport level on HIT-6 scores. DesignCross-sectional. SettingUnited States Service Academy. ParticipantsUnited States Service Academy cadets (N=2678) completed an HIT-6 questionnaire as part of their annual concussion baseline assessment. Cadets with a recent concussion were excluded from baseline testing. InterventionsNot applicable. Main Outcome MeasuresReference values were calculated and stratified by sex, concussion history, headache history, and competitive sport level. Mann-Whitney U and Kruskal-Wallis tests were used to examine the effect of sex, concussion history, headache history, and competitive sport level on HIT-6 scores (P<.05). ResultsOf the 3599 cadets baselined, 2687 cadets (23% female) agreed to participate in the study and completed the HIT-6. Female participants reported significantly worse HIT-6 scores compared with male participants both with (P<.001) and without (P<.001) a concussion history. In both sexes, participants with a headache history reported worse scores than those with no headache/concussion history and a concussion history (all P<.005). Female cadets who participated in intramural athletics reported worse HIT-6 scores at baseline than female intercollegiate athletes (P=.003). ConclusionsThis is the first study to stratify HIT-6 data by sex, concussion history, headache history, and sport level in a collegiate population at risk for concussions. Sex and headache history appear to influence HIT-6 scores and should be given special consideration when interpreting health-related quality of life deficits due to headache.

Effect of acupuncture on the cognitive function of migraine patients with depression/anxiety disorder

To observe the effect of five-element acupuncture on the cognitive function repair of migraine patients with depression/anxiety disorder. The migraine patients with depression/anxiety disorder (19 cases, 5 cases dropped off) were taken as the observation group, and received five-element acupuncture twice a week for 8 weeks. Healthy subjects (19 cases) were selected by demographic data matching as the control group. The cognitive function was evaluated with the event related potential (ERP) technique, and the latency and amplitude of visual evoked potential P300 were adopted as the observation indexes. The headache days (every 4 weeks), headache intensity [visual analogue scale(VAS) score], and headache impact test-6 (HIT-6) score, Hamilton depression scale (HAMD) score and Hamilton anxiety scale (HAMA) score were used as the observation indexes for curative effect. Before the treatment, latency of target stimulus at Fz [ (417.5±34.3) ms] in the observation group was extended compared with the healthy subjects of the control group [(388.6±42.1) ms, P<0.05]. In the observation group, the latency of each point target stimulus [Fz: (376.1±36.2) ms, F3: (374.8±37.6) ms, F4: (372.0±37.6) ms] after treatment were shorter than those [Fz: (417.5±34.3) ms, F3: (417.4±33.8) ms, F4: (416.0±36.6) ms] before treatment (P<0.05). Before and after treatment, there was no significant difference in the amplitude of each point between the observation group and the control group (P>0.05). In the observation group, the headache days was shorter than that before treatment (P<0.01), and the VAS score, HIT-6 score, HAMD score and HAMA score were all lower than before treatment (P<0.01). There are some cognitive impairments in migraine patients with depression/anxiety disorder. Five-element acupuncture not only relieves headache, anxiety and depression effectively, but also improves the activation level of the frontal lobe. It significantly repairs the impaired cognitive function.

Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study.

