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1. The ideal treatment timing for diabetic retinopathy: the molecular pathological mechanisms underlying early-stage diabetic retinopathy are a matter of concern

Author

Wen-Jie Sun, Xue-Dong An, Yue-Hong Zhang, Xue-Fei Zhao, Yu-Ting Sun, Cun-Qing Yang, Xiao-Min Kang, Lin-Lin Jiang, Hang-Yu Ji, and Feng-Mei Lian

Subjects
diabetic retinopathy, non-proliferative phase, neurovascular unit, blood-retinal barrier, inflammation, pathological changes, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Diabetic retinopathy (DR) is a prevalent complication of diabetes, significantly impacting patients’ quality of life due to vision loss. No pharmacological therapies are currently approved for DR, excepted the drugs to treat diabetic macular edema such as the anti-VEGF agents or steroids administered by intraocular route. Advancements in research have highlighted the crucial role of early intervention in DR for halting or delaying disease progression. This holds immense significance in enhancing patients’ quality of life and alleviating the societal burden associated with medical care costs. The non-proliferative stage represents the early phase of DR. In comparison to the proliferative stage, pathological changes primarily manifest as microangiomas and hemorrhages, while at the cellular level, there is a loss of pericytes, neuronal cell death, and disruption of components and functionality within the retinal neuronal vascular unit encompassing pericytes and neurons. Both neurodegenerative and microvascular abnormalities manifest in the early stages of DR. Therefore, our focus lies on the non-proliferative stage of DR and we have initially summarized the mechanisms involved in its development, including pathways such as polyols, that revolve around the pathological changes occurring during this early stage. We also integrate cutting-edge mechanisms, including leukocyte adhesion, neutrophil extracellular traps, multiple RNA regulation, microorganisms, cell death (ferroptosis and pyroptosis), and other related mechanisms. The current status of drug therapy for early-stage DR is also discussed to provide insights for the development of pharmaceutical interventions targeting the early treatment of DR.

Published
2023
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2. Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial

Author

De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Qing Ni, Feng-Mei Lian, and Xiao-Lin Tong

Subjects
Diabetic kidney disease, Traditional Chinese medicine, Treatment, Randomized controlled trial, Medicine (General), R5-920
Abstract

Abstract Background Diabetic kidney disease (DKD) is the main cause of end-stage kidney disease and has become a heavy economic and social burden due to its high prevalence and morbidity. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed that the Chinese herbal Tangshen Formula (TSF) may delay the progression of DKD, reducing microalbuminuria and macroalbuminuria and improving renal function. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of TSF in patients with DKD. Methods/design This trial is a 13-center, randomized, double-blind, placebo-controlled study. A total of 632 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus losartan) and a control group (placebo plus losartan). The trial cycle will last 24 weeks. The primary outcome will be the change in the urine microalbumin–creatinine ratio from baseline to week 24. The secondary outcome will be the change in the rate of progression to the clinical proteinuria period after intervention, the rate of urine microalbumin negative conversion, the rate of normal urinary microalbumin, the doubling rate of the baseline creatinine value and the glomerular filtration rate between the two groups. Safety in medication will also be evaluated. Discussion We hypothesize that patients with type 2 diabetes in the early stage of DKD will benefit from TSF. If successful, this study will provide evidence-based recommendations for clinicians. Trial registration ClinicalTrials.gov, NCT03009864. Registered January 2017.

Published
2019
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3. Utilizing network pharmacology to explore the underlying mechanism of Radix Salviae in diabetic retinopathy

Author

Chun-Li Piao, Jin-Li Luo, De Jin, Cheng Tang, Li Wang, Feng-Mei Lian, and Xiao-Lin Tong

Subjects
Radix Salviae, Network pharmacology, Diabetic retinopathy, Other systems of medicine, RZ201-999
Abstract

Abstract Introduction Radix Salviae (Dan-shen in pinyin), a classic Chinese herb, has been extensively used to treat diabetic retinopathy in clinical practice in China for many years. However, the pharmacological mechanisms of Radix Salviae remain vague. The aim of this study was to decrypt the underlying mechanisms of Radix Salviae in the treatment of diabetic retinopathy using a systems pharmacology approach. Methods A network pharmacology-based strategy was proposed to elucidate the underlying multi-component, multi-target, and multi-pathway mode of action of Radix Salviae against diabetic retinopathy. First, we collected putative targets of Radix Salviae based on the Traditional Chinese Medicine System Pharmacology database and a network of the interactions among the putative targets of Radix Salviae and known therapeutic targets of diabetic retinopathy was built. Then, two topological parameters, “degree” and “closeness certainty” were calculated to identify the major targets in the network. Furthermore, the major hubs were imported to the Database for Annotation, Visualization and Integrated Discovery to perform a pathway enrichment analysis. Results A total of 130 nodes, including 18 putative targets of Radix Salviae, were observed to be major hubs in terms of topological importance. The results of pathway enrichment analysis indicated that putative targets of Radix Salviae mostly participated in various pathways associated with angiogenesis, protein metabolism, inflammatory response, apoptosis, and cell proliferation. The putative targets of Radix Salviae (vascular endothelial growth factor, matrix metalloproteinases, plasminogen, insulin-like growth factor-1, and cyclooxygenase-2) were recognized as active factors involved in the main biological functions of treatment, which implied that these were involved in the underlying mechanisms of Radix Salviae on diabetic retinopathy. Conclusions Radix Salviae could alleviate diabetic retinopathy via the molecular mechanisms predicted by network pharmacology. This research demonstrates that the network pharmacology approach can be an effective tool to reveal the mechanisms of traditional Chinese medicine from a holistic perspective.

