Reductions in headache impact test (HIT-6) scores with fremanezumab and erenumab among patients with episodic migraine (EM) and 2–4 prior treatment failures: A network meta-analysis

ObjectiveTo evaluate the effect of erenumab on patient-reported, functional outcomes in patients with episodic migraine (EM) in whom 2–4 preventives were not useful from the Phase 3b LIBERTY study.MethodsAs previously reported, 246 patients with EM with 2–4 prior failed preventives were randomised 1:1 to subcutaneous erenumab 140 mg or placebo every 4 weeks for 12 weeks. This analysis evaluated Migraine Physical Function Impact Diary (MPFID), Headache Impact Test (HIT-6) and Work Productivity and Activity Impairment (WPAI) scores at Week 12. P values were nominal without multiplicity adjustment.ResultsErenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: −3.5 (−5.7 to –1.2) (p=0.003); MPFID-EA: −3.9 (−6.1 to –1.7)) (p<0.001) at 12 weeks. Patients on erenumab were more likely to have a ≥5-point reduction in MPFID score (OR vs placebo (95% CI) MPFID-EA: 2.1 (1.2 to 3.6); MPFID-PI: 2.5 (1.4 to 4.5)). A similar trend was observed for HIT-6 (TD: −3.0; p<0.001); significantly higher proportions of patients on erenumab reported a ≥5-point reduction (OR (95% CI): 2.4 (1.4 to 4.1)). In three out of four WPAI domains, erenumab showed improvement versus placebo.ConclusionAt 12 weeks, erenumab was efficacious on functional outcomes in patients with EM in whom 2–4 preventives were not useful.Trial registration detailsClinicalTrials.gov identifier: NCT03096834.

Download Full-text

Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab

Cephalalgia ◽

10.1177/0333102418789072 ◽

2018 ◽

Vol 38 (10) ◽

pp. 1622-1631 ◽

Cited By ~ 25

Author(s):

Dawn C Buse ◽

Richard B Lipton ◽

Yngve Hallström ◽

Uwe Reuter ◽

Stewart J Tepper ◽

...

Keyword(s):

Quality Of Life ◽

Impact Test ◽

Episodic Migraine ◽

Health Related Quality ◽

Double Blind ◽

Related Quality ◽

Health Related ◽

Headache Impact ◽

Assessment Questionnaire

Background We evaluated the effect of erenumab, a fully human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor, on migraine-related disability, impact, and health-related quality of life among patients with episodic migraine. Methods Patients enrolled in a phase 3, 6-month, double-blind, placebo-controlled study of once-monthly erenumab 70 and 140 mg for migraine prevention (STRIVE) used an eDiary during the baseline and double-blind treatment phases to complete validated, specific questionnaires, including the modified (monthly) Migraine Disability Assessment Questionnaire; Headache Impact Test; and Migraine-Specific Quality of Life Questionnaire-role function-restrictive (MSQ-RFR), -role function-preventive (MSQ-RFP), and -emotional function (MSQ-EF). Results A total of 955 patients were randomized to receive erenumab 70 mg (n = 317), erenumab 140 mg (n = 319), or placebo (n = 319). Erenumab versus placebo resulted in significantly greater improvements in all patient-reported outcomes; changes from baseline were numerically higher with 140 mg erenumab. Improvements occurred rapidly and were maintained over 6 months of treatment. Between-group differences from placebo over months 4–6 for the 70- and 140-mg dose groups were, respectively, −2.1 and −2.8 for modified (monthly) Migraine Disability Assessment Questionnaire, −2.1 and −2.3 for Headache Impact Test, 5.1 and 6.5 for MSQ-RFR, 4.2 and 5.4 for MSQ-RFP, and 5.2 and 6.7 for MSQ-EF ( p < 0.001 for all). Erenumab also significantly reduced the proportion of patients with severe and very severe migraine-related disability and increased the proportion of patients with clinically meaningful improvements in migraine-related impact and health-related quality of life. Conclusion Erenumab reduced migraine disability and impact and improved patients’ health-related quality of life, reinforcing its role as a promising new therapy for migraine prevention.

Download Full-text

Estimating quality of life in a headache referral population based on Migraine Disability Assessment Scale and Headache Impact Test

Current Journal of Neurology ◽

10.18502/cjn.v19i2.4944 ◽

2020 ◽

Author(s):

Mansoureh Togha ◽

Maral Seyed-Ahadi ◽

Elham Jafari ◽

Zahra Vahabi ◽

Fereshteh Naderi-Behdani ◽

...

