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Chronic Migraine (chronic + migraine)
Selected AbstractsSuboccipital Nerve Blocks for Suppression of Chronic Migraine: Safety, Efficacy, and Predictors of OutcomeHEADACHE, Issue 6 2010Silvia Weibelt RN (Headache 2010;50:1041-1044) Background., Approximately 1 in 50 Americans is afflicted by chronic migraine (CM). Many patients with CM describe cervicogenic headache. Options for treating CM effectively are at present quite limited. Objective., To determine the safety and efficacy of occipital nerve blocks (ONBs) used to treat cervicogenic chronic migraine (CCM) and to identify variables predictive of a positive treatment response. Methods., Using a uniform dose and injection paradigm, we performed ONBs consecutively on a series of patients presenting with CCM. Patients were stratified according to specific findings found to be present or absent on physical examination. A positive treatment outcome was defined as a 50% or greater reduction in headache days per month over the 30 days following treatment relative to the 30-day pre-treatment baseline. We used a 5-point Likert scale as one of the secondary outcome variables. Results., We treated 150 consecutive patients with unilateral (37) or bilateral (113) ONBs. At the 1-month follow-up visit 78 (52%) exhibited evidence of a positive treatment response according to the primary outcome variable, and 90 (60%) reported their headache disorder to be "better" (44; 29%) or "much better" (46; 30%). A total of 8 (5%) patients reported adverse events within the ensuing 72 hours, and 3 (2%) experienced adverse events that reversed spontaneously but required emergent evaluation and management. Conclusion., For suppression of CCM, ONBs may offer an attractive alternative to orally administered prophylactic therapy. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Topiramate Treatment of Chronic Migraine: A Randomized, Placebo-Controlled Trial of Quality of Life and Other Efficacy MeasuresHEADACHE, Issue 8 2009Stephen Silberstein MD Objective., To define yet more clearly the utility of topiramate in the treatment of chronic migraine, we evaluated prespecified secondary endpoints from a recent randomized, double-blind, placebo-controlled, multicenter clinical trial. Background., We previously reported that topiramate 100 mg per day produced a statistically significant reduction in mean monthly migraine/migrainous and migraine headache days compared with placebo treatment and that it was safe and generally well tolerated. Methods., Variables analyzed included between-treatment group differences in percent responders, change in the mean monthly rate of total headache days and headache-free days, change in average and worst daily headache severity, change in the mean monthly use of acute headache medications, and absolute change and percent change in a headache index. Additional analyses included evaluation of changes in: the associated symptoms of photophobia, phonophobia, and nausea; Migraine-Specific Quality of Life Questionnaire scores; Migraine Disability Assessment Scale scores; and Physician's and Subjects Global Impression of Change. Results., The intent-to-treat population consisted of 306 patients (topiramate, n = 153; placebo, n = 153). Categorical responder rates of reductions in mean monthly migraine/migrainous days for topiramate- vs placebo-treated subjects were as follows: for ,25% reduction: 68.6% vs 51.6% (P = .005); ,50%: 37.3% vs 28.8% (P = .093); and ,75%: 15.0% vs 9.2% (P = .061). The decrease in mean monthly total headache days and headache-free days for topiramate vs placebo treatment was 5.8 vs 4.7 days (P = .067). Compared with placebo, topiramate treatment resulted in statistically significant mean improvements in the Role Restrictive (P = .028) and Emotional Function (P = .036) domains of the Migraine-Specific Quality of Life Questionnaire, in the worst daily severity of migraine (P = .016), severity of photophobia (P = .032), frequency of vomiting (P = .018), photophobia (P = .038), phonophobia (P = .010), unilateral pain (P = .015), pulsatile pain (P = .023), and pain worsened because of physical activity (P = .047). In addition, there were trends observed (favoring topiramate) in average daily severity of migraine (P = .077), acute headache medication use (P = .127), severity of nausea (P = .098), frequency of nausea (P = .166), the Role Preventive domain of the Migraine-Specific Quality of Life Questionnaire (P = .061), and severity of phonophobia (P = .062). Conclusions., In addition to significantly reducing mean monthly migraine/migrainous and migraine headache days, treatment of chronic migraine with topiramate was effective with regard to several traditionally important and clinically relevant secondary outcomes in migraine prevention trials. Treatment with topiramate was well tolerated and not associated with serious adverse events. [source] Treatment-Refractory Chronic Migraine: The Ogre Emerges from the ShadowsHEADACHE, Issue 4 2009John F. Rothrock MD Editor-in-Chief No abstract is available for this article. [source] Research Submission: Chronic Headache and Comorbibities: A Two-Phase, Population-Based, Cross-Sectional StudyHEADACHE, Issue 8 2010Ariovaldo Da Silva Jr MD Background., Studies using resources of a public family health program to estimate the prevalence of chronic daily headaches (CDH) are lacking. Objectives., To estimate the 1-year