Published
2019
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4. Therapeutic mechanisms of traditional Chinese medicine to improve metabolic diseases via the gut microbiota

Author

Hai-Yu Zhang, Jia-Xing Tian, Feng-Mei Lian, Min Li, Wen-Ke Liu, Zhong Zhen, Jiang-Quan Liao, and Xiao-Lin Tong

Subjects
Gut microbiota, Metabolic disease, Therapeutic mechanism, Traditional Chinese medicine, Therapeutics. Pharmacology, RM1-950
Abstract

Metabolic diseases such as obesity, type 2 diabetes mellitus, and hyperlipidemia are associated with the dysfunction of gut microbiota. Traditional Chinese medicines (TCMs) have shown considerable effects in the treatment of metabolic disorders by regulating the gut microbiota. However, the underlying mechanisms are unclear. Studies have shown that TCMs significantly affect glucose and lipid metabolism by modulating the gut microbiota, particularly mucin-degrading bacteria, bacteria with anti-inflammatory properties, lipopolysaccharide- and short-chain fatty acid (SCFA)-producing bacteria, and bacteria with bile-salt hydrolase activity. In this review, we explored potential mechanisms by which TCM improved metabolic disorders via regulating gut microbiota composition and functional structure. In particular, we focused on the protection of the intestinal barrier function, modulation of metabolic endotoxemia and inflammatory responses, regulation of the effects of SCFAs, modulation of the gut-brain axis, and regulation of bile acid metabolism and tryptophan metabolism as therapeutic mechanisms of TCMs in metabolic diseases.

Published
2021
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5. Interactions Between Therapeutics for Metabolic Disease, Cardiovascular Risk Factors, and Gut Microbiota

Author

Qi-You Ding, Jia-Xing Tian, Min Li, Feng-Mei Lian, Lin-Hua Zhao, Xiu-Xiu Wei, Lin Han, Yu-Jiao Zheng, Ze-Zheng Gao, Hao-Yu Yang, Xin-Yi Fang, and Xiao-lin Tong

Subjects
metabolic therapy, gut microbiota, cardiovascular diseases, metformin, microbiota-targeted therapies, Microbiology, QR1-502
Abstract

With improved standards of living, the incidence of multiple metabolic disorders has increased year by year, especially major risk factors for cardiovascular disease such as hyperglycemia and hyperlipidemia, continues to increase. Emerging epidemiological data and clinical trials have shown the additional protective effects of some metabolic therapy drugs against cardiovascular diseases. A series of studies have found that these drugs may work by modulating the composition of gut microbiota. In this review, we provide a brief overview of the contribution of the gut microbiota to both metabolic disorders and cardiovascular diseases, as well as the response of gut microbiota to metabolic therapy drugs with cardiovascular benefits. In this manner, we link the recent advances in microbiome studies on metabolic treatment drugs with their cardiovascular protective effects, suggesting that intestinal microorganisms may play a potential role in reducing cardiovascular risk factors. We also discuss the potential of microorganism-targeted therapeutics as treatment strategies for preventing and/or treating cardiovascular disease and highlight the need to establish causal links between therapeutics for metabolic diseases, gut microbiota modulation, and cardiovascular protection.

Published
2020
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6. Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial

Author

De Jin, Wen-jing Huang, Xiang Meng, Fan Yang, Yu-jiao Zheng, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Qing Ni, Feng-mei Lian, and Xiao-lin Tong

Subjects
Diabetic distal symmetric polyneuropathy, Traditional Chinese medicine, Treatment, Clinical trials, Medicine (General), R5-920
Abstract

