Migraine-Specific Questionnaire Research Articles

Evaluation of the effect of erenumab on migraine-specific questionnaire in patients with chronic and episodic migraine.

Erenumab is a fully human anti-canonical calcitonin gene-related peptide receptor monoclonal antibody approved for migraine prevention. The Migraine-Specific Quality-of-Life Questionnaire (MSQ) is a 14-item patient-reported outcome instrument that measures the impact of migraine on health-related quality of life. Erenumab data from four phase II/III clinical trials were used to develop an item response theory (IRT) model within a nonlinear mixed effects framework, (i) evaluate the MSQ item information with respect to patient disability, (ii) characterize the longitudinal progression of the MSQ, and (iii) quantify the effect of erenumab on the MSQ in patients with migraine. The majority (80%) of information was found to be contained in 9 out of 14 items, extending the current knowledge on the reliability of the MSQ as a psychometric tool. Simulations across three MSQ domains show significant improvement from baseline, exceeding minimally important differences. Overall, the IRT model platform developed herein allows for systematic quantification of the effect of erenumab on the MSQ in patients with migraine.

Effects of Inhaling Essential Oil on Headache-Related Quality of Life Among Nurses Working in Emergency and Critical Care Units

Headache attacks are prevalent symptoms in emergency and critical care nurses. Prior evidence supports the analgesic effects of essential oils on headache symptoms. However, few empirical studies have examined how essential oil may further improve the relief of related symptoms. If essential oils are effective in headache relief, nurses' quality of life and care quality may also be improved. This study was designed to examine the effects of inhaling essential oil on (1) headache-related disability, (2) headache-related quality of life, and (3) perceived care quality in emergency and critical care nurses. A cluster randomized control trial and crossover experimental design were adopted. The participants, all nurses with headaches working in emergency and critical care units (N = 49) in a medical center in northern Taiwan, were cluster randomized to Group A and B. Group A wore a necklace with essential oil (100% Lavandula angustifolia 0.1 ml + 100% citrus bergamia 0.1 ml) for 28 days (intervention period), stopped wearing the necklace for 7 days (wash-out), and then wore the necklace without essential oil for 28 days (control period). Group B underwent the control period (28 days) first, followed by the wash-out (7 days) and then the intervention period (28 days). Data were collected using a self-administered questionnaires that was administered three times (at day 0, day 28, day 63). The questionnaire included a demographic and headache-related datasheet, headache diary, Headache Disability Index, Migraine-Specific Questionnaire version 2.1 (role restrictive, role preventive, and emotion function), SERVQUAL (Service Quality), DASS-21, and Copenhagen Burnout Inventory. Repeated measures ANOVA (RM-ANOVA) and generalized estimating equations (GEEs) were used to analyze data. Headache-related quality of life showed significant improvement in the role restrictive (β = 9.77, p = .008) and role preventive (β = 10.03, p = .018) domains. However, headache-related disability and care quality showed no significant differences (p > .05), indicating that inhaling essential oil had a positive effect on quality of life. The findings of this study support that using a necklace with essential oil (Lavandula angustifolia and citrus bergamia 1:1) for 28 days effectively improves quality of life, especially in the domain of role function, in nurses working in emergency and critical care units. Additional empirical studies may be developed in the future to promote the benefits of using essential oils to ease pain.

Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments

BackgroundGalcanezumab is a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) indicated for the preventive treatment of migraine. While galcanezumab has demonstrated efficacy in patients who did not respond to prior preventive medications in general, its efficacy in patients who did not benefit from individual, commonly prescribed preventive treatments due to inadequate efficacy or safety/tolerability remains unknown.MethodsCONQUER was a 3-month, randomized, double-blind, placebo-controlled, phase 3b study that enrolled patients with episodic or chronic migraine who had 2 to 4 migraine preventive medication category failures in the past 10 years. Patients were randomly assigned 1:1 to receive placebo (N = 230) or galcanezumab 120 mg/month (240 mg loading dose; N = 232). Post hoc analyses were conducted to determine the efficacy of galcanezumab in patients who had not benefited from six of the most commonly prescribed migraine preventive medications. The mean change from baseline in monthly migraine headache days and ≥ 50 % response rates were assessed over months 1–3. Improvement in Migraine-Specific Questionnaire Role Function-Restrictive (MSQ-RFR) scores were assessed at month 3. The endpoints were estimated via mixed model with repeated measures.ResultsThe most common treatment failures due to inadequate efficacy or safety/tolerability, which at least 20 % of patients reported trying without benefit, included topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and metoprolol. Patients who had not previously benefited from these treatments had a greater mean reduction in monthly migraine headache days across months 1–3 in the galcanezumab group compared to placebo (all p < 0.01). More patients treated with galcanezumab experienced a ≥ 50 % reduction from baseline in monthly migraine headache days across months 1–3 compared to placebo (all p < 0.05). Galcanezumab-treated patients had a greater improvement in mean MSQ-RFR scores at month 3 compared to placebo (all p < 0.01).ConclusionsIn this population, galcanezumab was effective in reducing monthly migraine headache days, improving response rates, and enhancing quality of life in patients who had not previously benefited from topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and/or metoprolol due to inadequate efficacy or safety/tolerability.Trial registrationClinicalTrials.gov NCT03559257 (CONQUER).

