Evidence map›Paper›PMID 28069051›Full record

Trial reportTrials2017

Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial.

Kai Zheng, Hong Shen, Jia Jia, Yuelin Lu, Lei Zhu, Lu Zhang, Zhaofeng Shen

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 10% 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

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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

7 authors at 1 institution in 1 country.

Kai ZhengFirst Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Hong ShenDepartment of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210029, China. jiangsutcm@163.com.
Jia JiaDepartment of Endocrinology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Yuelin LuDepartment of Gastroenterology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, 210029, China.
Lei ZhuDivision of Scientific Research, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Lu ZhangDivision of Scientific Research, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Zhaofeng ShenDivision of Scientific Research, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu, China.
Nanjing University of Chinese Medicine · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApproximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. METHODS/

designThis is a parallel, multicenter, randomized controlled trial. One hundred and twenty eligible patients will be randomly assigned to a traditional Chinese medicine group or azathioprine group. All patients will be given basic treatment, which includes steroids and 5-aminosalicylic acid. Patients allocated to the traditional Chinese medicine group will receive basic treatment plus Chinese herbal medicine granules, while patients in the azathioprine group will receive basic treatment plus azathioprine. The whole study will last 24 weeks. The primary outcome measure is the steroid-free remission rate. Secondary outcome measures are health-related quality of life, efficacy of endoscopic response, degree of mucosal healing, and inflammation indicators. DISCUSSION: Results from this study may provide evidence for the effectiveness of traditional Chinese medicine combined with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis. The findings will provide a basis for further confirmatory studies.

trial registrationChinese Clinical Trial Register, ChiCTR-IPR-15005760 . Registered on 2 January 2015.

Indexed as

Clinical ProtocolsMedicine, Chinese TraditionalAzathioprineColitis, UlcerativeDrugs, Chinese HerbalHumansMesalamineOutcome Assessment, Health CareAzathioprineDrugs, Chinese HerbalMesalamine5-aminosalicylic acidAzathioprineChinese herbal medicineSteroid-dependent ulcerative colitisStudy protocol

Identifiers

PMID28069051
PMCPMC5223474
OpenAlexW2567911426

What OpenQuestion holds

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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.