Evidence map›Paper›PMID 32522273›Full record

ArticleTrials2020

Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial.

Jingjuan Xu, Ruirui Wang, Shengfu You, Lei Zhang, Peiyong Zheng, Guang Ji, Baocheng Liu

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.0field-weighted citation impact, top 12% 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

17 citing papers in PubMed, 26 citations in OpenAlex.

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  15. Clinical Experience of Acupuncture Treatment for Non-Alcoholic Fatty Liver Disease.Evidence-based complementary and alternative medicine : eCAM · 2022
    Review
  16. Article
  17. Article
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 2 institutions in 1 country.

Jingjuan Xu *Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China.
Ruirui Wang *Shanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China.
Shengfu YouInstitute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South Wanping Road, Shanghai, 200032, China.
Lei ZhangShanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China.
Peiyong ZhengInstitute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, No. 725 South Wanping Road, Shanghai, 200032, China.
Guang JiShanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China. jiliver@vip.sina.com.
Baocheng LiuShanghai Innovation Center of TCM Health Service, Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Shanghai, 201203, China. baochliu@shutcm.edu.cn.
Shanghai University of Traditional Chinese Medicine · CNLonghua Hospital Shanghai University of Traditional Chinese Medicine · CN

Funding

China Postdoctoral Science Foundation 2018M630465National Natural Science Foundation of China 81573814National Natural Science Foundation of China 81603411National Natural Science Foundation of China 81620108030the shanghai hospital development center (Clinical Research Plan of SHDC) 16CR4024Athree-year action plan for Shanghai ZY(2018-2020)-CCCX-2001-01
6 · The paper itself

Abstract

backgroundNon-alcoholic fatty liver disease (NAFLD) is a common chronic liver disease characterized by excessive fat accumulation in the liver. One of the underlying pathophysiological mechanisms is insulin resistance (IR). Traditional Chinese medicine (TCM) has showed potential benefits in the management of NAFLD. Lingguizhugan decoction (LGZG) is a representative Chinese herbal formula; however, there is still no rigorous clinical trial supporting its application. METHODS/

designThis study will be a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 patients with NAFLD will be recruited and randomly assigned to the standard dose LGZG (SLGD) group, low dose LGZG (LLGD) group, or the placebo group based on a ratio of 1:1:1. The treatment period will be 12 weeks and the follow-up period will last 4 weeks. The primary outcome will be the proportions of participants with at least a 1-unit decrease of HOMA-IR from baseline to 12 weeks. Secondary outcomes will include the changes of body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, inflammatory responses, liver-kidney echo ratio by ultrasound, and various scales. Biological samples will also be collected for future researches on mechanism exploration. DISCUSSION: This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern and promote its application in community healthcare centers. In addition, potential mechanisms will be explored based on studies of oral and gut microbiota.

trial registrationChinese Clinical Trial Registry, ChiCTR1800014364. Registered on 1 January 2018. The final protocol version was V3.0.

Indexed as

Double-Blind MethodDrugs, Chinese HerbalHumansLiver Function TestsMedicine, Chinese TraditionalMulticenter Studies as TopicNon-alcoholic Fatty Liver DiseaseRandomized Controlled Trials as TopicSpleenTreatment OutcomeYang DeficiencyDrugs, Chinese HerbalLingguizhugan decoctionNon-alcoholic fatty liver diseaseRandomized controlled trialTraditional Chinese medicine

Identifiers

PMID32522273
PMCPMC7288405
OpenAlexW3032955024

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.