The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren’s syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial

Liu, Xia; Li, Xiaomei; Li, Zhijun; Zhao, Dongbao; Liu, Shengyun; Zhang, Miaojia; Fengxiao, Zhang; Zhu, Ping; Chen, Jinwei; Wei, Wei; Lin, Bing; Zhou, Yicheng; Chen, Jing; Pang, Yafei; Zhang, Lei; Sun, Xiaoxuan; Yu, Zhaojie; Jia, Yafei; Wang, Jia; Sun, Wenwen; Chiu, Frank Po‐Chao; Pang, Liping; Wang, Guochun

doi:10.1007/s10067-018-4315-8

Cited by 15 publications

(17 citation statements)

References 21 publications

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“…A total of 89 records were excluded after screening them based on the titles and abstracts. 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 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. The flow chart of trials selection was shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

“…Three included trials reported Adverse Events (AEs) (You and Wang, 2015; Zhou et al, 2016; Liu et al, 2018). Compared TGP with Placebo, there was a significant difference in AEs ( P = 0.04), which reported mild to moderate diarrhea in nineteen patients, gastrointestinal discomfort in two patients, mild dizziness in two patients, and leukopenia in one patient in the TGP group which involved 260 patients totally.…”

Section: Resultsmentioning

confidence: 99%

“…In our study, we included nine trials which contained TGP vs. PBO and TGP+IS vs. IS, along with a recent multi-center trial with high quality (Liu et al, 2018). Meanwhile, the heterogeneity was further processed through subgroup analysis and sensitivity analysis, which made our study, a more comprehensive version than Jin's.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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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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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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

et al. 2019

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“…The results showed that ESSPRI scores improved dramatically, significantly alleviated some dryness symptoms, and improved fatigue VAS during the 24-week trial. The rate of adverse events in the TGP group was 10.9%; the main adverse event was diarrhea at a rate of 4.8% 65…”

Section: Pharmacological Treatment To Treat Fatigue In Pss: a Real Chmentioning

confidence: 94%

<p>Managing fatigue in patients with primary Sjögren’s syndrome: challenges and solutions</p>

Miyamoto¹,

Lendrem²,

Ng³

et al. 2019

OARRR

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Primary Sjögren’s syndrome (pSS) patients identify fatigue as their most important symptom and the one most difficult to cope with, but there are still many challenges and few solutions to manage this debilitating symptom. Promising pharmacological treatments, such as rituximab, have failed in more stringent tests including randomized controlled trials (RCTs) and meta-analysis. While non-pharmacological interventions may be safer, less costly, and address other common comorbidities, to date only aerobic exercise seems to be effective at reducing fatigue in pSS. All interventions, pharmacological or not, need to be tested in high-quality RCTs. The aim of this review is to provide an overview of fatigue management in pSS and discuss potential opportunities for future research.

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“…It is recommended that patients with PSS are screened at least twice a year, including urine protein, urine pH, urine osmotic pressure, serum creatinine, glomerular filtration rate and electrolyte levels (9). The European League Against Rheumatism Sjogren's syndrome disease activity index may be used to assess renal disease activity during follow-up (10).…”

Section: Discussionmentioning

confidence: 99%

Case report on a 32‑year‑old female with elevated serum creatinine levels and primary Sj�gren's syndrome‑chronic interstitial nephritis

Huang

Deng

et al. 2019

Exp Ther Med

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Primary Sjögren's syndrome (PSS) is a chronic autoimmune disease characterized by lymphoplasmacytic infiltration of the exocrine glands, which results in multiple organs damage. Renal injury affects 0.3–27.0% of PSS patients, and tubulointerstitial nephritis is the most frequent form of nephropathy in PSS. The present study reports on the case of a 32-year-old female with a 1-year history of elevated serum creatinine levels, and a 6-month history of mild pain in the waist and leg. Blood biochemistry tests indicated a creatinine level of 221.3 µmol/l and estimated glomerular filtration rate of 24.6 ml/min/1.73 m2 [Chronic Kidney Disease Epidemiology (CKD-EPI) formula]. Accordingly, the patient was diagnosed with stage IV chronic kidney disease. To clarify the underlying cause of the disease, a kidney biopsy was performed, which revealed tubular epithelial cells with multiple focal and lamellar atrophy (~60%), as well as extensive renal interstitial fibrosis with scattered inflammatory cell infiltration. Based on these results, the patient was finally diagnosed with severe chronic interstitial nephritis, chronic kidney disease stage IV, PSS and anemia due to chronic kidney disease. The patient was treated with half-dose glucocorticoid (prednisone, 25 mg oral qd maintained up to 12 months). The patient's serum creatinine levels had decreased to 172.4 µmol/l after 1 month and to 178.7 µmol/l after 12 months. The present case concluded that young patients with chronic renal failure should first be assessed for rheumatic immune system diseases. PSS may involve several organs and the clinical manifestations may be varied. Although chronic renal failure is frequently the first manifestation of renal disorder due to PSS, it may be overlooked by clinicians. The present results suggest that further attention should be paid to determine the association between symptoms in the clinical setting.

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The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren’s syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial

Cited by 15 publications

References 21 publications

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

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

<p>Managing fatigue in patients with primary Sjögren’s syndrome: challenges and solutions</p>

Case report on a 32‑year‑old female with elevated serum creatinine levels and primary Sj�gren's syndrome‑chronic interstitial nephritis

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The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren’s syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial

Cited by 15 publications

References 21 publications

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

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

<p>Managing fatigue in patients with primary Sj&ouml;gren&rsquo;s syndrome: challenges and solutions</p>

Case report on a 32‑year‑old female with elevated serum creatinine levels and primary Sj�gren's syndrome‑chronic interstitial nephritis

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<p>Managing fatigue in patients with primary Sjögren’s syndrome: challenges and solutions</p>