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| A systematic review and Meta-analysis of efficacy and safety of “toxic theory-based treatment” for Sjögren’s syndrome |
| Hits 355 Download times 170 Received:April 27, 2025 |
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| DOI
10.11656/j.issn.1672-1519.2025.09.09 |
| Key Words
Sjögren’s syndrome;dryness obstruction;Meta-analysis;treatment based on toxin theory;dficiency-stasis-toxin theory |
| Author Name | Affiliation | E-mail | | LI Jianbin | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | LIU Wei | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | fengshiliuwei@163.com |
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| Abstract
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| [Objective] To systematically evaluate the efficacy and safety of “treatment based on toxin theory” for the treatment of Sjögren’s syndrome. [Methods] A comprehensive search was conducted in Chinese and English databases，including CNKI，WanFang，and PubMed，for randomized controlled trials（RCTs） up to December 2024. Two independent researchers screened the literature，extracted data，and assessed the risk of bias. RevMan 5.4 software was used to perform the Meta analysis，and the effect sizes were presented as Odds Ratios（OR） and Standardized Mean Differences（SMD）. [Results] A total of 25 RCTs involving 2 274 patients were included. The Meta-analysis showed that the “treatment based on toxin theory” group had a significantly higher overall clinical effective rate compared to the control group [OR=2.23，95%CI（1.77，2.82），P<0.05]. This treatment also showed significant efficacy in improving dry eye symptoms [tear break-up time，SMD=0.80，95%CI（0.37，1.23）] and dry mouth symptoms [salivary flow rate，SMD=1.51，95%CI（0.30，2.73），P<0.05]. The treatment significantly reduced Traditional Chinese Medicine（TCM） syndrome scores [SMD=-0.79，95%CI（-1.22，-0.37）]，inflammatory markers including C-reactive protein [CRP，SMD=-0.45，95%CI（-0.79，-0.11）]，and erythrocyte sedimentation rate [ESR，SMD=-0.29，95%CI（-0.45，-0.14）]，and decreased disease activity scores [ESSDAI，MD=-0.26，95%CI：（-0.49，-0.02）]. The intervention based on “Treatment based on toxin theory” specifically reduced IgG levels [subgroup analysis，SMD=-0.36，95%CI（-0.71，-0.02），P=0.039]，but the overall improvement in immunoglobulin levels（IgA/IgG） did not reach statistical significance. Regarding safety，the “treatment based on toxin theory” group had a significantly lower incidence of adverse reactions compared to the control group [3.67% vs 11.16%，RR=0.33，95%CI（0.24，0.46）]，with mild gastrointestinal discomfort or skin rashes being the primary adverse events. Sensitivity analysis indicated heterogeneity in some indicators，such as salivary flow rate and CRP，which may be related to the diversity of interventions and differences in treatment duration. [Conclusion] “Treatment based on toxin theory” shows superior efficacy compared to conventional treatments in improving clinical outcomes，alleviating symptoms，and suppressing inflammatory responses in patients with Sjögren’s syndrome. It also demonstrates high safety，providing a new option for clinical treatment of Sjögren’s syndrome. |
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