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Migraine Linked to Adverse Pregnancy Outcomes
Key clinical point: Pregnant women with a history of migraine are at an increased risk of adverse outcomes, including preeclampsia (PE) and low birth weight (LBW).
Major finding: Women with migraine had a higher risk for PE (odds ratio, 2.07; 95% confidence interval, 1.51-2.85) and LBW (odds ratio, 1.18; 95% confidence interval, 1.03-1.34) compared with women without migraine. No significant association was observed between the history of migraine and preterm birth or small for gestational age.
Study details: A systematic review and meta-analysis of 14 studies.
Disclosures: Authors declared no conflict of interest.
Citation: Aukes AM et al. Obstet Gynecol Surv. 2019 Dec. doi: 10.1097/OGX.0000000000000738.
Key clinical point: Pregnant women with a history of migraine are at an increased risk of adverse outcomes, including preeclampsia (PE) and low birth weight (LBW).
Major finding: Women with migraine had a higher risk for PE (odds ratio, 2.07; 95% confidence interval, 1.51-2.85) and LBW (odds ratio, 1.18; 95% confidence interval, 1.03-1.34) compared with women without migraine. No significant association was observed between the history of migraine and preterm birth or small for gestational age.
Study details: A systematic review and meta-analysis of 14 studies.
Disclosures: Authors declared no conflict of interest.
Citation: Aukes AM et al. Obstet Gynecol Surv. 2019 Dec. doi: 10.1097/OGX.0000000000000738.
Key clinical point: Pregnant women with a history of migraine are at an increased risk of adverse outcomes, including preeclampsia (PE) and low birth weight (LBW).
Major finding: Women with migraine had a higher risk for PE (odds ratio, 2.07; 95% confidence interval, 1.51-2.85) and LBW (odds ratio, 1.18; 95% confidence interval, 1.03-1.34) compared with women without migraine. No significant association was observed between the history of migraine and preterm birth or small for gestational age.
Study details: A systematic review and meta-analysis of 14 studies.
Disclosures: Authors declared no conflict of interest.
Citation: Aukes AM et al. Obstet Gynecol Surv. 2019 Dec. doi: 10.1097/OGX.0000000000000738.
Migraineurs Likely to Exhibit Metacognitive Deficits
Key clinical point: Patients with migraine are likely to have metacognitive deficits.
Major finding: Patients with migraine performed worse on measures of metacognitive functions, including accuracy score (P = .012), global monitoring (P = .015), monetary gains (P = .022), and control sensitivity (P = .027) compared with control participants.
Study details: An Italian study evaluated the metacognitive abilities of 64 patients with chronic and episodic migraine and 29 healthy control participants.
Disclosures: The authors declared no conflicts of interest.
Citation: Zucca M et al. J Clin Neurosci. 2020 Jan 5. doi: 10.1016/j.jocn.2019.12.048.
Key clinical point: Patients with migraine are likely to have metacognitive deficits.
Major finding: Patients with migraine performed worse on measures of metacognitive functions, including accuracy score (P = .012), global monitoring (P = .015), monetary gains (P = .022), and control sensitivity (P = .027) compared with control participants.
Study details: An Italian study evaluated the metacognitive abilities of 64 patients with chronic and episodic migraine and 29 healthy control participants.
Disclosures: The authors declared no conflicts of interest.
Citation: Zucca M et al. J Clin Neurosci. 2020 Jan 5. doi: 10.1016/j.jocn.2019.12.048.
Key clinical point: Patients with migraine are likely to have metacognitive deficits.
Major finding: Patients with migraine performed worse on measures of metacognitive functions, including accuracy score (P = .012), global monitoring (P = .015), monetary gains (P = .022), and control sensitivity (P = .027) compared with control participants.
Study details: An Italian study evaluated the metacognitive abilities of 64 patients with chronic and episodic migraine and 29 healthy control participants.
Disclosures: The authors declared no conflicts of interest.
Citation: Zucca M et al. J Clin Neurosci. 2020 Jan 5. doi: 10.1016/j.jocn.2019.12.048.
TENS Can Treat Migraine Attacks in the Emergency Department
Key clinical point: Transcutaneous electrical nerve stimulation (TENS) is an effective option for treating migraine attacks in the emergency department.
Major finding: The verum group showed significant improvements on the visual analog scale change from 0 to 120 minutes (P less than .001) and a Likert-type verbal pain scale (P less than .001) compared with the sham group. The need for additional analgesics after 120 minutes was lower in the verum group vs. sham group (2.6% vs. 76.9%).
Study details: A randomized-controlled study evaluated the effectiveness of TENS for emergency treatment of migraine in the verum (n=39) and sham (n=39) groups.
Disclosures: The authors declared no conflicts of interest.
Citation: Hokenek NM et al. Am J Emerg Med. 2020 Jan 15. doi: 10.1016/j.ajem.2020.01.024.
Key clinical point: Transcutaneous electrical nerve stimulation (TENS) is an effective option for treating migraine attacks in the emergency department.
Major finding: The verum group showed significant improvements on the visual analog scale change from 0 to 120 minutes (P less than .001) and a Likert-type verbal pain scale (P less than .001) compared with the sham group. The need for additional analgesics after 120 minutes was lower in the verum group vs. sham group (2.6% vs. 76.9%).
Study details: A randomized-controlled study evaluated the effectiveness of TENS for emergency treatment of migraine in the verum (n=39) and sham (n=39) groups.
Disclosures: The authors declared no conflicts of interest.
Citation: Hokenek NM et al. Am J Emerg Med. 2020 Jan 15. doi: 10.1016/j.ajem.2020.01.024.
Key clinical point: Transcutaneous electrical nerve stimulation (TENS) is an effective option for treating migraine attacks in the emergency department.
Major finding: The verum group showed significant improvements on the visual analog scale change from 0 to 120 minutes (P less than .001) and a Likert-type verbal pain scale (P less than .001) compared with the sham group. The need for additional analgesics after 120 minutes was lower in the verum group vs. sham group (2.6% vs. 76.9%).
