Evidence map›Paper›PMID 32398112›Full record

ArticleTrials2020

Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials.

Yi-Ming Chen, Jie-Min Deng, Yi Wen, Bin Chen, Jiang-Tao Hou, Bin Peng, Shi-Jing Zhang, Hong Mi, Qi-Long Jiang, Xia-Lin Wu and 2 more

Open access · goldAbstract readComparative StudyClinical 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 19% 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, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Plants (Basel, Switzerland) · 2021
    Review
  6. Methodological Considerations in N-of-1 Trials of Traditional Chinese Medicine.Evidence-based complementary and alternative medicine : eCAM · 2021
    Review
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

12 authors at 2 institutions in 1 country.

Yi-Ming ChenSchool of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.
Jie-Min DengSchool of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.
Yi WenThe First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Bin ChenThe First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Jiang-Tao HouThe First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Bin PengThe First Clinical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
Shi-Jing ZhangSchool of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China.
Hong MiThe First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Qi-Long JiangThe First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Xia-Lin WuThe First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
Feng-Bin LiuThe First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China. liufb163@163.com.
Xin-Lin ChenSchool of Basic Medical Science, Guangzhou University of Chinese Medicine, Guangzhou, China. chenxlsums@126.com.
First Affiliated Hospital of Guangzhou University of Chinese Medicine · CNGuangzhou University of Chinese Medicine · CN

Funding

National Natural Science Foundation of China 81774451Natural Science Foundation of Guangdong Province 2017A030313827Outstanding Youth Foundation of Guangdong Province Colleges and Universities YQ2015041
6 · The paper itself

Abstract

backgroundModified Sijunzi decoction (SJZD) has been used to treat ulcerative colitis (UC) in remission. However, more rigorous clinical trials are necessary to evaluate its effectiveness. Therefore, a series of single-case randomised controlled trials (N-of-1 trials) is proposed to compare the efficacy of modified SJZD with mesalazine for treating UC in remission.

methodsThis is a single-site, hospital-based, double-blind N-of-1 trial for 10 single subjects. Three cycles of N-of-1 trials are planned. There are two treatment periods in each cycle. Modified SJZD combined with mesalazine placebo or mesalazine combined with modified SJZD placebo will be randomised during each 8-week treatment period. There is no washout period in the study. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria. DISCUSSION: Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses. The findings will be interpreted with caution. We anticipate that the results will show that modified SJZD is effective for patients with UC in remission.

trial registrationChinese Clinical Trial Register, ID: ChiCTR1900024086. Registered on 24 June 2019.

Indexed as

AdultAgedAnti-Inflammatory Agents, Non-SteroidalColitis, UlcerativeDouble-Blind MethodDrugs, Chinese HerbalDrug Therapy, CombinationFemaleHumansMaleMesalamineMiddle AgedQuality of LifeRandomized Controlled Trials as TopicRemission InductionSafetyAnti-Inflammatory Agents, Non-SteroidalDrugs, Chinese HerbalMesalamineSijunzi decoctionMesalazineN-of-1 trialRandomised controlled trialSijunzi decoctionUlcerative colitis

Identifiers

PMID32398112
PMCPMC7218572
OpenAlexW3028014216

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.