Assessment of Utility in Migraine: Mapping the Migraine-Specific Questionnaire to the EQ-5D-5L

IntroductionThere are increasing demands for studies of cost-effectiveness to allocate resources for disease prevention and treatment strategies. The aim of this study is to measure quality of life in migraineurs, based on the Migraine-Specific Questionnaire (MSQ) and EQ-5D-5L, and thereafter map an algorithm to estimate health-state utility values from the MSQ in individuals with migraine. MethodsIn this cross-sectional study conducted between May and July 2018 in a tertiary headache clinic in Tehran, Iran, migraineurs diagnosed based on International Classification of Headache Disorders (ICHD)-3β were enrolled and were asked to complete the MSQ questionnaire and EQ-5D questionnaire. The Spearman correlation coefficient (ρ) was calculated to measure the correlation between the EQ-5D-5L and MSQ v2.1 domains’ score. A P value of <.05 was considered statistically significant. After statistical analysis, several regression models were presented to map the results of the MSQ domains to the utility index, and the preferred model was achieved based on goodness of fit and the model’s predictive performance. ResultsThe preferred MSQ algorithm had approximately the same prediction errors in all migraineurs, episodic and chronic migraine (root mean square error 0.24, 0.24, and 0.23, respectively). The preferred MSQ model explained a variance of 0.26 (R2) in episodic and 0.38 in chronic migraine in the EQ-5D-5L questionnaire. ConclusionThe preferred MSQ mapping algorithm will be suitable in estimating health state utilities in trials of patients with migraine that contain MSQ scores but lack utility values.

Socioeconomic impact of migraine in Italy: Results of a national survey

Background: Literature data indicate that migraine has a stronger impact on both healthcare consumption and quality of life (QoL) in women.&#x0D; Objectives: The objective of this article is to evaluate out-of-pocket (OoP) costs, productivity losses and cost of informal care of migraine in Italy, with a special focus on the detection of potential differences between male and female subjects.&#x0D; Methods: A cross-sectional study was conducted. Data were collected via a web-based survey platform, which included a socioeconomic questionnaire (five sections: clinical history; occupational status; informal assistance; visits, exams and treatments; and loss of productivity) and two questionnaires on QoL (EuroQol 5D 5L and Migraine-Specific Questionnaire, MSQ).&#x0D; Results: Six hundred and seven participants took part in the survey (average age of 42 years; female 70%). The duration of the attack (4-72 hours) was significantly much longer in women than in men (71% vs. 49%; p &lt; 0.001). Seventy per cent of the sample reported to be employed. Lower income was associated with women (p &lt; 0.001). Men received more informal assistance days than women (5.2 vs. 3.9 days; p = 0.007). The quarterly cost including OoP costs, informal assistance and lost productivity averaged €1,088 and was higher for men compared to women (€1,515 vs. €908; p &lt; 0.001). The MSQ reported a significantly worse QoL for women.&#x0D; Conclusion: The results seemed to prove that migraine is a gender disease. Moreover, a potentially unequal access to informal assistance and healthcare resources not covered by the Italian National Health Service is highlighted for women because of their lower average income and purchasing power compared to men.

The synergistic effects of nano-curcumin and coenzyme Q10 supplementation in migraine prophylaxis: a randomized, placebo-controlled, double-blind trial

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

Thyrotropin levels and severity of symptoms in migraine patients of tertiary headache center.

