Evidence map›Paper›PMID 31895776›Full record

ArticleMedicine2020

Individualized Chinese medicine for the treatment of diabetic patients with dry eye disease: A single-case randomized controlled protocol.

Ruibao Liu, Ying Zhao, Yanxia Wu, Minglu Guo, Yu Duan, Jianbin Ye, Xuejing Lu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Methodological Considerations in N-of-1 Trials of Traditional Chinese Medicine.Evidence-based complementary and alternative medicine : eCAM · 2021
    Review
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 at 1 institution in 1 country.

Ruibao LiuChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Ying ZhaoChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Yanxia WuChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Minglu GuoChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Yu DuanChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Jianbin YeChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Xuejing LuChengdu University of Traditional Chinese Medicine, Academy of Ophthalmology.
Chengdu University of Traditional Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe high incidence of Diabetes mellitus (DM) has become a serious challenge for the global epidemic. Increased blood glucose leads to abnormal ocular surface structure and metabolic disorder in patients. DM is a high-risk factor for dry eye disease (DED), with high incidence and increased difficulty in treatment. The disease can cause discomfort, visual impairment, tear film instability and ocular surface damage, and even cause corneal erosion in severe cases, which has a serious impact on people's daily life. Traditional Chinese Medicine (TCM) plays an important role in the evaluation and treatment of DM and its complications. However, whether TCM treatment could improve the treatment efficacy of DM suffering from DED remains poorly understood.

objectiveTo investigate the curative effect of TCM for the alleviation of clinical symptoms in Diabetic patients with DED, and to evaluate its long-term efficacy.

methodsThis trial is a single-case randomized, single-blind, placebo-controlled study. A total of 12 subjects will be recruited in this trial. The trial is divided into three cycles, and one cycle has 2 treatment periods. There is a washout period at each adjacent treatment stage. TCM individualized treatment and placebo will be randomized during the treatment period. The test period will last for 29 weeks, with 4 weeks for each treatment period and 1 week for each washout period to minimize carryover effects. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria. The outcomes will evaluate the efficacy of treatment by changes in the various observation indicators. DISCUSSION: This study will realize a patient-centered outcome approach necessary to provide clinical researchers with the evidence that TCM treatment can effectively improve the objective indicators of the eye and systemic symptoms in Diabetic patients with DED.

trial registrationThis study has been registered at the Chinese Clinical Trial Registry (http://www.chictr.org.cn, No. ChiCTR1900024481), (October, 2019).

Indexed as

Diabetes ComplicationsDry Eye SyndromesFemaleHumansMaleMedicine, Chinese TraditionalPatient-Centered CareRandomized Controlled Trials as TopicSingle-Blind Method

Identifiers

PMID31895776
PMCPMC6946556
OpenAlexW2997224898

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.