prevalence of CDH, as well as the presence of associated psychiatric and temporomandibular disorders (TMD) comorbidities, on the entire population of a city representative of the rural area of Brazil. Methods., This was a cross-sectional, population-based, 2-phase study. In the first phase, health agents interviewed all individuals older than 10 years, in a rural area of Brazil. In the second stage, all individuals who reported headaches on 4 or more days per week were then evaluated by a multidisciplinary team. CDH were classified according to the second edition of the International Classification of Headache Disorders (ICHD-2). Medication overuse headache was diagnosed, as per the ICHD-2, after detoxification trials. Psychiatric comorbidities and TMD were diagnosed based on the DSM-IV and on the Research Diagnostic Criteria for Temporomandibular Disorders criteria, respectively. Results., A total of 1631 subjects participated in the direct interviews. Of them, 57 (3.6%) had CDH. Chronic migraine was the most common of the CDH (21, 36.8%). Chronic tension-type headache (10, 17.5%), medication overuse headache (13, 22.8%) and probable medication overuse headache (10, 17.5%) were also common. Psychiatric disorders were observed in 38 (67.3%) of the CDH subjects. TMD were seen in 33 (58.1)% of them. Conclusions., The prevalence of CDH in the rural area of Brazil is similar to what has been reported in previous studies. A significant proportion of them have psychiatric comorbidities and/or TMD. In this sample, comorbidities were as frequent as reported in convenience samples from tertiary headache centers. (Headache 2010;50:1306-1312) [source] Endocrine Function Is Altered in Chronic Migraine Patients with Medication-OveruseHEADACHE, Issue 4 2006Innocenzo Rainero MD Objective.,To evaluate the effects of analgesic overuse on endocrine function in patients with chronic migraine and medication-overuse headache (CM-MOH). Background.,Chronic migraine is frequently associated with an overuse of symptomatic medications. Drugs currently used in acute migraine attacks are associated with several endocrine effects. At present, the endocrine effects of medication overuse in chronic migraine patients are unknown. Methods.,Eighteen patients with CM-MOH, diagnosed according to the ICHD-II criteria, and 18 healthy controls received an intravenous administration of GHRH, hCRH, and TRH. Plasma concentrations of GH, TSH, ACTH, and cortisol were measured for a 90-minute period after administration of the specific releasing hormones. Results.,Hormonal basal concentrations were similar in both groups. GH response to GHRH was significantly reduced in patients with CM-MOH in comparison with controls. TRH induced a reduction of TSH concentrations only at the end of the test. After hCRH administration, ACTH and cortisol concentrations were significantly higher in cases than in controls. A significant correlation between duration of the disease and altered hormonal response was found. Conclusions.,Our study shows that both corticotropic and somatotropic functions are significantly impaired in CM-MOH patients and suggests a role for hormones in the development of chronic migraine. [source] Role of botulinum toxin in migraine therapyDRUG DEVELOPMENT RESEARCH, Issue 7 2007Wilhelm J. Schulte-Mattler Abstract Botulinum toxin effectively blocks the release of acetylcholine from motor nerve terminals. Thus, botulinum toxin injections are well established in the treatment of disorders in which patients are impaired by involuntary muscle contractions. A remarkable pain reduction was frequently observed in these patients, and in vitro studies showed that botulinum toxin reduces not only the release of acetylcholine, but also the release of neuropeptides involved in pain perception. It was therefore hypothesized that botulinum toxin may help patients with pain not caused by muscular contractions, such as migraine or chronic daily headache, which includes chronic migraine. So far, the results of randomized, double-blind, placebo controlled trials on botulinum toxin in a total of 2,612 patients with migraine or with chronic daily headache were published. A superiority of botulinum toxin compared with placebo injections could not clearly be confirmed in any of the studies. One hypothesis derived from these results was that subgroups of patients with migraine can be defined in whom botulinum toxin may be efficacious. This hypothesis awaits confirmation. Interestingly, the efficacy of both botulinum toxin and placebo injections was found to be significant and similar to the efficacy of established oral migraine treatment. This finding may help explain the enthusiasm that followed the first open-label use of botulinum in patients with migraine. Drug Dev Res 68:397,402, 2007. © 2008 Wiley-Liss, Inc. [source] Brain Imaging in Migraine ResearchHEADACHE, Issue 9 2010David Borsook MD Understanding the pathophysiology and pharmacology of migraine has been driven by astute clinical observations, elegant experimental medicine studies, and importantly by studying highly effective anti-migraine agents in the laboratory and the clinic. Significant progress has been made in the use of functional brain imaging to compliment observational studies of migraine phenotypes by highlighting pathways within the brain that may be involved in predisposition to migraine, modulating migraine pain or that could be sensitive to pharmacological or behavioral