ObjectiveTo report the efficacy and safety of erenumab among patients with episodic migraine (EM) who were unsuccessful on 2 to 4 preventive treatments observed at week 64 of the open-label extension phase (OLEP) of A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies (LIBERTY) study (ClinicalTrials.gov NCT03096834).MethodsThe OLEP, evaluating monthly erenumab 140 mg for 3 years, enrolled 240 patients who completed the double-blind treatment phase (DBTP) of 12 weeks during which they received placebo or erenumab 140 mg subcutaneous injections every 4 weeks as monotherapy. Efficacy outcomes were evaluated through the initial 52 weeks of OLEP (from DBTP baseline to total 64 weeks) in the overall population, patients receiving erenumab in DBTP, and patients from the DBTP placebo arm who switched to erenumab in OLEP. Endpoints included reduction of ≥50% in monthly migraine days (MMD) from DBTP baseline and change in MMD from DBTP baseline, Headache Impact Test score, and Migraine Physical Function Impact Diary score (Physical Impairment and Everyday Activities).ResultsAltogether, the week 52 visit of the OLEP was completed by 204 of 240 (85.0%) patients. Among patients continuing erenumab, the 50% responder rate increased from 29.9% at weeks 9 to 12 to 44.3% at weeks 61 to 64. The 50% responder rate in patients who initiated erenumab in the OLEP remained higher in the OLEP (50.0% at week 61–64) than during DBTP (14.2% at weeks 9–12) compared to patients in continuous erenumab arm. In the OLEP, the 50% responder rate for the overall population increased from weeks 13 to 16 until weeks 37 to 40 and then remained stable through weeks 61 to 64. Patients treated with erenumab in DBTP showed sustained effects on all efficacy outcomes; those initiating erenumab in the OLEP demonstrated continued improvement from week 13 onward. Adverse events (AEs) were reported, considering both treatment groups, by ≈80.8% (serious AEs by 6.7%), 76.3% (5.9%) in the continuing erenumab arm, and 85.2% (7.4%) in those starting erenumab in OLEP. No deaths were reported.ConclusionsIn patients with EM who were unsuccessful on 2 to 4 prior preventive treatments, the LIBERTY study demonstrated sustained efficacy on erenumab monotherapy treatment through 64 weeks in both treatment arms. Safety of erenumab was consistent with that observed in previous clinical trials.Trial Registration InformationClinicalTrials.govIdentifier: NCT03096834.Classification of EvidenceThe current study provides Class IV evidence on data from patients with EM that erenumab is safe and provides sustained efficacy at 52 weeks.

Chronic Migraine and Medication Overuse Headache Worsening After OnabotulinumtoxinA Withdrawn Due to the Severe Acute Respiratory Syndrome-Coronavirus-2 Pandemic.

Introduction: OnabotulinumtoxinA (BT-A) is a preventive treatment for chronic migraine (CM), which needs to be administered regularly by a trained clinician every 3 months. The spread of the severe acute respiratory syndrome coronavirus-2 pandemic has forced many patients to momentarily stop the scheduled BT-A injections. The goal of this study was to explore whether those patients experienced a worsening of their CM and, if any, the clinical predictors of migraine worsening after BT-A withdrawal.Methods: This was a retrospective, multicenter study. Patients' clinical data were obtained from their clinical documentation stored at each center. In particular, the following variables were collected: the mean number of headache days in the last month (NHD), the average number of painkillers taken in the last month (AC), the average number of days in which patients took, at least, one painkiller in the last month (NDM), the average intensity of migraine using the numeric rating scale (NRS) score in the last month, and the average score obtained at the six-item Headache Impact Test. The variables mentioned earlier were compared before and after BT-A withdrawal.Results: After BT-A suspension, there was a significant increase in the NHD (P = 0.0313, Kruskal–Wallis rank test), AC (P = 0.0421, Kruskal–Wallis rank test), NDM (P = 0.0394, paired t-test), NRS score (P = 0.0069, Kruskal–Wallis rank test), and six-item Headache Impact Test score (P = 0.0372, Kruskal–Wallis rank test). Patients who were not assuming other preventive treatments other than BT-A displayed similar results. Patients who experienced a >30% worsening in NHD after BT-A was withdrawn displayed a longer CM history (P = 0.001, Kruskal–Wallis rank test), a longer MOH duration (P = 0.0017, Kruskal–Wallis rank test), a higher AC value at the baseline (P = 0.0149, Kruskal–Wallis rank test), a higher NDM (P = 0.0024, t-test), and a higher average value of the NRS score (P = 0.0073, Kruskal–Wallis rank test).Conclusion: BT-A withdrawn during severe acute respiratory syndrome coronavirus-2 pandemic was associated with a general worsening in patients suffering from CM, hence the need to continue BT-A injection to avoid patients' worsening.