Abstract Background Diabetic distal symmetric polyneuropathy (DSPN) is one of the most common microvascular complications of diabetes mellitus, and it has become a major public health problem worldwide because of its high and increasing prevalence, morbidity, and disability rate. The current medications for DSPN are not entirely satisfactory. Preliminary studies indicated that the Chinese herbal TangBi Formula may alleviate signs and symptoms and improve the velocity of nerve conduction in patients with DSPN. This study was designed to determine if Chinese herbal medicine used in combination with conventional treatment is more effective than conventional treatment alone. Methods/design We are conducting a multicenter, placebo-controlled, double-blind, randomized, controlled clinical trial as a means of assessing the therapeutic effects of traditional Chinese medicine (TCM) treatment. A total of 188 patients will be randomized in a 1:1 ratio to a treatment group (TangBi Formula plus mecobalamin) and a control group (placebo plus mecobalamin). The test period lasts 6 months, during which all of the patients will be given standard medical care as recommended by established guidelines. The primary outcome will be development of differences in changes in clinical symptoms and signs in patients and changes in Michigan Diabetic Neuropathy Score (MDNS) between the two groups before and after treatment. The secondary outcome will be changes in nerve conduction velocity and in single clinical signs and symptoms. Safety assessments and adverse events will also be evaluated. Discussion We postulate that patients with DSPN will benefit from therapy that includes TCM. If successful, this work will provide an evidence-based complementary therapeutic approach for treatment of DSPN. Trial registration ClinicalTrials.gov, NCT03010241 . Registered on 2 January 2017

Published
2017
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7. World Congress Integrative Medicine & Health 2017: part two

