Flunarizine 5mg tablets

ImportancePediatric migraine substantially impacts quality of life and academic performance among children and adolescents. Understanding the efficacy and safety of pharmacological interventions for migraine prophylaxis in this population is crucial for developing effective treatment strategies.ObjectiveTo conduct a comprehensive network meta-analysis to evaluate the efficacy and safety associated with pharmacological treatments for pediatric migraine prophylaxis among pediatric patients with a migraine diagnosis and assess interventions involving various oral pharmacological interventions compared with each other and placebo.Data sourcesPubMed, Embase, and SCOPUS were searched for publications up to September 2023. Search terms and indexing were chosen to encompass relevant studies, focusing on randomized clinical trials in pediatric migraine prophylaxis.Study selectionInclusion criteria targeted randomized clinical trials involving pediatric patients with migraine. Studies were selected based on their examination of oral pharmacological interventions. The search yielded an initial 9162 citations.Data extraction and synthesisData extraction adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Five investigators independently extracted study data into a spreadsheet in duplicate. Study-level estimates were calculated, employing a random-effects model for primary and secondary outcomes due to identified heterogeneity. Data analysis was conducted from December 2023 to March 2024.Main outcomes and measuresThe primary outcome was migraine frequency (number of attacks per month). Secondary outcomes included a 50% or greater responder rate, headache duration, headache intensity, and disability (assessed by pediatrics migraine-specific disability tool). Adverse events were also evaluated.ResultsThe analysis incorporated 45 trials with 3771 participants. Compared with placebo, pregabalin (ratio of means [RoM], 0.38; 95% CI, 0.18-0.79) and topiramate with vitamin D3 (RoM, 0.44; 95% CI, 0.30-0.65) were associated with reduction in migraine frequency. Flunarizine (RoM, 0.46; 95% CI, 0.26-0.81), levetiracetam (RoM, 0.47; 95% CI, 0.30-0.72), riboflavin (RoM, 0.50; 95% CI, 0.32-0.77), cinnarizine (RoM, 0.64; 95% CI, 0.46-0.88), topiramate (RoM, 0.70; 95% CI, 0.55-0.89), and amitriptyline (RoM, 0.73; 95% CI, 0.54-0.97) were also associated with reduction in migraine frequency, but these findings were drawn from individual studies. For the 50% or greater responder rate, flunarizine and α-lipoic acid (risk ratio [RR], 8.73; 95% CI, 2.44-31.20), flunarizine (RR, 4.00; 95% CI, 1.38-11.55), pregabalin (RR, 1.88; 95% CI, 1.13-3.14), and cinnarizine (RR, 1.46; 95% CI, 1.04-2.05) were associated with significantly greater effectiveness than placebo. Compared with placebo, propranolol and cinnarizine (RoM, 0.45; 95% CI, 0.28-0.72), pregabalin (RoM, 0.57; 95% CI, 0.33-0.96), valproate (RoM, 0.60; 95% CI, 0.49-0.72), levetiracetam (RoM, 0.62; 95% CI, 0.50-0.77), and cinnarizine (RoM, 0.64; 95% CI, 0.54-0.76) were significantly associated with reduction in headache intensity. However, no treatments were associated with significant improvements in quality of life or reduction of the duration of migraine attacks. Adverse events were higher with amitriptyline (RR, 3.81; 95% CI, 1.41-10.32), topiramate (RR, 4.34; 95% CI, 1.60-11.75), and valproate (RR, 5.93; 95% CI, 1.93-18.23) compared with placebo.Conclusions and relevanceIn this network meta-analysis of randomized clinical trials, topiramate and pregabalin were associated with reduction in headache frequency and intensity. Although there were also other drugs that showed statistically significant results (flunarizine, riboflavin, amitriptyline, and cinnarizine), more studies were required for a robust conclusion. None of the drugs were associated with improved quality of life or attack duration, underscoring the need for further research to develop more comprehensive treatment strategies and explore the potential of combination therapies, especially those involving vitamins. Future studies should focus on validating these findings and expanding the treatment landscape for pediatric migraine management.

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Highlights • Flunarizine Hydrochloride combined with TCM notably enhances migraine management.• Flunarizine Hydrochloride and TCM improve TCM scores, endothelin, NRS and VAS scores.• Flunarizine Hydrochloride combined with TCM reduces headache frequency and duration.• Standardized protocols are crucial to understand TCM's role in migraine management better.

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Background Pediatric migraine is a primary headache affecting daily activities and causing significant disability among children. However, clarity on the usage of prophylactic medications in children is yet to be established. This study was conducted with the aim of comparing the efficacy and safety of flunarizine and propranolol in the prophylaxis of pediatric migraine. Methodology An open-label randomized trial with parallel group assignment was conducted in the Department of Pediatrics of a tertiary care hospital in Northern India among patients aged five to 14 years with migraine having Pediatric Migraine Disability Assessment (PedMIDAS) score of 11 to 139 and a headache frequency of four or more days over a baseline period of 28 days. Enrolled patients were assigned randomly to receive either flunarizine (5 mg/day HS for the first month and then 10 mg/day HS for the next two months) or propranolol (1 mg/kg/day in two divided doses for three months) and then followed up monthly for three months for outcomes. The primary outcome was the proportion of children with a 50% or more reduction in the number of headache days compared to the 28-day baseline period with the last 28 days of the 12-week trial period. Secondary outcomes were headache-related disability (as measured by the absolute change in PedMIDAS score), the absolute change in the number of headache days, and the proportion and nature of adverse effects in the two groups. Results A total of 40 patients underwent randomization (20 in each group). Baseline parameters were comparable in the two groups. The primary outcome, that is, a 50% or more reduction in the number of headache days, was achieved in 10 out of 20 (50%) patients in the flunarizine group and 11 out of 20 (55%) patients in the propranolol group (p = 0.752). Both groups were comparable in terms of the primary outcome. There were also no significant between-group differences in terms of headache-related disability (change in PedMIDAS: 8.2 ± 2.97 in the flunarizine group vs 8.7 ± 3.95 in the propranolol group, p = 0.924) and absolute reduction in the number of headache days (4.3 ± 2.36 in the flunarizine group vs 4.3 ± 2.11 in the propranolol group, p = 0.989). Minor adverse effects like nausea, vomiting, drowsiness, and fatigue were comparable in the two groups. None of the patients reported any serious adverse events. Conclusion Flunarizine is as effective as propranolol for the prophylactic management of children with migraine. Both drugs were well-tolerated and safe.

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