Evidence map›Paper›PMID 26149448›Full record

Trial reportTrials2015

Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.

Sherman X Gu, Anthony L Zhang, Meaghan E Coyle, Xiumei Mo, George B Lenon, Noel E Cranswick, DaCan Chen, Charlie C Xue

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. 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 at 3 institutions in 2 countries.

Sherman X GuTraditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. sherman.gu@rmit.edu.au.
Anthony L ZhangTraditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. tony.zhang@rmit.edu.au.
Meaghan E CoyleTraditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. meaghan.coyle@rmit.edu.au.
Xiumei MoDepartment of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, Guangdong, China. moxiumeilsamay@163.com.
George B LenonTraditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. george.lenon@rmit.edu.au.
Noel E CranswickRoyal Children's Hospital, Murdoch Children's Research Institute, University of Melbourne, 50 Flemington Road, Parkville, 3052, VIC, Australia. noel.cranswick@rch.org.au.
DaCan ChenDepartment of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, 111 Dade Road, Guangzhou, 510120, Guangdong, China. 4910702@163.com.
Charlie C XueTraditional and Complementary Medicine Research Program, Health Innovations Research Institute and School of Health Sciences, Royal Melbourne Institute of Technology (RMIT) University, Plenty Road, P.O. Box 71, Bundoora, 3083, VIC, Australia. charlie.xue@rmit.edu.au.
RMIT University · AUChinese Academy of Medical Sciences & Peking Union Medical College · CNRoyal Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema. METHODS/

designWe have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children's Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period. DISCUSSION: Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema.

trial registrationAustralian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.

Indexed as

AdolescentAge FactorsChildClinical ProtocolsDermatitis, AtopicDermatologic AgentsDouble-Blind MethodDrugs, Chinese HerbalFeasibility StudiesFemaleHumansMalePilot ProjectsResearch DesignSeverity of Illness IndexSkinDermatologic AgentsDrugs, Chinese Herbalpei tu qing xin

Identifiers

PMID26149448
PMCPMC4495854
OpenAlexW2106381358

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.