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

Autor: Yen CM; Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan., Lin HC; Department of Chinese Medicine, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan.; Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan., Chen WS; Division of Allergy, Immunology and Rheumatology, Taipei Veterans General Hospital, Taipei, Taiwan.; School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan., Hsu CC; School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.; Department of Ophthalmology, Taipei Veterans General Hospital, Taipei, Taiwan., Liaw CC; Division of Chinese Materia Medica Development, National Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taipei, Taiwan., Kung YY; Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.; Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.; School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.; School of Chinese Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan., Ma CP; Department of Biomedical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan., Chen HY; Department of Traditional Chinese Medicine, Center for Traditional Chinese Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan., Su YT; Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan., Chang CM; Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.; Institute of Traditional Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.; School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.; School of Chinese Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Jazyk: angličtina
Zdroj: International journal of rheumatic diseases [Int J Rheum Dis] 2024 Nov; Vol. 27 (11), pp. e15398.
DOI: 10.1111/1756-185X.15398
Abstrakt: 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.
(© 2024 The Author(s). International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)
Databáze: MEDLINE