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Differences in Pediatric Headache Prescription Patterns by Diagnosis
Abstract
Background:
Few studies have reported prescription patterns for headache medication.
Objective:
The aim was to present the rates of specific medication prescribed to pediatric patients diagnosed with migraine, tension-type headache (TTH), and new daily persistent headache (NDPH), as well as differences in those prescription patterns by diagnosis, age, and gender.
Patients and methods:
A query using the i2b2 platform yielded 14,591 patients [migraine 10,547 (72.3%); TTH 3200 (21.9%); NDPH 844 (5.8%)] seen over a 3-year period, who were aged 4-17 years at the time of their visit and diagnosed with migraine, TTH, or NDPH.
Results:
Sumatriptan was the most frequently prescribed medication for migraine followed by amitriptyline. The most frequently prescribed medication for both TTH and NDPH was amitriptyline, followed by sumatriptan in TTH and by topiramate in NDPH. Age and gender differences were also found in prescription patterns of each of the diagnoses. The differences in prescription patterns found between the diagnoses, as well as age and gender differences found within the diagnoses, are discussed.
Conclusions:
A wide range of medications are prescribed to children and adolescents with headache, with most medications prescribed for off-label use. As these medications are not Food and Drug Administration (FDA) approved for use in children and adolescents with headache, there is a need for large scale, randomized controlled trials to assess the efficacy of these medications.
... Within the CDH population at tertiary centers, the prevalence of NDPH in children and adolescents ranges from 0.9 to 35%, compared to 1.7 to 10.8% in adults [19]. It maintains a female predominance throughout life, with a 2.5:1 female/male ratio in adults and a 1.8:1 female/male ratio in children and adolescents, and has an earlier age at onset in females (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35) than in males (26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45) [2]. ...
... In addition, muscle relaxers such as tizanidine and anti-emetics such as ondansetron, prochlorperazine, and promethazine are commonly used. As APAP/butalbital/caffeine is also prescribed, education is needed to reduce the risk of MOH [38]. While occipital nerve blocks appear to be more effective in cluster headache and migraine, two studies show some efficacy in pediatric NDPH [16,39]. ...
... While there is little evidence for which medications are most effective in pediatric patients, a 2018 study of prescription patterns in pediatric headache, including 844 patients with a diagnosis of NDPH, found that amitriptyline and topiramate were the most frequently prescribed medications in pediatric NDPH, accounting for more than 10% of patients. Other medications, such as gabapentin, zonisamide, propranolol, verapamil, clonidine, nortriptyline, sertraline, citalopram, fluoxetine, escitalopram, venlafaxine, and cyproheptadine, were also commonly prescribed to pediatric patients with NDPH [38]. A 2022 retrospective study of 46 patients with NDPH showed that 80% showed at least a 50% reduction in headache days with preventive medication, but 20% showed no response [12]. ...
Purpose of review: New daily persistent headache (NDPH) is a primary headache disorder characterized by the sudden onset of continuous pain and its intractability to treatment. It is more prevalent in the pediatric population than the adult population, but remains understudied and underdiagnosed. The purpose of the current article is to provide a current overview of new daily persistent headache in the pediatric and adolescent population, including history, pathophysiology, clinical findings, current and emerging treatment options, and the results of recent studies and meta-analyses. Recent findings: Despite recent studies and meta-analyses showing significant phenotypic overlap between chronic migraine and NDPH in the pediatric population, multiple recent studies have come to conflicting conclusions about the overlap of medication overuse in headache and pediatric NDPH. Recent studies reveal alterations in neuroimaging, particularly in functional connectivity, in patients with NDPH. Patients frequently remain treatment-refractory even to medications that have historically proven helpful in this population; however, new treatment options, including calcitonin gene-related peptide (CGRP) monoclonal antibodies, may be more effective. Summary: NPDH remains a perplexing and difficult-to-manage condition for both children and adults. Despite a higher prevalence in the pediatric population, there are relatively few studies to guide the evaluation and treatment of NDPH in pediatric and adolescent patients. Early treatment, both pharmacological and non-pharmacological, should be employed to reduce disability. Overall, further studies are needed to better understand pathogenesis and to identify more effective therapeutic strategies, both pharmacological and non-pharmacological.
... Recent studies on medical management of pediatric CDH Amitriptyline and topiramate both have been the most widely used medications to treat CDH in pediatric clinical settings [52]. In a small randomized trial comparing amitriptyline at 0.5 mg/kg/d and topiramate up to 100 mg/d in a sample of 57 children aged 9-16 years with CDH, response rates (defined as 50% reduction in headache days) were found to be fairly comparable at 61 and 50% of the sample, respectively, over a 4-month treatment period [53]. ...
Headache disorders subsumed under the term chronic daily headache (CDH), including chronic migraine, chronic tension-type headache and new daily persistent headache, affect up to 4% of the pediatric population and can be highly disabling and challenging to effectively treat. Although historically the knowledge base about this group of headache disorders in children primarily was derived from clinical observation and extrapolation from adult studies, over the past several years there have been important research findings relevant to the development and management of pediatric CDH that can help inform clinical practice. The intent of this paper is to provide a focused review on recent empirical work done on pediatric CDH and suggest avenues for future work.
Objective:
We aimed to compare the prescribing patterns of preventive medications between pediatric and adult neurologists for young adults with migraine.
Background:
Although preventive medications are effective for adults with migraine, studies in children have failed to demonstrate similar efficacy. As a result, lifestyle modifications and non-pharmacological interventions are often emphasized in children. It is not known whether young adults are prescribed preventive medications at different rates according to whether they are cared for by an adult or pediatric neurologist.
Methods:
We performed a multicenter retrospective cohort analysis of patients with migraine aged 18-25 years who were seen by a pediatric or adult neurologist at Mass General Brigham Hospital between 2017 and 2021. The primary outcome was whether the patient received a prescription for any preventive medication during the study period.
Results:
Among the 767 included patients, 290 (37.8%) were seen by a pediatric neurologist. Preventive medications were prescribed for 131/290 (45.2%; 95% confidence interval [CI]: 39.5%, 51.0%) patients seen by a pediatric neurologist and 206/477 (43.2%; 95% CI: 39.0%, 47.7%) patients seen by an adult neurologist (p = 0.591). In the mixed effects logistic regression model, clinician specialty was not associated with preventive medication use (adjusted odds ratio [AOR] 1.20, 95% CI: 0.62, 2.31). Female sex (AOR 1.69, 95% CI: 1.07, 2.66) and number of visits during the study period (AOR 1.64, 95% CI: 1.49, 1.80) were associated with receiving preventive medication.
Conclusion:
Approximately two fifths of young adults with migraine were prescribed preventive medications, and this proportion did not differ according to clinician specialty. Although these findings suggest that pediatric and adult neurologists provide comparable care, both specialties may be underusing preventive medications in this patient population.