Author

Carolyn Ee, Sharmala Thuraisingam, Marie Pirotta, Simon French, Charlie Xue, Helena Teede, Agnete E. Kristoffersen, Fuschia Sirois, Trine Stub, Jennifer Engler, Stefanie Joos, Corina Güthlin, Jennifer Felenda, Christiane Beckmann, Florian Stintzing, Roni Evans, Gert Bronfort, Daniel Keefe, Anna Taberko, Linda Hanson, Alex Haley, Haiwei Ma, Joseph Jolton, Lana Yarosh, Francis Keefe, Jung Nam, Liwanag Ojala, Mary J. Kreitzer, Careen Fink, Karin Kraft, Andrew Flower, George Lewith, Kim Harman, Beth Stuart, Felicity L. Bishop, Jane Frawley, Lilla Füleki, Eva Kiss, Tamas Vancsik, Tibor Krenacs, Martha Funabashi, Katherine A. Pohlman, Silvano Mior, Haymo Thiel, Michael D. Hill, David J. Cassidy, Michael Westaway, Jerome Yager, Eric Hurwitz, Gregory N. Kawchuk, Maeve O’Beirne, Sunita Vohra, Isabelle Gaboury, Chantal Morin, Katharina Gaertner, Loredana Torchetti, Martin Frei-Erb, Michael Kundi, Michael Frass, Eugenia Gallo, Valentina Maggini, Mattia Comite, Francesco Sofi, Sonia Baccetti, Alfredo Vannacci, Mariella Di Stefano, Maria V. Monechi, Luigi Gori, Elio Rossi, Fabio Firenzuoli, Rocco D. Mediati, Giovanna Ballerini, Paula Gardiner, Anna S. Lestoquoy, Lily Negash, Sarah Stillman, Prachi Shah, Jane Liebschutz, Pamela Adelstein, Christine Farrell-Riley, Ivy Brackup, Brian Penti, Robert Saper, Isabel Giralt Sampedro, Gilda Carvajal, Andreas Gleiss, Marie M. Gross, Dorothea Brendlin, Jonas Röttger, Wiebke Stritter, Georg Seifert, Noelle Grzanna, Rainer Stange, Peter W. Guendling, Wen Gu, Yan Lu, Jie Wang, Chengcheng Zhang, Hua Bai, Yuxi He, Xiaoxu Zhang, Zhengju Zhang, Dali Wang, Fengxian Meng, Alexander Hagel, Heinz Albrecht, Claudia Vollbracht, Wolfgang Dauth, Wolfgang Hagel, Francesco Vitali, Ingo Ganzleben, Hans Schultis, Peter Konturek, Jürgen Stein, Markus Neurath, Martin Raithel, Bianka Krick, Heidemarie Haller, Petra Klose, Gustav Dobos, Sherko Kümmel, Holger Cramer, Felix J. Saha, Anna Kowoll, Barbara Ebner, Bettina Berger, Kyung-Eun Choi, Lisha He, Han Wang, X. He, C. Gu, Y. Zhang, Linhua Zhao, Xiaolin Tong, Xinhui He, Chengjuan Gu, Ying Zhang, Robin S. T. Ho, Vincent C. H. Chung, Xinyin Wu, Charlene H. L. Wong, Justin C. Y. Wu, Samuel Y. S. Wong, Alexander Y. L. Lau, Regina W. S. Sit, Wendy Wong, Michelle Holmes, Felicity Bishop, Lynn Calman, Dave Newell, Jonathan Field, Win L. Htut, Dongwoon Han, Da I. Choi, Soo J. Choi, Ha Y. Kim, Jung H. Hwang, Ching W. Huang, Bo H. Jang, Fang P. Chen, Seong G. Ko, Wenjing Huang, De Jin, Fengmei Lian, Soobin Jang, Kyeong H. Kim, Eun K. Lee, Seung H. Sun, Ho Y. Go, Youme Ko, Sunju Park, Yong C. Shin, Hubert Janik, Natalie Greiffenhagen, Jürgen Bolte, Mariusz Jaworski, Miroslawa Adamus, Aleksandra Dobrzynska, Michael Jeitler, Jessica Jaspers, Christel von Scheidt, Barbara Koch, Andreas Michalsen, Nico Steckhan, Christian Kessler, Wen-jing Huang, Bing Pang, Feng-Mei Lian, Miek Jong, Erik Baars, Anja Glockmann, Harald Hamre, Mosaburo Kainuma, Aya Murakami, Toshio Kubota, Daisuke Kobayashi, Yasuhiro Sumoto, Norihiro Furusyo, Shin-Ichi Ando, Takao Shimazoe, Olaf Kelber, S. Verjee, Eva Gorgus, Dieter Schrenk, Kathi Kemper, Ellie Hill, Nisha Rao, Gregg Gascon, John Mahan, Gunver Kienle, Jörg Dietrich, Claudia Schmoor, Roman Huber, Weon H. Kim, Mansoor Ahmed, Luzhu He, Jung Hye Hwang, Nora Meggyeshazi, Csaba Kovago, Anne K. Klaus, Roland Zerm, Danilo Pranga, Thomas Ostermann, Marcus Reif, Hans Broder von Laue, Benno Brinkhaus, Matthias Kröz, Daniela Rodrigues Recchia, Hans B. von Laue, Christien T. Klein-Laansma, Mats Jong, Cornelia von Hagens, Jean P. Jansen, Herman van Wietmarschen, Miek C. Jong, Seung-Ho Sun, Ho-Yeon Go, Chan-Yong Jeon, Yun-Kyung Song, Seong-Gyu Ko, Anna K. Koch, Sybille Rabsilber, Romy Lauche, Jost Langhorst, Milena Trifunovic-Koenig, Evi Koster, Diana Delnoij, Lena Kroll, Kathrin Weiss, Ai Kubo, Sarah Hendlish, Andrea Altschuler, Nancy Connolly, Andy Avins, Jon