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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Meta-Analysis
Sample size
n = 632
Population
632 participants with primary Sjögren's syndrome
Methods
Eight databases were searched for randomized controlled trials (RCTs) reporting the use of TGP combined with HCQ for pSS, which are before May 10, 2022. Meta-analyses were performed on disappeared clinical symptoms (dry mouth and dry eyes), Schirmer's test, saliva flow test, ESR, IgG, IgM, IgA, and adverse events.

Objective

To assess the effectiveness and safety of the total glucosides of paeony (TGP) combined with hydroxychloroquine (HCQ) on the treatment of primary Sjögren's syndrome (pSS) by conducting a meta-analysis.

Methods

Eight databases were searched for randomized controlled trials (RCTs) reporting the use of TGP combined with HCQ for pSS, which are before May 10, 2022. Meta-analyses were performed on disappeared clinical symptoms (dry mouth and dry eyes), Schirmer's test, saliva flow test, erythrocyte sedimentation rate (ESR), index of immunoglobulin G (IgG), immunoglobulin M (IgM), immunoglobulin A (IgA), and adverse events (AEs). The Revman 5.4 software was used for this meta-analysis.

Results

Seven RCTs which included 632 participants were identified. The pooled results showed significant differences in clinical symptoms disappear (dry mouth and dry eyes) (p = .0004), IgM (p < .00001), IgA (p < .00001), salivary flow rate (p < .00001) and Schirmer's test (p = .02) in the comparison of TGP combined with HCQ and HCQ alone. For the IgG and ESR, both pooled and subgroup analyses showed that TGP + HCQ was superior to HCQ alone. For the safety analysis, no significant differences in AEs (p = .39) was revealed. The more frequently seen adverse reactions were diarrhea, vomit and there was no severe adverse events were reported in TGP + HCQ group.

Conclusion

Therefore, TGP + HCQ can be considered to be a potentially valid and safe combination for the treatment of pSS in the clinic.

Research Insights

Adverse Events Reported

  • PeonyOverall tolerability

    For the safety analysis, no significant differences in AEs (p = .39) was revealed.

    Finding
    No significant difference
    Significant
    No
  • Peonydiarrhea

    The more frequently seen adverse reactions were diarrhea, vomit and there was no severe adverse events were reported in TGP+HCQ group.

    Finding
    Reported
  • Peonyvomit

    The more frequently seen adverse reactions were diarrhea, vomit and there was no severe adverse events were reported in TGP+HCQ group.

    Finding
    Reported
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