Pasien osteoartritis sering menggunakan obat antiinflamasi non steroid seperti natrium diklofenak untuk mengatasi nyeri sendi. Penggunaan natrium diklofenak jangka panjang menimbulkan efek samping pada fungsi hati, ginjal, sistem organ gastrointestinal dan organ tubuh lainnya. Hasil penelitian menunjukkan efektivitas kombinasi ekstrak rimpang temulawak, jahe, kedelai dan kulit udang pada pasien osteoartritis, tetapi keamanannya dibanding natrium diklofenak belum banyak diteliti pada pasien osteoartritis. Penelitian ini adalah uji klinik fase III yang bertujuan untuk monitoring efek samping pemberian kombinasi ekstrak rimpang temulawak, jahe, kedelai dan kulit udang dibandingkan dengan natrium diklofenak pada pasien osteoartritis. Empat puluh tujuh subyek dengan diagnosa osteoartritis lutut dengan kriteria American College of Rhematology terbagi menjadi dua kelompok secara random yaitu kelompok uji (n=23) yang mendapat kombinasi ekstrak rimpang temulawak 100 mg, jahe 100 mg, kedelai 50 mg dan kulit udang 50 mg dan kelompok yang mendapat terapi natrium diklofenak 25 mg (n=24) 3 kali sehari peroral selama 14 hari. Monitoring efek samping meliputi efek samping yang muncul pada organ gastrointestinal, kardiovaskuler, susunan syaraf pusat dan organ lain selama 14 hari dan pemeriksaan laboratorium SGOT, SGPT, kreatinin serum, ureum serum, hemoglobin, leukosit dan trombosit yang dilakukan sebelum dan sesudah 14 hari. Analisis statistik efek samping dilakukan dengan uji Chi- Square dan analisis statistik perubahan kadar SGOT, SGPT, kreatinin serum, ureum serum, hemoglobin, leukosit dan trombosit yang dilakukan dengan t independent test, atau Mann Whitney-Wilcoxom test. Persentase munculnya efek samping pada organ gastrointestinal, kardiovaskuler, susunan syaraf pusat, dan organ lain pada pemberian kombinasi ekstrak rimpang temulawak 100 mg, jahe 100 mg, kedelai 50 mg dan kulit udang 50 mg tidak berbeda bermakna dibandingkan natrium diklofenak 25 mg. Pemberian kapsul uji menurunkan aktivitas SGPT secara bermakna (p<0,05) dibandingkan dengan natrium diklofenak 25 mg tetapi tidak berbeda bermakna pada fungsi hati (SGOT), fungsi ginjal (kreatinin dan ureum), dan fungsi sumsum tulang (hemoglobin, leukosit, dan trombosit).

Non-steroidal anti-inflammatory drugs such as diclofenac sodium were common drug given worldwide to reduce pain in osteoathritis. The long-term used of diclofenac sodium side effects was on liver, kidney, gastrointestinal and other organs. The earlier study result have shown the effectiveness of the combination of temulawak rhizome extract, ginger, soy and shrimp shells in osteoarthritis patients. This thirth clinial study purpose was to monitor the side effects of temulawak rhizome, ginger, soybean and shrimp shells extract in combination compared to diclofenac sodium in patients with osteoarthritis. Forty seven patients with knee osteoarthritis diagnosed by American College of Rhematology criteria were included in this study. This subject were dividedly into two groups to recieve either the combination of temulawak rhizome 100 mg, ginger 100 mg, soy 50 mg and shrimp shells 50 mg extract (n=23) or diclofenac sodium 25 mg (n = 24) three times a day orally for 14 days. The side effect that were monitored were side effects that appear in the gastrointestinal organs, cardiovascular, central nervous system and other organs for 14 days therapy and laboratory tests of SGOT, SGPT, creatinine serum, urea, hemoglobin, leukocytes and platelets were performed before and after 14 days. Chi-Square test were used to evaluate the side effects and independent t test or Mann-Whitney tests were used to evaluate changes of levels of SGOT, SGPT, serum creatinine, serum urea, hemoglobin, leukocytes and platelets between before and after intervention. Percentage of side effects on the gastrointestinal organs, cardiovascular, central nervous system and other organs in combination of ginger rhizome extract 100 mg, 100 mg of ginger, 50 mg of soy and 50 mg of shrimp shell group was not significantly different compared to diclofenac sodium 25 mg. SGPT activity in trial group was decrease significantly (p <0.05) compared to diclofenac sodium 25 mg but no significant difference in liver function (SGOT), kidney function (creatinine and urea), and bone marrow function (hemoglobin, leukocytes, and platelets).

Kata Kunci : Osteoartritis, kombinasi temulawak, jahe, kedelai dan kulit udang, natrium diklofenak, efek samping, fungsi hati, fungsi ginjal dan sumsum tulang.