To investigate the compatibility of a modified prescription of Simiao Pill (四妙丸) in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment

the index of blood uric acid

blood leukocyte count

score of clinical symptoms

etc. were observed and measured. The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%

significantly superior to that of the control group (68%

P<0.05). In terms of the improvement of main symptoms

the scores of four symptoms in all TCM treatment and control groups decreased after treatment

with statistically significant differences (P<0.05). Moreover

the scores markedly fell more so in the three Chinese herb groups than in the control group

and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. The modified prescriptions

based on the clinical research

clinical experience and traditional Chinese medicine theory

did show a better effect than Western medicine in this clinical study. Moreover

the prescriptions were precise

with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The modified prescription has a favorable prospect for future development and is worthy of further blind trials with larger samples.