The role of thyroid regulation in migraine is poorly understood, and data is contradictory. To study the possible association of clinical features of migraine with patients' thyroid function. One hundred and thirty migraine patients of a tertiary headache center took part in an open-label, cross-sectional comparative study. The Migraine Disability Assessment questionnaire, Spielberger State-Trait Anxiety Inventory, Beck Depression Inventory, Vanderbilt's Questionnaire of Pain Management, Gothenburg Quality of Life Questionnaire and Migraine-Specific Quality of Life questionnaire were used. The effectiveness of the attacks' therapy was assessed according to the Migraine Assessment of Current Therapy questionnaire. Levels of thyrotropine (thyroid stimulating hormone), thyroxine, and triiodothyronine were studied by standard immune chemiluminescent method using the Immulite-2000 set. An inverse correlation between levels of thyroid stimulating hormone in serum and duration of headache attacks was revealed. The effectiveness of abortive therapy for attacks showed a statistically significant positive correlation with thyroid stimulating hormone level. Quality of life measured by a general quality of life questionnaire, as well as the functional and social indices of a migraine-specific questionnaire, showed direct correlation with serum thyroid stimulating hormone. These results show an association of a more severe clinical course of migraine with lower thyroid stimulating hormone levels.

PRM88 - Estimating Patient Utility in Migraine: Longitudinal Analysis of Erenumab Clinical Trial Data

Migraine is a debilitating disease with substantial impact on patients’ health-related quality of life (HRQoL). Cost-utility analysis of migraine preventives requires the estimation of patient utility values and how these relate to monthly migraine days (MMD). The objective of this analysis is to model utility values in a longitudinal framework, allowing more accurate estimates of expected utility values. Data from two pivotal erenumab studies in episodic migraine (EM; NCT02456740) and chronic migraine (CM; NCT02066415) were pooled to analyze HRQoL outcomes. Migraine Specific Questionnaire (MSQ) version 2.1 and Headache Impact Test (HIT-6) condition-specific instruments were mapped to the EQ-5D using published mapping algorithms (Gillard et al. 2012) to generate generic, preference-based utility estimates, suitable for use in economic models. Longitudinal non-linear beta regressions were fitted between mapped EQ-5D utility values, MMD and treatment group (erenumab 140mg and placebo), adjusting for age, sex, race and baseline MMD in the various time periods considered. Expected utility values by MMD were calculated using the Delta method. Multilevel linear models and fractional response models with probit and logit links were also assessed. The analysis sample included data from 1,113 patients; 83.7% females with a mean age of 41.6 years. The longitudinal beta regression models closely approximated the observed utility values. Patients with 14 MMD were predicted to have MSQ mapped mean utility values of 0.608 (95% CI: 0.595–0.621) for patients treated with erenumab 140mg and 0.590 (0.577–0.602) for patients receiving placebo. The respective predicted HIT-6 mapped mean utility values were 0.698 (0.654–0.741) and 0.659 (0.629–0.689). Mapped utility values for erenumab patients were consistently higher than placebo patients with the same number of MMD. Linking patient QoL to MMD allows utility estimates for different levels of MMD to be predicted, for use in economic evaluations of preventive therapies.

Preventive therapy with citalopram added to a beta blocker does not result in quality-of-life improvement in patients with episodic migraine

Background: The quality of life of migraine patients, particularly mental domains, is severely diminished despite the preventive therapies available. We aimed to evaluate whether citalopram plus nadolol is superior to nadolol alone in terms of quality of life (QOL) in migraine patients. Methods: Adult patients with episodic migraine (≥ 3 headache days per month) were allocated by simple randomization to nadolol 40 mg daily plus citalopram 10 mg daily or to nadolol alone. Baseline visit confirmed the entry criteria and patients filled out a generic QOL (SF-36) as well a migraine-specific questionnaire (MSQoL), a measure of migraine-related disability (MIDAS), a headache calendar and Beck inventory for depression and anxiety. This battery was again completed after 16 weeks of therapy. Results: A total of 92 patients from a general neurology clinic completed the study, 85% females with migraine without aura. Fourty-four (47.83%) patients were allocated to nadolol therapy, and 48 (52.17%) to the combination of nadolol plus citalopram. After therapy, both groups had a similar gain in quality of life (SF-36 and MSQOL), but combination therapy was not superior to nadolol. Despite this improvement, all SF-36 domains remained below the population norms in both groups. Conclusion: Adding systematically citalopram 10 mg daily to a conventional migraine preventive drug (nadolol) does not result in an additional improvement in the QOL of migraine patients.

