Abstract
Objective: To assess the effectiveness and safety of the total glucosides of paeony (TGP) on the treatment of primary Sjögren's syndrome (pSS) by conducting a meta-analysis.Methods: Eight databases were searched from their inception to December 10, 2018 for randomized controlled trials (RCTs). The Revman 5.3 software was used for this meta-analysis.Results: Nine RCTs which included 770 participants were identified. Pooled results showed that significant difference in Schirmer's test (P < 0.00001) comparing TGP with placebo (PBO). However, the pooled results displayed significant differences in salivary flow rate, Schirmer's test, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), serum γ-globulin, immunoglobulin G (IgG), IgA, IgM, and effective rate (P ≤ 0.01) in the co-administration of TGP with immunosuppressant (IS) compared with IS alone. Subgroup analyses revealed both heterogeneities in ESR and serum γ-globulin were eliminated, showing combined intervention of TGP + IS being more advantageous than single usage of IS (P < 0.00001). However, the advantage varied among three subgroups and showed a gradual weakening over time. Furthermore, our results showed statistical significance in Schirmer's test (P = 0.0006), when hydroxychloroquine (HCQ) was jointly applied, but not in the case of combined TGP with methotrexate (MTX) (P = 0.41). For the safety analysis, the most common adverse events (AEs) were diarrhea or gastrointestinal discomfort, and no severe AEs were reported in TGP group. Meanwhile, six trials showed statistically insignificant differences between TGP + IS and IS in AEs (P = 0.76).Conclusions: Improving the lacrimal gland secretion (Schirmer's test) is the prominent function of TGP compared with PBO. TGP + IS can improve the clinical symptoms, such as lacrimal and salivary gland secretion function (Schirmer's test, salivary flow rate), inflammatory indices (ESR, CRP, and RF) and immunoglobulins (γ-globulin, IgG, IgA, and IgM) on the basis of IS monotherapy. In addition, TGP has an acceptable safety profile and AEs were not increased when TGP combined with IS in pSS. Therefore, TGP can be considered to be a potentially valid and safe drug for the treatment of pSS in the clinic. In view of the limitations of the included trials, the potential beneficial effectiveness and safety of TGP need additional high-quality, multi-center, and large-scale RCTs to assess its use in pSS treatment.
Highlights
Sjögren’s syndrome (SS) is a chronic systemic autoimmune disease characterized by the lymphocytic infiltration of exocrine glands in pathology and manifested by glandular dysfunction and classic sicca symptoms of dry eyes and mouth in clinic (Sandhya et al, 2017)
Our final analysis included 9 RCTs (Feng and Zhang, 2008; He, 2010; Cai, 2011; Yin, 2011; Zhao and Zhao, 2013; You and Wang, 2015; Liu and Deng, 2016; Zhou et al, 2016; Liu et al, 2018), with a total of 770 patients who were randomly grouped into total glucosides of paeony (TGP) with PBO (n = 389) (You and Wang, 2015; Zhou et al, 2016; Liu et al, 2018), or co-intervention of TGP and IS (TGP + IS) with IS alone (n = 381) (Feng and Zhang, 2008; He, 2010; Cai, 2011; Yin, 2011; Zhao and Zhao, 2013; Liu and Deng, 2016) by further analyzing the remaining full-text articles
We re-analyzed each subgroup to explore possible differences resulted from the combined applications of different IS and discovered statistical significance was observed in Schirmer’s test (MD = 2.70, 95%confidence internal (CI): 1.15 to 4.24, I2 = 84%, P = 0.0006) (Figure 9C), when HCQ was jointly applied, but not in the case of combined TGP with MTX (MD = 0.37, 95%CI: −0.51 to 1.62, I2 = 79%, P = 0.41) (Figure 9D)
Summary
Sjögren’s syndrome (SS) is a chronic systemic autoimmune disease characterized by the lymphocytic infiltration of exocrine glands in pathology and manifested by glandular dysfunction and classic sicca symptoms of dry eyes and mouth in clinic (Sandhya et al, 2017). According to latest epidemiological data, the prevalence of pSS is about 0.29 to 0.77% in China (Chinese Rheumatology Association, 2010), and the incidence and prevalence rates global wide are 6.92 (95% CI 4.98 to 8.86) per 100,000 persons and 60.82 (95% CI 43.69 to 77.94) per 100,000 persons, respectively (Qin et al, 2015) Key symptoms such as glandular features, musculoskeletal pain, and fatigue can result in harsh physical limitations, immense psychological distress, and severe complications such as lymphoma, even greater financial burdens on patients’ family in long term, which has been considerably affecting their quality of life, making it a heated research focus for medical specialists worldwide (Lackner et al, 2017; Ng et al, 2017; Stack et al, 2017; Alunno et al, 2018).
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