Study details: A randomized-controlled study evaluated the effectiveness of TENS for emergency treatment of migraine in the verum (n=39) and sham (n=39) groups.
Disclosures: The authors declared no conflicts of interest.
Citation: Hokenek NM et al. Am J Emerg Med. 2020 Jan 15. doi: 10.1016/j.ajem.2020.01.024.
Migraine is Bidirectionally Associated With Asthma
Key clinical point: Migraine and asthma have a reciprocal association with each other.
Major finding: Patients with asthma had a 47% higher risk for migraine (P less than .001) than control participants, and patients with migraine had a 37% higher risk for asthma (P less than .001).
Study details: The data were obtained from 2 Korean longitudinal follow-up studies (Study 1: 113,059 patients with asthma and 113,059 control participants; Study 2: 36,044 patients with migraine and 114,176 control participants).
Disclosures: This study was partly supported by a grant from the National Research Foundation of Korea. The authors declared no conflicts of interest.
Citation: Kim SY et al. Sci Rep. 2019 Dec 4. doi: 10.1038/s41598-019-54972-8.
Key clinical point: Migraine and asthma have a reciprocal association with each other.
Major finding: Patients with asthma had a 47% higher risk for migraine (P less than .001) than control participants, and patients with migraine had a 37% higher risk for asthma (P less than .001).
Study details: The data were obtained from 2 Korean longitudinal follow-up studies (Study 1: 113,059 patients with asthma and 113,059 control participants; Study 2: 36,044 patients with migraine and 114,176 control participants).
Disclosures: This study was partly supported by a grant from the National Research Foundation of Korea. The authors declared no conflicts of interest.
Citation: Kim SY et al. Sci Rep. 2019 Dec 4. doi: 10.1038/s41598-019-54972-8.
Key clinical point: Migraine and asthma have a reciprocal association with each other.
Major finding: Patients with asthma had a 47% higher risk for migraine (P less than .001) than control participants, and patients with migraine had a 37% higher risk for asthma (P less than .001).
Study details: The data were obtained from 2 Korean longitudinal follow-up studies (Study 1: 113,059 patients with asthma and 113,059 control participants; Study 2: 36,044 patients with migraine and 114,176 control participants).
Disclosures: This study was partly supported by a grant from the National Research Foundation of Korea. The authors declared no conflicts of interest.
Citation: Kim SY et al. Sci Rep. 2019 Dec 4. doi: 10.1038/s41598-019-54972-8.
Higher Prevalence of Migraine in Women with Endometriosis
Key clinical point: Women of reproductive age experiencing migraines should be screened for endometriosis.
Major finding: Migraine headache was more frequent in women with endometriosis than in those without endometriosis (35.2% vs. 17.4%; P = .003).
Study details: The data were obtained from a French case-control study of 314 nonpregnant women younger than 42 years.
Disclosures: The authors declared no conflicts of interest.
Citation: Maitrot-Mantelet L et al. Cephalalgia. 2019 Dec 6. doi: 10.1177/0333102419893965.
Key clinical point: Women of reproductive age experiencing migraines should be screened for endometriosis.
Major finding: Migraine headache was more frequent in women with endometriosis than in those without endometriosis (35.2% vs. 17.4%; P = .003).
Study details: The data were obtained from a French case-control study of 314 nonpregnant women younger than 42 years.
Disclosures: The authors declared no conflicts of interest.
Citation: Maitrot-Mantelet L et al. Cephalalgia. 2019 Dec 6. doi: 10.1177/0333102419893965.
Key clinical point: Women of reproductive age experiencing migraines should be screened for endometriosis.
Major finding: Migraine headache was more frequent in women with endometriosis than in those without endometriosis (35.2% vs. 17.4%; P = .003).
Study details: The data were obtained from a French case-control study of 314 nonpregnant women younger than 42 years.
Disclosures: The authors declared no conflicts of interest.
Citation: Maitrot-Mantelet L et al. Cephalalgia. 2019 Dec 6. doi: 10.1177/0333102419893965.
Shift Work Tied to Higher Migraine and Headache Risk
Key clinical point: Shift workers are more likely to develop migraines and headaches than day workers.
Major finding: Shift workers had a 72% and 25% higher risk of developing migraine and unspecified headache, respectively, compared with day workers.
Study details: A longitudinal study included 2,952 individuals for the analyses of shift work and headache and 2,272 individuals for the analyses of shift work and migraine from the Danish PRISME cohort.
Disclosures: The study was funded by NordForsk, Nordic Program on Health and Welfare. The original PRISME study was supported by the Danish Working Environment Research Fund. The authors declared no conflicts of interest.
Citation: Appel AM et al. Int Arch Occup Environ Health. 2020 Jan 11. doi: 10.1007/s00420-019-01512-6.
Key clinical point: Shift workers are more likely to develop migraines and headaches than day workers.
Major finding: Shift workers had a 72% and 25% higher risk of developing migraine and unspecified headache, respectively, compared with day workers.
Study details: A longitudinal study included 2,952 individuals for the analyses of shift work and headache and 2,272 individuals for the analyses of shift work and migraine from the Danish PRISME cohort.
Disclosures: The study was funded by NordForsk, Nordic Program on Health and Welfare. The original PRISME study was supported by the Danish Working Environment Research Fund. The authors declared no conflicts of interest.
Citation: Appel AM et al. Int Arch Occup Environ Health. 2020 Jan 11. doi: 10.1007/s00420-019-01512-6.
Key clinical point: Shift workers are more likely to develop migraines and headaches than day workers.
Major finding: Shift workers had a 72% and 25% higher risk of developing migraine and unspecified headache, respectively, compared with day workers.
Study details: A longitudinal study included 2,952 individuals for the analyses of shift work and headache and 2,272 individuals for the analyses of shift work and migraine from the Danish PRISME cohort.
Disclosures: The study was funded by NordForsk, Nordic Program on Health and Welfare. The original PRISME study was supported by the Danish Working Environment Research Fund. The authors declared no conflicts of interest.
