The Efficacy of Moderate-to-High Dose Oral Prednisolone Versus Low-to-Moderate Dose Intramuscular Corticotropin for Improvement of Hypsarrhythmia in West Syndrome: A Randomized, Single-Blind, Parallel Clinical Trial

Wanigasinghe, Jithangi; Arambepola, Carukshi; Ranganathan, Shalini Sri; Sumanasena, Samanmali P; Muhandiram, Eindrini

doi:10.1016/j.pediatrneurol.2014.03.014

Cited by 40 publications

(31 citation statements)

References 25 publications

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“…Further studies are needed, for example, to address the role of high dose oral prednisone in the management of epileptic spasms, and the use of the ketogenic diet in medically refractory epileptic spasms. 16,41,42 Although this report has provided a series of recommendations, for the most part it has identified the significant lack of evidence to support a standard of care with regard to the management of infants with epilepsy and the need for more targeted randomized controlled trials (RCTs) across all management areas, especially with respect to the role of AEDs. This report, initially intended as a guideline, was re-termed a recommendation, due to the lack of evidence-based data to support guideline statements.…”

Section: Discussion Of the Recommendationsmentioning

confidence: 99%

Summary of recommendations for the management of infantile seizures: TaskForceReport for theILAE Commission ofPediatrics

et al. 2015

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Summary Evidence‐based guidelines, or recommendations, for the management of infants with seizures are lacking. A Task Force of the Commission of Pediatrics developed a consensus document addressing diagnostic markers, management interventions, and outcome measures for infants with seizures. Levels of evidence to support recommendations and statements were assessed using the American Academy of Neurology Guidelines and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The report contains recommendations for different levels of care, noting which would be regarded as standard care, compared to optimal care, or “state of the art” interventions. The incidence of epilepsy in the infantile period is the highest of all age groups (strong evidence), with epileptic spasms the largest single subgroup and, in the first 2 years of life, febrile seizures are the most commonly occurring seizures. Acute intervention at the time of a febrile seizure does not alter the risk for subsequent epilepsy (class 1 evidence). The use of antipyretic agents does not alter the recurrence rate (class 1 evidence), and there is no evidence to support initiation of regular antiepileptic drugs for simple febrile seizures (class 1 evidence). Infants with abnormal movements whose routine electroencephalography (EEG) study is not diagnostic, would benefit from video‐EEG analysis, or home video to capture events (expert opinion, level U recommendation). Neuroimaging is recommended at all levels of care for infants presenting with epilepsy, with magnetic resonance imaging (MRI) recommended as the standard investigation at tertiary level (level A recommendation). Genetic screening should not be undertaken at primary or secondary level care (expert opinion). Standard care should permit genetic counseling by trained personal at all levels of care (expert opinion). Genetic evaluation for Dravet syndrome, and other infantile‐onset epileptic encephalopathies, should be available in tertiary care (weak evidence, level C recommendation). Patients should be referred from primary or secondary to tertiary level care after failure of one antiepileptic drug (standard care) and optimal care equates to referral of all infants after presentation with a seizure (expert opinion, level U evidence). Infants with recurrent seizures warrant urgent assessment for initiation of antiepileptic drugs (expert opinion, level U recommendation). Infantile encephalopathies should have rapid introduction and increment of antiepileptic drug dosage (expert opinion, level U recommendation). There is no high level evidence to support any particular current agents for use in infants with seizures. For focal seizures, levetiracetam is effective (strong evidence); for generalized seizures, weak evidence supports levetiracetam, valproate, lamotrigine, topiramate, and clobazam; for Dravet syndrome, strong evidence supports that stiripentol is effective (in combination with valproate and clobazam), whereas weak evidence supports that topiramate, zonisamide,...

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Section: Discussion Of the Recommendationsmentioning

confidence: 99%

Summary of recommendations for the management of infantile seizures: TaskForceReport for theILAE Commission ofPediatrics

et al. 2015

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“…The difference in outcomes particularly between ACTH and OCS may be due to the increased relapse rate that was present in the OCS group. Previous studies with shorter follow‐up often did not account for relapse rates, and the only long‐term follow‐up studies were smaller (24 and 97 subjects each) and used variable dosing of ACTH and OCS. This may have led to an overestimation of response rate to OCS.…”

Section: Discussionmentioning

confidence: 99%

“…Studies have reported response rates of 86 to 93% with high‐dose ACTH, although a randomized study indicated that high‐dose ACTH was not superior to low‐dose ACTH (20–30IU/day) . Some trials comparing ACTH and OCS utilized low doses (20–30IU) of ACTH, and failed to observe significant differences in response rates . The United Kingdom Infantile Spasms Study (UKISS) observed similar response rates between OCS and synthetic ACTH (tetracosactide; 70% and 76%), with both superior to vigabatrin (54%) .…”

