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

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)....

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Autores principales: Feng, Zhe, Zhang, Bi-qing, Zhu, Ya-mei, Yu, Bei-bei, Fu, Ling, Zhou, Ling-ling, Zhou, Xue-ping, Lu, Yan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6543198/
https://www.ncbi.nlm.nih.gov/pubmed/31178729
http://dx.doi.org/10.3389/fphar.2019.00550
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author Feng, Zhe
Zhang, Bi-qing
Zhu, Ya-mei
Yu, Bei-bei
Fu, Ling
Zhou, Ling-ling
Zhou, Xue-ping
Lu, Yan
author_facet Feng, Zhe
Zhang, Bi-qing
Zhu, Ya-mei
Yu, Bei-bei
Fu, Ling
Zhou, Ling-ling
Zhou, Xue-ping
Lu, Yan
author_sort Feng, Zhe
collection PubMed
description 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.
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spelling pubmed-65431982019-06-07 The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis Feng, Zhe Zhang, Bi-qing Zhu, Ya-mei Yu, Bei-bei Fu, Ling Zhou, Ling-ling Zhou, Xue-ping Lu, Yan Front Pharmacol Pharmacology 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. Frontiers Media S.A. 2019-05-24 /pmc/articles/PMC6543198/ /pubmed/31178729 http://dx.doi.org/10.3389/fphar.2019.00550 Text en Copyright © 2019 Feng, Zhang, Zhu, Yu, Fu, Zhou, Zhou and Lu. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Feng, Zhe
Zhang, Bi-qing
Zhu, Ya-mei
Yu, Bei-bei
Fu, Ling
Zhou, Ling-ling
Zhou, Xue-ping
Lu, Yan
The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis
title The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis
title_full The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis
title_fullStr The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis
title_full_unstemmed The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis
title_short The Effectiveness and Safety of Total Glucosides of Paeony in Primary Sjögren's Syndrome: A Systematic Review and Meta-Analysis
title_sort effectiveness and safety of total glucosides of paeony in primary sjögren's syndrome: a systematic review and meta-analysis
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6543198/
https://www.ncbi.nlm.nih.gov/pubmed/31178729
http://dx.doi.org/10.3389/fphar.2019.00550
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