Evidence map›Paper›PMID 25938778›Full record

Trial reportPloS one2015

Efficacy and safety of tangshen formula on patients with type 2 diabetic kidney disease: a multicenter double-blinded randomized placebo-controlled trial.

Ping Li, Yiping Chen, Jianping Liu, Jing Hong, Yueyi Deng, Fang Yang, Xiuping Jin, Jing Gao, Jing Li, Hui Fang and 7 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 4 pooled it
4.7field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 4 syntheses or guidelines pooled it, 87 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 8 institutions in 1 country.

Ping LiInstitute of Clinical Medical Science, China-Japan Friendship Hospital, Beijing, China.
Yiping ChenDepartment of Nephrology, Longhua Hospital, Shanghai University of TCM, Shanghai, China.
Jianping LiuCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Jing HongDepartment of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
Yueyi DengDepartment of Nephrology, Longhua Hospital, Shanghai University of TCM, Shanghai, China.
Fang YangResearch Center of Experimental Medicine, Hebei United University, Tangshan, China.
Xiuping JinDepartment of Endocrinology, Hebei United University Affiliated Hospital, Tangshan, China.
Jing GaoDepartment of Nephrology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
Jing LiDepartment of Nephrology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
Hui FangDepartment of Endocrinology, Tangshan Gongren Hospital, Tangshan, China.
Geling LiuDepartment of Endocrinology, Tangshan Gongren Hospital, Tangshan, China.
Liping ShiDepartment of Endocrinology, Kailuan General Hospital, Tangshan, China.
Jinhang DuDepartment of Nephrology, China-Japan Friendship Hospital, Beijing, China.
Yang LiSchool of Statistics, Renmin University of China, Beijing, China.
Meihua YanInstitute of Clinical Medical Science, China-Japan Friendship Hospital, Beijing, China.
Yumin WenInstitute of Clinical Medical Science, China-Japan Friendship Hospital, Beijing, China.
Wenying YangDepartment of Endocrinology, China-Japan Friendship Hospital, Beijing, China.
China-Japan Friendship Hospital · CNDongzhimen Hospital Affiliated to Beijing University of Chinese Medicine · CNNorth China University of Science and Technology · CNShanghai University of Traditional Chinese Medicine · CNTangshan Gongren Hospital · CNBeijing University of Chinese Medicine · CNKailuan General Hospital · CNRenmin University of China · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPersons 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.

methodsThe 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.

findingsAfter 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.

conclusionsBased 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.

trial registrationChinese Clinical Trial Registry ChiCTR-TRC-10000843.

Indexed as

AgedAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsDiabetic NephropathiesDrugs, Chinese HerbalDrug Therapy, CombinationFemaleGlomerular Filtration RateHumansMaleMedicine, Chinese TraditionalMiddle AgedProteinuriaTreatment OutcomeAngiotensin-Converting Enzyme InhibitorsAngiotensin Receptor AntagonistsDrugs, Chinese Herbal

Identifiers

PMID25938778
PMCPMC4418676
OpenAlexW1590230678

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.