Citation: Appel AM et al. Int Arch Occup Environ Health. 2020 Jan 11. doi: 10.1007/s00420-019-01512-6.
Pharmacologic prophylaxis fails in pediatric migraine
Clinicians hoped that medications used in adults – such as antidepressants, antiepileptics, antihypertensive agents, calcium channel blockers, and food supplements – would find similar success in children. Unfortunately, researchers found only short-term signs of efficacy over placebo, with no benefit lasting more than 6 months.
The study, conducted by a team led by Cosima Locher, PhD, of Boston Children’s Hospital, included 23 double-blind, randomized, controlled trials with a total of 2,217 patients; the mean age was 11 years. They compared 12 pharmacologic agents with each other or with placebo in the study, published online in JAMA Pediatrics.
In a main efficacy analysis that included 19 studies, only two treatments outperformed placebo: propranolol (standardized mean difference, 0.60; 95% confidence interval, 0.03-1.17) and topiramate (SMD, 0.59; 95% CI, 0.03-1.15). There were no statistically significant between-treatment differences.
The results had an overall low to moderate certainty.
When propranolol was compared to placebo, the 95% prediction interval (–0.62 to 1.82) was wider than the significant confidence interval (0.03-1.17), and comprised both beneficial and detrimental effects. A similar result was found with topiramate, with a prediction interval of –0.62 to 1.80 extending into nonsignificant effects (95% CI, 0.03-1.15). In both cases, significant effects were found only when the prediction interval was 70%.
In a long-term analysis (greater than 6 months), no treatment outperformed placebo.
The treatments generally were acceptable. The researchers found no significant difference in tolerability between any of the treatments and each other or placebo. Safety data analyzed from 13 trials revealed no significant differences between treatments and placebo.
“Because specific effects of drugs are associated with the size of the placebo effect, the lack of drug efficacy in our NMA [network meta-analysis] could be owing to a comparatively high placebo effect in children. In fact, there is indirect evidence [from other studies] that the placebo effect is more pronounced in children and adolescents than in adults,” Dr. Locher and associates said. They suggested that studies were needed to quantify the placebo effect in pediatric migraine, and if it was large, to develop innovative therapies making use of this.
The findings should lead to some changes in practice, Boris Zernikow, MD, PhD, of Children’s and Adolescents’ Hospital Datteln (Germany) wrote in an accompanying editorial.
Pharmacological prophylactic treatment of childhood migraine should be an exception rather than the rule, and nonpharmacologic approaches should be emphasized, particularly because the placebo effect is magnified in children, he said.
Many who suffer migraines in childhood will continue to be affected in adulthood, so pediatric intervention is a good opportunity to instill effective strategies. These include: using abortive medication early in an attack and using antimigraine medications for only that specific type of headache; engaging in physical activity to reduce migraine attacks; getting sufficient sleep; and learning relaxation and other psychological approaches to counter migraines.
Dr. Zernikow had no relevant financial disclosures. One study author received grants from Amgen and other support from Grunenthal and Akelos. The study received funding from the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment; the Swiss National Science Foundation; the Schweizer-Arau-Foundation; and the Theophrastus Foundation.
SOURCES: Locher C et al. JAMA Pediatrics. 2020 Feb 10. doi: 10.1001/jamapediatrics.2019.5856; Zernikow B. JAMA Pediatrics. 2020 Feb 10. doi: 10.1001/jamapediatrics.2019.5907.
Clinicians hoped that medications used in adults – such as antidepressants, antiepileptics, antihypertensive agents, calcium channel blockers, and food supplements – would find similar success in children. Unfortunately, researchers found only short-term signs of efficacy over placebo, with no benefit lasting more than 6 months.
The study, conducted by a team led by Cosima Locher, PhD, of Boston Children’s Hospital, included 23 double-blind, randomized, controlled trials with a total of 2,217 patients; the mean age was 11 years. They compared 12 pharmacologic agents with each other or with placebo in the study, published online in JAMA Pediatrics.
In a main efficacy analysis that included 19 studies, only two treatments outperformed placebo: propranolol (standardized mean difference, 0.60; 95% confidence interval, 0.03-1.17) and topiramate (SMD, 0.59; 95% CI, 0.03-1.15). There were no statistically significant between-treatment differences.
The results had an overall low to moderate certainty.
When propranolol was compared to placebo, the 95% prediction interval (–0.62 to 1.82) was wider than the significant confidence interval (0.03-1.17), and comprised both beneficial and detrimental effects. A similar result was found with topiramate, with a prediction interval of –0.62 to 1.80 extending into nonsignificant effects (95% CI, 0.03-1.15). In both cases, significant effects were found only when the prediction interval was 70%.
In a long-term analysis (greater than 6 months), no treatment outperformed placebo.
The treatments generally were acceptable. The researchers found no significant difference in tolerability between any of the treatments and each other or placebo. Safety data analyzed from 13 trials revealed no significant differences between treatments and placebo.
“Because specific effects of drugs are associated with the size of the placebo effect, the lack of drug efficacy in our NMA [network meta-analysis] could be owing to a comparatively high placebo effect in children. In fact, there is indirect evidence [from other studies] that the placebo effect is more pronounced in children and adolescents than in adults,” Dr. Locher and associates said. They suggested that studies were needed to quantify the placebo effect in pediatric migraine, and if it was large, to develop innovative therapies making use of this.
The findings should lead to some changes in practice, Boris Zernikow, MD, PhD, of Children’s and Adolescents’ Hospital Datteln (Germany) wrote in an accompanying editorial.
Pharmacological prophylactic treatment of childhood migraine should be an exception rather than the rule, and nonpharmacologic approaches should be emphasized, particularly because the placebo effect is magnified in children, he said.
Many who suffer migraines in childhood will continue to be affected in adulthood, so pediatric intervention is a good opportunity to instill effective strategies. These include: using abortive medication early in an attack and using antimigraine medications for only that specific type of headache; engaging in physical activity to reduce migraine attacks; getting sufficient sleep; and learning relaxation and other psychological approaches to counter migraines.