Efficacy of coenzyme Q10 for the prevention of migraine in women: A randomized, double-blind, placebo-controlled study

IntroductionCoenzyme Q10 (CoQ10), as a supplement with a special role in mitochondrial electron transport chain, has been suggested to have prophylactic effect on migraine attacks. The aim of this randomized, double-blind, placebo-controlled trial was to evaluate the effects of CoQ10 supplementation in the prevention of migraine in conjunction with routine care. MethodsEighty-four women with episodic migraine based on International Classification of Headache Disorder II were randomly allocated in to two groups to receive either 400mg/day CoQ10 or placebo beside usual prophylactic drugs. Frequency, severity and duration of attacks and headache disability based on migraine specific questionnaires (Headache Impact Test, Migraine Specific Quality of Life and Migraine Disability Assessment) were assessed at the baseline, after 6 and 12 weeks. ResultsSeventy-seven of 84 patients completed the study. The results showed significant effect of CoQ10 supplementation on frequency, severity and duration of attacks (All P<0.001). The percent changes for frequency, severity and duration of attacks in CoQ10 compared to placebo group were −56.7 vs. −41.9, −46.6 vs. −30.1 and −60.0 vs. −37.8 respectively. The number-needed-to-treat for at least 50% reduction in migraine frequency, severity and duration were 4.5, 4.4 and 3.6 respectively.CoQ10 group also had better scores in migraine specific questionnaires at the end of the study compared to control group (All P<0.001). There were no side-effects noted during the study. ConclusionWe concluded that CoQ10 supplementation provided in addition to current migraine prophylactic agents, is well tolerated and seems to be efficacious over time.

Cessation of Hairline Recession following Open Forehead Rejuvenation

The senior author (B.G.) observed that patients who underwent forehead rejuvenation using a pretrichial incision did not experience hairline recession. The aim of this study was to objectively measure the effects of forehead rejuvenation on hairline recession. A 15-year retrospective review was performed in 31 forehead rejuvenation patients [17 endoscopic and 14 open (pretrichial incision) with adequate early (within 1 year) and late (≥ 8 years) postoperative photographs] and 11 age- and follow-up-matched cosmetic surgery patients who did not have forehead rejuvenation. Hair recession was measured using the Mirror program for Windows by averaging two successive perpendicular distances from bilateral medial canthi to the hairline and dividing by the intercanthal distance. In pretrichial incision patients, the distance from the incision to the anterior hairline was recorded. The difference in short-term postoperative hairline measurements among groups was not significant (p = 0.445). Only the pretrichial group demonstrated significant stability between short-term and long-term hairline positions (p = 0.005). The pretrichial group demonstrated a stable or improved hairline position compared with either the endoscopic (p = 0.017) or control group (p = 0.006), whereas these patients demonstrated significant recession over time. Hairline measurements between early and late postoperative photographs in the endoscopic and control groups were not significant (p = 0.621). The pretrichial incision results in a stable hairline position over time compared with the endoscopic technique or matched controls. Pretrichial incision patients did not demonstrate separation between the scar and hairline, indicating no hair loss in this site.

Shared loci for migraine and epilepsy on chromosomes 14q12-q23 and 12q24.2-q24.3

To describe clinical characteristics and to identify susceptibility loci for epilepsy and migraine in a Finnish family with a complex phenotype. Participating family members were interviewed and medical files were reviewed. The seizure classification was made according to International League Against Epilepsy criteria. Migraine diagnosis was made using the validated Finnish Migraine Specific Questionnaire for Family Studies and criteria according to the current International Classification of Headache Disorders-II. DNA samples were obtained from 56 family members and nonparametric genome-wide linkage analyses were performed using 382 polymorphic microsatellite markers. The most promising loci were fine-mapped with additional microsatellite markers. Clinical data were obtained from 60 family members of whom 12 (20%) had idiopathic epileptic seizures. Eight of those 12 (67%) also had migraine. Altogether 33 of the 60 family members (55%) had migraine. Significant evidence of linkage was found between a locus on 14q12-q23 and migraine (p = 0.0001). Suggestive evidence of linkage in this region was also found for epilepsy with generalized tonic-clonic seizures (p = 0.0034). In addition, significant evidence of linkage was found at a locus on 12q24.2-q24.3 (p < 0.001) for migraine alone and for the combined phenotype of migraine and epilepsy. Our data suggest the occurrence of common susceptibility loci for epilepsy and migraine on chromosomes 14q12-q23 and 12q24.2-q24.3, implicating a shared genetic etiology for these 2 diseases.

