Efficacy and safety of the Chinese herbal medicine Yiaikang capsule in treating AIDS: a randomized, double-blind, controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: The Shuyu pill is a traditional Chinese medicine (TCM) formula, used to treat Xu Lao for over 1800 years. Studies have reported the effectiveness of Yiaikang capsules (YAK), a modified form of Shuyu pills, in AIDS treatment. However, clinical evidence for the management of AIDS using YAK is lacking. We aimed to evaluate the efficacy and safety of YAK combined with antiretroviral therapy (ART) among people living with HIV infection. MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled, multicenter study. Patients were assigned 1:1 to receive YAK combined with ART, or placebo combined with ART, for 48 weeks. The primary outcome was changes in CD4 counts. Secondary outcomes were changes in CD4+CCR5+ and CD4+CXCR4+ counts, HIV-1 load, inflammatory markers from the time of screening to week 48, and total TCM score every 4 weeks. RESULTS: We enrolled 144 patients from eight centers. No significant differences were observed in sex, age, CD4 counts, or other baseline characteristics between the two groups. At week 48, the adjusted mean CD4 count reached 488.7 cells/mm3 in the YAK group (95% confidence interval [CI]: 458.2, 519.2), compared with 385.9 cells/mm3 in the placebo group (95% CI: 354.1, 417.7), resulting in a substantial between-group difference of 102.8 cells/mm3 (95% CI: 59.6, 146.0; P < 0.001). TCM syndrome scores indicated that YAK combined with ART was more effective than placebo after 8 weeks (each P < 0.001). YAK significantly reduced the levels of activation markers (CD4+CCR5+, CD4+CXCR4+) and inflammatory cytokines (interleukin-4, interferon-gamma, and tumor necrosis factor-alpha) compared to placebo(P < 0.05). No serious adverse events were reported. CONCLUSIONS: YAK combined with ART promoted CD4 count recovery, improved TCM syndrome, and alleviated immune activation.