IMPORTANCE Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist. OBJECTIVE To determine the benefits of cognitive ...behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children’s Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up. INTERVENTIONS Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months. MAIN OUTCOMES AND MEASURES The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points). RESULTS At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 95% CI, 1.7-7.7 days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 95% CI, 3.3-24.9 points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 95% CI, 1.7-7.2; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups. CONCLUSIONS AND RELEVANCE Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00389038
Objective: To evaluate the efficacy of Coenzyme Q10 (CoQ10) supplementation in the prevention of migraine in children using a placebo-controlled, double-blinded, crossover, add-on trial. Background: ...CoQ10 has been demonstrated to have efficacy in migraine prevention in adults but lacks pediatric research with more rigorous methodology. CoQ10 has been observed to be deficient in a significant number of children and adolescents presenting to tertiary headache centers. CoQ10 has the potential to modify both the inflammatory changes that occur during recurrent migraine and the alteration of mitochondrial function. A deficit of CoQ10 could thus affect the response to treatment and clinical characteristics of migraine in children and adults. Methods: One-hundred-and-twenty children and adolescents with migraine headache were randomized in a crossover, double-blind, placebo-controlled, randomized, add-on study to receive a placebo or CoQ10 (100 mg) supplement for 224 days. Data for 76 patients were available at the crossover point and 50 were analysed at the endpoint. Response to treatment, overall headache improvement, and headache disability were assessed. Results: Both the placebo and CoQ10 groups showed reduced migraine frequency F(1, 60) = 15.68, p < 0.001, severity F(1, 54) = 8.09, p = 0.006, and duration F(1, 45) = 6.27, p = 0.016 over time. CoQ10 treated patients had a significantly greater improvement in frequency from subject reported baseline starting within 4 weeks of initiation. No group differences comparing the first 4 weeks of treatment with the last 4 weeks of treatment were found in migraine frequency F(1, 60) = 2.34, p > 0.05, severity F(1, 54) = 0.06, p > 0.05, or duration F(1, 45) = 0.14, p > 0.05. Conclusions: Overall, results of the study demonstrate that children and adolescents with migraine improved over time with multidisciplinary, standardized treatment regardless of supplementation with CoQ10 or placebo. There was no difference in headache outcomes between the CoQ10 and placebo groups at day 224. Due to the improvements seen in weeks 1–4, CoQ10 may lead to earlier improvement in headache severity, but given the sample size this conclusion warrants further investigation with a larger sample.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
We compared headache frequency trajectories between clinical trial participants who received cognitive-behavioral therapy (CBT) and amitriptyline (CBT+A) or headache education (HE) and amitriptyline ...(HE+A) to determine if there was a differential time course of treatment response between the groups. One hundred thirty-five patients (age 10-17 years) diagnosed with chronic migraine participated, attending 8 one-hour one-on-one CBT or HE sessions with a trained psychologist for 8 weekly sessions, 2 sessions at weeks 12 and 16, and a post-treatment visit at week 20. Participants kept daily headache diaries and completed take-home assignments between visits. Data from daily headache diaries are presented for each day and according to 28-day periods. Trajectories of improvement indicate initial decrease in headache days began during the first month of treatment, for both groups, and continued to decrease throughout treatment. The CBT+A group had greater daily improvement than the HE+A group. A significantly greater proportion of the CBT+A group had a ≥50% reduction in headache days each month, and a significantly greater proportion of the CBT+A group had ≤4 headache days per month in months 3 through 5. Results indicate the trajectory of decrease in headache days is significantly better for patients receiving CBT+A versus HE+A.
This article presents daily information about headache frequency over a 20-week clinical trial. Youth with chronic migraine who received CBT+A improved faster than those in the control group. Findings provide clinicians with evidence-based expectations for treatment response over time and ways of monitoring treatment success.
clinicaltrials.gov identifier NCT00389038.
Background.—Coenzyme Q10 (CoQ10) has been suggested to be effective in the prevention of migraine, and levels can be quantified with standardized reference ranges.
Objective.—This study documents the ...prevalence of CoQ10 deficiency in migraine headache and examines the potential effectiveness of supplementation.
Methods.—We assessed patients attending a tertiary care center with frequent headaches for CoQ10 deficiency. We recommended patients with low CoQ10 levels begin supplementation with CoQ10 as part of their multidisciplinary treatment plan. We assessed response to treatment including correction of CoQ10 deficiency, overall headache improvement, and headache disability.
