Medicamentos para prevenir las cefaleas migrañosas en ... - marchioli

Medicamentos para prevenir las cefaleas migrañosas en los niños
Characteristics of included studies
Notes
Allocation concealment
Study
Methods
Participants
Interventions
Outcomes
Notes
Allocation concealment
Study
Methods
Participants
Interventions
Outcomes
3 withdrawals. 1 - nausea and vomiting with clonidine, 2 - nausea with placebo.
Adverse events:
Clonidine: 8 - fatigue, 2 - nausea, 1 - disturbed rhythm of sleep-wake cycle and
menstruation.
Placebo: 3 - nausea, 2 - fatigue and irritability.
Aggregated events for all patients reported. No within-patient data reported. No variability
data reported.
B
Sillanpaa 1978
Not randomised, double-blind, placebo-controlled, parallel-group.
Method of blinding not described.
Migraine by Vahlquist 1955.
Symptomatic treatment not reported. 3 non-compliers. Method used to ascertain
compliance not reported.
42 patients. 5 withdrawals.
Groups A (19 patients) and B (18 patients) were comparable for type of headache, age
at onset, nausea, family history, unilateral pain, visual aura, frequency, and duration.
14/37 males. Age range: 6 to 15 years.
A: Papaverine 5 mg/kg divided into 2 or 3 doses for 1 month, then 10 mg/kg divided
into 2 or 3 doses for 1 month (n = 19). Follow up for mean of 4.5 months (n = 15).
B: Placebo for 2 months (n = 18). Follow up for mean of 4.5 months (n = 16).
Frequency, intensity, and duration.
No significant reduction in frequency with papaverine as compared to placebo during
2-month treatment period.
5 withdrawals. 3 - irregular administration, 2 - adverse events.
Adverse events: 1 - night restlessness, 1 - stomach ache and nausea.
Carryover effect.
B
Sills 1982
Randomised, double-blind, placebo-controlled, crossover.
Randomisation not described. Identical active and placebo.
Migraine defined as a periodic headache with at least 3 of the following features: aura,
nausea, vomiting, and positive family history.
Symptomatic treatment and compliance not reported.
51 randomised. 8 withdrawals.
Groups A (23 patients) and B (20 patients) were comparable for sex and type and
frequency of headaches.
24/43 males. Age range: 7 to 14 years.
A: Clonidine 25 mcg once daily for 1st month, then twice daily for 2nd month, then
thrice daily for 3rd month. Followed by placebo for 3 months.
B: Placebo for 3 months, then clonidine 25 mcg once daily for 1st month, then twice
daily for 2nd month, then thrice daily for 3rd month.
Number of attacks, total duration, duration of longest attack, mean duration of attack.
Non-parametric data provided. Investigators reported no significant difference in
outcomes between groups.
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