Wardle, David Lee, David Sibbritt, Jon Adams, Crystal Park, Gita Mishra, Johann Lechner, Inseon Lee, Younbyoung Chae, Jisu Lee, Seung H. Cho, Yujin Choi, Jee Y. Lee, Han S. Ryu, Sung S. Yoon, Hye K. Oh, Lyun K. Hyun, Jin O. Kim, Seong W. Yoon, Ju-Yeon Lee, Sang-Hoon Shin, Min Jang, Indra Müller, So-Hyun Janson Park, Lance Laird, Suzanne Mitchell, Xiaofei Li, Yunhui Wang, Jianhua Zhen, He Yu, Tiegang Liu, Xiaohong Gu, Hui Liu, Weiguo Ma, Xuezheng Shang, Yu Bai, Wei Liu, Collin Rooney, Amos Smith, Shirlene Lopes, Marcelo Demarzo, Maria do Patrocínio Nunes, Peter Lorenz, Carsten Gründemann, Miriam Heinrich, Manuel Garcia-Käufer, Franziska Grunewald, Silke Messerschmidt, Anja Herrick, Kim Gruber, Matthias Knödler, Carmen Steinborn, Taoying Lu, Lixin Wang, Darong Wu, Christina M Luberto, Daniel L. Hall, Emma Chad-Friedman, Suzanne Lechner, Elyse R. Park, Christina M. Luberto, Elyse Park, Janice Goodman, Sonja Luer, Matthias Heri, Klaus von Ammon, Ida Landini, Andrea Lapucci, Stefania Nobili, Enrico Mini, Clare McDermott, Selwyn Richards, Diane Cox, Sarah Frossell, Geraldine Leydon, Caroline Eyles, Hilly Raphael, Rachael Rogers, Michelle Selby, Charlotte Adler, Jo Allam, Xiangwei Bu, Honghong Zhang, Jianpeng Zhang, Michael Mikolasek, Jonas Berg, Claudia Witt, Jürgen Barth, Ivan Miskulin, Zdenka Lalic, Maja Miskulin, Albina Dumic, Damir Sebo, Aleksandar Vcev, Nasr A. A. Mohammed, Soo Jeung Choi, Hyea Bin Im, Anwesha Mukherjee, Amit Kandhare, Subhash Bodhankar, Prasad Thakurdesai, Niki Munk, Erica Evans, Amanda Froman, Matthew Kline, Matthew J. Bair, Frauke Musial, Terje Alræk, Harald J. Hamre, Lars Björkman, Vinjar M. Fønnebø, Feng-mei Lian, Qing Ni, Xiao-lin Tong, Xin-long Li, Wen-ke Liu, Shuo Feng, Xi-yan Zhao, Yu-jiao Zheng, Xue-min Zhao, Yi-qun Lin, Tian-yu Zhao, Xi-Yan Zhao, Hui Che Phd, Chen Zhang, Feng Liu, Lin-hua Zhao, Ru Ye, Cheng-juan Gu, Wenbo Peng, Diana De Carvalho, Mohamed El-Bayoumi, Bob Haig, Kimbalin Kelly, Darrell J. Wade, Emanuela Portalupi, Giampietro Gobo, Luigi Bellavita, Chiara Guglielmetti, Christa Raak, Myriam Teuber, Friedrich Molsberger, Ulrich von Rath, Ulrike Reichelt, Uta Schwanebeck, Sabine Zeil, Christian Vogelberg, Dolores Rodríguez Veintimilla, Guerrero Tapia Mery, Marisol Maldonado Villavicencio, Sandra Herrera Moran, Christian Sachse, Peter W Gündlin, Monirsadat Sahebkarkhorasani, Hoda Azizi, Dania Schumann, Tobias Sundberg, Matthew J. Leach, Susana Seca, Henry Greten, Sugir Selliah, Anu Shakya, Ha Yun Kim, Hyea B. Im, Anna Sherbakova, Gudrun Ulrich-Merzenich, Heba Abdel-Aziz, Erica Sibinga, Lindsey Webb, Jonathan Ellen, Kari Skrautvol, Dagfinn Nåden, Rhayun Song, Weronika Grabowska, Kamila Osypiuk, Gloria V. Diaz, Paolo Bonato, Moonkyoung Park, Jeffrey Hausdorff, Michael Fox, Lewis R. Sudarsky, Daniel Tarsy, James Novakowski, Eric A. Macklin, Peter M. Wayne, Inok Hwang, Sukhee Ahn, Myung-Ah Lee, Min K. Sohn, Oleg Sorokin, Dagmar Heydeck, Astrid Borchert, Christoph-Daniel Hohmann, Harmut Kühn, Clemens Kirschbaum, Tobias Stalder, Barbara Stöckigt, Michael Teut, Ralf Suhr, Daniela Sulmann, Chris Streeter, Patrica Gerbarg, Marisa Silveri, Richard Brown, John Jensen, Britta Rutert, Angelika Eggert, Alfred Längler, Christine Holmberg, Jin Sun, Xin Deng, Wen-Yuan Li, Bin Wen, Nicola Robinson, Jian-Ping Liu, Hyun K. Sung, Narae Yang, Seon M. Shin, Hee Jung, Young J. Kim, Woo S. Jung, Tae Y. Park, Kiyoshi Suzuki, Toshinori Ito, Seiya Uchida, Seika Kamohara, Naoya Ono, Mitsuyuki Takamura, Ayumu Yokochi, Kazuo Maruyama, Patricio Tapia, Katarzyna Thabaut, Anja Thronicke, Megan Steele, Harald Matthes, Cornelia Herbstreit, Friedemann Schad, Jiaxing Tian, Libo Yang, Tian Tian, Hewei Zhang, Xia Tian, CongCong Wang, Qian Yun Chai, Lijuan Zhang, Ruyu Xia, Na Huang, Yutong Fei, Jianpin Liu, Natalie Trent, Mindy Miraglia, Jeffrey Dusek, Edi Pasalis, Sat B. Khalsa, Milena Trifunovic-König, Anna Koch, Lisa Uebelacker, Geoffrey