scholarly journals Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Xu Lengnan ◽  
Zhao Ban ◽  
Wang Haitao ◽  
Liu Lili ◽  
Chen Aiqun ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Diabetic Nephropathy ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Stage Iv ◽  
Tripterygium Wilfordii ◽  
Tripterygium Wilfordii Hook F ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Tripterygium Wilfordii Hook

Background. Diabetic nephropathy (DN) is a major cause of chronic kidney disease (CKD). There are no effective treatments to prevent or reverse the progression of DN. A preliminary study showed that Tripterygium glycosides from Tripterygium wilfordii Hook F (TwHF) with valsartan decrease proteinuria in patients with DN. Objectives. The objective of the present study is to investigate the efficacy and safety of Tripterygium glycosides from TwHF, a traditional Chinese medicine, for the treatment of DN. Methods and Analysis. This is a prospective, single-center randomized controlled trial. Seventy participants diagnosed with DN were recruited and randomized 1 : 1 to two groups: (1) angiotensin receptor blocker (ARB) combined with TwHF and (2) ARB-only. The treatment period is 48 weeks. The primary endpoint is 24 h proteinuria decreased level (reduction of 30% vs. baseline) after 48 weeks of treatment. The secondary endpoints are (1) all-cause and cardiovascular-related mortality, (2) development of ESRD (serum creatinine>530.4 μmol/L or estimated glomerular filtration rate eGFR<15 mL/min/1.73 m2), (3) the need for renal replacement therapy, and (4) increased serum creatinine (2-fold higher than the baseline value or ≥442 μmol/L, with confirmation of the initial results after 4 weeks). A health economics analysis will be carried out. Discussion. A meta-analysis of RCTs carried out in patients with stage 4 (Mogensen classification) diabetic CKD showed that TwHF combined with an ARB was more effective than an ARB alone when considering 24 h proteinuria and serum albumin, but with an increase in adverse event (AE) frequency of 8%. This is a prospective clinical trial that may provide information on a safe and effective novel method for the treatment of DN, especially for patients with macroproteinuria. Ethics and Dissemination. The protocol is approved by the ethics committee of Beijing Hospital (2016BJYYEC-059-02). The results will be disseminated through peer-reviewed publications and international conferences. This trial is registered with ChiCTR-IOR-17010623.

scholarly journals Efficacy and Safety of Tripterygium Wilfordii Hook F on Psoriasis Vulgaris: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Meng Lv ◽  
Jingwen Deng ◽  
Nan Tang ◽  
Yuejin Zeng ◽  
Chuanjian Lu
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Combination Treatment ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Tripterygium Wilfordii ◽  
Tripterygium Wilfordii Hook F ◽  
Randomized Controlled ◽  
Tripterygium Wilfordii Hook

Background. Psoriasis is a chronic autoimmune-mediated skin disease that is characterized by persistent localized erythematous scaly plaque. Tripterygium wilfordii Hook F (TwHF), a well-known Chinese medicine that has been used for centuries in China to treat immune diseases, inflammation, and tumor, is accompanied by a degree of toxic effects. Its clinical efficacy and safety on psoriasis are incompletely understood. Aim. To summarize evidence concerning the efficacy and safety of TwHF in treating psoriasis. Methods. EMBASE, Ovid MEDLINE, PubMed, Web of Science, Springer, Cochrane Library, CNKI, CBM, Wanfang, and VIP database were searched up to October 2017. The included literature was assessed and extracted by two independent reviewers. To enhance the available evidence, a systematic review was performed to examine all relevant published literature relating to randomized controlled trials (RCTs) of TwHF. Relative ratios (RRs) and 95% confidence intervals (CIs) were calculated, and a meta-analysis was conducted with RevMan 5.3 software. Results. Twenty eligible RCTs with 1872 participants were included for systematic review and meta-analysis. Studies were assessed using the Cochrane risk of bias tool. The meta-analysis of add-on effect of TwHF conferred benefit for psoriasis: combination treatment with compound glycyrrhizin (four studies, OR = 0.34, 95% CI 0.22–0.52, P<0.00001, I2=0%), combination treatment with acitretin (three studies, OR = 0.25, 95% CI 0.10–0.63, P=0.003, I2=50%), and combination treatment with compound amino-polypeptide tablet (three studies, OR = 0.37, 95% CI 0.22–0.63, P=0.0002, I2=0%). Conclusions. Despite several mild side effects of TwHF, there is evidence that TwHF is an effective therapy for psoriasis. However, the conclusions are limited by the small number of included trials. More well-designed RCTs with extensive follow-up periods are warranted to clarify the effects and safety of TwHF in treating psoriasis. Trial Registration. This review was registered in the International Prospective Register of Systematic Reviews (CRD42016041363).