Keyword(s):

Quality Of Life ◽

Impact Test ◽

Medication Overuse Headache ◽

Episodic Migraine ◽

Population Based ◽

Assessment Scale ◽

Disability Assessment ◽

Headache Clinic ◽

Headache Impact

Background: Headache is among the most common disabling neurologic disorders. We measured quality of life in chronic migraine (CM) and episodic migraine (EM), stratified by medication overuse headache (MOH) and presence of aura. Methods: In this observational study, conducted from January 2016 to December 2018, adult patients referred to the tertiary headache clinic of Sina Hospital in Tehran, Iran, who met International Classification of Headache Disorders, 3rd Edition-beta (ICHD-3 β) criteria for migraine were classified to EM and CM subtyped based on presence of aura and MOH. Validated Farsi versions of Migraine Disability Assessment Scale (MIDAS) and 6-item Headache Impact Test (HIT-6) questionnaires were used. Results: A total of 2454 patients (1907 women) were enrolled from which 1261 (51.4%) patients had EM and 1193 (48.6%) had CM, while 908 subjects (37.0%) had MOH, of whom 890 (98.0%) had CM. Median scores of MIDAS and HIT-6 were significantly higher in patients with CM compared to EM sufferers. Chronic migraineurs with MOH had a significantly higher median score of MIDAS and HIT-6 compared to patients with non-MOH CM. Also, there was a moderate positive correlation between MIDAS (disability) and HIT-6 scores (impact on patients’ life) and a moderate correlation between HIT-6 and pain severity. Conclusion: The results of this study confirm that CM and MOH are associated with a higher headache-related disability and impact on life compared to EM. Therefore, treatment goals in prevention of MOH and migraine transformation warrant higher quality of life in patients with migraine.

Download Full-text

Case report: Manual therapies promote resolution of persistent post-concussion symptoms in a 24-year-old athlete

SAGE Open Medical Case Reports ◽

10.1177/2050313x20952224 ◽

2021 ◽

Vol 9 ◽

pp. 2050313X2095222

Author(s):

Susan Vaughan Kratz

Keyword(s):

Case Report ◽

Symptom Severity ◽

Impact Test ◽

Manual Therapies ◽

Symptom Checklist ◽

Post Concussion Syndrome ◽

Persistent Symptoms ◽

Short Period ◽

History Of ◽

Headache Impact

This case report illustrates the treatment outcomes of a collegiate athlete presenting with an 18-month history of post-concussion syndrome who received a series of mixed manual therapies in isolation of other therapy. Persistent symptoms were self-reported as debilitating, contributing to self-removal from participation in school, work, and leisure activities. Patient and parent interviews captured the history of multiple concussions and other sports-related injuries. Neurological screening and activities of daily living were baseline measured. Post-Concussion Symptom Checklist and Headache Impact Test-6™ were utilized to track symptom severity. Treatments applied included craniosacral therapy, manual lymphatic drainage, and glymphatic techniques. Eleven treatment sessions were administered over 3 months. Results indicated restoration of oxygen saturation, normalized pupil reactivity, and satisfactory sleep. Post-concussion syndrome symptom severity was reduced by 87% as reflected by accumulative Post-Concussion Symptom Checklist scores. Relief from chronic headaches was achieved, reflected by Headache Impact Test-6 scores. Restoration of mood and quality of life were reported. A 6-month follow-up revealed symptoms remained abated with full re-engagement of daily activities. The author hypothesized that post-concussion syndrome symptoms were related to compression of craniosacral system structures and lymphatic fluid stagnation that contributed to head pressure pain, severe sleep deprivation, and multiple neurological and psychological symptoms. Positive outcomes over a relatively short period of time without adverse effects suggest these therapies may offer viable options for the treatment of post-concussion syndrome.

Download Full-text

Reference Values for the Headache Impact Test-6 Questionnaire

Archives of Physical Medicine and Rehabilitation ◽

10.1016/j.apmr.2021.05.013 ◽

2021 ◽

Author(s):

Megan N. Houston ◽

Haley A. Bookbinder ◽

Sean P. Roach ◽

Jeremy D. Ross ◽

Michael J. Aderman ◽

...

Keyword(s):

Reference Values ◽

Impact Test ◽

Headache Impact

Download Full-text

Clinical correlates of hypothalamic functional changes in migraine patients

Cephalalgia ◽

10.1177/03331024211046618 ◽

2021 ◽

pp. 033310242110466

Author(s):

Roberta Messina ◽

Maria A Rocca ◽

Paola Valsasina ◽

Paolo Misci ◽

Massimo Filippi

Keyword(s):