ZUSAMMENFASSUNG
Der neu aufgetretene tägliche Kopfschmerz (englisch: new daily persistent headache, NDPH) ist 2004 als eigenständiger idiopathischer Kopfschmerz in die International Classification of Headache Disorders aufgenommen worden. Er ist wenig bekannt, obwohl die Prävalenz in etwa der des Clusterkopfschmerzes entspricht. Der Kopfschmerz ist definiert durch seinen plötzlichen Beginn innerhalb eines Tages und das seitdem ununterbrochene Auftreten ohne jegliche Pause. Der Kopfschmerz selbst ist unspezifisch und meistens von mittlerer Intensität. Die Pathophysiologie ist gänzlich unbekannt, obwohl eine postinfektiöse Genese immer wieder postuliert worden ist. Ein weiteres Merkmal ist das sehr schlechte Ansprechen auf sämtliche Therapieverfahren. Die Therapie ist dementsprechend rein empirisch; intravenöse Infusionen mit Lidocain oder Ketamin scheinen die beste, aber nur eine kurz anhaltende Wirksamkeit zu zeigen. Botulinumtoxin ist ebenfalls in einigen Fällen als wirksam beschrieben worden. Orale Therapieversuche scheitern sehr häufig. Wichtig für die Betroffenen ist es vor allem, eine korrekte Diagnose zu erhalten und zu lernen, mit dem Kopfschmerz umzugehen.
Background
Which, medication, if any, to use to prevent the headache of pediatric migraine has not been established.
Methods
We conducted a randomized, double-blind, placebo-controlled trial of amitriptyline (1 mg per kilogram of body weight per day), topiramate (2 mg per kilogram per day), and placebo in children and adolescents 8 to 17 years of age with migraine. Patients were randomly assigned in a 2:2:1 ratio to receive one of the medications or placebo. The primary outcome was a relative reduction of 50% or more in the number of headache days in the comparison of the 28-day baseline period with the last 28 days of a 24-week trial. Secondary outcomes were headache-related disability, headache days, number of trial completers, and serious adverse events that emerged during treatment.
Results
A total of 361 patients underwent randomization, and 328 were included in the primary efficacy analysis (132 in the amitriptyline group, 130 in the topiramate group, and 66 in the placebo group). The trial was concluded early for futility after a planned interim analysis. There were no significant between-group differences in the primary outcome, which occurred in 52% of the patients in the amitriptyline group, 55% of those in the topiramate group, and 61% of those in the placebo group (amitriptyline vs. placebo, P=0.26; topiramate vs. placebo, P=0.48; amitriptyline vs. topiramate, P=0.49). There were also no significant between-group differences in headache-related disability, headache days, or the percentage of patients who completed the 24-week treatment period. Patients who received amitriptyline or topiramate had higher rates of several adverse events than those receiving placebo, including fatigue (30% vs. 14%) and dry mouth (25% vs. 12%) in the amitriptyline group and paresthesia (31% vs. 8%) and weight loss (8% vs. 0%) in the topiramate group. Three patients in the amitriptyline group had serious adverse events of altered mood, and one patient in the topiramate group had a suicide attempt.
Conclusions
There were no significant differences in reduction in headache frequency or headache-related disability in childhood and adolescent migraine with amitriptyline, topiramate, or placebo over a period of 24 weeks. The active drugs were associated with higher rates of adverse events. (Funded by the National Institutes of Health; CHAMP ClinicalTrials.gov number, NCT01581281).
Serotonin is a monoamine neurotransmitter that plays a major role in both nociception and mood regulation. Alterations in the 5-hydroxytryptophan (5HT) system have been reported in chronic pain patients. In recent years, Selective Serotonin Reuptake Inhibitors (SSRIs) have been suggested as an alternative treatment for chronic pain due to the fact that they are better tolerated presenting less secondary effects than other antidepressants such as tricyclic antidepressants. Although several clinical trials have been published, the effectiveness of SSRI as treatment for pain conditions is inconclusive. This review aims to summarise what is known, regarding the effectiveness of SSRI as a treatment for chronic pain conditions in adults. A total of 36 studies involving a total of 1898 participants were included in this review. Of the 36 trials included in the review, 2 used zimelidine as treatment, 3 used escitalopram, 4 used fluvoxamine, 4 used sertraline, 6 used citalopram, 8 used paroxetine, 9 used fluoxetine, and one used both citalopram and paroxetine. Because the trials included in this review are quite heterogeneous, only qualitative analyses were performed. SSRI seems to have an effect on most of chronic pain conditions; however, further clinical trials with good methodology leading to low risk of bias are needed in order to conclude once and for all the effect of this drug class as treatment for chronic pain conditions.
BACKGROUND:
This is an update of the original Cochrane review first published in Issue 1, 2003, and previously updated in 2009 and 2012. Chronic pain affects many children, who report severe pain, disability, and distressed mood. Psychological therapies are emerging as effective interventions to treat children with chronic or recurrent pain. This update focuses specifically on psychological therapies delivered face-to-face, adds new randomised controlled trials (RCTs), and additional data from previously included trials.
OBJECTIVES:
There were three objectives to this review. First, to determine the effectiveness on clinical outcomes of pain severity, disability, depression, and anxiety of psychological therapy delivered face-to-face for chronic and recurrent pain in children and adolescents compared with active treatment, waiting-list, or standard medical care. Second, to evaluate the impact of psychological therapies on depression and anxiety, which were previously combined as 'mood'. Third, we assessed the risk of bias of the included studies and the quality of outcomes using the GRADE criteria.
SEARCH METHODS:
Searches were undertaken of CENTRAL, MEDLINE, EMBASE, and PsycINFO. We searched for further RCTs in the references of all identified studies, meta-analyses, and reviews. Trial registry databases were also searched. The date of most recent search was January 2014.
SELECTION CRITERIA:
RCTs with at least 10 participants in each arm post-treatment comparing psychological therapies with active treatment, standard medical care, or waiting-list control for children or adolescents with episodic, recurrent or persistent pain were eligible for inclusion. Only trials conducted in person (face-to-face) were considered. Studies that delivered treatment remotely were excluded from this update.
DATA COLLECTION AND ANALYSIS:
All included studies were analysed and the quality of outcomes were assessed. All treatments were combined into one class, psychological treatments. Pain conditions were split into headache and non-headache. Both conditions were assessed on four outcomes: pain, disability, depression, and anxiety. Data were extracted at two time points; post-treatment (immediately or the earliest data available following end of treatment) and at follow-up (between three and 12 months post-treatment).
