Evidence map›Paper›PMID 39039498›Full record

ArticleBMC complementary medicine and therapies2024

Efficacy, safety and mechanism of Simiaoyongan decoction in the treatment of carotid atherosclerotic plaque: a randomized, double-blind, placebo-controlled clinical trial protocol.

QinHua Fan, ZhongJian Tan, WenQuan Su, QingXiao Li, Dian Jin, YaWei Du, LiPing Zhang, ShengXian Wu

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  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

8 authors.

QinHua Fan *Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
ZhongJian Tan *Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
WenQuan SuDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
QingXiao LiDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Dian JinDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
YaWei DuDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
LiPing ZhangDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. lipingzhang10000@163.com.
ShengXian WuDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. wushx@sina.com.

Funding

General projects of the National Natural Science Foundation of China 82174340
6 · The paper itself

Abstract

introductionChronic inflammation is the major pathological feature of Atherosclerosis(As). Inflammation may accelerate plaque to develop, which is a key factor resulting in the thinning of the fibrous cap and the vulnerable rupture of plaque. Presently, clinical treatments are still lacking. It is necessary to find a safe and effective treatment for As inflammation. Simiaoyongan Decoction (SMYA) has potential anti-inflammatory and plaque protection effects. This protocol aims to evaluate the efficacy, safety, and mechanism of SMYA for patients with carotid atherosclerotic plaque. METHODS/

designThe assessment of SMYA clinical trial is designed as a randomized, double-blind, placebo-controlled study. The sample size is 86 cases in total, with 43 participants in the intervention group and the control group respectively. The intervention group takes SMYA, while the control group takes SMYA placebo. The medication lasts for 14 days every 10 weeks, with a total of 50 weeks. We will use carotid artery high resolution magnetic resonance imaging (HR-MRI) to measure plaque. The plaque minimum fiber cap thickness (PMFCT) is adopted as the primary outcome. The secondary outcomes include plaque fiber cap volume, volume percentage of fiber cap, lipid-rich necrotic core (LRNC) volume, volume percentage of LRNC, internal bleeding volume of plaque, internal bleeding volume percentage of plaque, plaque calcification volume, volume percentage of plaque calcification, lumen stenosis rate, average and a maximum of vessel wall thickness, vessel wall volume, total vessel wall load, carotid atherosclerosis score, hs-CRP, IL-1β and IL-6, the level of lipid profiles and blood glucose, blood pressure, and body weight. DISCUSSION: We anticipate that patients with As plaque will be improved from SMYA by inhibiting inflammation to enhance plaque stability. This study analyzes plaque by using HR-MRI to evaluate the clinical efficacy and safety of SMYA. Moreover, we conduct transcriptome analysis, proteomic analysis, and metagenomic analysis of blood and stool of participants to study the mechanism of SMYA against As plaque. This is the first prospective TCM trial to observe and treat As plaque by inhibiting inflammatory reaction directly. If successful, the finding will be valuable in the treatment of As plaque and drug development, especially in the "statin era". TRIAL REGISTRATION NUMBER: This trial is registered on Chinese Clinical Trials.gov with number ChiCTR2000039062 on October 15, 2020 ( http://www.chictr.org.cn ).

Indexed as

Drugs, Chinese HerbalPlaque, AtheroscleroticAdultAgedCarotid Artery DiseasesDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicDrugs, Chinese HerbalAtherosclerosis (As)High resolution magnetic resonance imaging (HR-MRI)Randomized controlled trialSimiaoyongan Decoction (SMYA)Traditional Chinese medicine (TCM)

Identifiers

PMID39039498
PMCPMC11265120

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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.