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Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial

BACKGROUND: Diabetic 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 wilfordi...

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Autores principales: Ge, Yongchun, Xie, Honglang, Li, Shijun, Jin, Bo, Hou, Jinhua, Zhang, Haitao, Shi, Mingjun, Liu, Zhihong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3670993/
https://www.ncbi.nlm.nih.gov/pubmed/23725518
http://dx.doi.org/10.1186/1479-5876-11-134
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author Ge, Yongchun
Xie, Honglang
Li, Shijun
Jin, Bo
Hou, Jinhua
Zhang, Haitao
Shi, Mingjun
Liu, Zhihong
author_facet Ge, Yongchun
Xie, Honglang
Li, Shijun
Jin, Bo
Hou, Jinhua
Zhang, Haitao
Shi, Mingjun
Liu, Zhihong
author_sort Ge, Yongchun
collection PubMed
description BACKGROUND: Diabetic 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. METHODS: A 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. RESULTS: At 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). CONCLUSIONS: TwHF 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 REGISTRATION: ClinicalTrials.gov: NCT00518362
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spelling pubmed-36709932013-06-05 Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial Ge, Yongchun Xie, Honglang Li, Shijun Jin, Bo Hou, Jinhua Zhang, Haitao Shi, Mingjun Liu, Zhihong J Transl Med Research BACKGROUND: Diabetic 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. METHODS: A 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. RESULTS: At 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). CONCLUSIONS: TwHF 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 REGISTRATION: ClinicalTrials.gov: NCT00518362 BioMed Central 2013-05-31 /pmc/articles/PMC3670993/ /pubmed/23725518 http://dx.doi.org/10.1186/1479-5876-11-134 Text en Copyright © 2013 Ge et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research
Ge, Yongchun
Xie, Honglang
Li, Shijun
Jin, Bo
Hou, Jinhua
Zhang, Haitao
Shi, Mingjun
Liu, Zhihong
Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial
title Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial
title_full Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial
title_fullStr Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial
title_full_unstemmed Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial
title_short Treatment of diabetic nephropathy with Tripterygium wilfordii Hook F extract: a prospective, randomized, controlled clinical trial
title_sort treatment of diabetic nephropathy with tripterygium wilfordii hook f extract: a prospective, randomized, controlled clinical trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3670993/
https://www.ncbi.nlm.nih.gov/pubmed/23725518
http://dx.doi.org/10.1186/1479-5876-11-134
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