Evidence map›Paper›PMID 29915910›Full record

ArticleChinese journal of integrative medicine2018

Stationary Treatment Compared with Individualized Chinese Medicine for Type 2 Diabetes Patients with Microvascular Complications: Study Protocol for a Randomized Controlled Trial.

Jian Huo, Li-Sha Liu, Wen-Yuan Jian, Jie-Ping Zeng, Jun-Guo Duan, Xue-Jing Lu, Shuo Yin

Abstract readClinical Trial ProtocolComparative Study
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In one paragraph

Article in Chinese journal of integrative medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

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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

7 authors.

Jian HuoCollege of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
Li-Sha LiuGood Clinical Practice Center, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
Wen-Yuan JianCollege of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
Jie-Ping ZengGood Clinical Practice Center, the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
Jun-Guo DuanCollege of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. duanjgs@126.com.
Xue-Jing LuCollege of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
Shuo YinCollege of Ophthalmology, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMicrovascular complications in type 2 diabetes (T2DM), including diabatic retinopathy (DR), diabetic kidney disease (DKD), diabetic peripheral neuropathy (DPN) are the leading causes of visual loss, end-stage renal disease or amputation, while the current therapies are still unsatisfactory. Chinese medicine (CM) has been widely used for treating diabetic mellitus. However, most of the previous studies focused on the single complication. The role of CM treatment in T2DM patients with 2 or multiple microvascular complications is not clear.

objectiveTo appraise the curative effect of CM in T2DM patients with 2 or multiple microvascular complications, and to compare the effects of stationary treatment and individualized treatment in T2DM patients with microvascular complications.

methodsThis trial will be an 8-center, randomized, controlled study with 8 parallel groups. A total of 432 patients will be randomized to 8 groups: DR study group (32 cases) and a corresponding control group (32 cases), DR+DKD study group (64 cases) and a corresponding control group (64 cases), DR+DPN study group (64 cases) and a corresponding control group (64 cases), DR+DKD+DPN study group (56 cases) and a corresponding control group (56 cases). The control group will receive stationary treatment, and the study group will receive individualized treatment based on CM syndrome differentiation in addition to stationary treatment. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The outcomes will assess efficacy of treatment, improvement in CM symptoms, safety assessments, adherence to the treatment, and adverse events.

conclusionThis study will provide evidence of evidence-based medicine for CM treatment in two or multiple microvascular complications caused by T2DM. (Registration No. ChiCTR-IPR-15007072).

Indexed as

Medicine, Chinese TraditionalDiabetes Mellitus, Type 2Diabetic AngiopathiesDrugs, Chinese HerbalHumansMulticenter Studies as TopicOutcome Assessment, Health CareRandomized Controlled Trials as TopicDrugs, Chinese HerbalChinese medicinediabetic microvascular complicationsQiming Granulerandomized controlled trial

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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.