therapeutic intervention (Fig. 1). In drug discovery, molecular imaging approaches compliment functional neuroimaging by visualizing migraine drug targets within the brain. Molecular imaging enables the selection and evaluation of drug candidates by confirming that they engage their targets sufficiently at well tolerated doses to test our therapeutic hypotheses. Figure 1.,. Imaging and defining the migraine brain disease state: from anatomy to chemical entities (targets) to functional systems (function and pathways) (from Borsook et al31 with permission, Nature Publishing Group). Migraine is a progressive disorder. Developing our knowledge of where drugs act in the brain and of how the brain is altered in both episodic migraine (interictal state and ictal state) and chronic migraine are important steps to understanding why there is such differential responsiveness to therapeutics among migraine patients and to improving how they are evaluated and treated. [source] Research Submission: Mixture Analysis of Age at Onset in Migraine Without Aura: Evidence for Three SubgroupsHEADACHE, Issue 8 2010Carlo Asuni MD (Headache 2010;50:1313-1319) Objective. , To verify the presence of different age at onset (AAO) subgroups of patients in a sample of patients with migraine without aura (MWA) and compare clinical correlates among them. Background., MWA is a long-lasting disease whose prognosis has not yet been fully investigated. Patients may present complete remission, partial clinical remission, persistence and progression (migraine attack frequency and disability may increase over time leading to chronic migraine). Limited evidence exists regarding the identification of risk factors or predictors which might influence migraine prognosis. AAO has been proven a useful tool in the investigation of the clinical, biological, and genetic characteristics able to influence the prognosis of a number of neuropsychiatric disorders. AAO distribution was studied using mixture analysis, a statistical approach that breaks down the empirical AAO distribution observed into a mixture of normal components. Methods., A sample of 334 outpatients affected by MWA, recruited in a clinical genetic study at our Headache Center from 2004 to 2008, was enrolled for this study. Diagnosis was made according to International Headache Society criteria 2004. AAO distribution in patients was studied using mixture analysis. Chi-square test was used to compare clinical correlates among identified subgroups. Logistic regression was performed in order to correct for effect of possible confounders. Results., Mixture analysis broke up the observed distribution of AAO into 3 normal theoretical distributions. Informational criteria clearly showed a better 3-component model rather than the 2-component one. An early-onset (,7 years of age), an intermediate-onset (,8 and ,22), and a late-onset group (,23) were identified. Comparison of clinical correlates among subgroups by means of chi-square test showed a statistically significant result for migraine frequency (,2 = 7.41, P = .02). Considering the frequency of migraine attacks as a main outcome, the regression model showed a higher AAO is associated with low frequency (odds ratio = 0.95; P = .02). Conclusions., The significant association between AAO and attack frequency found in our study supports the hypothesis that AAO could act as a predictor factor able to influence prognosis. AAO could represent a phenotype suitable for identifying MWA susceptibility genes. [source] Brief Communications: An Analysis of Migraine Triggers in a Clinic-Based PopulationHEADACHE, Issue 8 2010Diane Andress-Rothrock MS Background., Many migraineurs report attack "triggers," but relatively few published data exist regarding the relative prevalences of individual triggers, variations related to gender, duration of migraine or migraine subtype, or the existence of any regional variations in the prevalences and distributions of triggers. Objective., We sought to determine the prevalence and types of migraine triggers in our clinic population, to determine what influence gender, migraine subtype, or duration of migraine might have on the prevalences and types of triggers reported and to compare our findings with data derived from surveys we previously had conducted involving 2 clinic-based populations and 1 general population sample from other regions of the USA. Methods., We evaluated 200 consecutive new migraine patients referred to our clinic. All patients specifically were queried as to whether they had noted any of 7 specific factors to serve consistently as migraine attack triggers and additionally were surveyed as to whether they might have "other" triggers not listed on the intake questionnaire. Among the other data collected and analyzed were age, gender, age at time of migraine onset, and migraine subtype (ie, episodic vs chronic). Actively cycling females who reported menses as a trigger were questioned as to whether their menstrual migraine (MM) attacks differed from their non-menstrual migraines and, if so, how they differed. Results., One hundred and eighty-two patients (91%) reported at least 1 migraine trigger, and 165 (82.5%) reported multiple triggers. The most common trigger reported (59%) was "emotional stress," followed by "too much or little sleep" (53.5%), "odors" (46.5%), and "missing meals" (39%). Females or subjects of either gender with chronic migraine were no more likely