Safety and efficacy ofGanoderma lucidum(lingzhi) and San Miao San supplementation in patients with rheumatoid arthritis: A double‐blind, randomized, placebo‐controlled pilot trial

Abstract Objective To examine the efficacy of popular Chinese herbs used in a traditional Chinese medicine (TCM) combination of Ganoderma lucidum and San Miao San (SMS), with purported diverse health benefits including antioxidant properties in rheumatoid arthritis (RA). Methods We randomly assigned 32 patients with active RA, despite disease‐modifying antirheumatic drugs, to TCM and 33 to placebo in addition to their current medications for 24 weeks. The TCM group received G lucidum (4 gm) and SMS (2.4 gm) daily. The primary outcome was the number of patients achieving American College of Rheumatology (ACR) 20% response and secondary outcomes included changes in the ACR components, plasma levels, and ex vivo–induced cytokines and chemokines and oxidative stress markers. Results Eighty‐nine percent completed the 24‐week study. Fifteen percent in the TCM group compared with 9.1% in the placebo group achieved ACR20 ( P > 0.05). Pain score and patient's global score improved significantly only in the TCM group. The percentage, absolute counts, and CD4+/CD8+/natural killer/B lymphocytes ratio were unchanged between groups. CD3, CD4, and CD8 lymphocyte counts and markers of inflammation including plasma interleukin‐18 (IL‐18), interferon‐γ (IFNγ)–inducible protein 10, monocyte chemoattractant protein 1, monokine induced by IFNγ, and RANTES were unchanged. However, in an ex vivo experiment, the percentage change of IL‐18 was significantly lower in the TCM group. Thirteen patients reported 22 episodes (14 in placebo group and 8 in TCM group) of mild adverse effects. Conclusion G lucidum and San Miao San may have analgesic effects for patients with active RA, and were generally safe and well tolerated. However, no significant antioxidant, antiinflammatory, or immunomodulating effects could be demonstrated.