MAIN RESULTS:
Seven papers were identified in the updated search. Of these papers, five presented new trials and two presented follow-up data for previously included trials. Five studies that were previously included in this review were excluded as therapy was delivered remotely. The review thus included a total of 37 studies. The total number of participants completing treatments was 2111. Twenty studies addressed treatments for headache (including migraine); nine for abdominal pain; two for mixed pain conditions including headache pain, two for fibromyalgia, two for recurrent abdominal pain or irritable bowel syndrome, and two for pain associated with sickle cell disease.Analyses revealed psychological therapies to be beneficial for children with chronic pain on seven outcomes. For headache pain, psychological therapies reduced pain post-treatment and at follow-up respectively (risk ratio (RR) 2.47, 95% confidence interval (CI) 1.97 to 3.09, z = 7.87, p < 0.01, number needed to treat to benefit (NNTB) = 2.94; RR 2.89, 95% CI 1.03 to 8.07, z = 2.02, p < 0.05, NNTB = 3.67). Psychological therapies also had a small beneficial effect at reducing disability in headache conditions post-treatment and at follow-up respectively (standardised mean difference (SMD) -0.49, 95% CI -0.74 to -0.24, z = 3.90, p < 0.01; SMD -0.46, 95% CI -0.78 to -0.13, z = 2.72, p < 0.01). No beneficial effect was found on depression post-treatment (SMD -0.18, 95% CI -0.49 to 0.14, z = 1.11, p > 0.05). At follow-up, only one study was eligible, therefore no analysis was possible and no conclusions can be drawn. Analyses revealed a small beneficial effect for anxiety post-treatment (SMD -0.33, 95% CI -0.61 to -0.04, z = 2.25, p < 0.05). However, this was not maintained at follow-up (SMD -0.28, 95% CI -1.00 to 0.45; z = 0.75, p > 0.05).Analyses revealed two beneficial effects of psychological treatment for children with non-headache pain. Pain was found to improve post-treatment (SMD -0.57, 95% CI -0.86 to -0.27, z = 3.74, p < 0.01), but not at follow-up (SMD -0.11, 95% CI -0.41 to 0.19, z = 0.73, p > 0.05). Psychological therapies also had a beneficial effect for disability post-treatment (SMD -0.45, 95% CI -0.71 to -0.19, z = 3.40, p < 0.01), but this was not maintained at follow-up (SMD -0.35, 95% CI -0.71 to 0.02, z = 1.87, p > 0.05). No effect was found for depression or anxiety post-treatment (SMD -0.07, 95% CI -0.30 to 0.17, z = 0.54, p > 0.05; SMD -0.15, 95% CI -0.36 to 0.07, z = 1.33, p > 0.05) or at follow-up (SMD 0.06, 95% CI -0.16 to 0.28, z = 0.53, p > 0.05; SMD 0.05, 95% CI -0.24 to 0.33, z = 0.32, p > 0.05).
AUTHORS' CONCLUSIONS:
Psychological treatments delivered face-to-face are effective in reducing pain intensity and disability for children and adolescents (<18 years) with headache, and therapeutic gains appear to be maintained, although this should be treated with caution for the disability outcome as only two studies could be included in the follow-up analysis. Psychological therapies are also beneficial at reducing anxiety post-treatment for headache. For non-headache conditions, psychological treatments were found to be beneficial for pain and disability post-treatment but these effects were not maintained at follow-up. There is limited evidence available to estimate the effects of psychological therapies on depression and anxiety for children and adolescents with headache and non-headache pain. The conclusions of this update replicate and add to those of the previous review which found that psychological therapies were effective in reducing pain intensity for children with headache and non-headache pain conditions, and these effects were maintained at follow-up for children with headache conditions.
Migraine is a prevalent disabling neurological disorder associated with a wide range of medical and psychiatric comorbidities. Population- and clinic-based studies suggest that psychiatric comorbidities, particularly mood and anxiety disorders, are more common among persons with chronic migraine than among those with episodic migraine. Additional studies suggest that psychiatric comorbidities may be a risk factor for migraine chronification (i.e., progression from episodic to chronic migraine). It is important to identify and appropriately treat comorbid psychiatric conditions in persons with migraine, as these conditions may contribute to increased migraine-related disability and impact, diminished health-related quality of life, and poor treatment outcomes. Here, we review the current literature on the rates of several psychiatric comorbidities, including depression, anxiety, and post-traumatic stress disorder, among persons with migraine in clinic- and population-based studies. We also review the link between physical, emotional, and substance abuse, psychiatric disorders, and migraine. Finally, we review the data on psychiatric risk factors for migraine chronification and explore theories and evidence underlying the comorbidity between migraine and these psychiatric disorders.
To describe the prevalence, sociodemographic profile, and the burden of migraine in the United States in 1999 and to compare results with the original American Migraine Study, a 1989 population-based study employing identical methods.
A validated, self-administered questionnaire was mailed to a sample of 20 000 households in the United States. Each household member with severe headache was asked to respond to questions about symptoms, frequency, and severity of headaches and about headache-related disability. Diagnostic criteria for migraine were based on those of the International Headache Society. This report is restricted to individuals 12 years and older.
Of the 43 527 age-eligible individuals, 29 727 responded to the questionnaire for a 68.3% response rate. The prevalence of migraine was 18.2% among females and 6.5% among males. Approximately 23% of households contained at least one member suffering from migraine. Migraine prevalence was higher in whites than in blacks and was inversely related to household income. Prevalence increased from aged 12 years to about aged 40 years and declined thereafter in both sexes. Fifty-three percent of respondents reported that their severe headaches caused substantial impairment in activities or required bed rest. Approximately 31% missed at least 1 day of work or school in the previous 3 months because of migraine; 51% reported that work or school productivity was reduced by at least 50%.
Two methodologically identical national surveys in the United States conducted 10 years apart show that the prevalence and distribution of migraine have remained stable over the last decade. Migraine-associated disability remains substantial and pervasive. The number of migraineurs has increased from 23.6 million in 1989 to 27.9 million in 1999 commensurate with the growth of the population. Migraine is an important target for public health interventions because it is highly prevalent and disabling.
New daily persistent headache (NDPH) is a form of chronic daily headache (CDH) that may have features of both migraine and tension-type headache. In contrast with other types of CDH, NDPH is characterized by patients recalling the specific date their unremitting daily headache began. In comparison, chronic tension-type headache and chronic migraine are preceded by a gradually increasing frequency of headache. After several months, all three of these CDH forms often have a similar phenotype, making early history a key to diagnosing NDPH. Evaluations to exclude secondary causes are necessary but usually negative. NDPH is difficult to treat and requires a multimodal approach. Questions regarding NDPH remain unanswered. Additional prospective studies are necessary to further understand, characterize, diagnose, and treat NDPH.
Informatics for Integrating Biology and the Bedside (i2b2) is one of seven projects sponsored by the NIH Roadmap National Centers for Biomedical Computing (http://www.ncbcs.org). Its mission is to provide clinical investigators with the tools necessary to integrate medical record and clinical research data in the genomics age, a software suite to construct and integrate the modern clinical research chart. i2b2 software may be used by an enterprise's research community to find sets of interesting patients from electronic patient medical record data, while preserving patient privacy through a query tool interface. Project-specific mini-databases ("data marts") can be created from these sets to make highly detailed data available on these specific patients to the investigators on the i2b2 platform, as reviewed and restricted by the Institutional Review Board. The current version of this software has been released into the public domain and is available at the URL: http://www.i2b2.org/software.