than males or subjects with episodic migraine to report triggers or multiple triggers. Similarly, longer exposure to migraine did not correlate with a higher likelihood of reporting a trigger or multiple triggers. Fifty-three (62%) of 85 actively cycling females reported menses as a trigger, and of the 51 with menstrually related migraine, 34 (67%) reported their MM to be more severe, more refractory to symptomatic therapy or of longer duration than their non-menstrual attacks; 13 (24.5%) of the 53 women with apparent MM reported their MM to be at least occasionally manifested as status migrainosus. The prevalence and type of triggers reported by this predominantly white female population were similar to those reported by clinic-based populations in San Diego, California and Mobile, Alabama, and in a population-based sample of Hispanics in San Diego County. Conclusions., A large majority of migraineurs report migraine attack triggers, and the triggers most commonly reported include emotional stress, a disrupted sleep pattern, and various odors. These findings do not appear to vary according to geographic region or race/ethnicity. Among the triggers, MM appears inclined to provoke headache that is more severe, less amenable to treatment, or longer in duration than headaches that occur at other times during the cycle. (Headache 2010;50:1366-1370) [source] Suboccipital Nerve Blocks for Suppression of Chronic Migraine: Safety, Efficacy, and Predictors of OutcomeHEADACHE, Issue 6 2010Silvia Weibelt RN (Headache 2010;50:1041-1044) Background., Approximately 1 in 50 Americans is afflicted by chronic migraine (CM). Many patients with CM describe cervicogenic headache. Options for treating CM effectively are at present quite limited. Objective., To determine the safety and efficacy of occipital nerve blocks (ONBs) used to treat cervicogenic chronic migraine (CCM) and to identify variables predictive of a positive treatment response. Methods., Using a uniform dose and injection paradigm, we performed ONBs consecutively on a series of patients presenting with CCM. Patients were stratified according to specific findings found to be present or absent on physical examination. A positive treatment outcome was defined as a 50% or greater reduction in headache days per month over the 30 days following treatment relative to the 30-day pre-treatment baseline. We used a 5-point Likert scale as one of the secondary outcome variables. Results., We treated 150 consecutive patients with unilateral (37) or bilateral (113) ONBs. At the 1-month follow-up visit 78 (52%) exhibited evidence of a positive treatment response according to the primary outcome variable, and 90 (60%) reported their headache disorder to be "better" (44; 29%) or "much better" (46; 30%). A total of 8 (5%) patients reported adverse events within the ensuing 72 hours, and 3 (2%) experienced adverse events that reversed spontaneously but required emergent evaluation and management. Conclusion., For suppression of CCM, ONBs may offer an attractive alternative to orally administered prophylactic therapy. [source] No Influence of 5-HTTLPR Gene Polymorphism on Migraine Symptomatology, Comorbid Depression, and ChronificationHEADACHE, Issue 3 2010Thomas Wieser MD (Headache 2010;50:420-430) Background., The serotonergic system is thought to play an important role for mediating susceptibility to migraine and depression, which is frequently found comorbid in migraine. The functional polymorphism in the serotonin transporter gene linked polymorphic region (5-HTTLPR/SLC6A4) was previously associated with attack frequency and, thus, possibly with chronification. Objective., We hypothesized that patients with the "s" allele have higher attack frequency and, paralleling results in depression research, higher scores of depression. Methods., Genetic analysis of the SLC6A4 44 bp insertion/deletion polymorphism (5-HTTLPR) was performed in 293 patients with migraine with and without aura. Self-rating questionnaires were used for assessment of depression. Results., Multinomial logistic regression analysis found no evidence for association of the 5-HTTLPR polymorphism with either depression or migraine attack frequency. Conclusion., We were not able to demonstrate any influence of the serotonin transporter 5-HTTLPR polymorphism on migraine phenomenology (attack frequency or comorbid depression), thereby excluding this variant to be a common genetic denominator for chronic migraine and depression. [source] Childhood Maltreatment and Migraine (Part II).HEADACHE, Issue 1 2010Emotional Abuse as a Risk Factor for Headache Chronification (Headache 2010;50:32-41) Objectives., To assess in a headache clinic population the relationship of childhood abuse and neglect with migraine characteristics, including type, frequency, disability, allodynia, and age of migraine onset. Background., Childhood maltreatment is highly prevalent and has been associated with recurrent headache. Maltreatment is associated with many of the same risk factors for migraine chronification, including depression and anxiety, female sex, substance abuse, and obesity. Methods., Electronic surveys were completed by patients seeking treatment in headache clinics at 11 centers across the United States and Canada. Physician-determined data for all participants included the primary headache diagnoses based on the International Classification of Headache Disorders-2 criteria, average monthly headache