Functional Connectivity ◽

Resting State ◽

Visual Processing ◽

Episodic Migraine ◽

Resting State Functional Connectivity ◽

Functional Interaction ◽

Functional Changes ◽

Lingual Gyrus ◽

Headache Impact

Objective To elucidate the hypothalamic involvement in episodic migraine and investigate the association between hypothalamic resting state functional connectivity changes and migraine patients’ clinical characteristics and disease progression over the years. Methods Ninety-one patients with episodic migraine and 73 controls underwent interictal resting state functional magnetic resonance imaging. Twenty-three patients and controls were re-examined after a median of 4.5 years. Hypothalamic resting state functional connectivity changes were investigated using a seed-based correlation approach. Results At baseline, a decreased functional interaction between the hypothalamus and the parahippocampus, cerebellum, temporal, lingual and orbitofrontal gyrus was found in migraine patients versus controls. Increased resting state functional connectivity between the hypothalamus and bilateral orbitofrontal gyrus was demonstrated in migraine patients at follow-up versus baseline. Migraine patients also experienced decreased right hypothalamic resting state functional connectivity with ipsilateral lingual gyrus. A higher migraine attack frequency was associated with decreased hypothalamic-lingual gyrus resting state functional connectivity at baseline, while greater headache impact at follow-up correlated with decreased hypothalamic-orbitofrontal gyrus resting state functional connectivity at baseline. At follow-up, a lower frequency of migraine attacks was associated with higher hypothalamic-orbitofrontal gyrus resting state functional connectivity. Conclusions During the interictal phase, the hypothalamus modulates the activity of pain and visual processing areas in episodic migraine patients. The hypothalamic-cortical interplay changes dynamically over time according to patients’ clinical features.

Download Full-text

Validation of the Headache Impact Test (HIT-6™) across episodic and chronic migraine

Cephalalgia ◽

10.1177/0333102410379890 ◽

2010 ◽

Vol 31 (3) ◽

pp. 357-367 ◽

Cited By ~ 146

Author(s):

Min Yang ◽

Regina Rendas-Baum ◽

Sepideh F Varon ◽

Mark Kosinski

Keyword(s):

Chronic Migraine ◽

Discriminant Validity ◽

High Reliability ◽

Reliability And Validity ◽

Episodic Migraine ◽

Migraine Headaches ◽

Scale Scores ◽

Headache Pain ◽

Test Retest Reliability ◽

Headache Impact

Objective: The purpose of this study was to assess psychometric properties of the six-item Headache Impact Text (HIT-6™) across episodic and chronic migraine. Methods: Using a migraine screener and number of headache days per month (HDPM), participants from the National Survey of Headache Impact (NSHI) study and the HIT-6 validation study (HIT6-V) were selected for this study. Eligible participants were categorized into three groups: chronic migraine (CM: ≥ 15 HDPM); episodic migraine (EM: < 15 HDPM); non-migraine headaches. Reliability and validity of the HIT-6 were evaluated. Results: A total of 2,049 survey participants met the inclusion/exclusion criteria for this study. Participants were identified as 6.4% CM; 42.1% EM; 51.5% non-migraine, with respective mean HIT-6 scores: 62.5 ± 7.8; 60.2 ± 6.8; and 49.1 ± 8.7. High reliability was demonstrated with internal consistency (time1/time2) of 0.83/0.87 in NSHI, and 0.82/0.92 in HIT6-V. Intra-class correlation for test-retest reliability was very good at 0.77. HIT-6 scores correlated significantly ( p < .0001) with total Migraine Disability Assessment Scale scores ( r = 0.56), headache pain severity ( r = 0.46), and HDPM ( r = 0.29). Discriminant validity analysis showed significantly different HIT-6 scores ( F = 488.02, p < .0001) across the groups. Conclusion: Results from these analyses confirm that the HIT-6 is a reliable and valid tool for discriminating headache impact across episodic and chronic migraine.

Download Full-text

A Case Report on a Patient Treated with Combined Korean Medicine for Chronic Headache with Digestive Symptoms

The Journal of Internal Korean Medicine ◽

10.22246/jikm.2021.42.5.923 ◽

2021 ◽

Vol 42 (5) ◽

pp. 923-90

Author(s):

Gyu-cheol Choi ◽

Ji-eun Bae ◽

Jae-won Park ◽

Dong-jin Kim ◽

Jeong-su Hong

Keyword(s):

Medical Treatment ◽

Chronic Headache ◽

Impact Test ◽

Rating Scale ◽

Numerical Rating Scale ◽

Five Dimensions ◽

End Of Treatment ◽

Numerical Rating ◽

Headache Impact

Objectives: The purpose of this study was to examine the effect of combined Korean medical treatment on chronic headache with digestive symptoms.Methods: We collected data from October to December 2020 and evaluated the efficacy of combined Korean medical treatment using the Korean Headache Impact Test-g (KHIT-6), European Quality of Life Five Dimensions (EQ5D) Scale, and Numerical Rating Scale (NRS) at admission, after two weeks of hospitalization, and on discharge.Results: At the end of treatment, the patient had increased EQ5D and reduced KHIT-6 and NRS scores.Conclusions: After the combined Korean medical treatment, the patient showed improvement, suggesting the efficacy of treatment.

