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. 2019 May 24:10:550.
doi: 10.3389/fphar.2019.00550. eCollection 2019.

The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis

Zhe Feng  1 , Bi-Qing Zhang  2 , Ya-Mei Zhu  3 , Bei-Bei Yu  4 , Ling Fu  1 , Ling-Ling Zhou  5 , Xue-Ping Zhou  1 , Yan Lu  6
Affiliations

The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis

Zhe Feng et al. Front Pharmacol. .

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.

Keywords: effectiveness; meta-analysis; primary Sjögren's syndrome; safety; the total glucosides of paeony.

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Figures

Figure 1
Figure 1
Flow chart of trials selection.
Figure 2
Figure 2
Risk of bias graph of included studies.
Figure 3
Figure 3
Risk of bias summary of included studies.
Figure 4
Figure 4
Forest plots of TGP compared with PBO.
Figure 5
Figure 5
Forest plots comparing TGP+IS and IS.
Figure 6
Figure 6
Subgroup analysis of ESR based on intervention duration of TGP + IS vs. IS alone.
Figure 7
Figure 7
Subgroup analysis of serum γ-globulin based on intervention duration of TGP + IS vs. IS alone.
Figure 8
Figure 8
Subgroup analysis of Schirmer's test based on intervention duration of TGP + IS vs. IS alone.
Figure 9
Figure 9
(A–D) Schirmer's test based on different intervention time (sensitivity analysis).
Figure 10
Figure 10
(A,B) Subgroup analysis and sensitivity analysis of Schirmer's test based on different IS use.
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References

    1. Alunno A., Leone M. C., Giacomelli R., Gerli R., Carubbi F. (2018). Lymphoma and Lymphomagenesis in Primary Sjögren's Syndrome. Front. Med. 5:102. 10.3389/fmed.2018.00102 - DOI - PMC - PubMed
    1. Barone F., Colafrancesco S. (2016). Sjögren's syndrome: from pathogenesis to novel therapeutic targets. Clin. Exp. Rheumatol. 34, 58–62. - PubMed
    1. Both T., Dalm V., Hagen P. M., Daele P. (2017). Reviewing primary Sjögren's syndrome: beyond the dryness - From pathophysiology to diagnosis and treatment. Int. J. Med. Sci. 14, 191–200. 10.7150/ijms.17718 - DOI - PMC - PubMed
    1. Cai W. H. (2011). Clinical investigation of Sjogren's syndrome treated with total glucosides of peony. Contem. Med. 17, 10–11. 10.3969/j.issn.1009-4393.2011.36.006 - DOI
    1. Carsons S. E., Vivino F. B., Parke A., Carteron A., Sankar V., Brasington R., et al. . (2017). Treatment guidelines for rheumatologic manifestations of sjogren's syndrome: use of biologic agents, management of fatigue, and inflammatory musculoskeletal pain. Arthritis Care Res. 69, 517–527. 10.1002/acr.22968 - DOI - PubMed

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