Selective serotonin reuptake inhibitor (SSRI) prescriptions for children and adolescents have increased greatly in recent years despite a paucity of demonstrated safety and efficacy data and a lack of clear guidelines for use. Our study sought to describe family physician and pediatrician SSRI prescribing patterns for children and adolescents, identify influences on SSRI prescription variations, and describe the use of SSRI within the overall management of depression and other mental disorders in primary care.
A survey was mailed to all 596 active North Carolina general pediatricians and a random sample of 557 family physicians in primary care practice. Family physicians who did not see children in their practice were excluded. The survey instrument consisted of a 4-page questionnaire. Survey items included physician demographics, practice characteristics, general management, volume of pediatric patients with depressive symptoms, prescription of SSRIs for depression and other diagnoses, and potential influences on SSRI prescribing practices. The main outcomes were self-reported physician prescription of SSRIs for children and adolescents. Results were analyzed using chi(2) comparisons and logistic regression.
The overall response rate was 66% (55% family physicians and 76% pediatricians). Of the physicians, 72% had prescribed an SSRI for a child or adolescent. Depression was the most common reason for prescribing an SSRI; over two thirds of respondents had prescribed an SSRI for depression in a child 18 years of age or younger. Over half of the physicians reported they had prescribed an SSRI for a diagnosis other than depression in a child 18 years of age or younger. Attention-deficit/hyperactivity disorder was the most frequent use cited other than depression, followed by obsessive-compulsive disorder, aggression, eating disorders, and enuresis. Primary care physicians prescribed SSRIs for adolescents more commonly than for younger children. Only 6% of the respondents had ever prescribed an SSRI for a child younger than 6 years of age. In terms of SSRI prescriptions written for depression in the last 6 months, 32% of the physicians had recently prescribed SSRIs for adolescent patients and 6% for patients younger than 12 years of age. Family physicians were more likely than pediatricians to have recently prescribed SSRIs for adolescent patients (41% vs 26%), but there was no difference in recent SSRI prescriptions for children <12 years of age by physician specialty (4% vs 6%). Prescription of SSRIs was not associated with decreased use of counseling for treatment of depression, but prescription of SSRIs was associated with decreased use of referrals (63% vs 74%). There was no difference in the use of counseling between family physicians and pediatricians (61% vs 59%). However, pediatricians were more likely to use referrals in their usual approach to depression (77% vs 48%) compared with family physicians. More family physicians had prescribed SSRIs for pediatric patients compared with pediatricians (91% vs 58%), and more family physicians had prescribed SSRIs in combination with other psychotropic medications (54% vs 31%). For the majority of respondents, SSRI prescriptions constituted most of the medications used to treat childhood depression (75% of family physicians vs 61% of pediatricians). Family physicians were more likely to report a belief in the safety (63% vs 48%) and effectiveness (40% vs 32%) of SSRIs. Only 8% of physicians reported adequate training in the treatment of childhood depression and just 16% were comfortable with the treatment of depression. There were no specialty differences in training for the treatment of childhood depression; however, more family physicians than pediatricians agreed that they were comfortable with the management of childhood depression (22% vs 11%). (ABSTRACT TRUNCATED)
To describe the patterns of medical treatment for migraineurs in the United States.
Over the past decade, many new treatments for migraine have become available and awareness of migraine has improved. However, there is little information about the patterns of medical treatment in the US society.
A validated self-administered headache questionnaire was mailed to a random sample of 120,000 US households. Each household member with severe headaches was asked to complete the survey. The questionnaire assessed headache features, disability, and patterns of medical treatment. Subjects were classified according to their use of headache preventive medication, as current users, coincident users (using effective medications for other medical reasons), lapsed users (had used in the past but not at the time of the survey), or never users.
In 162,576 participants, the prevalence of migraine was 17.1% in women and 5.6% in men. Only 56.2% of those with migraine had ever received a medical diagnosis. Ninety-eight percent of the migraineurs used acute treatment for their migraine attacks. Forty-nine percent (49%) usually used over-the-counters, 20% usually used prescription medications, and 29% used both. Only 12.4% of migraineurs indicated that they were taking a migraine preventive medication, but 17.2% were using medications with potential antimigraine effects for other medical reasons. Current or past use of preventive medication was more likely in women than men (odds ratio [OR] = 1.37, 95% confidence interval [CI] 1.27-1.48), increased with age and individuals with high MIDAS grade (Grade IV vs I, OR 2.35, 95% CI 2.09-2.64). Preventive medication use increased with awareness of migraine and with illness severity.
Migraine remains undertreated in the US population. Barriers to preventive treatment are greater in younger age groups, men, and people unaware that they have migraine.
Pediatric migraine is a disabling condition, which can cause a significant impact on quality of life. Currently, no drugs have been approved by the FDA for its preventive treatment. Our aim was to review the medical literature concerning the efficacy and tolerability of topiramate in the prophylactic treatment of migraine in children and adolescents. A total of five papers were reviewed: two randomized controlled trials (RCTs), a post-hoc subset analysis of adolescents who had been included in three RCTs carried out on adults and two open studies. Topiramate has been proven to reduce headache frequency and the accompanying disability. The frequency of side effects varied considerably among studies, the most frequent being weight loss, anorexia, abdominal pain, difficulties in concentrating, sedation and paresthesia. Since these adverse events, although often transitory, may be distressing for the child, we strongly recommend to assess the disability caused by the migraine episodes before deciding to initiate a prophylactic treatment. Nevertheless, dropout rates due to side effects in the studies were very low.
Objective:
To examine whether sleep disturbance differs by headache diagnosis in a pediatric sample, and whether this effect remains when other factors affecting sleep are included.
Background:
Primary headache disorders can be severe and disabling, impacting a child's functioning and quality of life. Many children and adolescents with chronic headaches also experience sleep difficulties, and there is likely a bidirectional relationship between headaches and sleep difficulties. Sleep problems may intensify functional and developmental difficulties in youth with chronic headaches. Despite this, research on sleep has largely been conducted only on those with migraines, with a dearth of studies including samples with tension-type headache (TTH) or new daily persistent-headache (NDPH).
Methods:
This retrospective chart review included 527 patients, ages 7-17 years, with a primary headache diagnosis of migraine (n = 278), TTH (n = 157), and NDPH (n = 92). Patients completed measures of disability, anxiety, and depression and their parents completed measures of sleep disturbance.
