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document
Topiramate improves health-related quality of life when used to prevent migraine . OBJECTIVE To assess changes in health-related quality of life ( HRQoL ) measures among patients receiving topiramate ( TPM ) 100 mg/d in two divided doses for migraine prevention in three randomized , double-blind , placebo-controlled , 26-week trials with similar protocols and study populations . BACKGROUND Migraine substantially impairs HRQoL and work productivity before , during , and after attacks . Approximately 50 % of patients with migraine could be recommended for preventive therapies , yet only 3 % to 5 % of patients receive them . TPM is an effective and generally well-tolerated migraine prophylactic ( preventive ) therapy for adults , as demonstrated in several randomized , double-blind , placebo-controlled trials . The most common adverse events in double-blind , placebo-controlled studies of TPM in migraine prevention are paresthesia , fatigue , anorexia , nausea , taste alteration , and diarrhea . DESIGN AND METHODS The Migraine-Specific Questionnaire ( MSQ , version 2.1 ) was used to assess the effect of TPM 100 mg/d on the functionality and HRQoL of randomized intent-to-treat ( ITT ) and study-completer populations pooled from three randomized , double-blind , placebo-controlled trials . MSQ scores ( 0 to 100 , higher score indicates better functioning ) were assessed for the following three domains : role restriction ( examines the degree to which performance of daily activities is limited by migraine ) , role prevention ( examines the degree to which performance of daily activities is interrupted by migraine ) , and emotional function ( examines feelings of frustration and helplessness due to migraine ) . Between-group differences from baseline in mean MSQ domain scores for TPM 100 mg/d and placebo were compared using a mixed-effects model with piecewise linear regression . Effect sizes were calculated to estimate the magnitude of change in HRQoL that can be associated with TPM therapy . RESULTS TPM 100 mg/d significantly improved all three MSQ domains compared with placebo for both the ITT ( TPM , n = 372 ; placebo , n = 362 ) and study-completer ( TPM , n = 220 ; placebo , n = 216 ) populations ( P < .001 for all three domains , both populations ) . Effect sizes for TPM 100 mg/d varied from 0.40 to 0.78 , indicating that the changes in MSQ scores for TPM 100 mg/d were moderate and may be clinically significant . CONCLUSION TPM 100 mg/d has been shown to be effective in the prevention of migraine headache in adults . As the MSQ results from the three randomized , placebo-controlled trials indicate , HRQoL is significantly improved for up to 6 months following initiation of treatment .
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Intervention_Pharmacological
Topiramate
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Intervention_Pharmacological
topiramate ( TPM )
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
TPM
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Intervention_Control
placebo
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Intervention_Pharmacological
TPM therapy
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
placebo
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
placebo
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
TPM
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Intervention_Pharmacological
TPM
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Outcome_Physical
health-related quality of life
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Outcome_Physical
health-related quality of life ( HRQoL ) measures
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Outcome_Physical
HRQoL
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Outcome_Other
work productivity
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Outcome_Other
effective and generally well-tolerated
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Outcome_Adverse-effects
paresthesia , fatigue , anorexia , nausea , taste alteration , and diarrhea
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Outcome_Physical
Migraine-Specific Questionnaire ( MSQ
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Outcome_Physical
MSQ scores
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Outcome_Mental
emotional function
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Outcome_Physical
MSQ domain scores
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Outcome_Physical
MSQ domains
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Outcome_Physical
MSQ scores
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Outcome_Physical
migraine headache
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Outcome_Physical
HRQoL
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Participant_Condition
migraine
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Participant_Condition
patients receiving topiramate ( TPM ) 100 mg/d in two divided doses for migraine prevention
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Participant_Condition
similar protocols and study populations
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Participant_Condition
intent-to-treat ( ITT ) and study-completer populations
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Participant_Condition
migraine headache
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Participant_Age
adults