Comparative study of magnesium, sodium valproate, and concurrent magnesium-sodium valproate therapy in the prevention of migraine headaches: a randomized controlled double-blind trial

ObjectiveThis study aimed to assess the efficacy of concurrent magnesium-sodium valproate therapy and compare it with either magnesium or sodium valproate alone in migraine prophylaxis.Materials and methodsThis randomized single-center double-blind parallel-group controlled clinical trial study was conducted on migraine patients within the age range of 18–65 years. The subjects with at least four monthly attacks were randomly assigned to group A (n = 82) sodium valproate, group B (n = 70) magnesium with sodium valproate, and group C (n = 70) magnesium. The patients passed a one-month baseline without prophylactic therapy and then received a 3-month treatment. The characteristics of migraine, including frequency, severity, duration of the attacks, and the number of painkillers taken per month, were monthly recorded in each visit. The Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) scores were recorded at the baseline and after 3 months of treatment in each group. Within- and between-group analyses were performed in this study.ResultsThe obtained results revealed a significant reduction in all migraine characteristics in all groups compared to those reported for the baseline (P < 0.001). Intragroup data analysis indicated that there was no statistically significant difference in headache frequency between groups A and B in the third month (P = 0.525); nevertheless, three other parameters showed a significant reduction in group B, compared to those reported for group A in the third month (P < 0.05). On the other hand, group C could not effectively reduce measured parameters in the patients, compared to groups A and B after 3 months (P < 0.001). Furthermore, the MIDAS and HIT-6 scores significantly diminished in groups A, B, and C compared to those reported at the baseline (P < 0.001), and these changes were more significant in groups A and B than in group C (P < 0.001).ConclusionThe obtained results of this study revealed that magnesium could enhance the antimigraine properties of sodium valproate in combination therapy and reduce the required valproate dose for migraine prophylaxis.

Headache and migraine in mitochondrial disease and its impact on life\u2014results from a cross-sectional, questionnaire-based study

Headache is frequent in patients with mitochondrial disorders. Previous studies point to a higher prevalence of headache in these patients than in the general population. As mitochondrial disorders often present a variety of other symptoms, the question arises how much the presence of headache really influences daily life. We performed a cross-sectional, questionnaire-based study investigation with 61 patients with a genetically proved mitochondrial disease mainly composed of CPEO phenotype. Headache was examined using a standardized questionnaire, and classified according to ICHD-2. Headache-related disability was evaluated by the Headache-Impact-Test-6 (HIT-6). Additionally, depression and anxiety were examined using the Hospital Anxiety and Depression Scale (HADS) and Short-Form-Health Survey (SF-12) was used to investigate the health-related quality of life. Headache was reported by 43/61 (70.5%) of the patients. 35/61 patients (57.4%) described a Tension-type headache (TTH) and 26 patients (42.6%) a migraine. Patients reporting headache had a significantly higher HIT-6 score than those without (mean: 54.47 vs. 38.47, p < 0.001). The HIT-6 score was significantly higher in patients reporting a migraine compared to those with a tension-type headache (mean: 62.13 vs. 46.18, p < 0.001). In the HADS score and in the SF-12 were not significantly influenced by the occurrence of headache. This study confirms the previously reported frequent occurrence of headache in a large cohort of patients with a confirmed mitochondrial disease. Migraine had the greatest impact on daily living, which appeared not to be confounded by depression and anxiety. Thus, we conclude that Migraine may be a substantial contributor for burden of disease in patients with mitochondrial diseases.

Prevalence, Disability, and Management Patterns of Migraine in Korea: Nationwide Survey Data from 2009 and 2018.