Results.—CoQ10 was measured in 1550 patients (mean age 13.3 ± 3.5, range 3 to 22 years). The mean total CoQ10 level was 0.60 ± 0.20 μg/mL (range 0.21 to 1.77 μg/mL). Of these patients, 32.9% were below the reference range. Patients with low CoQ10 were recommended to start 1 to 3 mg/kg per day of CoQ10 in liquid gel capsule formulation. In a subset of patients who returned for timely follow‐up (mean, 97 days), the total CoQ10 level improved to 1.20 ± 0.59 μg/mL (P < .0001), while the headache frequency improved from 19.2 ± 10.0 to 12.5 ± 10.8 (P < .001) and headache disability assessed with PedMIDAS improved from 47.4 ± 50.6 to 22.8 ± 30.6 (P < .001).
Conclusions.—Deficiency of CoQ10 may be common in pediatric and adolescent migraine. Determination of deficiency and consequent supplementation may result in clinical improvement. Further analysis involving more scientifically rigorous methodology will be required to confirm this observation.
Background
Fifty-three percent of adolescent girls report headaches at the onset of menses, suggesting fluctuations of ovarian hormones trigger migraine during puberty.
Aims
To determine if urinary ...metabolites of estrogen and progesterone are associated with days of headache onset (HO) or severity in girls with migraine.
Methods
This was a pilot study and included 34 girls with migraine balanced across three age strata (pre-pubertal (8–11), pubertal (12–15), and post-pubertal (16–17) years of age). They collected daily urine samples and recorded the occurrence and severity of headache in a daily diary. Urine samples were assayed for estrone glucuronide (E1G) and pregnandiol glucuronide (PdG) and the daily change was calculated (ΔE1G, ΔPdG). Pubertal development was assessed by age, pubertal development score (PDS), and menstrual cycle variance. The primary outcome measures were HO days and headache severity. Generalized linear mixed models were used, and included the hormonal variables and three different representations of pubertal development as covariates.
Results
Models of HO days demonstrate a significant age*PdG interaction (OR 0.85 95% CI 0.75, 0.97) for a 1 standard deviation increase in PdG and three-year increase in age. A separate model showed a significant PDS*PdG interaction (OR −0.85 95% CI; 0.76, 0.95). ΔPDG was associated with headache severity in unadjusted models (p < 0.017).
Conclusion
Age and pubertal development could moderate the effect of ovarian hormones on days of headache onset in girls with migraine.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background and ObjectivesThe prevalence of generalized joint hypermobility (GJH) is 5-65% in children and adolescents. The hypothesis of this study was to see whether there is an association between ...headache characteristics and GJH in children and adolescents with migraine. MethodsWe performed a primary retrospective case-control analysis of an established database of patients with headache aged 5-17 years. ResultsWe included 5435 participants. Approximately 31.6% of participants (1,719/5,435) were diagnosed with GJH (Beighton score ≥ 6). Nausea (73.1% vs 67.5%, χ2 with 1 degree of freedom = 17.0, p < 0.0001), phonophobia (87.3% vs 78.8%, χ2 with 1 degree of freedom = 18.0, p < 0.0001), and the PedMIDAS score (48.2 ± 52.5, 95% CI 45.7-50.6 vs 41.6 ± 51.2, 95% CI 40.0-43.3, effect size = 0.13, p < 0.0001) were noted to be more severe in participants with GJH than those without GJH. DiscussionYouths with GJH and migraine were noted to have more severe migraine characteristics.
Objective
The objective of this secondary analysis of results from a previously published trial (Clinical Trials Registration Number: NCT00389038) in chronic migraine in children and adolescents was ...to examine if participants who received cognitive behavioral therapy and amitriptyline reached a greater level of reduction in headache frequency that no longer indicated a recommendation for preventive treatment as compared to those who received headache education and amitriptyline.
Background
Chronic migraine negatively affects children's home, school, and social activities. Preventive medication therapy is suggested for 5 or more headaches per month. Reduction to one headache day per week or less may suggest that preventive treatment is no longer indicated and provide a clinically relevant outcome for treatment efficacy and patient care.
Methods
Randomized study participants (N = 135) kept a daily record of their headache frequency during 20 weeks of treatment and during a 1 year follow‐up period. Baseline headache frequency was determined at the end of a 28 day screening period. Post treatment frequency was determined at 20 weeks (N = 128 completed) and post treatment follow‐up was measured 12 months later (N = 124 completed). A chi‐square test of independence was conducted by treatment group and by time point to determine group differences in the proportion of headache days experienced.
Results
At 20 weeks (post treatment), 47% of the cognitive behavioral therapy plus amitriptyline group had ≤4 headache days per month compared to 20% of the headache education plus amitriptyline group, (P = .0011), and 32% of the cognitive behavioral therapy plus amitriptyline group had ≤3 headache days per month at 20 weeks compared to 16% of the headache education plus amitriptyline group, (P = .0304). At the month 12 follow‐up, 72% of the cognitive behavioral therapy plus amitriptyline group had ≤4 headache days per month compared to 52% of the headache education plus amitriptyline group, (P = .0249), and 61% of the cognitive behavioral therapy plus amitriptyline group had ≤3 headache days per month at their month 12 follow‐up compared to 40% of the headache education plus amitriptyline group, (P = .0192).