Download Full-text

Sinusitis Independently Predicts the Presence of Headache Following Endoscopic Transsphenoidal Resection for Pituitary Adenomas

10.21203/rs.3.rs-760943/v1 ◽

2021 ◽

Author(s):

Jiayu Gu ◽

Xiaoqun Chen ◽

Yunzhi Zou ◽

Shuo Yang ◽

Siyu Chen ◽

...

Keyword(s):

Risk Factors ◽

Pituitary Adenomas ◽

Pituitary Apoplexy ◽

Meta Analysis ◽

Confidential Interval ◽

Endoscopic Endonasal ◽

Postoperative Headache ◽

The One ◽

Headache Impact ◽

Transsphenoidal Resection

Abstract Purpose Headache is common among patients with pituitary adenomas undergone endoscopic endonasal surgery (EES), but was seldomly concerned before. The present study aims to investigate the incidence and profile of risk factors of headache after EES.Methods A meta-analysis was performed to evaluate the occurrence proportions of postoperative headache in patients with pituitary adenomas. Then, a cohort of 101 patients undergone EES were enrolled for analyzing risk factors of headache. The Headache Impact Test (HIT-6) was used to score the headache preoperatively, 1 month and 3 months postoperatively. Results A total of 18 studies and 4442 participants were included for meta-analysis. The pooled occurrence proportion of postoperative headache was 29% (95% confidential interval: 20-38%). For the 101 patients enrolled in the present study, 26 (25.74%) of them had a HIT-6 scores of > 55 preoperatively, but decreased to 22 (21.78%) at 1 month, and 6 (5.94%) at 3 months, postoperatively. Multivariate analysis showed that pituitary apoplexy (OR=3.591, 95%CI 1.219-10.575, p=0.020) and Hardy's grade C-D (OR=21.06, 95%CI 2.25-197.02, p=0.008) were independently risk factors for preoperative headache. In contrast, postoperative sinusitis (OR=3.88, 95%CI 1.16-13.03, P=0.028) and Hardy's grade C-D (OR=10.53, 95%CI 1.02-109.19, P=0.049) independently predicted the presence of postoperative headache at 1 month. At 3 months postoperatively, the proportion of sinusitis tended to be higher in the headache group than the one in non-headache group (100% vs. 30.0%, p=0.070). Conclusion Headache is very common following EES for pituitary adenomas. Prophylactic management of postoperative sinusitis may help to alleviate postoperative headache.

Download Full-text

Flunarizine as prophylaxis for episodic migraine: a systematic review with meta-analysis

Ból ◽

10.5604/01.3001.0013.4615 ◽

2019 ◽

Vol 20 (1) ◽

pp. 25-38

Author(s):

Anker Stubberud ◽

Nikolai Melseth Flaaen ◽

Douglas C. McCrory ◽

Sindre Andre Pedersen ◽

Mattias Linde

Keyword(s):

Confidence Interval ◽

Meta Analysis ◽

Episodic Migraine ◽

Pooled Analysis ◽

Risk Of Bias ◽

Current Guideline ◽

Data Synthesis ◽

Randomized Controlled ◽

The Mean ◽

Meta Analyses

Based on few clinical trials, flunarizine is considered a first-line prophylactic treatment for migraine in several guidelines. In this meta-analysis, we examined the pooled evidence for its effectiveness, tolerability, and safety. Prospective randomized controlled trials of flunarizine as a prophylaxis against migraine were identified from a systematic literature search, and risk of bias was assessed for all included studies. Reduction in mean attack frequency was estimated by calculating the mean difference (MD), and a series of secondary outcomes –including adverse events (AEs) – were also analyzed. The database search yielded 879 unique records. Twentyfive studies were included in data synthesis. We scored 31/175 risk of bias items as “high”, with attrition as the most frequent bias. A pooled analysis estimated that flunarizine reduces the headache frequency by 0.4 attacks per 4 weeks compared with placebo (5 trials, 249 participants: MD 20.44; 95% confidence interval 20.61 to 2 0.26). Analysis also revealed that the effectiveness of flunarizine prophylaxis is comparable with that of propranolol (7 trials, 1151 participants, MD 20.08; 95% confidence interval 20.34 to 0.18). Flunarizine also seems to be effective in children. The most frequent AEs were sedation and weight increase. Meta-analyses were robust and homogenous, although several of the included trials potentially suffered from high risk of bias. Unfortunately, reporting of AEs was inconsistent and limited. In conclusion, pooled analysis of data from partially outdated trials shows that 10- mg flunarizine per day is effective and well tolerated in treating episodic migraine – supporting current guideline recommendations.

Download Full-text