Background and PurposeIdentifying changes in the prevalence, disability, and management patterns of migraine is important for reducing the burden of this disease. However, data on the changes in these variables are scarce.MethodsWe compared data obtained in the 2009 Korean Headache Survey and the 2018 Korean Sleep-Headache Survey.ResultsThe 1-year migraine prevalence did not differ significantly between 2018 and 2009 [5.2% (114/2,200) vs. 6.0% (91/1,507), p=0.492]. The number of days with missed activity due to headache during the previous 3 months was larger in the 2018 survey than in the 2009 survey [1.1±2.9 vs. 0.3±1.0 days (mean±standard deviation), p=0.013]. The number of days with reduced productivity during the previous 3 months did not differ significantly between the two surveys (0.8±2.8 vs. 1.4±1.4 days, p=0.679). The proportion of subjects with a substantial-to-severe headache impact (Headache Impact Test-6 score ≥56) was marginally larger in the 2018 survey than in the 2009 survey [42.1% (48/114) vs. 29.7% (27/91), p=0.066]. The rate of lifetime medical consultations did not differ between the 2018 and 2009 surveys [34.2% (39/114) vs. 30.8% (28/91), p=0.615].ConclusionsMigraine prevalence was stable over the 9-year period between the surveys, but disability due to missed activity was greater in 2018 than in 2009 in Korea.

Radiological society of North America: 106th annual meeting, November 29 to December 5, 2020

Radiological society of North America: 106th annual meeting, November 29 to December 5, 2020

Open Label Prospective Experience of Supplementation with a Fixed Combination of Magnesium, Vitamin B2, Feverfew, Andrographis Paniculata and Coenzyme Q10 for Episodic Migraine Prophylaxis.

Background: To investigate the efficacy and safety of supplementation with a fixed combination of magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10 in episodic migraine (EM) prevention. Methods: A pilot, single-arm, open-label study was conducted. After a one-month baseline period, the above-described supplementation was introduced in 113 EM Greek patients, who were prospectively followed-up for three months. The primary endpoint was the change in monthly migraine days between baseline period (BSL) and the third month of supplementation (T3). Secondary endpoints included changes in mean intensity of migraine and in days with use of acute migraine medications. Changes in scores of Migraine Disability Assessment questionnaire (MIDAS), Headache Impact Test-6 (HIT-6), Migraine Therapy Assessment questionnaire (MTAQ), Migraine-Specific Quality-of-life questionnaire (MSQ-QOL), Hospital Anxiety and Depression Scale (HADS) were also evaluated. Those with ≥50% reduction in monthly migraine days at T3, compared to BSL were considered supplementation-responders. Results: The mean number of migraine days was significantly decreased between BSL and T3 (9.4 ± 3.7 vs. 6.1 ± 3.5; p < 0.001). Likewise, days with peak headache intensity of >4/10 (5.7 ± 3.4 vs. 4.9 ± 3.1; p < 0.001) as well as days using acute headache medications per month (8.9 ± 3.6 vs. 5.7 ± 3.4; p < 0.001) were significantly reduced. At T3, 64 patients (56.6%) were classified as responders. The beneficial effect of supplementation was also associated with significant changes in HIT-6, MIDAS, MTAQ and MSQ-QOL scores. There were no safety concerns. Conclusions: The supplementation we have tested appears to be an effective and well-tolerated preventive approach against EM. A randomized, placebo-controlled study is needed to confirm our results.

Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study.