Dr. Zernikow had no relevant financial disclosures. One study author received grants from Amgen and other support from Grunenthal and Akelos. The study received funding from the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment; the Swiss National Science Foundation; the Schweizer-Arau-Foundation; and the Theophrastus Foundation.
SOURCES: Locher C et al. JAMA Pediatrics. 2020 Feb 10. doi: 10.1001/jamapediatrics.2019.5856; Zernikow B. JAMA Pediatrics. 2020 Feb 10. doi: 10.1001/jamapediatrics.2019.5907.
Clinicians hoped that medications used in adults – such as antidepressants, antiepileptics, antihypertensive agents, calcium channel blockers, and food supplements – would find similar success in children. Unfortunately, researchers found only short-term signs of efficacy over placebo, with no benefit lasting more than 6 months.
The study, conducted by a team led by Cosima Locher, PhD, of Boston Children’s Hospital, included 23 double-blind, randomized, controlled trials with a total of 2,217 patients; the mean age was 11 years. They compared 12 pharmacologic agents with each other or with placebo in the study, published online in JAMA Pediatrics.
In a main efficacy analysis that included 19 studies, only two treatments outperformed placebo: propranolol (standardized mean difference, 0.60; 95% confidence interval, 0.03-1.17) and topiramate (SMD, 0.59; 95% CI, 0.03-1.15). There were no statistically significant between-treatment differences.
The results had an overall low to moderate certainty.
When propranolol was compared to placebo, the 95% prediction interval (–0.62 to 1.82) was wider than the significant confidence interval (0.03-1.17), and comprised both beneficial and detrimental effects. A similar result was found with topiramate, with a prediction interval of –0.62 to 1.80 extending into nonsignificant effects (95% CI, 0.03-1.15). In both cases, significant effects were found only when the prediction interval was 70%.
In a long-term analysis (greater than 6 months), no treatment outperformed placebo.
The treatments generally were acceptable. The researchers found no significant difference in tolerability between any of the treatments and each other or placebo. Safety data analyzed from 13 trials revealed no significant differences between treatments and placebo.
“Because specific effects of drugs are associated with the size of the placebo effect, the lack of drug efficacy in our NMA [network meta-analysis] could be owing to a comparatively high placebo effect in children. In fact, there is indirect evidence [from other studies] that the placebo effect is more pronounced in children and adolescents than in adults,” Dr. Locher and associates said. They suggested that studies were needed to quantify the placebo effect in pediatric migraine, and if it was large, to develop innovative therapies making use of this.
The findings should lead to some changes in practice, Boris Zernikow, MD, PhD, of Children’s and Adolescents’ Hospital Datteln (Germany) wrote in an accompanying editorial.
Pharmacological prophylactic treatment of childhood migraine should be an exception rather than the rule, and nonpharmacologic approaches should be emphasized, particularly because the placebo effect is magnified in children, he said.
Many who suffer migraines in childhood will continue to be affected in adulthood, so pediatric intervention is a good opportunity to instill effective strategies. These include: using abortive medication early in an attack and using antimigraine medications for only that specific type of headache; engaging in physical activity to reduce migraine attacks; getting sufficient sleep; and learning relaxation and other psychological approaches to counter migraines.
Dr. Zernikow had no relevant financial disclosures. One study author received grants from Amgen and other support from Grunenthal and Akelos. The study received funding from the Sara Page Mayo Endowment for Pediatric Pain Research, Education, and Treatment; the Swiss National Science Foundation; the Schweizer-Arau-Foundation; and the Theophrastus Foundation.
SOURCES: Locher C et al. JAMA Pediatrics. 2020 Feb 10. doi: 10.1001/jamapediatrics.2019.5856; Zernikow B. JAMA Pediatrics. 2020 Feb 10. doi: 10.1001/jamapediatrics.2019.5907.
FROM JAMA PEDIATRICS
Dependent trait in chronic migraine may predict nonresponse to onabotulinumtoxin A
according to research published in the January issue of Headache. The research may be the first to show that personality traits predict response to onabotulinumtoxin A in this population.
“These findings point out that conducting an evaluation of personality traits in patients with chronic migraine might be helpful in the prediction of the course and election of the treatment, as well as identifying patients who might benefit from a multidisciplinary approach,” wrote Alicia Gonzalez-Martinez, MD, of the Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria de La Princesa in Madrid and colleagues. “Categorical questionnaires such as the Salamanca screening test seem to be useful for this purpose.”
Researchers used ICD-10 personality criteria
Personality patterns in patients with migraine and other primary headaches have been the subject of decades of research. Munoz et al. found that certain personality traits are associated with migraine and chronic migraine, and this association may influence clinical management and treatment. The effect of personality traits on response to treatment, however, had not been studied previously.
Dr. Gonzalez-Martinez and colleagues hypothesized that cluster C traits (e.g., obsessive-compulsive, dependent, and anxious), as defined by ICD-10, are associated with nonresponse to onabotulinumtoxin A. To test this hypothesis, they conducted a case-control observational study in a cohort of patients with chronic migraine. Eligible patients presented to one of two headache units of a tertiary hospital between January and May 2018. The investigators obtained a complete headache history and demographic information from each patient. Patients had at least two treatment cycles of onabotulinumtoxin A. Dr. Gonzalez-Martinez and colleagues defined treatment response as a reduction in the number of monthly migraine days of at least 50% after at least two treatment cycles.
The investigators assessed participants’ personality traits by administering the Salamanca test, a brief categorical inventory that examines 11 personality traits using 22 questions. Patients completed the test at the beginning of the study period and before they were classified as responders or nonresponders.
Medication overuse was a potential confounder
The study population included 112 patients with chronic migraine. One hundred patients (89%) were women. Participants’ mean age at initiation of onabotulinumtoxin A treatment was 43 years. The population’s mean duration of chronic migraine was 29 months. Eighty-three patients (74.1%) had medication overuse, and 96 (85.7%) responded to onabotulinumtoxin A.
