Evaluation of traditional Chinese medicine tea bag TBDESJS in patients with Sjögren's syndrome and dry eye syndrome: A phase II pilot study

Abstract Ethnopharmacological Relevance Sjögren's syndrome (SJS) and dry eye syndrome (DES) are characterized by ocular dryness from inadequate tear production or excessive evaporation. To evaluate the effectiveness of TBDESJS (Chun‐Yu‐Ching‐Hua‐Yin, CYCHY), a TCM tea bag, in treating SJS and DES patients compared with healthy controls (NHC). Materials and Methods This phase II pilot study included 100 participants (60 SJS, 30 DES, 10 NHC) across 8 weeks, assessing changes in Schirmer's test, OSDI, ESSPRI, PSQI, FIRST, and artificial tear usage, using repeated measurement ANOVA and Tukey's honestly significant difference (HSD) for analysis. Results Total 97 subjects completed the trial, for the left eye (OS) of Schirmer's test, significant improvements at 4, and 8 weeks were observed in SJS (0.13 ± 0.43–5.77 ± 2.87, and 7.60 ± 4.84 mm) and DES (0.21 ± 0.41–6.21 ± 2.97, and 7.86 ± 3.47 mm) (all p < .001). For the right eye (OD), significant improvements were observed in SJS (0.13 ± 0.39–6.77 ± 4.53, and 8.79 ± 5.92 mm) and DES (0.34 ± 0.55–6.59 ± 2.50, and 8.24 ± 3.42 mm) (all p < .001). Secondary outcomes showed reduced the dryness of ESSPRI scores in SJS (6.37 ± 1.97–5.57 ± 1.79, p < .001) and DES (6.10 ± 1.97–5.28 ± 2.23, p < .05). PSQI global scores improved significantly in all groups at 8 weeks ( p < .05). Artificial tear usage decreased in SJS (4.93 ± 2.45–1.00 ± 0.82 times/day), DES (4.47 ± 1.99–0.66 ± 0.67 times/day) (all p < .001). No serious adverse events in this study. Conclusion TBDESJS significantly improved tear production, ocular dryness, and sleep quality, indicating potential neural regulation, anti‐inflammatory and immunomodulatory benefits. These findings advocate for TBDESJS (Chun‐Yu‐Ching‐Hua‐Yin, CYCHY)'s comprehensive therapeutic value in SJS and DES treatment, emphasizing the need for further research to understand long‐term effects and mechanisms.