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Adverse Events Associated With Treatment of Tripterygium wilfordii Hook F: A Quantitative Evidence Synthesis.

ABSTRACT: Background: Tripterygium wilfordii Hook F can cause adverse effects (AEs) in clinical application and may be harmful to human health. This study aim to summarize the AEs caused by T. wilfordii tgpolyglycoside (TWP), the most common preparation of T. wilfordii Hook F for clinical use. Methods: The Cochrane Library, EMBASE, PubMed, and Web of Science were searched to identify potential articles on this topic. All single-arm trials, controlled clinical trials, and randomized controlled trials were selected and summarized. Meta-regression was used to determine the sources of heterogeneity, and subgroups were used to identify factors leading to AEs. Results: Forty-six studies, comprising 25 randomized controlled trials, 13 controlled clinical trials, and 8 single-arm trials, were included in this meta-analysis, representing 2437 enrolled TWP-treated participants. Combined intervention, drug dosage, medication treatment, pharmaceutical manufacturers, and specific organ toxicity were identified as potential factors leading to TWP-induced AEs in this meta-analysis. In patients treated with TWP, the global incidence of AEs was 30.75% (95% confidence interval [21.18-40.33], I 2 = 97%), and that of severe grade AEs was 4.68% (95% confidence interval [0.00-12.72], I 2 = 53%). Organ-specific analyses indicated that TWP treatment elicited intestinal toxicity, reproductive toxicity, hepatotoxicity, nephrotoxicity, hematotoxicity, cutaneous toxicity, and other damages. The AEs analyzed in the subgroups of combined intervention, drug dosage, medication treatment, and pharmaceutical manufacturers were considered as primary outcomes, and organic-specific AEs were considered as secondary outcomes. Conclusions: The occurrence of TWP-induced AEs was systemic, organ-specific, and related to medication course, combined intervention, and drug dosage.

SUBMITTER: Ru Y

PROVIDER: S-EPMC6851843 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Adverse Events Associated With Treatment of Tripterygium wilfordii Hook F: A Quantitative Evidence Synthesis.

Ru Yi Y Luo Ying Y Zhou Yaqiong Y Kuai Le L Sun Xiaoying X Xing Meng M Liu Liu L Lu Yi Y Hong Seokgyeong S Chen Xi X Song Jiankun J Luo Yue Y Fei Xiaoya X Li Bin B Li Xin X

Frontiers in pharmacology 20191106

Background: Tripterygium wilfordii Hook F can cause adverse effects (AEs) in clinical application and may be harmful to human health. This study aim to summarize the AEs caused by T. wilfordii tgpolyglycoside (TWP), the most common preparation of T. wilfordii Hook F for clinical use. Methods: The Cochrane Library, EMBASE, PubMed, and Web of Science were searched to identify potential articles on this topic. All single-arm trials, controlled clinical trials, and ...[more]

PMID: 31780926

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Project description:BackgroundDiabetic nephropathy (DN) is the most common cause of end-stage renal failure. Although angiotensin II receptor blockers (ARBs) can be used to attenuate proteinuria in DN patients, their efficacy remains limited. This clinical trial aimed to evaluate the efficacy of Tripterygium wilfordii Hook F (TwHF) extract in the treatment of type 2 diabetes mellitus (DM)-induced nephropathy.MethodsA total of 65 DN patients with proteinuria levels ≥ 2.5 g/24 h and serum creatinine levels<3 mg/dl were enrolled in this six-month, prospective, randomized, controlled study. The patients were randomized into treatment groups that received either 120 mg of TwHF extract per day for three months, followed by 60 mg per day for three more months, or 160 mg of valsartan daily for six months. The urinary protein and estimated glomerular filtration (eGFR) level were measured at one, three, and six months after the commencement of treatment. The primary measure of treatment efficacy was a reduction in the 24-h urine protein level between baseline and the end of the study, and the secondary measure of treatment efficacy was a reduction in the eGFR value.ResultsAt the end of the treatment period, the mean urine protein level in the TwHF group was dramatically decreased (4.99 ± 2.25 g/24 h vs 2.99 ± 1.81 g/24 h, p< 0.01), with decreases at one, three, and six months of 32.9%, 38.8%, and 34.3%, respectively. In contrast, the proteinuria in the valsartan group was not significantly attenuated, and the decreases in urine protein levels at treatment months one, three, and six were 1.05%, 10.1%, and -11.7%, respectively. The mean decrease in eGFR in the valsartan group was greater than that in the TwHF group (26.4% vs. 13.7%, respectively; p =0.067).ConclusionsTwHF extract can reduce the urine protein level of DN patients and represents a novel, potentially effective, and safe drug for the treatment of DN patients with proteinuria.Trial registrationClinicalTrials.gov: NCT00518362.