Cluster A traits in the population included paranoid (prevalence, 10.7%), schizoid (38.4%), and schizotypal (7.1%). Cluster B traits included histrionic (50%), antisocial (1.8%), narcissistic (9.8%), emotional instability subtype impulsive (27.7%), and emotional instability subtype limit (EISL, 24.1%). Cluster C traits were anxious (58.9%) anancastic (i.e., obsessive-compulsive, 54.5%), and dependent (32.1%).
The investigators found no differences in demographics between responders and nonresponders. In a univariate analysis, dependent traits (e.g., passivity and emotional overdependence on others) and EISL traits (e.g., impulsivity and disturbed self-image) were significantly more common among nonresponders. In a multivariate analysis, dependent traits remained significantly associated with nonresponse to onabotulinumtoxin A.
Medication overuse was a potential confounder in the study, according to Dr. Gonzalez-Martinez and colleagues. One of the study’s limitations was its absence of a healthy control group. Another was the fact that the psychometrics of the Salamanca screening test have not been published in a peer-reviewed journal and may need further examination.
Dependent personality “may also be part of the proposed chronic pain sufferer personality,” wrote the investigators. “Early detection of personality traits could improve management and outcome of chronic migraine patients. Additionally, the possibility to predict the effectiveness of onabotulinumtoxin A therapy may reduce costs and latency time of effect in patients with improbable effectiveness.”
The study had no outside funding, and the authors reported no conflicts of interest.
SOURCE: Gonzalez-Martinez A et al. Headache. 2020;60(1):153-61.
according to research published in the January issue of Headache. The research may be the first to show that personality traits predict response to onabotulinumtoxin A in this population.
“These findings point out that conducting an evaluation of personality traits in patients with chronic migraine might be helpful in the prediction of the course and election of the treatment, as well as identifying patients who might benefit from a multidisciplinary approach,” wrote Alicia Gonzalez-Martinez, MD, of the Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria de La Princesa in Madrid and colleagues. “Categorical questionnaires such as the Salamanca screening test seem to be useful for this purpose.”
Researchers used ICD-10 personality criteria
Personality patterns in patients with migraine and other primary headaches have been the subject of decades of research. Munoz et al. found that certain personality traits are associated with migraine and chronic migraine, and this association may influence clinical management and treatment. The effect of personality traits on response to treatment, however, had not been studied previously.
Dr. Gonzalez-Martinez and colleagues hypothesized that cluster C traits (e.g., obsessive-compulsive, dependent, and anxious), as defined by ICD-10, are associated with nonresponse to onabotulinumtoxin A. To test this hypothesis, they conducted a case-control observational study in a cohort of patients with chronic migraine. Eligible patients presented to one of two headache units of a tertiary hospital between January and May 2018. The investigators obtained a complete headache history and demographic information from each patient. Patients had at least two treatment cycles of onabotulinumtoxin A. Dr. Gonzalez-Martinez and colleagues defined treatment response as a reduction in the number of monthly migraine days of at least 50% after at least two treatment cycles.
The investigators assessed participants’ personality traits by administering the Salamanca test, a brief categorical inventory that examines 11 personality traits using 22 questions. Patients completed the test at the beginning of the study period and before they were classified as responders or nonresponders.
Medication overuse was a potential confounder
The study population included 112 patients with chronic migraine. One hundred patients (89%) were women. Participants’ mean age at initiation of onabotulinumtoxin A treatment was 43 years. The population’s mean duration of chronic migraine was 29 months. Eighty-three patients (74.1%) had medication overuse, and 96 (85.7%) responded to onabotulinumtoxin A.
Cluster A traits in the population included paranoid (prevalence, 10.7%), schizoid (38.4%), and schizotypal (7.1%). Cluster B traits included histrionic (50%), antisocial (1.8%), narcissistic (9.8%), emotional instability subtype impulsive (27.7%), and emotional instability subtype limit (EISL, 24.1%). Cluster C traits were anxious (58.9%) anancastic (i.e., obsessive-compulsive, 54.5%), and dependent (32.1%).
The investigators found no differences in demographics between responders and nonresponders. In a univariate analysis, dependent traits (e.g., passivity and emotional overdependence on others) and EISL traits (e.g., impulsivity and disturbed self-image) were significantly more common among nonresponders. In a multivariate analysis, dependent traits remained significantly associated with nonresponse to onabotulinumtoxin A.
Medication overuse was a potential confounder in the study, according to Dr. Gonzalez-Martinez and colleagues. One of the study’s limitations was its absence of a healthy control group. Another was the fact that the psychometrics of the Salamanca screening test have not been published in a peer-reviewed journal and may need further examination.
Dependent personality “may also be part of the proposed chronic pain sufferer personality,” wrote the investigators. “Early detection of personality traits could improve management and outcome of chronic migraine patients. Additionally, the possibility to predict the effectiveness of onabotulinumtoxin A therapy may reduce costs and latency time of effect in patients with improbable effectiveness.”
The study had no outside funding, and the authors reported no conflicts of interest.
SOURCE: Gonzalez-Martinez A et al. Headache. 2020;60(1):153-61.
according to research published in the January issue of Headache. The research may be the first to show that personality traits predict response to onabotulinumtoxin A in this population.
“These findings point out that conducting an evaluation of personality traits in patients with chronic migraine might be helpful in the prediction of the course and election of the treatment, as well as identifying patients who might benefit from a multidisciplinary approach,” wrote Alicia Gonzalez-Martinez, MD, of the Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria de La Princesa in Madrid and colleagues. “Categorical questionnaires such as the Salamanca screening test seem to be useful for this purpose.”
Researchers used ICD-10 personality criteria
Personality patterns in patients with migraine and other primary headaches have been the subject of decades of research. Munoz et al. found that certain personality traits are associated with migraine and chronic migraine, and this association may influence clinical management and treatment. The effect of personality traits on response to treatment, however, had not been studied previously.
