Chinese Herbal Medicine (Zi Shen Qing) for Mild-to-Moderate Systematic Lupus Erythematosus: A Pilot Prospective, Single-Blinded, Randomized Controlled Study.

Objective. The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula Zi Shen Qing (ZSQ) in the treatment of systematic lupus erythematosus (SLE) in Chinese patients. Methods. A randomized controlled trial was conducted over 12 weeks in 84 Chinese patients who reported total scores of SLE Disease Activity Index-2000 (SLEDAI-2000) was from 5 to 14. The primary outcome was the changes of the SLEDAI-2000. The secondary outcomes included score changes of Chinese Medicine Syndromes (CMS), the changes of steroid dosage, the incidence of disease flare-up and biologic markers. Results. ZSQ significantly reduced SLEDAI-2000, the total scores of CMS in the treatment group compared with the controlled group (P < 0.05). Superiority of ZSQ over controlled group was also observed with greater improvement in the withdrawal dosage of corticosteroids and the incidence of disease flare-up (P < 0.05). There were no serious adverse events, and safety indices of whole blood counts, renal and liver functions were normal, both before and after the treatment. Conclusion. ZSQ is safe and effective for decreasing SLE disease activity and withdrawal dosage of corticosteroids in the mild to moderate SLE patients with "Deficiency of Qi and Yin" Pattern.