frequency, whether headaches transformed from episodic to chronic, and if headaches were continuous. Analysis includes all persons with migraine with aura, and migraine without aura. Questionnaire collected information on demographics, social history, age at onset of headaches, migraine-associated allodynic symptoms, headache-related disability (The Headache Impact Test-6), current depression (The Patient Health Questionnaire-9), and current anxiety (The Beck Anxiety Inventory). History and severity of childhood (<18 years) abuse (sexual, emotional, and physical) and neglect (emotional and physical) was gathered using the Childhood Trauma Questionnaire. Results., A total of 1348 migraineurs (88% women) were included (mean age 41 years). Diagnosis of migraine with aura was recorded in 40% and chronic headache (,15 days/month) was reported by 34%. Transformation from episodic to chronic was reported by 26%. Prevalence of current depression was 28% and anxiety was 56%. Childhood maltreatment was reported as follows: physical abuse 21%, sexual abuse 25%, emotional abuse 38%, physical neglect 22%, and emotional neglect 38%. In univariate analyses, physical abuse and emotional abuse and neglect were significantly associated with chronic migraine and transformed migraine. Emotional abuse was also associated with continuous daily headache, severe headache-related disability, and migraine-associated allodynia. After adjusting for sociodemographic factors and current depression and anxiety, there remained an association between emotional abuse in childhood and both chronic (odds ratio [OR] = 1.77, 95% confidence intervals [CI]: 1.19-2.62) and transformed migraine (OR = 1.89, 95% CI: 1.25-2.85). Childhood emotional abuse was also associated with younger median age of headache onset (16 years vs 19 years, P = .0002). Conclusion., Our findings suggest that physical abuse, emotional abuse, and emotional neglect may be risk factors for development of chronic headache, including transformed migraine. The association of maltreatment and headache frequency appears to be independent of depression and anxiety, which are related to both childhood abuse and chronic daily headache. The finding that emotional abuse was associated with an earlier age of migraine onset may have implications for the role of stress responses in migraine pathophysiology. [source] A Double-Blind Comparison of OnabotulinumtoxinA (BOTOX®) and Topiramate (TOPAMAX®) for the Prophylactic Treatment of Chronic Migraine: A Pilot StudyHEADACHE, Issue 10 2009Ninan T. Mathew MD Background., There is a need for effective prophylactic therapy for chronic migraine (CM) that has minimal side effects. Objective., To compare the efficacy and safety of onabotulinumtoxinA (BOTOX®, Allergan, Inc., Irvine, CA) and topiramate (TOPAMAX®, Ortho-McNeil, Titusville, NJ) prophylactic treatment in patients with CM. Methods., In this single-center, double-blind trial, patients with CM received either onabotulinumtoxinA, maximum 200 units (U) at baseline and month 3 (100 U fixed-site and 100 U follow-the-pain), plus an oral placebo, or topiramate, 4-week titration to 100 mg/day with option for additional 4-week titration to 200 mg/day, plus placebo saline injections. OnabotulinumtoxinA or placebo saline injection was administered at baseline and month 3 only, while topiramate oral treatment or oral placebo was continued through the end of the study. The primary endpoint was treatment responder rate assessed using Physician Global Assessment 9-point scale (+4 = clearance of signs and symptoms and ,4 = very marked worsening [about 100% worse]). Secondary endpoints included the change from baseline in the number of headache (HA)/migraine days per month (HA diary), and HA disability measured using Headache Impact Test (HIT-6), HA diary, Migraine Disability Assessment (MIDAS) questionnaire, and Migraine Impact Questionnaire (MIQ). The overall study duration was approximately 10.5 months, which included a 4-week screening period and a 2-week optional final safety visit. Follow-up visits for assessments occurred at months 1, 3, 6, and 9. Adverse events (AEs) were documented. Results., Of 60 patients randomized to treatment (mean age, 36.8 ± 10.3 years; 90% female), 36 completed the study at the end of the 9 months of active treatment (onabotulinumtoxinA, 19/30 [63.3%]; topiramate, 17/30 [56.7%]). In the topiramate group, 7/29 (24.1%) discontinued study because of treatment-related AEs vs 2/26 (7.7%) in the onabotulinumtoxinA group. Between 68% and 83% of patients for both onabotulinumtoxinA and topiramate groups reported at least a slight (25%) improvement in migraine; response to treatment was assessed using Physician Global Assessment at months 1, 3, 6, and 9. Most patients in both groups reported moderate to marked improvements at all time points. No significant between-group differences were observed, except for marked improvement at month 9 (onabotulinumtoxinA, 27.3% vs topiramate, 60.9%, P = .0234, chi-square). In both groups, HA/migraine days decreased and MIDAS and HIT-6 scores improved. Patient-reported quality of life measures assessed using MIQ after treatment with onabotulinumtoxinA paralleled those seen after treatment with topiramate in most respects. At month 9, 40.9% and 42.9% of patients in the onabotulinumtoxinA and topiramate groups, respectively, reported ,50% reduction in HA/migraine days. Forty-one treatment-related AEs were reported in 18 