Dr. Gonzalez-Martinez and colleagues hypothesized that cluster C traits (e.g., obsessive-compulsive, dependent, and anxious), as defined by ICD-10, are associated with nonresponse to onabotulinumtoxin A. To test this hypothesis, they conducted a case-control observational study in a cohort of patients with chronic migraine. Eligible patients presented to one of two headache units of a tertiary hospital between January and May 2018. The investigators obtained a complete headache history and demographic information from each patient. Patients had at least two treatment cycles of onabotulinumtoxin A. Dr. Gonzalez-Martinez and colleagues defined treatment response as a reduction in the number of monthly migraine days of at least 50% after at least two treatment cycles.
The investigators assessed participants’ personality traits by administering the Salamanca test, a brief categorical inventory that examines 11 personality traits using 22 questions. Patients completed the test at the beginning of the study period and before they were classified as responders or nonresponders.
Medication overuse was a potential confounder
The study population included 112 patients with chronic migraine. One hundred patients (89%) were women. Participants’ mean age at initiation of onabotulinumtoxin A treatment was 43 years. The population’s mean duration of chronic migraine was 29 months. Eighty-three patients (74.1%) had medication overuse, and 96 (85.7%) responded to onabotulinumtoxin A.
Cluster A traits in the population included paranoid (prevalence, 10.7%), schizoid (38.4%), and schizotypal (7.1%). Cluster B traits included histrionic (50%), antisocial (1.8%), narcissistic (9.8%), emotional instability subtype impulsive (27.7%), and emotional instability subtype limit (EISL, 24.1%). Cluster C traits were anxious (58.9%) anancastic (i.e., obsessive-compulsive, 54.5%), and dependent (32.1%).
The investigators found no differences in demographics between responders and nonresponders. In a univariate analysis, dependent traits (e.g., passivity and emotional overdependence on others) and EISL traits (e.g., impulsivity and disturbed self-image) were significantly more common among nonresponders. In a multivariate analysis, dependent traits remained significantly associated with nonresponse to onabotulinumtoxin A.
Medication overuse was a potential confounder in the study, according to Dr. Gonzalez-Martinez and colleagues. One of the study’s limitations was its absence of a healthy control group. Another was the fact that the psychometrics of the Salamanca screening test have not been published in a peer-reviewed journal and may need further examination.
Dependent personality “may also be part of the proposed chronic pain sufferer personality,” wrote the investigators. “Early detection of personality traits could improve management and outcome of chronic migraine patients. Additionally, the possibility to predict the effectiveness of onabotulinumtoxin A therapy may reduce costs and latency time of effect in patients with improbable effectiveness.”
The study had no outside funding, and the authors reported no conflicts of interest.
SOURCE: Gonzalez-Martinez A et al. Headache. 2020;60(1):153-61.
FROM HEADACHE
Celecoxib oral solution treats migraine effectively in randomized trial
, according to trial results published in the January issue of Headache.
Two hours after treatment, a significantly greater proportion of patients who received the liquid solution, known as DFN-15, had freedom from pain and freedom from their most bothersome accompanying symptom – nausea, photophobia, or phonophobia – compared with patients who received placebo. The pain freedom rates were 35.6% with celecoxib oral solution and 21.7% with placebo. The rates of freedom from the most bothersome symptom were 57.8% with celecoxib oral solution and 44.8% with placebo.
About 9% of patients who received celecoxib oral solution had treatment-emergent adverse events related to the study drug, the most common of which were dysgeusia (4.2%) and nausea (3.2%). In comparison, about 6% of patients who received placebo had treatment-emergent adverse events. There were no serious treatment-emergent adverse events.
“DFN‐15 has the potential to become a reliable and convenient acute therapeutic option for patients with migraine,” said lead author Richard B. Lipton, MD, and colleagues. Dr. Lipton is affiliated with the Albert Einstein College of Medicine in New York.
Assessing celecoxib in migraineurs
Evidence-based guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, diclofenac, ibuprofen, and naproxen, as effective acute migraine treatments, but these medications may increase the risk of adverse gastrointestinal events, the authors said. Celecoxib, a selective cyclooxygenase (COX)-2 inhibitor, is indicated for the treatment of acute pain in patients with ankylosing spondylitis, osteoarthritis, primary dysmenorrhea, and rheumatoid arthritis. Although it produces analgesia similar to other NSAIDs, among patients with osteoarthritis and rheumatoid arthritis, celecoxib is associated with significantly lower risk of gastrointestinal events, compared with naproxen and ibuprofen, and significantly lower risk of renal events, compared with ibuprofen.
Researchers have studied an oral capsule form of celecoxib (Celebrex, Pfizer) as an acute treatment for migraine in an open-label study that compared celecoxib with naproxen sodium. “While preliminary results suggest comparable efficacy but better tolerability than widely used and guideline-recommended NSAIDs, celecoxib is not currently approved for migraine,” the authors said.
Compared with the oral capsule formulation, the oral liquid solution DFN-15 has a faster median time to peak concentration under fasting conditions (within 1 hour vs. 2.5 hours), which “could translate into more rapid onset of pain relief,” the authors said. In addition, DFN-15 may have greater bioavailability, which could lower dose requirements and improve safety and tolerability. To compare the efficacy, tolerability, and safety of 120-mg DFN-15 with placebo for the acute treatment of migraine, researchers conducted a randomized, double-blind, placebo-controlled study.
Participants used single-dose bottles
Researchers randomized 622 patients 1:1 to DFN-15 or placebo, and 567 treated a migraine during the trial. Patients had a mean age of 40 years, and 87% were female. Patients had episodic migraine with or without aura, no signs of medication overuse, and two-eight migraine attacks per month. For the trial, patients treated a single migraine attack of moderate to severe intensity within 1 hour of onset. “Each subject was given a single‐dose bottle of DFN‐15 120 mg or matching placebo containing 4.8 mL liquid,” Dr. Lipton and colleagues said. “They were instructed to drink the entire contents of the bottle to ensure complete consumption of study medication.”
Freedom from pain and freedom from the most bothersome symptom at 2 hours were the coprimary endpoints. “DFN‐15 was also significantly superior to placebo on multiple secondary 2‐hour endpoints, including freedom from photophobia, pain relief, change in functional disability from baseline, overall and 24‐hour satisfaction with treatment, and use of rescue medication,” they reported.