Tremont, Lee Gillette, Gary Epstein-Lubow, David Strong, Ana Abrantes, Audrey Tyrka, Tanya Tran, Brandon Gaudiano, Ivan Miller, Gerhild Ullmann, Yuhua Li, Sujata Vaidya, Vinod Marathe, Ana C. Vale, Jacquelyne Motta, Fabíola Donadão, Angela C. Valente, Luana C. Carvalho Valente, Ricardo Ghelman, Dusan Vesovic, Dragan Jevdic, Aleksandar Jevdic, Katarina Jevdic, Mihael Djacic, Dragica Letic, Drago Bozic, Marija Markovic, Slobodan Dunjic, Gordana Ruscuklic, Dezire Baksa, Kenan Vrca, Ann Vincent, Dietlind Wahner-Roedler, Mary Whipple, Maria M. Vogelius, Iris Friesecke, Peter W. Gündling, Saswati Mahapatra, Rebecca Hynes, Kimberly Van Rooy, Sherry Looker, Aditya Ghosh, Brent Bauer, Susanne Cutshall, Harald Walach, Ana Borges Flores, Michael Ofner, Andreas Kastner, Gerhard Schwarzl, Hermann Schwameder, Nathalie Alexander, Gerda Strutzenberger, Xianwei Bu, Jianping Zhang, Shang Wang, Jinfeng Shi, Yu Hao, Jun Wu, Zeji Qiu, Yuh-Hai Wang, Chi-Jung Lou, Sam Watts, Peter Wayne, Gloria Vergara-Diaz, Brian Gow, Jose Miranda, Lewis Sudarsky, Eric Macklin, Kathrin Wode, Jenny Bergqvist, Britt-Marie Bernhardsson, Johanna Hök Nordberg, Lena Sharp, Roger Henriksson, Yeonju Woo, Min K. Hyun, Hao Wu, Tian-Fang Wang, Yan Zhao, Yu Wei, Lei Tian, Lei He, Xue Wang, Ruohan Wu, Mei Han, Patrina H. Y. Caldwell, Shigang Liu, Jing Zhang, Jianping Liu, Qianyun Chai, Zhongning Guo, Congcong Wang, Zhijun Liu, Xun Li, I. J. Yang, V. Ruberio Lincha, S. H. Ahn, D. U. Lee, H. M. Shin, Lu Yang, N. Yang, H. Sung, S. M. Shin, H. Y. Go, H. Jung, Y. Kim, T. Y. Park, Angela Yap, Yu H. Kwan, Chuen S. Tan, Syed Ibrahim, Seng B. Ang, Alfred Yayi, Jeong E. Yoo, Ho R. Yoo, Sae B. Jang, Hye L. Lee, Ala’a Youssef, Shahira Ezzat, Amira Abdel Motaal, Hesham El-Askary, Xiaotong Yu, Yashan Cui, Younghee Yun, Jin-Hyang Ahn, Bo-Hyung Jang, Kyu-Seok Kim, Inhwa Choi, Augustina Glinz, Fadime ten Brink, Arnd Büssing, Christoph Gutenbrunner, Bert Helbrecht, Tiesheng Fang, Fengxion Meng, Zhiming Shen, Ruixin Zhang, Fan Wu, Ming Li, Xinyun Xuan, Xueyong Shen, Ke Ren, Brian Berman, Zian Zheng, Yuxiang Wan, Xueyan Ma, Fei Dong, Suzie Zick, Richard Harris, Go E. Bae, Jung N. Kwon, Hye Y. Lee, Jong K. Nam, Sang D. Lee, Dong H. Lee, Ji Y. Han, Young J. Yun, Ji H. Lee, Hye L. Park, Seong H. Park, Chiara Bocci, Giovanni B. Ivaldi, Ilaria Vietti, Ilaria Meaglia, Marta Guffi, Rubina Ruggiero, Marita Gualea, Emanuela Longa, Massimo Bonucci, Sarah Croke, Lourdes Diaz Rodriguez, Juan C. Caracuel-Martínez, Manuel F. Fajardo-Rodríguez, Angélica Ariza-García, Francisca García-De la Fuente, Manuel Arroyo-Morales, Maria S. Estrems, Vicente G. Gómez, Mónica Valero Sabater, Rosaria Ferreri, Simonetta Bernardini, Roberto Pulcri, Franco Cracolici, Massimo Rinaldi, Claudio Porciani, Peter Fisher, John Hughes, Ariadna Mendoza, Hugh MacPherson, Jacqueline Filshie, Antonia Di Francesco, Alberto Bernardini, Monica Messe, Vincenzo Primitivo, Piera A. Iasella, Monica Taminato, Jaqueline Do Carmo Alcantara, Katia R. De Oliveira, Debora C. De Azevedo Rodrigues, Juliana R. Campana Mumme, Olga K. Matsumoto Sunakozawa, Vicente Odone Filho, Joshua Goldenberg, Andrew Day, Masa Sasagawa, Lesley Ward, Kieran Cooley, Thora Gunnarsdottir, Ingibjorg Hjaltadottir, Mahdie Hajimonfarednejad, Nicole Hannan, Rut Hellsing, Susanne Andermo, Maria Arman, Iris von Hörsten, Patricia Vásquez Torrielo, Carmen L. Andrade Vilaró, Francisco Cerda Cabrera, Henny Hui, Eric Ziea, Dora Tsui, Joyce Hsieh, Christine Lam, Edith Chan, Mark P. Jensen, Samuel L. Battalio, Joy Chan, Karlyn A. Edwards, Kevin J. Gertz, Melissa A. Day, Leslie H. Sherlin, Dawn M. Ehde, Bo-Hyoung Jang, Anja Börner, Jihong Lee, Boram Lee, Gyu T. Chang, Alejandra Menassa, Yoshiharu Motoo, Jürgen Müller, Sabine Rabini, Bettina Vinson, Martin Storr, Martin Niemeijer, Joop Hoekman, Wied Ruijssenaaars, Faith C. Njoku, Arne J. Norheim, Filiz Okumus, and Halime Oncu-Celik