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confidence: 99%

Response to treatment in a prospective national infantile spasms cohort

Knupp

Coryell

Nickels

et al. 2016

Annals of Neurology

203

220

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Objective Infantile spasms are seizures associated with a severe epileptic encephalopathy presenting in the first 2 years of life, and optimal treatment continues to be debated. This study evaluates early and sustained response to initial treatments and addresses both clinical remission and electrographic resolution of hypsarrhythmia. Secondarily, it assesses whether response to treatment differs by etiology or developmental status. Methods The National Infantile Spasms Consortium established a multicenter, prospective database enrolling infants with new diagnosis of infantile spasms. Children were considered responders if there was clinical remission and resolution of hypsarrhythmia that was sustained at 3 months after first treatment initiation. Standard treatments of adrenocorticotropic hormone (ACTH), oral corticosteroids, and vigabatrin were considered individually, and all other nonstandard therapies were analyzed collectively. Developmental status and etiology were assessed. We compared response rates by treatment group using chi-square tests and multivariate logistic regression models. Results Two hundred thirty infants were enrolled from 22 centers. Overall, 46% of children receiving standard therapy responded, compared to only 9% who responded to nonstandard therapy (p<0.001). Fifty-five percent of infants receiving ACTH as initial treatment responded, compared to 39% for oral corticosteroids, 36% for vigabatrin, and 9% for other (p<0.001). Neither etiology nor development significantly modified the response pattern by treatment group. Interpretation Response rate varies by treatment choice. Standard therapies should be considered as initial treatment for infantile spasms, including those with impaired development or known structural or genetic/metabolic etiology. ACTH appeared to be more effective than other standard therapies.

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“…We further excluded six nonrandomized studies, six systematic reviews without raw data, six conference abstracts, two editorials, and six other articles that did not meet the inclusion criteria. In the remaining published 13 articles, one study group had four articles reporting related data; another study group had five articles with related data . Thus, to avoid using overlapping data, we selected the most recently published report for each of these groups to be included in the analyses; this also provided the outcomes with the longest follow‐up.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness of corticosteroids versus adrenocorticotropic hormone for infantile spasms: a systematic review and meta‐analysis

Chang

Chen

et al. 2019

Ann Clin Transl Neurol

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ObjectiveTo compare the therapeutic effectiveness of oral corticosteroids with that of adrenocorticotrophic hormone for infantile spasms.MethodsPubMed, Embase, Scopus, and the Cochrane library were searched to retrieve studies published before December 2018 to identify pediatric patients with a diagnosis of infantile spasms. The interventions of oral corticosteroids and adrenocorticotrophic hormone were compared. We included only randomized controlled trials that reported the cessation of spasms as treatment response. The primary outcome was clinical spasm cessation on day 13 or 14. The secondary outcomes were the resolution of hypsarrhythmia, side effects, continued spasm control, spasm relapse rate, and subsequent epilepsy rate. Following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses, the study‐level quality assessment was conducted using the Cochrane risk‐of‐bias tool.ResultsAfter extensive review, 39 articles were included for meticulous evaluation. Five randomized controlled trials with a total of 239 individuals were eligible for further analysis. No significant difference was detected between the corticosteroids and adrenocorticotrophic hormone in the cessation of clinical spasms (odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.16 to 1.81; P = 0.32). The subgroups of high‐dose prednisolone versus adrenocorticotrophic hormone and low‐dose prednisone versus adrenocorticotrophic hormone also exhibited no significant difference. Furthermore, the two subgroups did not differ in terms of hypsarrhythmia resolution, side effects, relapse rate, or subsequent epilepsy rate.InterpretationThis meta‐analysis suggests that high‐dose prednisolone is not inferior to adrenocorticotrophic hormone and that it be considered a safe and effective alternative treatment.

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The Efficacy of Moderate-to-High Dose Oral Prednisolone Versus Low-to-Moderate Dose Intramuscular Corticotropin for Improvement of Hypsarrhythmia in West Syndrome: A Randomized, Single-Blind, Parallel Clinical Trial

Cited by 40 publications

References 25 publications

Summary of recommendations for the management of infantile seizures: TaskForceReport for theILAE Commission ofPediatrics

Summary of recommendations for the management of infantile seizures: TaskForceReport for theILAE Commission ofPediatrics

Response to treatment in a prospective national infantile spasms cohort

Effectiveness of corticosteroids versus adrenocorticotropic hormone for infantile spasms: a systematic review and meta‐analysis

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