Evidence map›Paper›PMID 26098833›Full record

Trial reportPloS one2015

The Efficacy and Safety of Chinese Herbal Medicine Jinlida as Add-On Medication in Type 2 Diabetes Patients Ineffectively Managed by Metformin Monotherapy: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.

Fengmei Lian, Jiaxing Tian, Xinyan Chen, Zhibin Li, Chunli Piao, Junjie Guo, Licheng Ma, Lijuan Zhao, Chengdong Xia, Chong-Zhi Wang and 2 more

Full text 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 40 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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

40 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  12. The efficacy and safety ofDrug design, development and therapy · 2018
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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

12 authors.

Fengmei LianGuang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Jiaxing TianGuang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Xinyan ChenGuang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Zhibin LiShijiazhuang Hospital of Traditional Chinese Medicine, Shijiazhuang, China.
Chunli PiaoThe Affiliated Hospital to Changchun University of Chinese Medicine, Changchun, China.
Junjie GuoShanxi Province Hospital of Traditional Chinese Medicine, Taiyuan, China.
Licheng MaBethune International Peace Hospital, Shijiazhuang, China.
Lijuan ZhaoThe Affiliated Hospital to Shanxi University of Traditional Chinese Medicine, Taiyuan, China.
Chengdong XiaXiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Chong-Zhi WangTang Center for Herbal Medicine Research, University of Chicago, Chicago, IL, United States of America.
Chun-Su YuanTang Center for Herbal Medicine Research, University of Chicago, Chicago, IL, United States of America.
Xiaolin TongGuang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetformin plays an important role in diabetes treatment. Studies have shown that the combined use of oral hypoglycemic medications is more effective than metformin monotherapy. In this double-blind, randomized, placebo-controlled, multicenter trial, we evaluated whether Jinlida, a Chinese herbal medicine, enhances the glycemic control of metformin in type 2 diabetes patients whose HbA1c was ineffectively controlled with metformin alone.

methodsA total of 186 diabetes patients were enrolled in this double-Blind, randomized, placebo-controlled, multicenter trial. Subjects were randomly allocated to receive either Jinlida (9 g) or the placebo TID for 12 consecutive weeks. All subjects in both groups also continuously received their metformin without any dose change. During this 12-week period, the HbA1c, FPG, 2 h PG, body weight, BMI were assessed. HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA-β) were also evaluated.

resultsAt week 12, compared to the HbA1c level from week 0, the level of the Jinlida group was reduced by 0.92 ± 1.09% and that of the placebo group was reduced by 0.53 ± 0.94%. The 95% CI was 0.69-1.14 for the Jinlida group vs. 0.34-0.72 for the placebo group. There was a very significant HbA1c reduction between the two groups after 12 weeks (p < 0.01). Both FG and 2 h PG levels of the Jinlida group and placebo group were reduced from week 0. There were a very significant FG and 2 h PG level reductions between the two groups after 12 weeks (both p < 0.01). The Jinlida group also showed improved β-cell function with a HOMA-β increase (p < 0.05). No statistical significance was observed in the body weight and BMI changes. No serious adverse events were reported.

conclusionJinlida significantly enhanced the hypoglycemic action of metformin when the drug was used alone. This Chinese herbal medicine may have a clinical value as an add-on medication to metformin monotherapy.

trial registrationChinese Clinical Trial Register ChiCTR-TRC-13003159.

Indexed as

Body WeightDiabetes Mellitus, Type 2Double-Blind MethodDrugs, Chinese HerbalDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin ResistanceInsulin-Secreting CellsMaleMetforminMiddle AgedDrugs, Chinese HerbalGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsjinlidaMetformin

Identifiers

PMID26098833
PMCPMC4476735

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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.