Results:
Sleep disturbance was greater in patients with TTH (10.34 ± 5.94, P = .002) and NDPH (11.52 ± 6.40, P < .001) than migraine (8.31 ± 5.89). Across patient groups, greater sleep disturbance was significantly associated with higher levels of functional disability (rs ≥ .16), anxiety (rs ≥ .30), and depression (rs ≥ .32). Additionally, higher pain levels were significantly associated with greater sleep disturbance among TTH patients (r = .23), with this association non-significant among the other headache groups. When simultaneously examining demographic, pain-related, and emotional distress factors, older age, higher levels of disability and depression, and NDPH diagnosis were all significant predictors of greater sleep disturbance (r(2) = .25).
Conclusions:
Assessment and treatment of sleep problems in pediatric patients with chronic headache is important with several contextual and headache diagnostic factors influencing the severity of sleep disturbance.
Aim:
The purpose of this retrospective multicenter study was to evaluate the use and the self-perceived efficacy and tolerability of pharmacological and non-pharmacological treatments in children and adolescents with primary headaches.
Methods:
Study of a cohort of children and adolescents diagnosed with primary headache, consecutively referred to 13 juvenile Italian Headache Centers. An ad hoc questionnaire was used for clinical data collection.
Results:
Among 706 patients with primary headaches included in the study, 637 cases with a single type of headache (migraine 76% - with and without aura in 10% and 67% respectively; tension-type headache 24%) were selected (mean age at clinical interview: 12 years). Acetaminophen and non-steroidal anti-inflammatory drugs (in particular ibuprofen) were commonly used to treat attacks, by 76% and 46% of cases respectively. Triptans were used overall by 6% of migraineurs and by 13% of adolescents with migraine, with better efficacy than acetaminophen and non-steroidal anti-inflammatory drugs. Preventive drugs were used by 19% of migraineurs and by 3% of subjects with tension-type headache. In migraineurs, flunarizine was the most frequently used drug (18%), followed by antiepileptic drugs (7%) and pizotifen (6%), while cyproheptadine, propanolol and amitriptyline were rarely used. Pizotifen showed the best perceived efficacy and tolerability. Melatonin and nutraceuticals were used by 10% and 32% of subjects, respectively, both for migraine and tension-type headache, with good results in terms of perceived efficacy and tolerability. Non-pharmacological preventive treatments (i.e. relaxation techniques, biofeedback, cognitive-behavioral therapy, acupuncture) were used only by 10% of cases (migraine 9%, tension-type headache 15%).
Discussion:
Non-steroidal anti-inflammatory drugs, especially ibuprofen, should be preferred to acetaminophen for acute attacks of migraine or tension-type headache, because they were usually more effective and well tolerated. Triptans could be used more frequently as first or almost second choice for treating migraine attack in adolescents. Non-pharmacological preventive treatments are recommended by some pediatric guidelines as first-line interventions for primary headaches and their use should be implemented in clinical practice. Prospective multicenter studies based on larger series are warranted to better understand the best treatment strategies for young people with primary headaches.
Headache is very common in children and young people. The correct advice and treatment requires consideration of a wide differential diagnosis between primary and secondary headaches, and also of the different types of primary headache. The International Classification of Headache Disorders gives useful descriptions and diagnostic criteria that are especially useful for primary headaches. The National Institute for Health and Care Excellence (NICE) Clinical Guideline 150 provides evidence-based recommendations on treatments for adults and young people from age 12 years. However, the same principles can be applied to younger children when a specific diagnosis can be made. Key recommendations from the NICE Quality Standards include, establishing a precise diagnosis if possible, avoiding, diagnosing and treating medication overuse headache, and combining a triptan with a non-steroidal anti-inflammatory drug or paracetamol as the first-line acute/rescue treatment for migraine with or without aura. Although rare in children and young people, it is important to diagnose new daily persistent headache, as it responds poorly or not at all to medication; and paroxysmal hemicrania as it responds very well to indomethacin but not to other commonly used analgesics. When faced with difficulties in reaching a precise diagnosis or in finding effective therapies, further advice should be sought from a children's headache clinic or specialist.
Treatment of pediatric migraine remains an unmet medical need. There continues to be a paucity of pediatric randomized controlled trials for the treatment of migraine, both in the acute and preventive settings. Pediatric studies are often complicated by high placebo-response rates and much of our current practice is based on adult trials. This lack of significant pediatric studies results in a wide variation in migraine management both amongst clinicians and between institutions, and evidence-based treatments are not always administered. In this article, we aim to briefly review newly approved abortive and preventive agents for migraine in the pediatric age group. Over-the-counter anti-inflammatory medications, including ibuprofen, naproxen sodium, aspirin, and acetaminophen are reasonable first-line options for abortive therapy. In addition, studies have shown triptans, or migraine-specific agents, to be safe and effective in children and adolescents and several formulations have been approved for the pediatric population, including rizatriptan, almotriptan, zolmitriptan nasal spray, and naproxen sodium/sumatriptan in combination.
Background:
Migraine is common in children and adolescents and can be disabling. Being able to predict which patients will respond to triptans based on their clinical phenotype would be helpful. Adult data suggest cranial autonomic symptoms and aura predict triptan response. This study examined clinical predictors of triptan response in pediatric migraineurs.
Methods:
This chart review study included all patients less than 18 years old with migraine who were seen at the University of California, San Francisco Headache Center in 2014. Univariate χ(2) analyses were performed, followed by multivariate logistic regression modeling.
Results:
Of 127 pediatric migraineurs, 70 (55%) had chronic migraine and 24 (19%) had aura. The majority (55%) had at least one cranial autonomic symptom. Of 65 with triptan outcome data, 47 (73%) benefitted from a triptan. In univariate analyses, triptan benefit was seen in 65% with chronic migraine versus 88% with episodic migraine (P = 0.048), 67% with aura versus 74% without (P = 0.66), and 70% with cranial autonomic symptom versus 74% without (P = 0.76). In a multivariate logistic regression model, chronic migraine, aura, and cranial autonomic symptom were not statistically significant predictors of triptan benefit: chronic migraine: 0.25 (0.06-1.04); aura: 0.65 (0.09-4.45); cranial autonomic symptom: 0.75 (0.22-2.52).
Conclusions:
In univariate analysis, individuals with chronic migraine were less likely to benefit from triptans. In contrast to what has been documented in adults, cranial autonomic symptoms and aura did not predict triptan response, although our small sample size limited the study's power. Larger pediatric studies are needed, and future pediatric triptan trials should provide response rates stratified by clinical variables such as aura.
New regulatory initiatives have been designed to ensure that new drugs and biologicals include adequate pediatric labeling for the claimed indications at the time of, or soon after, approval. However, because such labeling may not immediately be available, off-label use (or use that is not included in the approved label) of therapeutic agents is likely to remain common in the practice of pediatrics. This policy statement was written to address questions practitioners have regarding off-label use. The purpose of off-label use is to benefit the individual patient. Practitioners may use their professional judgment to determine these uses. Practitioners should understand that the Food and Drug Administration does not regulate off-label use.