Project description:BackgroundExtracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases.ObjectiveTo compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active rheumatoid arthritis.DesignRandomized, controlled trial. A computer-generated code with random, permuted blocks was used to assign treatment.Setting2 U.S. academic centers (National Institutes of Health, Bethesda, Maryland, and University of Texas, Dallas, Texas) and 9 rheumatology subspecialty clinics (in Dallas and Austin, Texas; Tampa and Fort Lauderdale, Florida; Arlington, Virginia; Duncanville, Pennsylvania; Wheaton and Greenbelt, Maryland; and Lansing, Michigan).Patients121 patients with active rheumatoid arthritis and 6 or more painful and swollen joints.InterventionTwHF extract, 60 mg 3 times daily, or sulfasalazine, 1 g twice daily. Patients could continue stable doses of oral prednisone or nonsteroidal anti-inflammatory drugs but had to stop taking disease-modifying antirheumatic drugs at least 28 days before randomization.MeasurementsThe primary outcome was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR 20) at 24 weeks. Secondary end points were safety; radiographic scores of joint damage; and serum levels of interleukin-6, cholesterol, cortisol, and adrenocorticotropic hormone.ResultsOutcome data were available for only 62 patients at 24 weeks. In a mixed-model analysis that imputed data for patients who dropped out, 65.0% (95% CI, 51.6% to 76.9%) of the TwHF group and 32.8% (CI, 21.3% to 46.0%) of the sulfasalazine group met the ACR 20 response criteria (P=0.001). Patients receiving TwHF also had significantly higher response rates for ACR 50 and ACR 70 in mixed-model analyses. Analyses of only completers showed similar significant differences between the treatment groups. Significant improvement was demonstrated in all individual components of the ACR response, including the Health Assessment Questionnaire disability score. Interleukin-6 levels rapidly and significantly decreased in the TwHF group. Although not statistically significant, radiographic progression was lower in the TwHF group. The frequency of adverse events was similar in both groups.LimitationsOnly 62% and 41% of patients continued receiving TwHF extract and sulfasalazine, respectively, during the 24 weeks of the study. Long-term outcome data were not collected on participants who discontinued treatment.ConclusionIn patients who continued treatment for 24 weeks and could also use stable oral prednisone and nonsteroidal anti-inflammatory drugs, attainment of the ACR 20 response criteria was significantly greater with TwHF extract than with sulfasalazine.

Project description:ObjectivesTo summarize the quantity and quality of evidence for using Tripterygium wilfordii Hook. f. (TwHF) preparations in patients with rheumatoid arthritis (RA) and to find the reasons of the disparity by comprehensively appraising the related systematic reviews (SRs).MethodsWe performed an overview of evidence for the effectiveness and safety of TwHF preparations for patients with RA. We searched seven literature databases from inception to July 15, 2021. We included SRs of TwHF preparations in the treatment of RA. Four tools were used to evaluate the reporting quality, methodological quality, risk of bias, and the certainty of evidence for the included SRs, which are the PRISMA, the AMSTAR-2, the ROBIS, and the GRADE approach.ResultsWe included 27 SRs (with 385 studies and 33,888 participants) for this overview. The AMSTAR-2 showed that 19 SRs had critically low methodological quality and the remaining 8 had low methodological quality. The rate of overlaps was 68.31% (263/385), and the CCA (corrected covered area) was 0.53, which indicated the degree of overlap is slight. Based on the assessment of ROBIS, all 27 SRs were rated as low risk in phase 1; one SR was rated as low risk in domain 1, 9 SRs were in low risk in domain 2, 16 SRs were in low risk in domain 3, and 16 SRs were in low risk in domain 4 in phase 2; 7 SRs were rated as low risk in phase 3. Among 27 items of PRISMA, 15 items were reported over 70% of compliance, the reporting quality of 16 SRs was rated as "fair," and 11 were "good." Using GRADE assessment, moderate quality of evidence was found in 5 outcomes, and 5 outcomes were low quality.ConclusionThe use of TwHF preparations for the treatment of RA may be clinically effective according to the moderate-quality evidence. There are methodological issues, risk of bias, and reporting deficiencies still needed to be improved. SRs with good quality and further randomized clinical trials that focus on clinical important outcomes are needed.

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Adverse Events Associated With Treatment of Tripterygium wilfordii Hook F: A Quantitative Evidence Synthesis.

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Adverse Events Associated With Treatment of <i>Tripterygium wilfordii</i> Hook F: A Quantitative Evidence Synthesis.

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