Evidence map›Paper›PMID 35461237›Full record

ArticleTrials2022

Effects of Jianpi Lishi Jiedu granules on colorectal adenoma patients after endoscopic treatment: study protocol for a randomized, double-blinded, placebo-controlled clinical trial.

Hao Wu, Yuzhen Huang, Lu Yang, Kunhan Su, Shuo Tian, Xin Chen, Siyu Li, Wanli Liu

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Review
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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

8 authors at 1 institution in 1 country.

Hao WuNanjing University of Chinese Medicine, Nanjing, China.
Yuzhen HuangNanjing University of Chinese Medicine, Nanjing, China.
Lu YangNanjing University of Chinese Medicine, Nanjing, China.
Kunhan SuNanjing Integrated Traditional Chinese and Western Medicine Hospital Affiliated with Nanjing University of Chinese Medicine, Nanjing, China.
Shuo TianNanjing University of Chinese Medicine, Nanjing, China.
Xin ChenNanjing University of Chinese Medicine, Nanjing, China.
Siyu LiNanjing University of Chinese Medicine, Nanjing, China.
Wanli LiuNanjing University of Chinese Medicine, Nanjing, China. 18951768998@163.com.ORCID http://orcid.org/0000-0003-1475-2185
Nanjing University of Chinese Medicine · CN

Funding

Jiangsu Province Chinese Medicine Leading Talent Jiangsu traditional Chinese medicine science and education[2018] No.4
6 · The paper itself

Abstract

backgroundColorectal adenomas (CRAs) are precancerous lesions of the large intestine presenting as colorectal polyps. At present, the conventional treatment methods for CRA mainly include high-frequency electrocoagulation and electroexcision, biopsy forceps polypectomy, cauterization by laser and microwave, and other endoscopic interventions. The principal advantages conferred by these treatment strategies include less trauma, quick postoperative recovery, and simplicity to perform. However, the higher recurrence rates and insignificant improvement of postoperative symptoms after endoscopic surgery are considerable drawbacks to this approach. Besides, there is currently no effective pharmacotherapy to prevent the recurrence of CRA. Jianpi Lishi Jiedu (JLJ) granules are a form of traditional Chinese medicine (TCM) used to manage postoperative patients with CRA, which has shown a certain degree of efficacy in clinical practice. However, its effectiveness and safety profile have not been convincingly evaluated. The purpose of this study is to evaluate the clinical efficacy and safety profile of JLJ granules in the management of postoperative patients with CRA and to observe the recurrence rate of adenoma in these patients.

methodsA randomized, double-blind, and placebo-controlled clinical trial is performed in this study. A total of 80 postoperative patients with CRA will be randomly classified into the Jianpi Lishi Jiedu granules group or the placebo control group. Patients in both groups shall receive 3 months of intervention, after which medical follow-up and safety evaluation will be performed for all of the patients. The primary outcome is the recurrence rate of adenomas within 12 months. The secondary outcomes are the cardinal TCM symptom scores, minor TCM symptom scores, Bristol Stool Scale, efficacy of TCM symptoms, safety indicators, and blinding assessment. DISCUSSION: In this study, the impact on the recurrence of adenomas and the efficacy and safety of JLJ granules in terms of improving the clinical symptoms of postoperative patients with CRA will be evaluated.

trial registrationTrial registration Chinese Clinical Trial Registry ChiCTR 2100044297. Registered on March 16, 2021.

Indexed as

AdenomaColorectal NeoplasmsDrugs, Chinese HerbalDouble-Blind MethodHumansMedicine, Chinese TraditionalRandomized Controlled Trials as TopicTreatment OutcomeDrugs, Chinese HerbalClinical efficacyColorectal adenomasJianpi Lishi Jiedu granulesRandomized controlled trialRecurrenceStudy protocol

Identifiers

PMID35461237
PMCPMC9034522
OpenAlexW4224870231

What OpenQuestion holds

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Registered trials

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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.