onabotulinumtoxinA-treated patients vs 87 in 25 topiramate-treated patients, and 2.7% of patients in the onabotulinumtoxinA group and 24.1% of patients in the topiramate group reported AEs that required permanent discontinuation of study treatment. Conclusions., OnabotulinumtoxinA and topiramate demonstrated similar efficacy in the prophylactic treatment of CM. Patients receiving onabotulinumtoxinA had fewer AEs and discontinuations. [source] Topiramate Treatment of Chronic Migraine: A Randomized, Placebo-Controlled Trial of Quality of Life and Other Efficacy MeasuresHEADACHE, Issue 8 2009Stephen Silberstein MD Objective., To define yet more clearly the utility of topiramate in the treatment of chronic migraine, we evaluated prespecified secondary endpoints from a recent randomized, double-blind, placebo-controlled, multicenter clinical trial. Background., We previously reported that topiramate 100 mg per day produced a statistically significant reduction in mean monthly migraine/migrainous and migraine headache days compared with placebo treatment and that it was safe and generally well tolerated. Methods., Variables analyzed included between-treatment group differences in percent responders, change in the mean monthly rate of total headache days and headache-free days, change in average and worst daily headache severity, change in the mean monthly use of acute headache medications, and absolute change and percent change in a headache index. Additional analyses included evaluation of changes in: the associated symptoms of photophobia, phonophobia, and nausea; Migraine-Specific Quality of Life Questionnaire scores; Migraine Disability Assessment Scale scores; and Physician's and Subjects Global Impression of Change. Results., The intent-to-treat population consisted of 306 patients (topiramate, n = 153; placebo, n = 153). Categorical responder rates of reductions in mean monthly migraine/migrainous days for topiramate- vs placebo-treated subjects were as follows: for ,25% reduction: 68.6% vs 51.6% (P = .005); ,50%: 37.3% vs 28.8% (P = .093); and ,75%: 15.0% vs 9.2% (P = .061). The decrease in mean monthly total headache days and headache-free days for topiramate vs placebo treatment was 5.8 vs 4.7 days (P = .067). Compared with placebo, topiramate treatment resulted in statistically significant mean improvements in the Role Restrictive (P = .028) and Emotional Function (P = .036) domains of the Migraine-Specific Quality of Life Questionnaire, in the worst daily severity of migraine (P = .016), severity of photophobia (P = .032), frequency of vomiting (P = .018), photophobia (P = .038), phonophobia (P = .010), unilateral pain (P = .015), pulsatile pain (P = .023), and pain worsened because of physical activity (P = .047). In addition, there were trends observed (favoring topiramate) in average daily severity of migraine (P = .077), acute headache medication use (P = .127), severity of nausea (P = .098), frequency of nausea (P = .166), the Role Preventive domain of the Migraine-Specific Quality of Life Questionnaire (P = .061), and severity of phonophobia (P = .062). Conclusions., In addition to significantly reducing mean monthly migraine/migrainous and migraine headache days, treatment of chronic migraine with topiramate was effective with regard to several traditionally important and clinically relevant secondary outcomes in migraine prevention trials. Treatment with topiramate was well tolerated and not associated with serious adverse events. [source] 24-Hour Distribution of Migraine AttacksHEADACHE, Issue 1 2008Karl Alstadhaug MD Background., It is a widespread opinion that migraine attacks arise more frequently in the morning and that circadian rhythms may be responsible for the temporal pattern in migraine. However, only one small prospective study has previously been published on this topic. Objective., To investigate circadian variation in migraine. Method., Eighty-nine females in fertile age who had participated in a previous questionnaire-based study volunteered to prospectively record in detail every migraine attack for 12 consecutive months. We reviewed all diary entries covering the period from March 2004 through April 2005, and did time-series analysis. Results., Fifty-eight patients had complete recordings over the 12 months and 26 completed the diaries for 1,11 months. Three patients were excluded due to missing data and 2 patients were excluded due to chronic migraine or medication-overuse headache. A total of 2314 attacks were experienced, in average 27.5 per patient (range 1,75). By fitting a sine curve to the data there was a harmonic trend with a peak around 13.40 and the peak/low ratio was 25.6 (95% CI: 8.3,78.6). Conclusion., The main finding in our study is that migraine attacks tend to recur in a harmonic 24-hour cyclic manner with a peak around the middle of the day and that there is no difference between migraine with aura and migraine without aura regarding this. [source] A Retrospective, Comparative Study on the Frequency of Abuse in Migraine and Chronic Daily HeadacheHEADACHE, Issue 3 2007B. Lee Peterlin DO Objective.,To assess and contrast the relative frequency of a past history of physical and/or sexual abuse in patients with chronic daily headache (CDH) versus migraine. Background.,A number of risk factors have been identified as risk factors for chronification of headache disorders. Limited data exist regarding the influence of physical and/or