Objective To explore the effects of five-tone therapy combined with external application of Sanhuang Powder on symptoms and quality of life in patients with acute gouty arthritis (GA). Methods A total of 140 patients with acute GA were enrolled and randomly divided into control group, five-tone group, Sanhuang Powder group, or combined group, with 35 cases in each group. The control group received standard anti-inflammatory and analgesic treatment (etoricoxib tablets 120 mg/d) and routine nursing, based on which the five-tone group was given five-tone therapy, the Sanhuang Powder group was given external application of Sanhuang Powder, and the combined group received both five-tone therapy and external application of Sanhuang Powder. All four groups were treated for 1 week. Inflammatory indicators (C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]), traditional Chinese medicine symptom scores, sleep quality (Pittsburgh Sleep Quality Index [PSQI] score), negative emotions (Hospital Anxiety and Depression Scale [HADS] score), and health status (36-Item Short Form Health Survey [SF-36] score) before and after treatment, as well as traditional Chinese medicine clinical efficacy and safety, were compared among the 4 groups. Results Before treatment, there was no statistically significant difference in the level of CRP or ESR, traditional Chinese medicine symptom scores, as well as PSQI, HADS, or SF-36 score among the four groups (all P>0.05). After 1 week of treatment, the levels of CRP and ESR, traditional Chinese medicine symptom scores, and PSQI, HADS, and SF-36 scores of the four groups were improved compared with those before treatment (all P<0.05); the levels of CRP and ESR, as well as traditional Chinese medicine symptom scores, in the combined group were lower than those in the other three groups, the total effective rate of traditional Chinese medicine clinical efficacy in the combined group (97.14%) was higher than in the control group (80.00%), and the PSQI, HADS, and SF-36 scores of the combined group were superior to those of the other 3 groups (all P<0.05). During the treatment period, all patients had stable vital signs, no abnormalities were found in safety indicators, and no obvious allergic reactions were observed. Conclusion For patients with acute GA, on the basis of standard Western medicine treatment, combined application of five-tone therapy and external application of Sanhuang Powder can more effectively inhibit inflammation and relieve clinical symptoms, with better efficacy than Western medicine alone or single traditional Chinese medicine therapy, and it can also improve patients' sleep, mood, and overall quality of life, with good safety.

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