Efektivitas Siproheptadin sebagai Terapi Profilaktik Migren pada Anak

Abstract

Background. Migraine is a cause of recurrent headache in childhood. The efficacy of cyproheptadine is well known as antihistamine, but there are few studies involving the drug’s effect in pediatric migraine. Objective. To determine the effectiveness of cyproheptadine in the prophylactic treatment of childhood migraine. Methods. A randomized placebo-controlled clinical trial study was performed at Medan, province of Sumatera Utara. 100 children with migraine according to International Headache Society criteria were included in the study. The patients were divided into two groups; each group was given 4 mg of cyproheptadine or placebo for 12 weeks. Headache frequency was measured in headache days per month, duration was measured in hours and Functional disability was measured by Pediatric Migraine Disability Assessment (PedMIDAS). The efficacy was measured before intervention and 1,2 and 3 months after intervention. Results. A total of 100 patients, ranging in age from 11 – 18 years (mean age, 15,5 years), were treated with cyproheptadine or placebo for headache. Mean headache attacks per month with daily diaries were calculated at monthly intervals. Compared to baseline, there was significant difference on PedMIDAS grading of migraines in both groups (p 0.05), but there are side effect of cyproheptadine until 73% Conclusion. Cyproheptadine appears to be effective as alternative prophylactic treatment of childhood migraine. The pediatricians should consider the significant side effects of this drugb

Latar Belakang. Migren menyebabkan nyeri kepala berulang pada anak. Manfaat siproheptadin diketahui baik sebagai antihistamin, tetapi hanya sedikit penelitian tentang efek obat sebagai terapi profilaksis migren pada anak. Tujuan. Untuk mengetahui efektivitas siproheptadin sebagai terapi profilaktik migren pada anak Metode. Penelitian secara uji klinis randomisasi dengan kontrol plasebo dilaksanakan di kota Medan, propinsi Sumatera Utara. Sebanyak 100 anak penderita migren yang memenuhi kriteria inklusi sebagai sampel penelitian. Pasien dibagi kedalam dua kelompok: masing-masing diberi siproheptadin atau plasebo selama 12 minggu. Frekuensi nyeri kepala dinilai dengan hari per bulan, durasi dalam jam dan disabilitas menggunakan Pediatric Migraine Disability Assessment (PedMIDAS). Manfaat obat dinilai dan dibandingkan sebelum intervensi dan bulan 1,2 dan ke 3 setelah intervensi Hasil. Terdapat 100 anak menderita migren usia 11 sampai 18 tahun (rata-rata 15,5 tahun), yang mendapat siproheptadin atau plasebo. Frekuensi dan durasi migren per bulan dinilai dengan catatan harian nyeri kepala setiap bulan. Terdapat perbedaan signifikan derajat PedMIDAS pada kedua kelompok (p < 0,05). Frekuensi dan durasi nyeri kepala per bulan berbeda signifikan setelah terapi (siproheptadin p=0,009, 95% CI: 0,001 sampai 0,030 dan p= 0,029, 95% CI: 0,690 sampai 27,510), dibanding kelompok plasebo (p > 0,05), namun terdapat efek samping siproheptadin sebanyak 73% Kesimpulan. Siproheptadin efektif sebagai alternatif terapi profilaksis migren pada anak, namun tetap harus mempertimbangkan efek samping obat.