sexual abuse on primary headache disorders. Methods.,This was a retrospective chart review of 183 consecutive new headache patients seen from December 2004 through August 2005 at an outpatient tertiary-care center. Patients were included in the study if they had chronic daily headache (with criteria for medication over-use headache or chronic migraine), or migraine with or without aura. A history of physical and/or sexual abuse was systematically asked of all headache patients at their first visit in the clinic. This information was then transferred to a semi-standardized form and the relative frequency of abuse in both groups contrasted. Results.,Of the 161 patients included in the study, 90.1% were female with a mean age of 36.4 ± 12.0. A total of 59.0% of the patients were diagnosed with CDH and 41.0% were diagnosed with migraine. Overall, 34.8% of all patients, 40.0% of CDH patients, and 27.3% of migraine patients had a history of physical and/or sexual abuse. The relative frequency of a history of physical and/or sexual abuse was higher in the CDH group as compared to the migraine group (P= .048). Conclusion.,The relative frequency of abuse is higher in CDH sufferers than migraineurs, suggesting that physical and sexual abuse may be risk factors for chronification. [source] Application of the ICHD-II Criteria to the Diagnosis of Primary Chronic Headaches Via a Computerized Structured RecordHEADACHE, Issue 1 2007Paola Sarchielli MD Background.,The authors recently developed a software program designed to analyze clinical data from patients affected by primary headache. The program is based exclusively on the International Classification of Headache Disorders 2nd edition (ICHD-II) criteria. This software examines all the diagnoses of primary headaches on the basis of the variables needed to fulfill these mandatory criteria. Methods.,We tested the software, Primary Headaches Analyser 1.0 INT (PHA), by entering and analyzing clinical data from 200 consecutive patients affected by primary chronic headaches and evaluating the corresponding output diagnoses. Results.,The diagnosis of chronic migraine (1.5.1) was obtained in 68 cases (34 %) and that of probable chronic migraine (1.6.5) plus probable medication-overuse headache (8.2.8) in 46 (23%). Chronic tension-type headache (2.3) and probable chronic tension-type headache (2.4.3) plus probable medication-overuse headache (8.2.8) were diagnosed in 24 (12%) and 2 (1%) patients, respectively. Moreover, 4 and 12 patients, respectively, received both the diagnosis of chronic migraine (1.5.1) plus chronic tension-type headache (2.3) and of probable migraine (1.6.1) without aura plus chronic tension-type headache (2.3). In the remaining 44 cases (22%), none of the chronic primary headaches disorders defined by ICHD-II received an output diagnosis from the program. This was due mainly to the fact that the criteria fulfilled were insufficient for the diagnoses of migraine without (1.1) aura plus chronic migraine or, more infrequently, chronic tension-type headache. Conclusions.,Our software program permitted diagnoses of chronic migraine, chronic tension-type or their probable forms (with or without MOH) in 78% of 200 patients with headache 15 or more days per month. In the remaining cases the inability to provide a specific diagnosis may be explained in part by the fact that the criteria for both diagnoses are too stringent and do not accurately reflect variations of the headache pattern in these chronic forms. [source] Endocrine Function Is Altered in Chronic Migraine Patients with Medication-OveruseHEADACHE, Issue 4 2006Innocenzo Rainero MD Objective.,To evaluate the effects of analgesic overuse on endocrine function in patients with chronic migraine and medication-overuse headache (CM-MOH). Background.,Chronic migraine is frequently associated with an overuse of symptomatic medications. Drugs currently used in acute migraine attacks are associated with several endocrine effects. At present, the endocrine effects of medication overuse in chronic migraine patients are unknown. Methods.,Eighteen patients with CM-MOH, diagnosed according to the ICHD-II criteria, and 18 healthy controls received an intravenous administration of GHRH, hCRH, and TRH. Plasma concentrations of GH, TSH, ACTH, and cortisol were measured for a 90-minute period after administration of the specific releasing hormones. Results.,Hormonal basal concentrations were similar in both groups. GH response to GHRH was significantly reduced in patients with CM-MOH in comparison with controls. TRH induced a reduction of TSH concentrations only at the end of the test. After hCRH administration, ACTH and cortisol concentrations were significantly higher in cases than in controls. A significant correlation between duration of the disease and altered hormonal response was found. Conclusions.,Our study shows that both corticotropic and somatotropic functions are significantly impaired in CM-MOH patients and suggests a role for hormones in the development of chronic migraine. [source] Factors Associated With Burden of Primary Headache in a Specialty ClinicHEADACHE, Issue 6 2003Eugene M. Cassidy MRCPsych Objective.,To examine factors associated with social, occupational, and psychological burden of common primary headache (migraine and tension-type headache). Background.,The personal and social burden of primary headache is high. Health, occupational, social, and psychological