Efficacy and safety of tangshen formula on patients with type 2 diabetic kidney disease: a multicenter double-blinded randomized placebo-controlled trial.
BACKGROUND
Persons with diabetes are at high risk of developing diabetic kidney disease (DKD), which is associated with high morbidity and mortality. Current drug therapies for DKD, such as angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), are not entirely satisfactory. This study aimed to evaluate the additional benefit and safety of the Chinese herbal granule Tangshen Formula (TSF) in treating DKD.


METHODS
The study was designed as a six-center randomized, double-blind, placebo-controlled trial. From April 2007 through December 2009, 180 patients with DKD were enrolled. In addition to conventional treatment with ACEIs or ARBs, 122 participants were randomly assigned to receive TSF and 58 participants to receive placebo for 24 weeks. Primary outcome was urinary protein level, measured by urinary albumin excretion rate (UAER) for participants with microalbuminuria, 24-hour urinary protein (24h UP) for participants with macroalbuminuria. Secondary outcomes included renal function, serum lipids, quality of life, symptoms, and adverse events.


RESULTS
After 24 weeks of treatment, no statistically significant difference in UAER (TSF -19.53 μg/min compared with placebo -7.01 μg/min, with a mean difference of -12.52 μg/min; 95%CI, -68.67 to 43.63, P = 0.696) was found between TSF and placebo groups. However, TSF displayed a statistically significant decrease in 24h UP (TSF-0.21 g compared with placebo 0.36 g, with a mean difference of -0.57g; 95%CI, -1.05 to -0.09, P = 0.024). Estimated glomerular filtration rate (eGFR) was improved in both patients with microalbuminuria and macroalbuminuria, with a mean difference of 15.51 ml/min/1.73 m2 (95%CI, 3.71 to 27.31), 9.01 ml/min/1.73 m2 (95%CI, -0.10 to 18.13), respectively. Other secondary outcomes showed no statistically significant difference between groups or in the incidence of adverse events.


CONCLUSIONS
Based on conventional treatments, TSF appears to provide additional benefits compared with placebo in decreasing proteinuria and improving eGFR in DKD patients with macroalbuminuria. Nevertheless, further study is needed to evaluate TSF treating patients with microalbuminuria.


BACKGROUND
Chinese Clinical Trial Registry ChiCTR-TRC-10000843.
Institute of Clinical Medical Science, China-Japan Friendship Hospital, Beijing, China.
Ping
P
Li
Department of Nephrology, Longhua Hospital, Shanghai University of TCM, Shanghai, China.
Yiping
Y
Chen
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Jianping
J
Liu
Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
Jing
J
Hong
Department of Nephrology, Longhua Hospital, Shanghai University of TCM, Shanghai, China.
Yueyi
Y
Deng
Research Center of Experimental Medicine, Hebei United University, Tangshan, China.
Fang
F
Yang
Department of Endocrinology, Hebei United University Affiliated Hospital, Tangshan, China.
Xiuping
X
Jin
Department of Nephrology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
Jing
J
Gao
Department of Nephrology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
Jing
J
Li
Department of Endocrinology, Tangshan Gongren Hospital, Tangshan, China.
Hui
H
Fang
Department of Endocrinology, Tangshan Gongren Hospital, Tangshan, China.
Geling
G
Liu
Department of Endocrinology, Kailuan General Hospital, Tangshan, China.
Liping
L
Shi
Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.
Jinhang
J
Du
School of Statistics, Renmin University of China, Beijing, China.
Yang
Y
Li
Institute of Clinical Medical Science, China-Japan Friendship Hospital, Beijing, China.
Meihua
M
Yan
Institute of Clinical Medical Science, China-Japan Friendship Hospital, Beijing, China.
Yumin
Y
Wen
Department of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
Wenying
W
Yang
D000368:Aged; D057911:Angiotensin Receptor Antagonists / Q000627:therapeutic use; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D003928:Diabetic Nephropathies / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D011507:Proteinuria / Q000188:drug therapy / Q000652:urine; D016896:Treatment Outcome
D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D004365:Drugs, Chinese Herbal