While it has been established that headaches in the pediatric age group are relatively common, the characterization of headache disorders and their treatment in this group has historically been limited. Due to the paucity of controlled studies on prophylaxis of the primary headache disorders in children, the diagnosis of migraine often rests on criteria similar to those used in adults. Data from adult studies are often extrapolated and applied to the pediatric patient. Although it appears that many prophylactic agents are safe, well tolerated and efficacious in children, currently only topiramate is FDA-approved for use in patients 12 years and over. As a result, despite often experiencing significant disability, many children who present to their physician with migraines do not receive preventive therapy. One-third of adolescents meet the criteria for warranting prophylactic therapy, yet few are offered a preventative medication. Moreover, controlled clinical trials investigating the use of both abortive and prophylactic medications in children have suffered from high placebo response rates. A diverse group of medications are used to prevent migraine attacks, including antidepressants, antiepileptics, antihistamines and antihypertensive agents, yet there still remains a serious lack of controlled studies on the pharmacological treatment of pediatric migraine.
Despite limited evidence from the literature surrounding safety or efficacy, butalbital-containing medicines (BCMs) have maintained their rank as "go-to" prescribed migraine and headache relief drugs in the United States, despite bans on these barbiturates in Germany and other European countries. Providers at the Pediatric Headache Program at Boston Children's Hospital recommend that clinicians prescribe triptan-based medications instead of BCMs, given the known negative side effects of BCMs on the general population, and the uncertain longitudinal trajectory of BCMs on developing brains.
© 2014 American Headache Society.
Background
Here we report the prescription patterns by drug type, age and sex of patients, at a large academic pediatric hospital. As there are few guidelines based on outcome studies in pediatric migraine, physician treatment approaches in children vary.
Methods
Using the i2b2 query tool, we determined that over an approximately four year period, 4839 patients between the ages of 2 and 17 were seen at Boston Children's Hospital for migraine with or without aura, 59% female and 41% male. RESULTS The most common medications prescribed to this population were sumatriptan, amitriptyline, topiramate, ondansetron, and cyproheptadine.
Conclusions
Our findings support recent data regarding choices of medication in the pediatric population, and additionally support current studies and future investigation into controlled trials in the pediatric population.
New daily persistent headache is a primary headache disorder marked by a unique temporal profile which is daily from onset. For many sufferers this is their first ever headache. Very little is known about the pathogenesis of this condition. It might be a disorder of abnormal glial activation with persistent central nervous system inflammation and it may be a syndrome that occurs in individuals who have a history of cervical hypermobility. At present there is no known specific treatment and many patients go for years to decades without any improvement in their condition despite aggressive therapy. This article will present an up-to-date overview of new daily persistent headache on the topics of clinical presentation, treatment, diagnostic criteria, and presumed pathogenesis. It will also provide some of the authors own treatment suggestions based on recognized triggering events and some suggestions for future clinical trials.
We have established a multisite, international database of 3500 individuals diagnosed with Tourette syndrome (TS). The male:female ratio is 4.3:1 for the total sample, with wide variation among sites; the male excess occurs at every site. Anger control problems, sleep difficulties, coprolalia, and self-injurious behavior only reach impressive levels in individuals with comorbidity. Anger control problems are strongly correlated with comorbidity, regardless of site, region, or whether assessed by neurologists or psychiatrists. The mean age at onset of tics is 6.4 years. At all ages, about 12% of individuals with TS have no reported comorbidity. The most common reported comorbidity is attention-deficit-hyperactivity disorder. Males are more likely to have comorbid disorders than females. The earlier the age at onset, the greater the likelihood of a positive family history of tics. An understanding of the factors producing these and other variations might assist in better subtyping of TS. Because behavioral problems are associated with comorbidity, their presence should dictate a high index of suspicion of the latter, whose treatment may be at least as important as tic reduction. The established database can be used as the entry point for further research when large samples are studied and generalizability of results is important.
OPINION STATEMENT: Migraine is a biologic disorder of the brain characterized by a heterogeneous array of symptoms and episodes of disabling headache. By definition, such attacks last between 4 and 72 h without treatment, with the disability arising from a variety of factors including severe pain, gastrointestinal symptoms such as nausea or vomiting, and sensory sensitivities to light, noise, or odor. All these features may be exacerbated by stimulation, motion, or activity, often rendering the patient completely immobile. Although retreat and rest, coupled with local application of ice, may provide some measure of comfort, most of those with migraine hunt for therapeutic solutions. In designing acute headache treatment strategies, it is imperative for clinicians to recognize the variability between individuals in the frequency, intensity, and duration of attacks. Certain patients require more aggressive options. It is also crucial to identify the significant intra-individual variability of migraine; most patients describe an assortment of headaches of different intensities and time to disability. Less intense episodes, which patients often term sinus, tension, or regular headaches, usually represent milder versions of migraine, simplifying both diagnostic and therapeutic approaches. Evidence-based guidelines and clinical experience support the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the management of mild to moderate migraine attacks. Recommend migraine-specific agents (triptans and dihydroergotamine) when the attacks are more severe or have consistently failed to respond to the use of NSAIDs in the past. Encourage those with less frequent episodic migraine to use their acute agents at the earliest signs of headache. Advise those with frequent headache (>10 days per month) to limit acute treatments to only the most disabling episodes in order to avoid the "medication overuse" phenomenon. Consider rescue or back-up therapy. Do not use compounds containing butalbital or opiates (or place extreme limits on them), out of concern for progression to chronic migraine.
the aim of this study was to review systematically the prevalence of headache and migraine in children and adolescents and to study the influence of sex, age, and region of residence on the epidemiology.
we systematically searched the literature in electronic databases to cover the period between 1 January 1990 and 31 December 2007. We assessed and included population-based studies on epidemiology of headache and migraine in children and adolescents if they fulfilled the following criteria: (1) reporting on unselected childhood population; (2) reliable methods of data collection using a questionnaire or face-to-face interviews; (3) using the International Headache Society's (IHS) criteria (1988 or 2004) for the diagnosis of migraine; and (4) provision of sufficient and explicit data for analysis. We used Excel, Stata, and Confidence Interval Analysis software.
we identified and analysed 50 population-based studies reporting the prevalence of headache and/or migraine in children and adolescents (<20y). The estimated prevalence of headache over periods between 1 month and lifetime in children and adolescents is 58.4% (95% confidence interval [CI] 58.1-58.8). Females are more likely to have headache than males (odds ratio [OR] 1.53, 95% CI 1.48-1.6). The prevalence of migraine over periods between 6 months and lifetime is 7.7% (95% CI 7.6-7.8). Females are more likely than males to have migraine (OR 1.67, 95% CI 1.60-1.75). Regional differences in prevalence of migraine, though statistically significant, may not be of clinical significance. The change in the IHS's criteria for the diagnosis of migraine was not associated with any significant change in the prevalence of migraine.
this study confirms the global high prevalence of headache and migraine in children and adolescents. Sex, age, and regional differences are evident.
