ABSTRAK Latar Belakang : Aphanizomenon Flos Aquae merupakan suatu spesiesganggang biru-hijau yang dimanfaatkan sebagai suplemen nutrisi di seluruh duniatermasuk di Indonesia dan diketahui memiliki banyak aktivitas biologisbermanfaat seperti efek anti-inflamasi, anti-oksidan dan analgetik. Osteoartritis(OA) lutut merupakan permasalahan yang cukup sering didapatkan pada lanjutusia (lansia) namun sampai saat ini belum tersedia modalitas farmakologik sebagai terapi ajuvan yang sesuai dan aman pada kelompok lansia. Aphanizomenon Flos Aquae dapat menjadi alternatif yang baik sebagai terapiajuvan dalam tatalaksana pasien lansia dengan OA lutut. Tujuan Penelitian : Mengkaji pengaruh AFA terhadap perbaikan klinis OA lututpada lansia berdasarkan indeks WOMAC.Metode : Dilakukan uji klinis acak tersamar ganda mulai November 2014 hinggaMei 2015 terhadap pasien lanjut usia dengan OA lutut di poliklinik Geriatri danReumatologi di RSUP Hasan Sadikin Bandung. Subjek dibagi menjadi 2kelompok yaitu satu kelompok mendapat kapsul berisi AFA 2 kali 2 kapsul (1,28g/hari) dan kelompok lainnya mendapat plasebo selama 60 hari. Skor IndeksWOMAC dinilai pada hari ke-1 dan hari ke-60 untuk menilai luaran klinis pasienOA. Perbedaan skor indeks WOMAC pada akhir penelitian dianalisis dengan ujiMann-Whitney. Hasil : Dari total 254 subjek didapatkan 98 subjek yang memenuhi kriteria awalpenelitian dan kemudian dilakukan randomisasi menjadi kelompok perlakuan danplasebo, masing-masing terdiri dari 49 subjek. Kedua kelompok sebanding padaseluruh faktor prognostik penting. Setelah analisis, skor indeks WOMACkomposit kelompok AFA berbeda secara bermakna (p<0,001) dibanding plasebopada akhir penelitian dengan masing-masing skor 8 (median,RIK 3-18) vs. 18(median,RIK 8-32). Tidak ditemukan adanya efek samping yang serius selamapenelitian. Simpulan : Aphanizomenon Flos Aquae dapat memperbaiki klinis berdasarkanskor indeks WOMAC serta aman diberikan pada pasien lansia dengan OA lutut. ABSTRACT Background: Aphanizomenon Flos Aquae is a species of blue-green algae whichis commonly used as nutritional supplement in the world, including in Indonesiaand is known to have many beneficial biological activities such as antiinflammatory,anti-oxidantand analgesics. Osteoarthritis (OA) knee is a problemthat is quite common in the older people but until now there has not beenpharmacologic modalities as a adjunctive therapy available which are suitable and safe. Aphanizomenon Flos Aquae may become a good alternative as an adjunctive therapy in older patients with knee OA.Objective : To determine the effect of AFA on the improvement of clinicaloutcome of Knee OA in older patients based on WOMAC index scores.Methods : A double-blind randomized clinical trial was conducted fromNovember 2014 until May 2015 to older adult patients with Knee OA at theGeriatric and Rheumatology clinic in Hasan Sadikin General Hospital. Thesubjects were divided into groups, each group received capsules containing AFA2 times 2 capsules (1.28 gr/day) and the other received placebo for 60 days.WOMAC Index scores were assessed at day 1 and day 60. The difference inassessment of WOMAC index scores of each group at the end of the study wereanalyzed by Mann-Whitney. Results : Out of total 254 subjects, there were 98 patients who met the initialcriteria and were randomized into two groups, AFA and placebo group with eachconsisting of 49 subjects. Both groups were comparable in all importantprognostic factors. The composite WOMAC Index scores in AFA group wassignificantly different than the placebo group at the end of the study (p <0.001),with each score of 8 (IQR,median 3-18) vs. 18 (IQR,median 8-32) respectively.There was no serious adverse events found throughout the study. Conclusion : Aphanizomenon Flos Aquae was able to show clinical improvement based on WOMAC scoring index and safe to use in the older adults with Knee OA.;Background: Aphanizomenon Flos Aquae is a species of blue-green algae whichis commonly used as nutritional supplement in the world, including in Indonesiaand is known to have many beneficial biological activities such as antiinflammatory,anti-oxidantand analgesics. Osteoarthritis (OA) knee is a problemthat is quite common in the older people but until now there has not beenpharmacologic modalities as a adjunctive therapy available which are suitable and safe. Aphanizomenon Flos Aquae may become a good alternative as an adjunctive therapy in older patients with knee OA.Objective : To determine the effect of AFA on the improvement of clinicaloutcome of Knee OA in older patients based on WOMAC index scores.Methods : A double-blind randomized clinical trial was conducted fromNovember 2014 until May 2015 to older adult patients with Knee OA at theGeriatric and Rheumatology clinic in Hasan Sadikin General Hospital. Thesubjects were divided into groups, each group received capsules containing AFA2 times 2 capsules (1.28 gr/day) and the other received placebo for 60 days.WOMAC Index scores were assessed at day 1 and day 60. The difference inassessment of WOMAC index scores of each group at the end of the study wereanalyzed by Mann-Whitney. Results : Out of total 254 subjects, there were 98 patients who met the initialcriteria and were randomized into two groups, AFA and placebo group with eachconsisting of 49 subjects. Both groups were comparable in all importantprognostic factors. The composite WOMAC Index scores in AFA group wassignificantly different than the placebo group at the end of the study (p <0.001),with each score of 8 (IQR,median 3-18) vs. 18 (IQR,median 8-32) respectively.There was no serious adverse events found throughout the study. Conclusion : Aphanizomenon Flos Aquae was able to show clinical improvement based on WOMAC scoring index and safe to use in the older adults with Knee OA. |