clinical and immunological consequences of total glucosides of paeony treatment in Sjögren's syndrome: A randomized controlled pilot trial

Abstract Background The total glucosides of paeony (TGP) can inhibit inflammation and alleviate symptoms in autoimmune diseases. This study investigated the clinical and immunological consequences of TGP treatment in patients with primary Sjogren's syndrome (SS). Methods We conducted a randomized, double-blinded, placebo-controlled clinical trial in 45 patients with primary SS. Patients were randomized at 2:1 ratio to either TGP group ( n  = 29) or placebo group ( n  = 16) and followed up for 24 weeks. The primary outocme was the European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI). The secondary outcomes were stimulated and unstimulated salivary flow rate, Schirmer's test and erythrocyte sedimentation rate (ESR), immuneglobulin (Ig), anti-nuclear antibody (ANA), anti-SSA, and anti-SSB. The proportions of B cells in peripheral blood and the levels of serum inerleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ) and B cell activating factor belonging to the TNF family (BAFF) were measured at baseline and at the end of follow up of 24 weeks. Results The average score of ESSPRI in both groups had no statistical significance at 24th week. The mean of ESSPRI in the dry-mouth part of questionnaire in patients who scored 3 to 6 points was significantly reduced in the TGP group changed from (4.81 ± 0.60) at baseline to (4.20 ± 1.46) ( P  = 0.027) at week 24. Stimulated salivary flow rate increased at week 24 from (1.80 ± 0.39) to (2.01 ± 0.51) ( P  = 0.031) and unstimulated salivary flow rate increased from (0.65 ± 0.46) to (0.78 ± 0.45) ( P  = 0.011) in the TGP group, but the placebo group showed no significant difference. Erythrocyte sedimentation rate (ESR) was decreased significantly compared to the placebo group at 12- and 24-week from (40.9 ± 18.0) to (29.4 ± 12.2) ( P  = 0.003) and (30.4 ± 17.3) ( P  = 0.024). The percentage of naive B cells decreased at week 24 in the TGP group from (77.34 ± 12.20) to (64.59 ± 15.60) ( P  = 0.005) while memory B cells increased from (21.79 ± 11.97) to (34.21 ± 15.48) ( P  = 0.006) respectively. The concentrations of TNF-α and IFN-γ decreased in the TGP group at week 24 from (32.51 ± 26.67) to (24.22 ± 13.56) ( P  = 0.017) and (10.71 ± 8.94) to (6.55 ± 4.88) ( P  = 0.022), respectively. No significant difference in ANA titer, anti-SSA antibodies, anti-SSB antibodies, C3 concentration or C4 concentration was observed between the two groups. Conclusion TGP appears to improve the glandular secreting function and decrease the level of inflammatory cytokines.