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Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial

Purpose: We investigated the effects of Traditional Chinese Medicine (TCM) on the occurrence and progression of albuminuria in patients with type 2 diabetes. Methods: In this randomized, double-blind, multicenter, controlled trial, we enrolled 600 type 2 diabetes without diabetic nephropathy (DN) or...

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Autores principales: Shi, Ruifeng, Wang, Yanping, An, Xiaofei, Ma, Jianhua, Wu, Tongzhi, Yu, Xiaojin, Liu, Su, Huang, Liji, Wang, Lijuan, Liu, Jingshun, Ge, Jing, Qiu, Shanhu, Yin, Han, Wang, Xiaolai, Wang, Yao, Yang, Bingquan, Yu, Jiangyi, Sun, Zilin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402447/
https://www.ncbi.nlm.nih.gov/pubmed/30873118
http://dx.doi.org/10.3389/fendo.2019.00100
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author Shi, Ruifeng
Wang, Yanping
An, Xiaofei
Ma, Jianhua
Wu, Tongzhi
Yu, Xiaojin
Liu, Su
Huang, Liji
Wang, Lijuan
Liu, Jingshun
Ge, Jing
Qiu, Shanhu
Yin, Han
Wang, Xiaolai
Wang, Yao
Yang, Bingquan
Yu, Jiangyi
Sun, Zilin
author_facet Shi, Ruifeng
Wang, Yanping
An, Xiaofei
Ma, Jianhua
Wu, Tongzhi
Yu, Xiaojin
Liu, Su
Huang, Liji
Wang, Lijuan
Liu, Jingshun
Ge, Jing
Qiu, Shanhu
Yin, Han
Wang, Xiaolai
Wang, Yao
Yang, Bingquan
Yu, Jiangyi
Sun, Zilin
author_sort Shi, Ruifeng
collection PubMed
description Purpose: We investigated the effects of Traditional Chinese Medicine (TCM) on the occurrence and progression of albuminuria in patients with type 2 diabetes. Methods: In this randomized, double-blind, multicenter, controlled trial, we enrolled 600 type 2 diabetes without diabetic nephropathy (DN) or with early-stage DN. Patients were randomly assigned (1:1) to receive Liuwei Dihuang Pills (LWDH) (1.5 g daily) and Ginkgo biloba Tablets (24 mg daily) orally or matching placebos for 24 months. The primary endpoint was the change in urinary albumin/creatinine ratio (UACR) from baseline to 24 months. Results: There were 431 patients having UACR data at baseline and 24 months following-up in both groups. Changes of UACR from baseline to follow-up were not affected in both groups: −1.61(−10.24, 7.17) mg/g in the TCM group and −0.73(−7.47, 6.75) mg/g in the control group. For patients with UACR ≥30 mg/g at baseline, LWDH and Ginkgo biloba significantly reduced the UACR value at 24 months [46.21(34.96, 58.96) vs. 20.78(9.62, 38.85), P < 0.05]. Moreover, the change of UACR from baseline to follow-up in the TCM group was significant higher than that in the control group [−25.50(−42.30, −9.56] vs. −20.61(−36.79, 4.31), P < 0.05]. Conclusion: LWDH and Ginkgo biloba may attenuate deterioration of albuminuria in type 2 diabetes patients. These results suggest that TCM is a promising option of renoprotective agents for early stage of DN. Trial registration: The study was registered in the Chinese Clinical Trial Registry. (no. ChiCTR-TRC-07000037, chictr.org)
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spelling pubmed-64024472019-03-14 Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial Shi, Ruifeng Wang, Yanping An, Xiaofei Ma, Jianhua Wu, Tongzhi Yu, Xiaojin Liu, Su Huang, Liji Wang, Lijuan Liu, Jingshun Ge, Jing Qiu, Shanhu Yin, Han Wang, Xiaolai Wang, Yao Yang, Bingquan Yu, Jiangyi Sun, Zilin Front Endocrinol (Lausanne) Endocrinology Purpose: We investigated the effects of Traditional Chinese Medicine (TCM) on the occurrence and progression of albuminuria in patients with type 2 diabetes. Methods: In this randomized, double-blind, multicenter, controlled trial, we enrolled 600 type 2 diabetes without diabetic nephropathy (DN) or with early-stage DN. Patients were randomly assigned (1:1) to receive Liuwei Dihuang Pills (LWDH) (1.5 g daily) and Ginkgo biloba Tablets (24 mg daily) orally or matching placebos for 24 months. The primary endpoint was the change in urinary albumin/creatinine ratio (UACR) from baseline to 24 months. Results: There were 431 patients having UACR data at baseline and 24 months following-up in both groups. Changes of UACR from baseline to follow-up were not affected in both groups: −1.61(−10.24, 7.17) mg/g in the TCM group and −0.73(−7.47, 6.75) mg/g in the control group. For patients with UACR ≥30 mg/g at baseline, LWDH and Ginkgo biloba significantly reduced the UACR value at 24 months [46.21(34.96, 58.96) vs. 20.78(9.62, 38.85), P < 0.05]. Moreover, the change of UACR from baseline to follow-up in the TCM group was significant higher than that in the control group [−25.50(−42.30, −9.56] vs. −20.61(−36.79, 4.31), P < 0.05]. Conclusion: LWDH and Ginkgo biloba may attenuate deterioration of albuminuria in type 2 diabetes patients. These results suggest that TCM is a promising option of renoprotective agents for early stage of DN. Trial registration: The study was registered in the Chinese Clinical Trial Registry. (no. ChiCTR-TRC-07000037, chictr.org) Frontiers Media S.A. 2019-02-22 /pmc/articles/PMC6402447/ /pubmed/30873118 http://dx.doi.org/10.3389/fendo.2019.00100 Text en Copyright © 2019 Shi, Wang, An, Ma, Wu, Yu, Liu, Huang, Wang, Liu, Ge, Qiu, Yin, Wang, Wang, Yang, Yu and Sun. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Endocrinology
Shi, Ruifeng
Wang, Yanping
An, Xiaofei
Ma, Jianhua
Wu, Tongzhi
Yu, Xiaojin
Liu, Su
Huang, Liji
Wang, Lijuan
Liu, Jingshun
Ge, Jing
Qiu, Shanhu
Yin, Han
Wang, Xiaolai
Wang, Yao
Yang, Bingquan
Yu, Jiangyi
Sun, Zilin
Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial
title Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial
title_full Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial
title_fullStr Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial
title_full_unstemmed Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial
title_short Efficacy of Co-administration of Liuwei Dihuang Pills and Ginkgo Biloba Tablets on Albuminuria in Type 2 Diabetes: A 24-Month, Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical Trial
title_sort efficacy of co-administration of liuwei dihuang pills and ginkgo biloba tablets on albuminuria in type 2 diabetes: a 24-month, multicenter, double-blind, placebo-controlled, randomized clinical trial
topic Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6402447/
https://www.ncbi.nlm.nih.gov/pubmed/30873118
http://dx.doi.org/10.3389/fendo.2019.00100
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