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Published on: June 2, 2014
Effect of Propranolol Prophylaxis on Headache Frequency in Children with Migraine Without Aura: A Randomized,
D Keerthana1, Devendra Mishra2, Meenakshi Kanwar Chauhan3
1Department of Pediatrics, Maulana Azad Medical College (University of Delhi), Lok Nayak Hospital, Delhi, 110002, India. keerthanadhanapaul31@gmail.com.
Insights
Propranolol showed effectiveness in reducing headache frequency in children with migraine, but its impact was comparable to placebo. Further research is needed to establish its role in pediatric migraine prevention.
Area of Science:
- Pediatric Neurology
- Clinical Pharmacology
- Migraine Research
Background:
- Migraine is a common neurological disorder in children.
- Prophylactic treatments are essential for managing frequent migraine attacks.
- The efficacy of propranolol in pediatric migraine prophylaxis requires further investigation.
Purpose of the Study:
- To compare the efficacy of propranolol prophylaxis versus placebo in reducing headache frequency in children with migraine.
- To evaluate the impact of propranolol on migraine-related disability and severity.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- Children aged 6-12 years with migraine without aura were enrolled.
- Participants received either oral propranolol (1-3 mg/kg/d) or placebo for 3 months.
Main Results:
- Both propranolol and placebo significantly reduced headache frequency (p=0.002).
- No significant differences were observed between groups in headache attacks, severity, or disability.
- Adverse effects were more frequent in the propranolol group.
Conclusions:
- Propranolol demonstrated effectiveness for migraine prophylaxis in children, similar to placebo.
- Larger placebo-controlled trials are necessary to determine the definitive role of propranolol in pediatric migraine management.
Objective:
To compare the efficacy of propranolol prophylaxis with placebo on headache frequency in children with migraine over the 3-mo follow-up.
Methods:
In this randomized, double-blind, placebo-controlled trial children aged 6-12 y with newly diagnosed migraine without aura as per the International Classification for Headache Disorders, 3rd edition (ICHD-3) criteria were enroled. They were randomized to the intervention group receiving oral propranolol (1-3 mg/kg/d, BID) and the control group receiving a similar looking, inert, oral placebo for migraine prophylaxis for 3 mo. The number of migraine attacks over the 3-mo follow-up (using a headache diary) was the primary outcome. Pediatric Migraine Disability Assessment Scale (PedMIDAS) was used for assessing disability and Visual analogue scale was used for assessing headache severity. Analysis was done on intention-to-treat basis.
Results:
Twenty children (10 in each group) completed the study. The two groups were similar at baseline. Both the study drugs produced significant reduction of headache frequency after the study intervention (p = 0.002). However, there was no difference between the two groups with respect to either the median (IQR) number of headache attacks [22 (20, 25) vs. 14 (10, 20); p = 0.05], headache severity [1 (0, 1) vs. 0.5 (0, 1); p = 0.48] or migraine disability [39.5 (28, 44) vs. 35 (22, 38); p = 0.27]. Adverse effects were higher in the intervention group (p = 0.52).
Conclusions:
Propranolol was effective for migraine prophylaxis in children but the effect was not higher than placebo. Larger placebo-controlled trials of propranolol need to be conducted to decide its place in migraine prophylaxis in children.
Trial Registration:
Thailand Clinical Trials Registry; TCTR20200621001.
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