Evidence map›Paper›PMID 37076843›Full record

ArticleBMC complementary medicine and therapies2023

Effectiveness and safety analysis of Danggui Shaoyao Powder for the treatment of non-alcoholic fatty liver disease: study protocol for a randomized, double-blind, placebo-controlled clinical trial.

Qian Huang, Ziming An, Xin Xin, Qinmei Sun, Siting Gao, Sheng Lv, Xiao Xu, Shuohui Yang, Fang Lu, Jie Yuan and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.5field-weighted citation impact, top 17% 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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. 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

14 authors at 2 institutions in 1 country.

Qian Huang *Institute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Ziming An *Institute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Xin XinKey Laboratory of Liver and Kidney Diseases, Shanghai University of Traditional Chinese Medicine, Ministry of Education, Shanghai, China.
Qinmei SunInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Siting GaoInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Sheng LvInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Xiao XuInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shuohui YangDepartment of Radiology, Shanghai Municipal Hospital of Traditional Chinese MedicineShanghai University of Traditional Chinese Medicine, Shanghai, China.
Fang LuDepartment of Radiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Jie YuanDepartment of Radiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yu ZhaoInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Yiyang HuInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Ping LiuInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Qin FengInstitute of Liver DiseasesShuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China. fengqin@shutcm.edu.cn.
Shanghai University of Traditional Chinese Medicine · CNShuguang Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe incidence of non-alcoholic fatty liver disease (NAFLD) has been on the rise in recent years, and there are no effective drugs to treat NAFLD; therefore, effective prevention and treatment of NAFLD have become a new challenge. Danggui Shaoyao Powder (DGSY) is a classic prescription commonly used in clinical practice and has been shown to reduce hepatic steatosis in patients with NAFLD. In addition, previous studies have shown that DGSY can alleviate hepatic steatosis and inflammation in NAFLD mice. Although clinical practice and basic studies have shown that DGSY is effective in NAFLD, high levels of clinical evidence are lacking. Therefore, a standardized RCT study protocol is required to evaluate its clinical efficacy and safety. METHODS AND ANALYSIS: This study will be a randomized, double-blind, placebo-controlled, and single-center trial. According to the random number table, NAFLD participants will be randomly divided into the DGSY or placebo group for 24 weeks. The follow-up period will be 6 weeks after drug withdrawal. The primary outcome is the relative change in MRI-proton density fat fraction (MRI-PDFF) from baseline to 24 weeks. Absolute changes in serum alanine aminotransferase (ALT), liver stiffness measurement (LSM), body mass index (BMI), blood lipid, blood glucose, and insulin resistance index will be selected as secondary outcomes to comprehensively evaluate the clinical efficacy of DGSY in the treatment of NAFLD. The safety of DGSY will be evaluated by renal function, routine blood and urine tests, and electrocardiogram. DISCUSSION: This study will provide evidence-based medical corroboration for the clinical application of DGSY and promote the development and application of this classic prescription.

trial registrationhttp://www.chictr.org.cn . TRIAL NUMBER: ChiCTR2000029144. Registered on 15 Jan 2020.

Indexed as

Non-alcoholic Fatty Liver DiseaseBlood GlucoseHumansInflammationPowdersRandomized Controlled Trials as TopicTreatment OutcomeBlood GlucosePowdersDanggui Shaoyao PowderNon-alcoholic fatty liver diseaseRandomized controlled trialTraditional Chinese medicine

Identifiers

PMID37076843
PMCPMC10114303
OpenAlexW4366422414

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.