Adapted Finnish Migraine‐Specific Questionnaire for family studies (FMSQFS): a validation study in two languages

The hypothesis of a genetic component in the etiology of migraine is getting a foothold. However, to explore genetic associations, precision in clinical phenotypization is crucial. For this reason, migraine-specific questionnaires, well discriminating between primary headaches, are required when large numbers of individuals need to be assessed. We adapted and translated in two languages, German and Italian, the Finnish Migraine-Specific Questionnaire for use in family studies. This adaptation proved to be reliable when differentiating from primary headaches, and to be in very good agreement with the standard for comparison. However, discriminating between migraine with and without aura still relays on a specialist evaluation. This article describes the validation of this questionnaire.

Neuromodulators for Migraine Prevention

Migraine is a debilitating condition characterized by a cycle of painful headaches and headache-related symptoms interspersed with periods of worry, distress, and apprehension. The negative impact of migraine on patient functioning, workplace productivity, and other daily activities has been demonstrated through the use of a variety of clinician- and patient-reported assessment tools, including the Migraine-Specific Questionnaire and the Migraine Disability Assessment questionnaire. In addition to considering the frequency and severity of migraine, clinicians need to encourage more open dialogue with their patients about the impact of this disorder on daily activities and productivity. Only then can the most appropriate course of treatment be determined. Appropriately prescribed acute and preventive therapies should break the cycle of migraine and improve the daily activities of patients with this chronic condition. Divalproex sodium and topiramate are neuromodulators that are approved by the US Food and Drug Administration (FDA) for the prophylaxis (prevention) of migraine headache in adults. Non-FDA-approved neuromodulators sometimes used in the management of migraine headache include gabapentin, lamotrigine, levetiracetam, and zonisamide. All medications need to be titrated, and treatment-related adverse events need to be managed appropriately. Preventive medications should be taken for at least 2-3 months to ascertain their therapeutic effect.

Smile: First Observational Prospective Cohort Study of Migraine in Primary Care in France. Description of Methods and Study Population

The SMILE study was conducted among migraine patients consulting in primary care in France. The first phase aimed to describe the study sample of patients at entry to the study, especially emotional dimension (Hospital Anxiety and Depression scale), functional impact (abridged Migraine Specific Questionnaire), stress (Perceived Stress Scale) and coping behaviours (brief COPE inventory avoidance subscale, Coping Strategies Questionnaire catastrophizing subscale), as well as treatments used and their effectiveness and treatments prescribed at end of consultation. Results indicate that consulting migraine patients suffer frequent migraine attacks, exhibit substantial levels of anxiety, functional impact and stress, and often use maladaptive coping strategies. Abortive treatments appear ineffective in most patients (74%). Patients with more affected psychometric variables and treatment ineffectiveness are more likely to be deemed eligible for prophylactic treatment. These data highlight the seriousness of migraine and maladjustment of patients consulting in primary care.

The impact of migraine prevention on daily activities: a longitudinal and responder analysis from three topiramate placebo-controlled clinical trials