factors contributing to burden in people with disabling headache have not been fully unravelled. Methods.,One hundred eighty consecutive patients with either migraine or tension-type headache attending a specialty headache outpatient clinic for the first time were evaluated over a 9-month period. Headache subtype was operationally defined according to International Headache Society criteria. Headache frequency, duration, and severity were recorded. Occupational and social disability were quantified using the Migraine Disability Assessment questionnaire. Psychological burden was quantified using the 28-item General Health Questionnaire, the Beck Depression Inventory, and the State-Trait Anxiety Inventory. Premorbid vulnerability to life stress was quantified using the neuroticism subscale of the Eysenck Personality Inventory. Results.,Patients with frequent (chronic) headache scored higher on the Migraine Disability Assessment questionnaire and had higher Beck Depression Inventory and General Health Questionnaire depression scores than those with less frequent (episodic) headache. Frequency of headache, but not pain severity, duration, or diagnosis, predicted both Migraine Disability Assessment total disability and General Health Questionnaire/Beck Depression Inventory depression. Neuroticism was predictive of depression but not disability. Patients with chronic migraine had the highest depression and disability scores. Conclusion.,The number of days per month with headache is a key determinant of headache-related burden in those attending specialty clinics. Frequent (chronic) headache is associated with significantly higher psychopathology scores and general social impairment, but the direction of this relationship is not clear. Those with migraine and chronicity are the most impaired. [source] Correlations between alexithymia and pain severity, depression, and anxiety among patients with chronic and episodic migrainePSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 3 2010Irem Yalug MD Aims:, Some studies have found elevated alexithymia among patients with chronic pain, but the correlations between alexithymia and the severity of pain, depression, and anxiety among migraine patients are unclear. The aims of the present study were to investigate whether individuals suffering from episodic migraine (EM) differ from those with chronic migraine (CM) in regards to depression, anxiety, and alexithymia measures and to investigate the association of alexithymia with the results of depression and anxiety test inventories and illness characteristics. Methods:, A total of 165 subjects with EM and 135 subjects with CM were studied. The Beck Depression Inventory (BDI), State,Trait Anxiety Inventory (STAI), and Toronto Alexithymia Scale (TAS) were administered to all subjects. The correlation between alexithymia and sociodemographic variables, family history of migraine and illness characteristics (pain severity, frequency of episode, duration of illness) were evaluated. Results:, Compared with EM patients, the CM patients had significantly higher scores on measures of depression but not alexithymia and anxiety. There was a positive correlation between TAS scores and age and education in both migraine groups, but there was no correlation between TAS scores and other demographic variables. Depression and anxiety were significantly correlated with alexithymia in both migraine groups. Conclusion:, Our results indicate that CM patients are considerably more depressive than EM patients. In this study, depression and anxiety were significantly correlated with alexithymia in both migraine groups. Our results demonstrate a positive association between depression, anxiety, and alexithymia in migraine patients. [source] Development and Validation of the Headache Needs Assessment (HANA) SurveyHEADACHE, Issue 4 2001Joyce A. Cramer BS Objective.,To develop and validate a brief survey of migraine-related quality-of-life issues. The Headache Needs Assessment (HANA) questionnaire was designed to assess two dimensions of the chronic impact of migraine (frequency and bothersomeness). Methods.,Seven issues related to living with migraine were posed as ratings of frequency and bothersomeness. Validation studies were performed in a Web-based survey, a clinical trial responsiveness population, and a retest reliability population. Headache characteristics (eg, frequency, severity, and treatment), demographic information, and the Headache Disability Inventory were used for external validation. Results.,The HANA was completed in full by 994 adults in the Web survey, with a mean total score of 77.98 ± 40.49 (range, 7 to 175). There were no floor or ceiling effects. The HANA met the standards for validity with internal consistency reliability (Cronbach , = .92, eigenvalue for the single factor = 4.8, and test-retest reliability = 0.77). External validity showed a high correlation between HANA and Headache Disability Inventory total scores (0.73, P<.0001), and high correlations with disease and treatment characteristics. Conclusions.,These data demonstrate the psychometric properties of the HANA. The brief questionnaire may be a useful screening tool to evaluate the impact of migraine on individuals. The two-dimensional approach to patient-reported quality of life allows individuals to weight the impact of both frequency and bothersomeness of chronic migraines on multiple aspects of daily life. [source] | ||||||||||