scholarly journals A Randomized Controlled Trial of the Effects of Febuxostat Therapy on Adipokines and Markers of Kidney Fibrosis in Asymptomatic Hyperuricemic Patients With Diabetic Nephropathy

2016 ◽  
Vol 3 ◽  
pp. 205435811667534 ◽  
Author(s):  
Srinivasan Beddhu ◽  
Rebecca Filipowicz ◽  
Bin Wang ◽  
Guo Wei ◽  
Xiaorui Chen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Uric Acid ◽  
Diabetic Nephropathy ◽  
Transforming Growth Factor ◽  
Controlled Trial ◽  
Kidney Fibrosis ◽  
Randomized Controlled ◽  
Plasma Uric Acid ◽  
Secondary Endpoints

Background: In observational studies, higher uric acid levels are associated with metabolic syndrome, diabetes, and kidney disease. Objective: The objective of this study is to examine whether reduction of plasma uric acid with febuxostat, a xanthine oxido reductase inhibitor, impacts adipose tissue oxidative stress, adipokines, and markers of systemic inflammation or kidney fibrosis. Design: This was a double-blinded randomized controlled trial. Setting: Academic university setting was used. Patients: Overweight or obese adults with hyperuricemia and type 2 diabetic nephropathy were included. Measurements: Adipose tissue thiobarbituric acid reducing substances (TBARS) and adiponectin concentrations and urinary transforming growth factor–β (TGF-β) were primary endpoints. Plasma C-reactive protein, high molecular weight–adiponectin, interleukin–6, tumor necrosis factor–α, and TBARS and albuminuria were among predefined secondary endpoints. Methods: Participants were randomly assigned to febuxostat (n = 40) or matching placebo (n = 40) and followed for 24 weeks. Results: Baseline plasma uric acid levels were 426 ± 83 µmol/L; 95% completed the study. Estimated glomerular filtration rate (eGFR) declined from 54 ± 17 mL/min/1.73 m2 at baseline to 51 ± 17 mL/min/1.73 m2 at 24 weeks ( P = .05). In separate mixed-effects models, compared with placebo, febuxostat reduced uric acid by 50% ( P < .001) but had no significant effects on subcutaneous adipose tissue TBARS (−7.4%, 95% confidence interval [CI], 57.4%-101.4%) or adiponectin (6.7%, 95% CI, 26.0%-53.8%) levels or urinary TGF-β/creatinine ratio (18.0%, 95% CI, 10.0%-54.8%) or secondary endpoints. Limitations: Relatively modest sample size and short duration of follow-up. Conclusions: In this population with progressive diabetic nephropathy, febuxostat effectively reduced plasma uric acid. However, no detectable effects were observed for the prespecified primary or secondary endpoints. Trial Registration: The study was registered in clinicaltrials.gov (NCT01350388).

Acupuncture Therapy in Reducing Pain in Patients with Low Back Pain: Meta Analysis

2020 ◽  
Author(s):  
Elisa Novitasari ◽  
◽  
RB. Soemanto ◽  
Hanung Prasetya ◽  
◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Acupuncture Therapy ◽  
Chronic Low Back Pain ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Low Back ◽  
Randomized Controlled ◽  
Keywords Low Back Pain

ABSTRACT Background: With growing evidence of high prevalence in developing countries, LBP is no longer recognized as a disorder confined to high-income nations but is a major health problem globally. The functional limitations and consequent disability create a heavy economic burden on individuals and society. This study aimed to acupuncture therapy in reducing pain in patients with low back pain. Subjects and Method: A meta-analysis and systematic review was conducted by search published articles from PubMed, Google Schoolar, Mendeley, Hindawi, and Clinical key databases. Keywords used “acupuncture low back pain” OR “acupuncture chronic pain” AND “efficacy acupuncture” AND “chronic low back pain” AND “effect acupuncture for low back pain” AND “randomized controlled trial” AND “visual analogue scale”. The inclusion criteria were full text and using randomized controlled trial (RCT) study design. The articles were selected by PRISMA flow chart and the quantitative data were analyzed by Revman 5.3. Results: 7 studies were met criteria. This study showed that acupuncture therapy reduced pain in patients with low back pain (Mean Difference= -0.40; 95% CI= -0.80 to 0.01; p= 0.05) with heterogeneity I2= 83%. Conclusion: Acupuncture therapy reduces pain in patients with low back pain. Keywords: low back pain, acupuncture chronic low back pain, randomized controlled trial. Correspondence: Elisa Novitasari. Masters Program in Public Health, Universitas Sebelas Maret. Jl. Ir. Sutami 36A, Surakarta 57126, Central Java. Email: [email protected]. Mobile: 085727851938. DOI: https://doi.org/10.26911/the7thicph.05.43

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