Subjects
Other systems of medicine, RZ201-999
Published
2017
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8. Chinese herbal medicine Tangshen Formula Treatment For Type 2 Diabetic Kidney Disease in Early Stage : study protocol for a randomized controlled trial

Author

De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Feng-Mei Lian, Qing Ni, and Xiao-Lin Tong

Abstract

Abstract Background: Diabetic kidney disease (DKD) is the main cause of end stage kidney disease(ESKD) and It has become a heavy economic and social burden due to its high prevalence and morbidity. However, the current therapies for DKD are not entirely perfect. The most effective strategy is that patients with DKD should be diagnosed and treated early. Preliminary studies showed the Chinese herbal Tangshen Formula(TSF) may delay the progression of DKD, reducing micro-and macro-albuminuria, improving renal function. This trial was conducted to assess the effectiveness and safety of TSF used in combination with conventional treatment. Methods/design: We are implementing a randomized, placebo-controlled, multicenter, clinical trial as a means of evaluating the effectiveness and safety of TSF. 623 participants will be randomized in a 1:1 ratio to an experiment group (TSF plus Losartan) and a control group (placebo plus Losartan). The trial cycle lasts 24 weeks. The primary outcome will be changes in ACR from baseline to 24 weeks between the two groups and ACR will be compared at baseline and treatment endpoint in each group. The secondary outcome will be changes in the ratio of progression into the clinical proteinuria period after intervention, Urine micro albumin negative conversion rate, the ratio of normal urinary micro albumin, doubling rate of baseline creatinine value and GFR between the two groups. Safety in medication will also be evaluated. Discussion: We hypothesize that type 2 diabetic patients in early stage of DKD will benefit from TSF. If successful, this study will provide an evidence-based complementary remedies for delaying the progression of DKD. Trial registration: ClinicalTrials.gov (NCT03009864) Keywords: Diabetes Kidney Disease, Traditional Chinese medicine, Treatment, Clinical trials，Randomized controlled trial

Published
2019

9. Effects of TangWang prescription intervention in type 2 non-proliferative diabetic retinopathy：a study protocol for a randomized controlled trial

Author

WenJing Huang, De Jin, Xiang Meng, Fan Yang, Yu-jiao Zheng, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Feng-Mei Lian, Xiao-Lin Tong, and Qing Ni

Abstract

Background: Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory. This study is designed to provide evidence that a traditional Chinese medicine (TCM) formulation delays the development of DR. Methods: This study is a randomized, double-blind, placebo-controlled parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups, and receive a basic treatment. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a P < 0.05 will be considered statistically significant. Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients’ conditions will be monitored and the data collected for analysis. If successful, this study will provide evidence that the TCM formulation delays the development of DR. Trial registration: ClinicalTrials.gov, NCT03025399. Registered on January 19 2017. Keywords: Diabetic retinopathy, TangWang prescription, randomized controlled trial, traditional Chinese medicine

Published
2019

10. Beneficial effects of Fu-Zheng-Qu-Zhuo oral liquid combined with standard integrated therapy in patients with chronic kidney disease (stage 3–4)

Author

Feng-Mei Lian, Lee Wang, Ling-Xin Kong, Nan-nan Zhang, Xiang-rong Rao, Xi-wen Dai, Xiu-juan Wang, Bao-Min Huo, Kun Pei, and Shen Li

Subjects
Male, complementary therapies, medicine.medical_treatment, 030232 urology & nephrology, Administration, Oral, Comorbidity, Kaplan-Meier Estimate, Severity of Illness Index, Gastroenterology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, eGFR-Slope, chronic kidney disease (stage 3–4), Hazard ratio, Clinical Trial/Experimental Study, General Medicine, Middle Aged, Treatment Outcome, Creatinine, 030220 oncology & carcinogenesis, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Disease Progression, Drug Therapy, Combination, Female, Fu-Zheng-Qu-Zhuo oral liquid, Glomerular Filtration Rate, Research Article, medicine.medical_specialty, Renal function, Placebo, randomized placebo-controlled clinical trial, 03 medical and health sciences, Double-Blind Method, Internal medicine, medicine, Humans, Renal Insufficiency, Chronic, Dialysis, Proportional Hazards Models, business.industry, medicine.disease, chemistry, Multivariate Analysis, business, Biomarkers, Drugs, Chinese Herbal, Follow-Up Studies, Phytotherapy, Kidney disease
Abstract