“A new COX‐2 inhibitor that is effective and rapidly absorbed could provide an important new option for a wide range of patients,” the authors said. “Though cross‐study comparisons are problematic, the current results for DFN‐15 indicate that its efficacy is similar to that of NSAIDs and small‐molecule calcitonin gene‐related peptide receptor antagonists (gepants), based on placebo‐subtracted rates pain freedom in acute treatment trials (14%‐21%). DFN‐15 may also be useful among triptan users, who are at elevated risk of medication‐overuse headache and for whom TEAEs within 24 hours postdose are common. ... The form and delivery system of DFN‐15 – a ready‐to‐use solution in a 4.8‐mL single‐use bottle – may support patient adherence.”
The trial had robust placebo response rates, which may have been influenced by “the novelty of a ready‐made oral solution, which has not been previously tested for the acute treatment of migraine,” the authors noted. In addition, the trial does not address the treatment of mild pain or treatment across multiple attacks.
The trial was supported by Dr. Reddy’s Laboratories, manufacturer of DFN-15. Two authors are employed by and own stock in Dr. Reddy’s. Dr. Lipton and a coauthor disclosed research support from and consulting for Dr. Reddy’s.
SOURCE: Lipton RB et al. Headache. 2020;60(1):58-70. doi: 10.1111/head.13663.
, according to trial results published in the January issue of Headache.
Two hours after treatment, a significantly greater proportion of patients who received the liquid solution, known as DFN-15, had freedom from pain and freedom from their most bothersome accompanying symptom – nausea, photophobia, or phonophobia – compared with patients who received placebo. The pain freedom rates were 35.6% with celecoxib oral solution and 21.7% with placebo. The rates of freedom from the most bothersome symptom were 57.8% with celecoxib oral solution and 44.8% with placebo.
About 9% of patients who received celecoxib oral solution had treatment-emergent adverse events related to the study drug, the most common of which were dysgeusia (4.2%) and nausea (3.2%). In comparison, about 6% of patients who received placebo had treatment-emergent adverse events. There were no serious treatment-emergent adverse events.
“DFN‐15 has the potential to become a reliable and convenient acute therapeutic option for patients with migraine,” said lead author Richard B. Lipton, MD, and colleagues. Dr. Lipton is affiliated with the Albert Einstein College of Medicine in New York.
Assessing celecoxib in migraineurs
Evidence-based guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, diclofenac, ibuprofen, and naproxen, as effective acute migraine treatments, but these medications may increase the risk of adverse gastrointestinal events, the authors said. Celecoxib, a selective cyclooxygenase (COX)-2 inhibitor, is indicated for the treatment of acute pain in patients with ankylosing spondylitis, osteoarthritis, primary dysmenorrhea, and rheumatoid arthritis. Although it produces analgesia similar to other NSAIDs, among patients with osteoarthritis and rheumatoid arthritis, celecoxib is associated with significantly lower risk of gastrointestinal events, compared with naproxen and ibuprofen, and significantly lower risk of renal events, compared with ibuprofen.
Researchers have studied an oral capsule form of celecoxib (Celebrex, Pfizer) as an acute treatment for migraine in an open-label study that compared celecoxib with naproxen sodium. “While preliminary results suggest comparable efficacy but better tolerability than widely used and guideline-recommended NSAIDs, celecoxib is not currently approved for migraine,” the authors said.
Compared with the oral capsule formulation, the oral liquid solution DFN-15 has a faster median time to peak concentration under fasting conditions (within 1 hour vs. 2.5 hours), which “could translate into more rapid onset of pain relief,” the authors said. In addition, DFN-15 may have greater bioavailability, which could lower dose requirements and improve safety and tolerability. To compare the efficacy, tolerability, and safety of 120-mg DFN-15 with placebo for the acute treatment of migraine, researchers conducted a randomized, double-blind, placebo-controlled study.
Participants used single-dose bottles
Researchers randomized 622 patients 1:1 to DFN-15 or placebo, and 567 treated a migraine during the trial. Patients had a mean age of 40 years, and 87% were female. Patients had episodic migraine with or without aura, no signs of medication overuse, and two-eight migraine attacks per month. For the trial, patients treated a single migraine attack of moderate to severe intensity within 1 hour of onset. “Each subject was given a single‐dose bottle of DFN‐15 120 mg or matching placebo containing 4.8 mL liquid,” Dr. Lipton and colleagues said. “They were instructed to drink the entire contents of the bottle to ensure complete consumption of study medication.”
Freedom from pain and freedom from the most bothersome symptom at 2 hours were the coprimary endpoints. “DFN‐15 was also significantly superior to placebo on multiple secondary 2‐hour endpoints, including freedom from photophobia, pain relief, change in functional disability from baseline, overall and 24‐hour satisfaction with treatment, and use of rescue medication,” they reported.
“A new COX‐2 inhibitor that is effective and rapidly absorbed could provide an important new option for a wide range of patients,” the authors said. “Though cross‐study comparisons are problematic, the current results for DFN‐15 indicate that its efficacy is similar to that of NSAIDs and small‐molecule calcitonin gene‐related peptide receptor antagonists (gepants), based on placebo‐subtracted rates pain freedom in acute treatment trials (14%‐21%). DFN‐15 may also be useful among triptan users, who are at elevated risk of medication‐overuse headache and for whom TEAEs within 24 hours postdose are common. ... The form and delivery system of DFN‐15 – a ready‐to‐use solution in a 4.8‐mL single‐use bottle – may support patient adherence.”
The trial had robust placebo response rates, which may have been influenced by “the novelty of a ready‐made oral solution, which has not been previously tested for the acute treatment of migraine,” the authors noted. In addition, the trial does not address the treatment of mild pain or treatment across multiple attacks.
The trial was supported by Dr. Reddy’s Laboratories, manufacturer of DFN-15. Two authors are employed by and own stock in Dr. Reddy’s. Dr. Lipton and a coauthor disclosed research support from and consulting for Dr. Reddy’s.