BackgroundTopiramate is approved for the prophylaxis (prevention) of migraine headache in adults. The most common adverse events in the three pivotal, randomized, double-blind, placebo-controlled trials were paresthesia, fatigue, cognitive impairment, anorexia, nausea, and taste alteration. In these trials, topiramate 100 mg/d significantly improved Migraine-Specific Questionnaire (MSQ) scores versus placebo (p < 0.001). The MSQ measures how much migraine limits/interrupts daily performance. Pooled analyses of pivotal trial data were conducted to further assess how topiramate 100 mg/d affects daily activities and patient functioning.MethodsMean MSQ and Medical Outcome Study Short Form 36 (SF-36) change scores (baseline to each double-blind assessment point) were calculated for pooled intent-to-treat (ITT) patients. Additionally, pooled ITT patients receiving topiramate 100 mg/d or placebo were combined and divided into two responder groups according to percent reduction in monthly migraine frequency: < 50% responders or ≥ 50% responders. Between-group differences were assessed using analysis of covariance.ResultsOf 756 patients (mean age 39.8 years, 86% female), 384 received topiramate 100 mg/d and 372 placebo. Topiramate significantly improved all three MSQ domains throughout the double-blind phase versus placebo (p = 0.024 [week 8], p < 0.001 [weeks 16 and 26] for role prevention; p < 0.001 for role restriction and emotional function [all time points]). Topiramate 100 mg/d significantly improved SF-36 physical component scores (PCS) throughout the double-blind phase versus placebo (p < 0.001, all time points) and significantly improved mental component scores (MCS) at week 26 (p = 0.043). The greatest topiramate-associated improvements on SF-36 subscales were seen for bodily pain and general health perceptions (p < 0.05; weeks 8, 16, and 26), and physical functioning, vitality, role-physical, and social functioning (p < 0.05; weeks 16 and 26). Significantly greater improvements in all three MSQ domains, as well as the PCS and MCS of SF-36, were observed for ≥ 50% responders versus < 50% responders (p < 0.001). Significantly greater percentages of topiramate-treated patients were ≥ 50% responders versus placebo (46% versus 23%; p < 0.001).ConclusionTopiramate 100 mg/d significantly improved daily activities and patient functioning at all time points throughout the double-blind phase. Daily function and health status significantly improved for those achieving a ≥ 50% migraine frequency reduction.

Assessing the Ability of Topiramate to Improve the Daily Activities of Patients With Migraine

To assess the impact of topiramate on the daily activities of patients with migraine. We performed a randomized, double-blind, placebo-controlled multicenter trial Initiated on March 1, 2001, and completed on April 4, 2002. Patient-reported data from the Migraine Specific Questionnaire (MSQ) and the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) were collected at baseline and at weeks 8, 16, and 26 from an intent-to-treat population receiving either topiramate, 50, 100, or 200 mg/d, or placebo. Two activity-related MSQ domains (role restrictive [MSQ-RR] and role prevention [MSQ-RP]) and 2 activity-related SF-36 domains (role physical [SF36-RP] and vitality [SF36-VT]) were the prospectively designated secondary outcome measures. The changes in MSQ and SF-36 scores for each treatment group were calculated by measuring the area under the curve from week 8 (the beginning of the maintenance period) through week 26 of the double-blind phase, relative to the prospective baseline. A mixed-effect piecewise linear regression model was used to estimate average domain score over time. Patients receiving topiramate, 100 or 200 mg/d, had significantly reduced mean monthly (28-day) migraine frequency (P = .008 and P < .001, respectively) compared with placebo, but not patients receiving topiramate, 50 mg/d (P = .48). Topiramate significantly improved mean MSQ-RR domain scores (50 mg/d [P = .02], 100 mg/d [P< .001], and 200 mg/d [P < .001]) and mean MSQ-RP domain scores (50 mg/d [P = .007], 100 mg/d [P = .001], and 200 mg/d [P= .002]) vs placebo. Topiramate, 100 and 200 mg/d, significantly improved mean SF36-RP domain scores vs placebo (P = .02). Topiramate (all doses) improved SF36-VT domain scores, although not significantly vs placebo. Changes in prospectively designated domain scores were significantly correlated with changes in mean monthly migraine frequency (P < or = .001 [MSQ domains], P < or = .002 [SF-36 domains]). Patient-reported migraine-specific outcomes measured by the MSQ-RR and MSQ-RP domains improved significantly for those receiving topiramate (all doses) vs placebo. The SF36-RP domain scores improved significantly for patients receiving 100 or 200 mg/d of topiramate. Improvements in all 4 prospectively selected MSQ and SF-36 domains were significantly correlated with decreases in mean monthly migraine frequency.