Tension-type headache (TTH) is the most prevalent type of headache across all age groups worldwide. TTH is common, disabling, and associated with medical and psychiatric comorbidities. This review will focus on the epidemiologies of episodic and chronic TTH in various age groups, factors associated with progression and remission, comorbidities, and the burden of TTH.
KEY FINDINGS: Over the last 10 years, the percentage of Americans who took at least one prescription drug in the past month increased from 44% to 48%. The use of two or more drugs increased from 25% to 31%. The use of five or more drugs increased from 6% to 11%. In 2007-2008, 1 out of every 5 children and 9 out of 10 older Americans reported using at least one prescription drug in the past month. Those who were without a regular place for health care, health insurance, or prescription drug benefit had less prescription drug use compared with those who had these benefits. The most commonly used types of drugs included: asthma medicines for children, central nervous system stimulants for adolescents, antidepressants for middle-aged adults, and cholesterol lowering drugs for older Americans.
Headache is a common complaint in childhood with up to 75% of children reporting a notable headache by the age of 15 years. Paediatric migraine is the most frequent recurrent headache, occurring in up to 28% of older teenagers. Migraine can have a substantial effect on the life of the child, as well as their family, leading to lost school days and withdrawal from social interactions. Early recognition can lead to successful treatment, improved outcome, and reduced disability. The treatment strategy needs to be multipronged and can include acute therapy (which can vary depending on the severity of the headache), preventive therapy (when the headaches are frequent or causing substantial disability), and biobehavioural therapy (to assist with coping with recurrent headaches). Additional factors can contribute to exacerbations of headaches, including comorbid disorders and pubertal changes, which might lead to the development of menstrual migraine. When all these factors are effectively managed, there should be an improvement in long-term outcome and prevention of disease progression.
The aim of this study was to investigate whether the IHS criteria for migraine and tension-type headache depend on gender. Among 409 children and adolescents with recurrent idiopathic headache seen at a university outpatient clinic, girls had significantly more often migraine with aura. Also, there was a trend towards a higher frequency of tension-type headache in girls. In migraine, aggravation of headache by physical activity and occurrence of aura symptoms were more common in females, whereas vomiting and phonophobia occurred more often in males. In tension-type headache, females more often reported mild intensity of headache. All other criteria were similar in both sexes. Age influenced the expression of some of the accompanying symptoms in the various types of migraine, but had only minimal influence on other diagnostic criteria of migraine and tension-type headache in females as well as in males. Our study suggests that the frequency of migraine (except that of migraine with aura) is similar among girls and boys, that tension-type headache may occur more often in girls, and that gender has some influence on the IHS criteria for migraine, but almost no influence on those of tension-type headache.
Headaches are very common during childhood and become increasingly frequent during adolescence. The diagnosis of primary headache disorders (e.g., migraine and tension-type headache) rests principally on clinical criteria as set forth by the International Headache Society. Treatment options include acute or episodic measures, prophylactic agents and non-pharmacological or behavioural interventions. From review of available evidence, the most efficacious acute treatments of paediatric migraine include the non-steroidal anti-inflammatory agent ibuprofen at 7.5 - 10 mg/kg/dose or nasal sumatriptan at doses of 5 or 20 mg. For those patients with headaches that occur with sufficient frequency and severity to warrant daily prophylaxis, controlled data are limited. Agents which are likely to be beneficial include amitriptyline, flunarizine (not available in the US) and cyproheptadine. Clinical experience with the anti-epileptic agents topiramate and valproate suggests an expanding role for the prevention of paediatric migraine in the future.
To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents.
A double-blind, placebo-controlled, two-way crossover trial was conducted in three hospital outpatient departments, with 8 to 17 year olds diagnosed with migraine serving as subjects (International Headache Society 1988). A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks. The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of >/==" BORDER="0">40 kg. The primary efficacy endpoint was headache relief by two grades on a 5-grade face scale at 2 hours.
Eighty-three patients used both treatments and 11 only the first. At 2 hours, the primary endpoint was reached nearly twice as often after sumatriptan (n = 53/83; 64%) as after placebo (n = 32/83; 39%) (p = 0.003). Already at 1 hour, headache relief was seen more often after sumatriptan (n = 42/83; 51%) than after placebo (n = 24/83; 29%) (p = 0.014). The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses (n = 94). Other endpoints, including child's preference and using rescue medication, also favored sumatriptan. The most common adverse effect was a bad taste after sumatriptan, reported in 29% (n = 26/90) of the attacks. No serious adverse effects were observed.
Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age.
To assess the extent of off-label prescribing in specialty headache practice.
A prospective record was kept of all prescriptions written during a 30-day period in a tertiary care headache program affiliated with two teaching hospitals. Each drug was categorized as "on-label," defined as approved by the FDA for a headache or general pain indication, and used in accordance with label instructions, or "off-label," defined as any use of a drug not covered in the FDA-approved package insert.
A total of 379 prescriptions were written during a 30-day period. One hundred and seventy-eight prescriptions (47%) met the criteria for off-label use. In all, 23 categories of off-label treatment were prescribed during the study, but just 4 accounted for over half of all off-label prescriptions: newer antiepileptic drugs such as topiramate and lamotrigine (each accounted for n = 26, 15% of off-label prescriptions), newer antidepressants, especially venlafaxine (n = 27; 15% of off-label prescriptions), and botulinum toxin type A (n = 13; 7% of off-label prescriptions). Two hundred and one prescriptions met criteria for on-label use. The largest percentages of prescriptions written for approved, on-label indications were for triptans (n = 74; 37% of on-label prescriptions), and nonsteroidal anti-inflammatory drugs (n = 64; 32% of on-label prescriptions).
Off-label prescribing is common in the specialty management of headache conditions. We conclude that it is within the current standard of care, and an integral part of practice, to use off-label medications in the treatment of complex headache conditions.
To review evidence on the pharmacologic treatment of the child with migraine headache.
The authors reviewed, abstracted, and classified relevant literature. Recommendations were based on a four-tiered scheme of evidence classification. Treatment options were separated into medications for acute headache and preventive medications.
The authors identified and reviewed 166 articles. For acute treatment, five agents were reviewed. Sumatriptan nasal spray and ibuprofen are effective and are well tolerated vs placebo. Acetaminophen is probably effective and is well tolerated vs placebo. Rizatriptan and zolmitriptan were safe and well tolerated but were not superior to placebo. For preventive therapy, 12 agents were evaluated. Flunarizine is probably effective. The data concerning cyproheptadine, amitriptyline, divalproex sodium, topiramate, and levetiracetam were insufficient. Conflicting data were found concerning propranolol and trazodone. Pizotifen, nimodipine, and clonidine did not show efficacy.
