Uji Klinis Manfaat Asam Folat dalam Mengurangi Keparahan Diare Akut

Abstract

Background Diarrhea has been a health problem in children under five years old. Although the mortality caused by acute diarrhea has fallen, morbidity has been increasing in developing countries such as Indonesia. The main management of acute diarrhea are preventing and treating dehydration, preventing malnutrition, reducing the duration and severity of the diarrhea, and preventing reoccurrence of future episodes. The previous study in South Africa indicates that oral folate significantly shortened the duration of acute diarrhea in children. Some studies were undertaken to evaluate the clinical benefit of folic acid for reducing the severity of acute diarrhoea, but the results have been controversial. Objective The aim of the study is to assess the effect of folic acid in reducing the severity of diarrhea in children. Methods This study was a single masked randomized clinical trial in children aged six months until five years old at local goverment clinic of Kecamatan Secanggang, Kabupaten Langkat, Propinsi Sumatera Utara, from August 2009 until January 2010. All children with diarrhea were treated with oral rehydration due to WHO standard. The recruitment of samples with consecutive sampling. The patient who according the inclusion and exclusion criteria were included in this study, then randomized with random list into two groups. The group I were given oral folic acid 5 mg every day, and group II were given placebo one capsul every day. Both group were given medication for five days. The cessation of diarrhea was defined as reduction of the severity of acute diarrhea that was showed as changes in frequency of diarrhea, consistency and volume of stool, and duration of diarrhea after treatment. In order to compare the difference between two group used t-test independent and chi kuadrat, and analysis of intention to treat. Results One hundred and twelve children were participated in this study. Fifty six children were given folic acid and 56 children were placebo. There were significant differences at second day in the consistency of the stool (P:0.02) and the volume of diarrhea (147.52 ml vs 303.21 ml P:0.001), but the frequency of diarrhea was significant at third day (1.9 vs 2.8 times P: 0.001). Thus, there were significant differences in the cessation of duration diarrhea (91.3 hours vs 117.9 hours P : 0.001 IK 95%: -36.50; -16.64) and the duration of diarrhea (123.6 hours vs 147.4 hours P: 0.001 IK 95%: -38.41; -9.94) between folic acid group and placebo group. Conclusions Administration of folic acid was clinical benefitial to reduce the severity of diarrhea in young children with acute diarrhea.

Latar Belakang Diare telah menjadi masalah kesehatan pada anak usia di bawah lima tahun. Meskipun angka kematian karena diare telah menurun, angka kesakitan karena diare masih tetap tinggi di negara berkembang seperti Indonesia. Penanganan utama diare akut adalah mencegah dan dan mengobati dehidrasi, mencegah kekurangan nutrisi, mengurangi durasi diare, serta mencegah kejadian diare berulang. Hasil studi sebelumnya di Afrika Selatan menunjukkan bahwa asam folat oral secara signifikan mengurangi durasi diare akut pada anak. Telah ada beberapa studi lagi tentang penggunaan asam folat untuk mengurangi keparahan diare akut tetapi hasilnya masih kontroversial. Tujuan. Menilai manfaat asam folat dalam mengurangi keparahan diare akut pada anak. Metode Uji klinis acak tersamar tunggal, dilakukan pada anak usia enam bulan sampai lima tahun di unit pelayanan kesehatan yang ada di delapan desa di wilayah kerja Puskesmas Kecamatan Secanggang, Kabupaten Langkat, Propinsi Sumatera Utara, mulai Agustus 2009 sampai Januari 2010. Semua anak diare yang datang, direhidrasi terlebih dahulu sesuai standar WHO. Setelah itu pasien dipilih secara konsekutif sampling. Pasien yang memenuhi kriteria inklusi dan eksklusi dimasukkan dalam penelitian, diacak menjadi dua kelompok. Kelompok I diberikan asam folat oral dengan 1 x 5 mg, kelompok II diberi plasebo 1 x 1 tab selama lima hari. Keparahan diare ditentukan berdasarkan perubahan frekuensi diare, konsistensi tinja, volume tinja dan durasi diare setelah pemberian terapi. Untuk membandingkan perbedaan antara kedua kelompok digunakan uji t independen dan uji kaikuadrat, juga dilakukan analisis intention to treat. Hasil Seratus dua belas anak ikut berpartisipasi pada studi ini, diacak menjadi dua kelompok. Lima puluh enam anak diberi asam folat dan 56 anak diberi plasebo. Ditemukan perbedaan yang signifikan di hari kedua pada konsistensi tinja (P: 0.02) dan volume diare (147.52 ml vs 303.21 P:0.001 ml), sedangkan frekuensi diare mulai berbeda secara signifikan pada hari ketiga (1.9 vs 2.8 kali P: 0.001). Ditemukan perbedaan yang signifikan durasi diare sembuh antara kelompok asam folat dan plasebo (91.3 jam vs 117.9 jam P : 0.001 IK 95%: -36.50; -16.64). Dengan demikian ditemukan juga perbedaan yang signifikan lama diare diantara kedua kelompok (123.6 jam vs 147.4 jam P: 0.001 IK 95%: -38.41; -9.94). Kesimpulan Pemberian asam folat secara klinis efektif mengurangi keparahan diare pada anak dengan diare akut.