Supplemental Digital Content is available in the text, Background: The high worldwide prevalence of chronic kidney disease (CKD) is a critical health problem and the development of more effective therapies is urgently needed. We conducted a randomized, double-blinded, placebo-controlled clinical trial from October 2010 to December 2012 to assess whether Fu-Zheng-Qu-Zhuo oral liquid (FZQZ) has a beneficial effect in preventing CKD progression when added to standard integrated therapies. Methods: Patients with CKD stage 3 to 4 from 3 hospitals in Beijing, China were enrolled. Patients were randomly assigned to the FZQZ or placebo groups and were treated with standard integrated therapy plus FZQZ or placebo (20 mL each time, 3 times/d) for 12 months. Patients received post-trial follow-up until October 2014. The primary outcome was the estimated glomerular filtration rate (eGFR)-Slope (mL/min per 1.73 m2 per month) during the in-trial time, which was calculated by the eGFR regression curve estimated from each serum creatinine measurement during the in-trial period. Secondary outcomes were changes in 24-h urine protein excretion (24-h UP) and albumin and hemoglobin levels from baseline during the in-trial period. Time to composite endpoint events (initiation of long-term dialysis, doubling of serum creatinine, or CKD-related death during the in-trial and post-trial phases) was assessed as a secondary outcome. Results: A total of 68 patients (43 in the FZQZ group and 25 in the placebo group) completed the in-trial and post-trial phases, with an average follow-up time of 31.6 ± 9.6months. The FZQZ group had amean eGFR-Slope of 0.25 ± 1.44 as compared with −0.72 ± 1.46 (mL/min per 1.73m2 per month) in the placebo group during the in-trial period (P = .003). The FZQZ group showed decreased 24-h UP, with a change from baseline of −0.08 (interquartile range [IQR], −0.33 to 0.01) versus 0.01 (IQR, −0.19 to 0.33) g/24h in the placebo group (P = .049). Decreased risk of composite endpoint events was observed only in the post-trial phase (hazard ratio = 0.42, 95% confidence interval: 0.16–1.11, P = .038). No significant differences in albumin and hemoglobin level changes were observed. Conclusion: Adding FZQZ oral liquid to standard integrated therapies may aid in attenuating CKD progression.

Published
2017

11. Beneficial effects of Fu-Zheng-Qu-Zhuo oral liquid combined with standard integrated therapy in patients with chronic kidney disease (stage 3-4): A randomized placebo-controlled clinical trial.

Author

Shen Li, Xiang-Rong Rao, Xi-Wen Dai, Kun Pei, Lee Wang, Bao-Min Huo, Xiu-Juan Wang, Ling-Xin Kong, Nan-Nan Zhang, Feng-Mei Lian, Li, Shen, Rao, Xiang-Rong, Dai, Xi-Wen, Pei, Kun, Wang, Lee, Huo, Bao-Min, Wang, Xiu-Juan, Kong, Ling-Xin, Zhang, Nan-Nan, and Lian, Feng-Mei

Published
2017
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12. The rs1142345 in TPMT Affects the Therapeutic Effect of Traditional Hypoglycemic Herbs in Prediabetes.

Author

Xi Li, Feng-Mei Lian, Dong Guo, Lan Fan, Jie Tang, Jing-Bo Peng, Hong-Wen Deng, Zhao-Qian Liu, Xin-Hua Xiao, Yan-Rong Wang, Ke-Yi Qu, Sheng Deng, Qi Zhong, Yi-Ling Sha, Yan Zhu, Yu-Jing Bai, Xin-Yan Chen, Qiang Zhou, Hong-Hao Zhou, and Xiao-Lin Tong

Subjects
*BLOOD sugar analysis, *TYPE 2 diabetes prevention, *HYPOGLYCEMIC agents, *PREDIABETIC state, *DNA analysis, *GLUCOSE intolerance, *ALLELES, *ALTERNATIVE medicine, *GENES, *GENETICS, *GLUCOSE tolerance tests, *LONGITUDINAL method, *MEDICAL cooperation, *BOTANIC medicine, *CHINESE medicine, *HEALTH outcome assessment, *REGRESSION analysis, *RESEARCH, *RESEARCH funding, *STATISTICAL sampling, *STATISTICS, *LOGISTIC regression analysis, *DATA analysis, *STATISTICAL significance, *BODY mass index, *RANDOMIZED controlled trials, *TREATMENT effectiveness, *PRE-tests & post-tests, *BLIND experiment, *DATA analysis software, *DESCRIPTIVE statistics, *THERAPEUTICS
Abstract

Therapeutic interventions in prediabetes are important in the primary prevention of type 2 diabetes (T2D) and its chronic complications. However, little is known about the pharmacogenetic effect of traditional herbs on prediabetes treatment. A total of 194 impaired glucose tolerance (IGT) subjects were treated with traditional hypoglycemic herbs (Tianqi Jiangtang) for 12 months in this study. DNA samples were genotyped for 184 mutations in 34 genes involved in drug metabolism or transportation. Multinomial logistic regression analysis indicated that rs1142345 (A > G) in the thiopurine S-methyltransferase (TPMT) gene was significantly associated with the hypoglycemic effect of the drug (P = 0.001, FDR P = 0.043). The "G" allele frequencies of rs1142345 in the healthy (subjects reverted from IGT to normal glucose tolerance), maintenance (subjects still had IGT), and deterioration (subjects progressed from IGT to T2D) groups were 0.094, 0.214, and 0.542, respectively. Binary logistic regression analysis indicated that rs1142345 was also significantly associated with the hypoglycemic effect of the drug between the healthy and maintenance groups (P = 0.027, OR = 4.828) and between the healthy and deterioration groups (P = 0.001, OR = 7.811). Therefore, rs1142345 was associated with the clinical effect of traditional hypoglycemic herbs. Results also suggested that TPMT was probably involved in the pharmacological mechanisms of T2D. [ABSTRACT FROM AUTHOR]

Published
2013
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