Definitions of the strength of the recommendations (A, B, C, U) and classification of the evidence (Class I through Class IV) are provided at the end of the "Major Recommendations" field.
Recommendations for the Acute Treatment of Migraine in Children and Adolescents
- Ibuprofen is effective and should be considered for the acute treatment of migraine in children (Level A).
- Acetaminophen is probably effective and should be considered for the acute treatment of migraine in children (Level B).
- Sumatriptan nasal spray is effective and should be considered for the acute treatment of migraine in adolescents (Level A).
- There are no data to support or refute use of any oral triptan preparations in children or adolescents (Level U).
- There are inadequate data to make a judgment on the efficacy of subcutaneous sumatriptan (Level U).
Recommendations for Preventive Therapy of Migraine in Children and Adolescents
- Flunarizine is probably effective for preventive therapy and can be considered for this purpose but is not available in the United States (Level B).
- There is insufficient evidence to make any recommendations concerning the use of cyproheptadine, amitriptyline, divalproex sodium, topiramate, or levetiracetam (Level U).
- Recommendations cannot be made concerning propranolol or trazodone for preventive therapy as the evidence is conflicting (Level U).
- Pizotifen and nimodipine (Level B) and clonidine (Level B) did not show efficacy and are not recommended.
Definitions:
Rating of Recommendation
A = Established as effective, ineffective, or harmful (or established as useful/predictive or not useful/predictive) for the given condition in the specified population
B = Probably effective, ineffective, or harmful (or probably useful/predictive or not useful/predictive) for the given condition in the specified population
C = Possibly effective, ineffective, or harmful (or possibly useful/predictive) for the given condition in the specified population
U = Data inadequate or conflicting. Given current knowledge, treatment (test, predictor) is unproven.
Translation of Evidence to Recommendations
Level A rating requires at least two consistent class I studies.*
Level B rating requires at least one class I study or two consistent class II studies.
Level C rating requires at least one class II study or two consistent class III studies.
Level U rating for studies not meeting criteria for class I-class III
* In exceptional cases, one convincing class I study may suffice for an "A" recommendation if 1) all criteria met, 2) magnitude of effect >5, and 3) narrow confidence intervals (lower limit >2).
Rating of a Therapeutic Article
Class I: Prospective, randomized, controlled clinical trial with masked outcome assessment, in a representative population. The following are required:
- Primary outcome(s) is/are clearly defined.
- Exclusion/inclusion criteria are clearly defined.
- Adequate accounting for dropouts and crossovers with numbers sufficiently low to have minimal potential for bias
- Relevant baseline characteristics are presented and substantially equivalent among treatment groups, or there is appropriate statistical adjustment for differences.
Class II: Prospective matched group cohort study in a representative population with masked outcome assessment that meets a-d above OR a randomized, controlled trial in a representative population that lacks one criterion a-d
Class III: All other controlled trials (including well-defined natural history controls or patients serving as own controls) in a representative population, where outcome is independently assessed, or independently derived by objective outcome measurement**
Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion
** Objective outcome measurement - an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data).