For children (>age 6 years), ibuprofen is effective and acetaminophen is probably effective and either can be considered for the acute treatment of migraine. For adolescents (>12 years of age), sumatriptan nasal spray is effective and should be considered for the acute treatment of migraine. For preventive therapy, flunarizine is probably effective and can be considered, but is not available in the United States. There are conflicting or insufficient data to make any other recommendations for the preventive therapy of migraine in children and adolescents. For a clinical problem so prevalent in children and adolescents, there is a disappointing lack of evidence from controlled, randomized, and masked trials.
The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and tolerability of the zolmitriptan conventional tablet at three different doses for the treatment of a single migraine attack in adolescents.
Preliminary data from an open-label study suggested that the zolmitriptan conventional tablet could be effective in the treatment of acute migraine in adolescent patients. Methods: Migraine patients aged 12 to 17 years (n = 850) were randomized to receive zolmitriptan 2.5, 5, or 10 mg, or placebo for treatment of a single migraine attack. Patients recorded migraine headache intensity before and after treatment using a 4-point scale.
There was no statistically significant improvement between zolmitriptan 10 mg (2 x 5 mg tablet) and placebo for the primary efficacy variable, headache response at 2 hours, nor any of the secondary variables tested. Two-hour headache response rates were 54%, 53%, and 57% for zolmitriptan 10, 5, and 2.5 mg, respectively, and 58% for placebo. Two-hour pain-free rates were 25%, 19%, and 23% for zolmitriptan 10, 5, and 2.5 mg, respectively, and 20% for placebo. Zolmitriptan was well tolerated, with a tolerability profile similar to the pattern seen in adults.
The similar efficacy between zolmitriptan and placebo appears to be the result of the high placebo response rate. This is a recognized issue in pediatric migraine studies and there is an ongoing debate on ways to address this problem. Since this study was initiated, there has been some debate on the appropriateness of the 2-hour endpoint for response rates in adolescent studies, given the shorter duration of headache pain in adolescents compared with adults. Furthermore, accurate information regarding the timeliness of treatment and reporting of headache-related information by adolescents is difficult.
To examine the efficacy of rizatriptan and the consistency of treatment response in migraine attacks of children and adolescents.
We conducted a double-blind, placebo-controlled three-way crossover trial in patients ages 6 to 17 years diagnosed with migraine in two pediatric hospital outpatient clinics. Two doses of rizatriptan and a matching placebo were administered at home during three attacks. Rizatriptan dose was 5 mg for those with a body weight of 20 to 39 kg, and 10 mg for those with a body weight of 40 kg or more. The primary efficacy endpoint was headache relief by two grades on a five-grade face scale at 2 hours.
Ninety-six patients used all three treatments, 10 used two, and 10 only the first. At 2 hours, the primary endpoint was reached twice as often after both treatments of rizatriptan (first 74%, n = 71/96; second 73%, n = 70/96) as after placebo (36%, n = 35/96) (p < 0.001). Already at 1 hour, rizatriptan was clearly more effective as headache relief was reported by 50% (n = 48/96) and 55% (n = 53/96) of children after the first and the second dose of rizatriptan, compared to 29% (n = 28/96) after placebo (p = 0.004). Rizatriptan was superior at 3 and 4 hours, and the other endpoints also favored rizatriptan. Efficacy of rizatriptan was constant over the two treated attacks, and the findings were similar in children using the dose of 5 and 10 mg. No serious adverse effects were observed.
Oral rizatriptan is effective and well-tolerated for migraine attacks in children over age 6 years.
1) To reassess the prevalence of migraine in the United States; 2) to assess patterns of migraine treatment in the population; and 3) to contrast current patterns of preventive treatment use with recommendations for use from an expert headache panel.
A validated self-administered headache questionnaire was mailed to 120,000 US households, representative of the US population. Migraineurs were identified according to the criteria of the second edition of the International Classification of Headache Disorders. Guidelines for preventive medication use were developed by a panel of headache experts. Criteria for consider or offer prevention were based on headache frequency and impairment.
We assessed 162,576 individuals aged 12 years or older. The 1-year period prevalence for migraine was 11.7% (17.1% in women and 5.6% in men). Prevalence peaked in middle life and was lower in adolescents and those older than age 60 years. Of all migraineurs, 31.3% had an attack frequency of three or more per month, and 53.7% reported severe impairment or the need for bed rest. In total, 25.7% met criteria for "offer prevention," and in an additional 13.1%, prevention should be considered. Just 13.0% reported current use of daily preventive migraine medication.
Compared with previous studies, the epidemiologic profile of migraine has remained stable in the United States during the past 15 years. More than one in four migraineurs are candidates for preventive therapy, and a substantial proportion of those who might benefit from prevention do not receive it.
Goadsby PJ, Zanchin G, Geraud G, de Klippel N, Diaz-Insa S, Gobel H, Cunha L, Ivanoff N, Falques M & Fortea J. Early vs. non-early intervention in acute migraine—‘Act when Mild (AwM)’. A double-blind, placebo-controlled trial of almotriptan. Cephalalgia 2008; 28:383–391. London. ISSN 0333-1024
The study was designed to compare the response to almotriptan in migraine patients who take medication early in the course of the attack with that when medication is taken after pain has become moderate or severe. A randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) comparing treatment administration when pain intensity was mild and within 1 h of headache onset vs. pain that had become moderate or severe was conducted. Of 491 migraineurs enrolled, 403 were evaluable [intention-to-treat population (ITT)]. Their mean age was 38 years, 84% were female and they had a mean of 3.7 attacks/month. Of these patients, 10% did not take medication according to their randomly allocated basal pain intensity (mild or moderate/severe) and were subsequently reassigned to that group for this analysis—‘Act when Mild (AwM)’ group. In the almotriptan arms, 53% of mild basal pain and 38% of moderate/severe basal pain patients were pain free at 2 h (P = 0.03; primary end-point). Corresponding proportions in the placebo groups were 25% and 17% (statistically significant vs. respective almotriptan arms). Secondary end-points (ITT) were also significantly in favour of early intervention with almotriptan, both between and across treatment groups, such as sustained pain free: 45.6% vs. 30.5% (P = 0.02). Adverse events were reported in < 5% of treated patients in all groups (NS), with no serious events. Treatment with almotriptan while migraine pain is still mild provides statistically significant and clinically relevant enhancements in efficacy compared with treatment when pain has reached higher severity levels.
Headache Classification Committee of the International Headache Society (IHS)
Headache Classification Committee of the International Headache Society (IHS). The international classification of headache
disorders, (beta version. Cephalalgia. 2013;33(9):629-808.
Trial of amitriptyline, topiramate, and placebo for pediatric migraine
- S W Powers
- C S Coffey
- L A Chamberlin
- D J Ecklund
- E A Klingner
- J W Yankey
- SW Powers