RESUMO
Objective To investigate the clinical efficacy of heat-clearing and diuresis-promoting herbal formula Tongfeng Recipe in treating damp-turbidity-heat accumulation type of gout with tophus. Methods Sixty qualified patients were randomized into treatment group and control group, 30 cases in each group. The control group was given oral use of Febuxostat Tablets, and the treatment group was given Tongfeng Recipe combined with Febuxostat Tablets. After treatment for 6 months, we compared the changes of serum uric acid, the maximum diameter of the tophi, attack frequency of gout, scores of traditional Chinese medicine (TCM) syndromes, and adverse reaction in the two groups. Results (1) During the trial, 2 cases from the treatment group and 3 from the control group were lost to follow-up, and the final included case number of the treatment group and control group was 28, 27 respectively. (2) After treatment, the serum uric acid level in the two groups was decreased (P<0.01 compared with that before treatment), and the decrease in the treatment group was superior to that in the control group (P<0.05). (3) After treatment, the percentage of patients with serum uric acid less than 60mg/L in the treatment group and control group was 96.43％, 77.78％ respectively, the difference being significant(P<0.05).(4) After treatment, the maximum diameter of the tophi was reduced in the two groups(P<0.05 compared with that before treatment), and the decrease in the treatment group was superior to that in the control group (P<0.05). (5) After treatment, the scores of TCM syndromes in the two groups were markedly improved (P < 0.01 compared with those before treatment) , and the improvement in the treatment group was superior to that in the control group (P < 0.05). (6) During the treatment, acute attack of gout occurred in one case of the treatment group and in 7 cases of the control group, the difference being significant (P<0.05). The treatment group had 4 cases of diarrhea and one case of hepatic function injury, and the control group had 3 cases of diarrhea and one case of hepatic function injury , the difference being insignificant between the two groups (P > 0.05). Conclusion Heat-clearing and diuresis-promoting herbal formula Tongfeng Recipe exerts certain effect in treating damp-turbidity-heat accumulation type of gout with tophus, and the recipe is effective on decreasing serum uric acid, preventing the acute attack of gout induced by anti-uric acid treatment, and improving TCM syndromes.