Conclusions
Participants who received cognitive behavioral therapy and amitriptyline were more likely than participants who received headache education plus amitriptyline to reach the clinically meaningful outcome of less than or equal to 4 headache days per month at both time points. These results may help inform what treatment outcomes are possible for children and adolescents suffering from chronic migraine and provides further evidence for behavioral treatment to be considered as a key part of a first line treatment regimen.
Chronic pain in children is associated with significant negative impact on social, emotional, and school functioning. Previous studies on the impact of pain on children’s functioning have primarily ...used mixed samples of pain conditions or single pain conditions (eg, headache and abdominal pain) with relatively small sample sizes. As a result, the similarities and differences in the impact of pain in subgroups of children with chronic pain have not been closely examined.
OBJECTIVE:To compare pain characteristics, quality of life, and emotional functioning among youth with pediatric chronic migraine (CM) and juvenile fibromyalgia (JFM).
METHODS:We combined data obtained during screening of patients for 2 relatively large intervention studies of youth (age range, 10 to 18 y) with CM (N=153) and JFM (N=151). Measures of pain intensity, quality of life (Pediatric Quality of Life; PedsQL, child and parent-proxy), depressive symptoms (Children’s Depression Inventory), and anxiety symptoms (Adolescent Symptom Inventory-4—Anxiety subscale) were completed by youth and their parent. A multivariate analysis of covariance controlling for effects of age and sex was performed to examine differences in quality of life and emotional functioning between the CM and JFM groups.
RESULTS:Youth with JFM had significantly higher anxiety and depressive symptoms, and lower quality of life in all domains. Among children with CM, overall functioning was higher but school functioning was a specific area of concern.
DISCUSSION:Results indicate important differences in subgroups of pediatric pain patients and point to the need for more intensive multidisciplinary intervention for JFM patients.
Explore predictors of improvement in headache days and migraine-related disability through a secondary analysis of the cognitive-behavioral therapy plus amitriptyline trial in children and ...adolescents (Clinical Trials Registration Number: NCT00389038). Participants were 135 youth aged 10–17 years old diagnosed with chronic migraine. Predictor variables included group assignment (treatment or control), baseline scores from depression and quality of life measures, and demographic variables. Criterion variables included headache days and migraine-related disability. Higher baseline depression scores were indicative of more days with headache post-treatment regardless of group assignment. Family income at the higher-end of the low-income range was significantly associated with less migraine-related disability regardless of group assignment (Household Income: HINC-01 in The United States Census Bureau. Bureau, U,
2020
). Results from this secondary analysis identify depression symptoms and family income as predictors that can impact headache frequency and migraine-related disability. Self-reported symptoms of depression and family income are important factors to consider as part of the biopsychosocial model of care.
Objective
The purpose of this investigation was to examine treatment adherence to medication and lifestyle recommendations among pediatric migraine patients using electronic monitoring systems.
...Background
Nonadherence to medical treatment is a significant public health concern, and can result in poorer treatment outcomes, decreased cost‐effectiveness of medical care, and increased morbidity. No studies have systematically examined adherence to medication and lifestyle recommendations in adolescents with migraine outside of a clinical trial.
Methods
Participants included 56 adolescents ages 11‐17 who were presenting for clinical care. All were diagnosed with migraine with or without aura or chronic migraine and had at least 4 headache days per month. Medication adherence was objectively measured using electronic monitoring systems (Medication Event Monitoring Systems technology) and daily, prospective self‐report via personal electronic devices. Adherence to lifestyle recommendations of regular exercise, eating, and fluid intake were also assessed using daily self‐report on personal electronic devices.
Results
Electronic monitoring indicates that adolescents adhere to their medication 75% of the time, which was significantly higher than self‐reported rates of medication adherence (64%). Use of electronic monitoring of medication detected rates of adherence that were significantly higher for participants taking once daily medication (85%) versus participants taking twice daily medication (59%). Average reported adherence to lifestyle recommendations of consistent noncaffeinated fluid intake (M = 5 cups per day) was below recommended levels of a minimum of 8 cups per day. Participants on average also reported skipping 1 meal per week despite recommendations of consistently eating three meals per day.
Conclusions
Results suggest that intervention focused on adherence to preventive treatments (such as medication) and lifestyle recommendations may provide more optimal outcomes for children and adolescents with migraine and their families. Once daily dosing of medication may be preferred to twice daily medication for increased medication adherence among children and adolescents.
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