Effect of Propranolol Prophylaxis on Headache Frequency in Children with Migraine Without Aura : A Randomized, Double-Blind, Placebo-Controlled Trial
© 2022. The Author(s), under exclusive licence to Dr. K C Chaudhuri Foundation..
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.
| Errataetall: |
CommentIn: Indian J Pediatr. 2023 Sep;90(9):855. - PMID 37162730 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:90 |
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| Enthalten in: |
Indian journal of pediatrics - 90(2023), 9 vom: 22. Sept., Seite 880-885 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Keerthana, D [VerfasserIn] |
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| Links: |
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| Themen: |
9Y8NXQ24VQ |
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| Anmerkungen: |
Date Completed 14.09.2023 Date Revised 06.11.2023 published: Print-Electronic CommentIn: Indian J Pediatr. 2023 Sep;90(9):855. - PMID 37162730 Citation Status MEDLINE |
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| doi: |
10.1007/s12098-022-04279-w |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 500 | |a CommentIn: Indian J Pediatr. 2023 Sep;90(9):855. - PMID 37162730 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. The Author(s), under exclusive licence to Dr. K C Chaudhuri Foundation. | ||
| 520 | |a OBJECTIVE: To compare the efficacy of propranolol prophylaxis with placebo on headache frequency in children with migraine over the 3-mo follow-up | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: Thailand Clinical Trials Registry; TCTR20200621001 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Disability | |
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| 650 | 4 | |a Prevention | |
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| 700 | 1 | |a Chauhan, Meenakshi Kanwar |e verfasserin |4 aut | |
| 700 | 1 | |a Juneja, Monica |e verfasserin |4 aut | |
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