To assess the effectiveness, safety, and tolerability of erenumab in a real-life migraine population, while trying to identify responsiveness predictors. Erenumab is a fully human Ig-2 monoclonal antibody blocking the calcitonin gene-related peptide receptor, indicated for migraine prophylaxis. Phase II and III trials demonstrated that erenumab is effective, safe, and well tolerated in the prevention of episodic and chronic migraine (CM), showing an early onset of action. This is a multicenter, prospective, cohort, and real-life study. We considered for enrolment all consecutive patients aged 18-65 affected by high-frequency episodic migraine (HFEM) or CM, with or without medication overuse, visited at nine Italian Headache Centers from December 20, 2018 to September 30, 2019. Each patient was treated with erenumab 70mg, administered subcutaneously every 4weeks. Treatment duration was planned to last from 6 to 12months, depending on the patient's response. The primary endpoint was the change in monthly migraine days (MMDs) at weeks 9-12 compared to baseline. Secondary endpoints included changes in monthly analgesics intake, ≥50%, ≥75%, and 100% responder rates and any variation in the Visual Analog Scale (VAS) and Headache Impact Test scores (HIT). In total, 372 migraine patients were treated with at least one dose of erenumab 70mg. At weeks 9-12, erenumab decreased MMDs by 4.5±4.1days (mean±SD) in patients with HFEM and by 9.3±9.1 (mean±SD) days in those with CM compared to baseline. At weeks 9-12 VAS score was reduced by 1.9±1.9 (mean±SD), HIT score by 10.7±8.8 (mean±SD), and median monthly analgesics intake passed from 12.0 (interquartile range [IQR] 10.0-14.0) to 5.0 (IQR 3.0-7.0) in HFEM. In CM patients, VAS was reduced by 1.7±2.0 (mean±SD), HIT by 9.7±10.4 (mean±SD), and median monthly analgesics intake passed from 20.0 (IQR 15.0-30.0) to 8.0 (IQR 5.0-15.0). At week 12, ≥50% responders were 60/101 (59.4%) for HFEM and 146/263 (55.5%) for CM, ≥75% responders were 17/101 (16.8%) and 59/263 (22.4%) and 100% responders 1/101 (1.0%) and 3/263 (1.1%), respectively. Erenumab responsiveness in HFEM was positively associated with unilateral pain localization (OR: 3.03, 95% CI: 1.24-7.40; p=0.015), whereas in CM responsiveness was positively associated with and baseline migraine frequency (OR: 1.06, 95% CI:1.02-1.11; p=0.031), dopaminergic symptoms (OR: 2.01, 95% CI: 1.14-3.52; p=0.015), and negatively associated with psychiatric comorbidities (OR: 0.43, 95% CI: 0.20-0.93; p=0.003). Erenumab 70mg is effective, safe, and well tolerated in real life. Easily obtainable clinical features might be of help in predicting patient's responsiveness.

Oral flunarizine versus oral amitriptyline in migraine prophylaxis – A prospective open label study

Objectives: To compare the effectiveness and tolerability of flunarizine and amitriptyline in migraine prophylaxis. Also to assess the disability associated with migraine using Migraine Disability Assessment Test (MIDAS) and Headache Impact Test-6 (HIT-6) questionnaires. Materials and Methods: The study was a prospective observational, open-label, comparative study, conducted for six months among migraine patients attending Tertiary Care Hospital, Mandya. Patients were prescribed either Amitriptyline 25 mg or flunarizine 10 mg OD for three months. Effectiveness was assessed by the number of episodes of migraine attacks, pain severity score on Visual Analogue Scale (VAS), tolerability of adverse reactions reported and disability assessed using MIDAS and HIT-6 questionnaires. Results: Out of 103 patients, 55 were prescribed Amitriptyline and 48 patients flunarizine. 49.5% of patients were between 18 to 30 years of age. At the end of three months of treatment, the frequency and severity of headaches decreased from baseline in both the groups. The overall percentage of responders with >50% reduction from baseline in number of migraine episodes and pain severity together were 67.3% and 50% in amitriptyline and flunarizine groups respectively. There was reduction in MIDAS and HIT-6 scores in both groups, without significant difference between the groups. Both the drugs were well tolerated, with most common adverse effects being dry mouth, somnolence, and constipation. Conclusion: Both amitriptyline and flunarizine are effective in prophylaxis of migraine, with significant reduction in number of episodes and severity of headache from baseline to end of treatment. However, Amitriptyline had a higher overall responder rate when compared to Flunarizine, with similar tolerability profile. Keywords: Migraine prophylaxis, Amitriptyline, Flunarizine, MIDAS, HIT-6.

Study of Additive Effect of Yoga and Physical Therapies to Standard Pharmacologic Treatment in Migraine.