Mapping Pain Generators for Surgical Treatment of Migraine Headaches

Mapping Pain Generators for Surgical Treatment of Migraine Headaches

The impact of migraine on daily activities: effect of topiramate compared with placebo

ABSTRACTObjective: Assess the impact of migraine preventive therapy on patient-reported routine daily activities using the Migraine Specific Questionnaire (MSQ) and the Medical Outcomes Study Short Form-36 (SF-36) in patients with migraine who participated in a 26-week, randomized, double-blind, placebo-controlled trial of topiramate for migraine prevention.Methods: Patients were required to have 3–12 migraines and ≤ 15 headache days/month during the baseline phase. Patients who failed > 2 adequate regimens of migraine preventive therapy were excluded. MSQ and SF‐36 data were collected at baseline, weeks 8, 16, and 26 from 469 patients receiving either topiramate 50, 100, or 200 mg/day or placebo. Patients entered a double-blind, 8‐week titration period followed by an 18‐week maintenance period. Two activity-related MSQ domains (Role Restrictive [RR] and Role Prevention [RP]) and two activity-related SF‐36 domains (Role Physical [SF‐36‐RP] and Vitality [SF‐36‐VT]) were prospectively designated as the outcome measures. Changes in MSQ and SF‐36 scores during the double-blind phase relative to prospective baseline scores were compared between topiramate- and placebo-treated groups. Specifically, a mixed-effect piecewise linear regression model was used to estimate average domain score over time, and areas under the domain-over-time curve (AUC) were compared using a 2‐sided t‐test, with multiplicity adjustment.Results: In the intent-to-treat population (N = 469), topiramate (all doses) significantly improved mean MSQ‐RR domain scores versus placebo (topiramate 50 mg/day, p = 0.035; topiramate 100 mg/day; p < 0.001; topiramate 200 mg/day, p = 0.001). Topiramate-associated improvements in mean MSQ‐RP domain scores were significant versus placebo only for topiramate 100 mg/day ( p = 0.045). SF‐36‐RP and SF‐36‐VT domain scores improved (not significant versus placebo) for topiramate 100 and 200 mg/day. Changes in these MSQ and SF‐36 domain scores significantly correlated with changes in mean monthly migraine frequency.Conclusion: Improvements in patient-reported outcomes specific for migraine (measured by the MSQ) were significantly better for patients receiving topiramate than for those receiving placebo. Improvements in the prospectively selected MSQ and SF‐36 domains were significantly correlated with the decrease in mean monthly migraine frequency observed with topiramate treatment.

Topiramate Improves Health‐Related Quality of Life When Used to Prevent Migraine

To assess changes in health-related quality of life (HRQoL) measures among patients receiving topiramate (TPM) 100 mg/d in two divided doses for migraine prevention in three randomized, double-blind, placebo-controlled, 26-week trials with similar protocols and study populations. Migraine substantially impairs HRQoL and work productivity before, during, and after attacks. Approximately 50% of patients with migraine could be recommended for preventive therapies, yet only 3% to 5% of patients receive them. TPM is an effective and generally well-tolerated migraine prophylactic (preventive) therapy for adults, as demonstrated in several randomized, double-blind, placebo-controlled trials. The most common adverse events in double-blind, placebo-controlled studies of TPM in migraine prevention are paresthesia, fatigue, anorexia, nausea, taste alteration, and diarrhea. The Migraine-Specific Questionnaire (MSQ, version 2.1) was used to assess the effect of TPM 100 mg/d on the functionality and HRQoL of randomized intent-to-treat (ITT) and study-completer populations pooled from three randomized, double-blind, placebo-controlled trials. MSQ scores (0 to 100, higher score indicates better functioning) were assessed for the following three domains: role restriction (examines the degree to which performance of daily activities is limited by migraine), role prevention (examines the degree to which performance of daily activities is interrupted by migraine), and emotional function (examines feelings of frustration and helplessness due to migraine). Between-group differences from baseline in mean MSQ domain scores for TPM 100 mg/d and placebo were compared using a mixed-effects model with piecewise linear regression. Effect sizes were calculated to estimate the magnitude of change in HRQoL that can be associated with TPM therapy. TPM 100 mg/d significantly improved all three MSQ domains compared with placebo for both the ITT (TPM, n = 372; placebo, n = 362) and study-completer (TPM, n = 220; placebo, n = 216) populations (P < .001 for all three domains, both populations). Effect sizes for TPM 100 mg/d varied from 0.40 to 0.78, indicating that the changes in MSQ scores for TPM 100 mg/d were moderate and may be clinically significant. TPM 100 mg/d has been shown to be effective in the prevention of migraine headache in adults. As the MSQ results from the three randomized, placebo-controlled trials indicate, HRQoL is significantly improved for up to 6 months following initiation of treatment.