SOURCE: Lipton RB et al. Headache. 2020;60(1):58-70. doi: 10.1111/head.13663.
, according to trial results published in the January issue of Headache.
Two hours after treatment, a significantly greater proportion of patients who received the liquid solution, known as DFN-15, had freedom from pain and freedom from their most bothersome accompanying symptom – nausea, photophobia, or phonophobia – compared with patients who received placebo. The pain freedom rates were 35.6% with celecoxib oral solution and 21.7% with placebo. The rates of freedom from the most bothersome symptom were 57.8% with celecoxib oral solution and 44.8% with placebo.
About 9% of patients who received celecoxib oral solution had treatment-emergent adverse events related to the study drug, the most common of which were dysgeusia (4.2%) and nausea (3.2%). In comparison, about 6% of patients who received placebo had treatment-emergent adverse events. There were no serious treatment-emergent adverse events.
“DFN‐15 has the potential to become a reliable and convenient acute therapeutic option for patients with migraine,” said lead author Richard B. Lipton, MD, and colleagues. Dr. Lipton is affiliated with the Albert Einstein College of Medicine in New York.
Assessing celecoxib in migraineurs
Evidence-based guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, diclofenac, ibuprofen, and naproxen, as effective acute migraine treatments, but these medications may increase the risk of adverse gastrointestinal events, the authors said. Celecoxib, a selective cyclooxygenase (COX)-2 inhibitor, is indicated for the treatment of acute pain in patients with ankylosing spondylitis, osteoarthritis, primary dysmenorrhea, and rheumatoid arthritis. Although it produces analgesia similar to other NSAIDs, among patients with osteoarthritis and rheumatoid arthritis, celecoxib is associated with significantly lower risk of gastrointestinal events, compared with naproxen and ibuprofen, and significantly lower risk of renal events, compared with ibuprofen.
Researchers have studied an oral capsule form of celecoxib (Celebrex, Pfizer) as an acute treatment for migraine in an open-label study that compared celecoxib with naproxen sodium. “While preliminary results suggest comparable efficacy but better tolerability than widely used and guideline-recommended NSAIDs, celecoxib is not currently approved for migraine,” the authors said.
Compared with the oral capsule formulation, the oral liquid solution DFN-15 has a faster median time to peak concentration under fasting conditions (within 1 hour vs. 2.5 hours), which “could translate into more rapid onset of pain relief,” the authors said. In addition, DFN-15 may have greater bioavailability, which could lower dose requirements and improve safety and tolerability. To compare the efficacy, tolerability, and safety of 120-mg DFN-15 with placebo for the acute treatment of migraine, researchers conducted a randomized, double-blind, placebo-controlled study.
Participants used single-dose bottles
Researchers randomized 622 patients 1:1 to DFN-15 or placebo, and 567 treated a migraine during the trial. Patients had a mean age of 40 years, and 87% were female. Patients had episodic migraine with or without aura, no signs of medication overuse, and two-eight migraine attacks per month. For the trial, patients treated a single migraine attack of moderate to severe intensity within 1 hour of onset. “Each subject was given a single‐dose bottle of DFN‐15 120 mg or matching placebo containing 4.8 mL liquid,” Dr. Lipton and colleagues said. “They were instructed to drink the entire contents of the bottle to ensure complete consumption of study medication.”
Freedom from pain and freedom from the most bothersome symptom at 2 hours were the coprimary endpoints. “DFN‐15 was also significantly superior to placebo on multiple secondary 2‐hour endpoints, including freedom from photophobia, pain relief, change in functional disability from baseline, overall and 24‐hour satisfaction with treatment, and use of rescue medication,” they reported.
“A new COX‐2 inhibitor that is effective and rapidly absorbed could provide an important new option for a wide range of patients,” the authors said. “Though cross‐study comparisons are problematic, the current results for DFN‐15 indicate that its efficacy is similar to that of NSAIDs and small‐molecule calcitonin gene‐related peptide receptor antagonists (gepants), based on placebo‐subtracted rates pain freedom in acute treatment trials (14%‐21%). DFN‐15 may also be useful among triptan users, who are at elevated risk of medication‐overuse headache and for whom TEAEs within 24 hours postdose are common. ... The form and delivery system of DFN‐15 – a ready‐to‐use solution in a 4.8‐mL single‐use bottle – may support patient adherence.”
The trial had robust placebo response rates, which may have been influenced by “the novelty of a ready‐made oral solution, which has not been previously tested for the acute treatment of migraine,” the authors noted. In addition, the trial does not address the treatment of mild pain or treatment across multiple attacks.
The trial was supported by Dr. Reddy’s Laboratories, manufacturer of DFN-15. Two authors are employed by and own stock in Dr. Reddy’s. Dr. Lipton and a coauthor disclosed research support from and consulting for Dr. Reddy’s.
SOURCE: Lipton RB et al. Headache. 2020;60(1):58-70. doi: 10.1111/head.13663.
FROM HEADACHE
Many children who present to headache clinics have joint hypermobility
Key clinical point: About one-quarter of pediatric patients with headache have joint hypermobility.
Major finding: Among children with headache and joint hypermobility, 80% had severe headache disability.
Study details: A prospective, single-center study of 76 children with headache.
Disclosures: The study was not supported by funding, and the investigators had no disclosures.
Citation: Sahjwani D et al. CNS 2019, Abstract 101.
Key clinical point: About one-quarter of pediatric patients with headache have joint hypermobility.
Major finding: Among children with headache and joint hypermobility, 80% had severe headache disability.
Study details: A prospective, single-center study of 76 children with headache.
Disclosures: The study was not supported by funding, and the investigators had no disclosures.
Citation: Sahjwani D et al. CNS 2019, Abstract 101.
Key clinical point: About one-quarter of pediatric patients with headache have joint hypermobility.
Major finding: Among children with headache and joint hypermobility, 80% had severe headache disability.
Study details: A prospective, single-center study of 76 children with headache.
Disclosures: The study was not supported by funding, and the investigators had no disclosures.
Citation: Sahjwani D et al. CNS 2019, Abstract 101.