Objective We aimed to evaluate and compare the effectiveness of physical and yoga therapies as an adjuvant therapy along with standard pharmacologic treatment in patients with migraine. Materials and Methods A total of 61 consenting patients diagnosed to have migraine were randomized into three groups to receive either standard treatment alone, physical therapy along with standard treatment, or yoga therapy along with standard treatment. The respective adjuvant intervention was taught to the respective group of patients and they were advised to perform it daily for 3 months with weekly telephonic reminders and review of their activity logs. Outcome measures assessed were headache frequency, Short-Form McGill Pain Questionnaire (SF-MPQ), and Headache Impact Test-6 (HIT-6) at recruitment and once every month for 3 months. Statistical Analysis Statistical analysis of the study was done by using Stata 14.1 software. All the descriptive statistics, paired t -test was used to compare the difference between pre and postintervention values of headache frequency, SF-MPQ, and HIT-6 score within all the three groups. Analysis of variance test and post hoc test were used to compare the differences between all groups for outcome measures ( p < 0.05). Results Headache frequency and the visual analog scale before intervention compared during each month intervals for 3 months in all the three groups were significantly decreased in all the three groups ( p < 0.005). Yoga or physical therapy as an adjuvant to standard treatment leads to a higher reduction in headache frequency and severity. Sensory and affective pain ratings of SF-MPQ and HIT-6 also showed a significant improvement at 1 to 3 months of treatment compared with baseline in all the three groups. Conclusion Either physical or yoga therapy as an adjuvant to standard pharmacologic treatment may further improve the quality of life and reduce headache frequency in patients with migraine.

The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine.

IntroductionThe phase 3 PREEMPT trials demonstrated efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. OnabotulinumtoxinA significantly reduced headache frequency from baseline vs. placebo at 24 weeks; however, this measure may not fully capture the benefits of treatment. We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes according to headache responder status.MethodsA post hoc analysis pooled 24-week data from the placebo-controlled, randomized, double-blind treatment phases of the PREEMPT trials. Patients were stratified by randomized treatment (onabotulinumtoxinA vs. placebo) and headache day responder status (responder vs. nonresponder). Headache day responders had a ≥ 50% headache day reduction from baseline measured at weeks 21–24. Outcomes evaluated were patient-reported reductions in moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire. Missing values were estimated using a modified last-observation-carried-forward approach.ResultsIn the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), headache day responder rates were 308/688 (45%) for onabotulinumtoxinA- and 238/696 (34%) for placebo-treated patients. At 24 weeks compared with baseline, onabotulinumtoxinA nonresponders showed significantly (all P < 0.01) greater mean (standard error) reductions vs. placebo nonresponders in moderate-to-severe headache days (– 3.5 [0.2] vs. − 2.4 [0.2]) and Headache Impact Test scores (– 2.3 [0.3] vs. – 0.8 [0.2]), and greater mean improvements in Migraine-Specific Quality of Life Questionnaire domains (Restrictive, 8.8 [1.0] vs. 2.9 [0.8]; Preventive, 6.0 [1.0] vs. 1.8 [0.8]; Emotional, 8.5 [1.3] vs. 2.8 [1.1]). Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.ConclusionsRelative to placebo nonresponders, onabotulinumtoxinA nonresponders experienced significant reductions in moderate-to-severe headache days and disability and improvement in quality of life, implying that the full benefits of onabotulinumtoxinA are not captured by headache day reduction.Trial RegistrationClinicalTrials.gov identifiers, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).

Erenumab in Chronic Migraine: An Australian Experience.

To determine the effectiveness and safety of erenumab in patients with chronic migraine in the real-world setting of 3 headache centers in Australia. Patients with migraine were prescribed erenumab (70 or 140mg) in the setting of either a product familiarization program or paid access to the medication in 3 headache centers in Australia. We obtained baseline and monthly prospective data on monthly headache days, monthly migraine days, monthly triptan use days, monthly codeine use days, Headache Impact Test-6 scores, and adverse reactions. In this paper, we present our data at 3 and 6months in our subgroup of patients with chronic migraine with and without medication overuse. A total of 170 patients with chronic migraine were prescribed erenumab in the 3 headache centers. At 3months, 100/170 (58.8%) had 50% or greater reduction in monthly migraine days. At 6months, 79/170 (46.5%) had 50% or greater reduction in monthly migraine days. At 6months, there was a mean reduction in monthly headache days of 9.2days, a mean reduction in monthly migraine days of 10.2days. There were few adverse events reported. This is the first report from 3 Australian headache centers about erenumab in the real world. Our analysis has supported erenumab as an effective and well-tolerated migraine preventative therapy for patients with chronic migraine who have failed many preventative therapies.

Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study.

ObjectiveTo assess the long-term safety, tolerability, and efficacy of fremanezumab, a fully humanized monoclonal antibody approved for the preventive treatment of migraine.MethodsA 52-week, multicenter, randomized, double-blind, parallel-group study evaluated fremanezumab monthly or quarterly in adults with chronic migraine (CM) or episodic migraine (EM). Safety and tolerability were assessed by adverse event (AE) monitoring (performed by the investigators), systematic local injection-site assessments (immediately and 1 hour after injection), laboratory/vitals assessments, and immunogenicity testing. Prespecified exploratory evaluations included change from baseline in the monthly number of migraine days, headache days of at least moderate severity, and days with any acute headache medication use. Change from baseline in headache-related disability (6-item Headache Impact Test scores) was also measured.ResultsOf 1,890 patients enrolled, 551 and 559 patients with CM received quarterly and monthly dosing; 394 and 386 patients with EM received quarterly or monthly, respectively. The most commonly reported AEs were injection-site reactions (induration 33%, pain 31%, and erythema 26%). Fremanezumab reduced monthly migraine days (CM quarterly −7.2 days, CM monthly −8.0 days, EM quarterly −5.2 days, EM monthly −5.1 days) and headache days of at least moderate severity (CM quarterly −6.4 days, CM monthly −6.8 days, EM quarterly −4.4, EM monthly −4.2 days) from baseline to 12 months. Reductions in any acute headache medication use and headache-related disability were also maintained over 12 months.ConclusionsFremanezumab quarterly and fremanezumab monthly were well tolerated and demonstrated sustained improvements in monthly migraine days, headache days, and headache-related disability for up to 12 months in patients with migraine.ClinicalTrials.govNCT02638103.Classification of evidenceThis study provides Class IV evidence that long-term fremanezumab treatment is safe, well tolerated, and effective at sustaining reductions in monthly migraine and headache days.

A prospective real-world analysis of erenumab in refractory chronic migraine

BackgroundClinical trials have shown the safety and clinical superiority of erenumab compared to placebo in chronic migraine (CM). The aim of this analysis is to evaluate the effectiveness and tolerability of erenumab in a real-world setting in patients with refractory CM.MethodsThis is a prospective single centre real-world audit conducted in patients with CM with and without medication overuse, refractory to established preventive medications, who received monthly erenumab for 6 months.ResultsOf 164 patients treated, 162 patients (female = 135, mean age 46 ± 14.3 years old) were included in the audit. Patients had failed a mean of 8.4 preventive treatments at baseline and 91% of patients failed Botulinum toxin type A at baseline. The mean reduction in monthly migraine days was 6.0 days at month 3 (P = 0.002) and 7.5 days at month 6 (P < 0.001) compared to baseline. The mean reduction in monthly headache days was 6.3 days (P < 0.001) at month 3 and 6.8 days (P < 0.001) at month 6. At month 3, 49%, 35% and 13% and at month 6, 60%, 38% and 22% of patients obtained at least a 30%, 50% and 75% reduction in migraine days, respectively. The percentage of patients with medication overuse was reduced from 54% at baseline to 20% at month 3 and to 25% at month 6. Compared to baseline, the mean reduction of Headache Impact Test-6 score was 7.7 points at month 3 (from 67.6 ± 0.4 to 59.9 ± 0.9) (P < 0.001) and of 7.5 points at month 6 (60.1 ± 1.3) (P = 0.01). The percentage of patients with severe headache-related disability (HIT-6: 60–78) was reduced from 96% at baseline to 68% after three monthly treatments and to 59% after six treatments. At least one side effect was reported by 48% of patients at month 1, 22% at month 3 and 15% at month 6. Constipation (20%) and cold/flu-like symptoms (15%) were the most frequent adverse events reported.ConclusionErenumab may be an effective and well tolerated therapy for medically refractory CM patients with and without medication overuse.