Efficacy and safety of fire needle therapy for plaque psoriasis: a randomized, single-blind, multicenter clinical trial

BACKGROUND: Psoriasis treatment still requires further exploration. Fire needle therapy, an external method used in traditional Chinese medicine (TCM), is considered to have a definite effect on psoriasis, but lacks high-level clinical evidence. OBJECTIVE: To determine the efficacy and safety of fire needle therapy for psoriasis treatment. METHODS: This randomized, single-blind, multicenter clinical trial was conducted in five large hospitals in China. In total, 78 patients with plaque psoriasis aged 18 years or older were randomized to receive either fire needle therapy or control therapy over 4 weeks, with a 4-week follow-up. The full analysis and intention-to-treat sets were used for statistical analysis. RESULTS: After treatment, the Psoriasis Area and Severity Index (PASI) score in the fire needle therapy group was significantly lower (-1.15 ± 1.10 [95% confidence interval, CI: -1.51, -0.79] vs. -2.72 ± 2.15 [95% CI: -3.47, -1.97], P < 0.01), while the PASI50, PASI75 and PASI90 scores were substantially higher than those of the control group (77.14% vs. 42.11%, 57.14% vs. 21.05%, and 40.00% vs. 0%, P < 0.01). Fire needle therapy significantly improved the quality of life of patients with psoriasis (7.03 ± 4.01 [95% CI: 5.73, 8.33] vs. 3.66 ± 3.32 [95% CI: 2.50, 4.82], P < 0.05), with no adverse reactions. Further, there was no significant difference in recurrence rates between the two groups (0% vs. 6.06%, P > 0.05). CONCLUSION: Fire needle therapy is an effective and safe treatment for plaque psoriasis which improves patient quality of life. These findings support its use and suggest that it can be recommended as a valuable treatment option in clinical practice.