Inflammatory cytokines, autoantibodies and salivary gland function in Sjögren's syndrome: Effects of T. wilfordii as Hook F medical wine and tripterygium glycosides tablets.

OBJECTIVE: This study was conceived to compare the clinical efficacy of Tripterygium wilfordii Hook F (TWHF) medical wine and Tripterygium glycoside tablets (TGTs) in patients with primary Sjögren's syndrome (pSS), mainly focusing on inflammatory markers, autoantibody profiles, and salivary gland function.

MATERIALS AND METHODS: In this prospective, randomized controlled trial, 90 pSS patients were enrolled and randomly assigned into a TWHF medical wine group (Observation) or TGTs group (Control), receiving either TWHF medical wine (8 mL, twice daily) or TGTs (10 mg, 3 times daily) for 12 weeks. Primary outcomes included unstimulated whole saliva (UWS) flow rate, EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and positivity rates of anti-SSA/SSB antibodies. Secondary outcomes included subjective symptom scores (EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)), serum IgG levels, and safety profiles.

RESULTS: Baseline characteristics were comparable between the two groups. After 12 weeks, the Observation group showed significantly greater improvements in UWS and ESSDAI scores. The positive rates of anti-SSA and anti-SSB had decreased in both groups, with a more pronounced decline observed in the observation group, though between-group differences were not statistically significant. ESSPRI scores and IgG levels were significantly reduced in both groups, with more pronounced changes in the Observation group. No severe adverse events occurred, and both treatments were well tolerated with comparable safety profiles.

CONCLUSION: TWHF medical wine is more effective than TGTs in improving salivary gland function, systemic disease activity, and immunological profiles in pSS patients, with comparable safety. These results suggest that TWHF medical wine is a suitable alternative treatment for primary Sjögren's syndrome.