Evidence map›Paper›PMID 33463052›Full record

Trial reportClinical and translational medicine2021

Add-on effect of PSORI-CM01 to topical calcipotriol for moderate psoriasis vulgaris: A multi-center, randomized, double-blind pilot study.

Shefton Parker, Anthony Lin Zhang, Claire Shuiqing Zhang, Greg Goodman, Zehuai Wen, Yuhong Yan, Danni Yao, Huimei Wu, Hao Deng, Chuanjian Lu and 1 more

Abstract readLetterMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational medicine, 2021. 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
–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

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. 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

11 authors.

Shefton ParkerChina-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.
Anthony Lin ZhangChina-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.
Claire Shuiqing ZhangChina-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.ORCID 0000-0003-3866-602X
Greg GoodmanThe Dermatological Institute of Victoria, South Yarra, Victoria, Australia.
Zehuai WenChina-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.
Yuhong YanGuangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Danni YaoGuangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Huimei WuGuangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Hao DengGuangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Chuanjian LuChina-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.
Charlie Changli XueChina-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMild-moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non-steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI-CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double-blinded, placebo-controlled randomized controlled trial (RCT) evaluating the effects of PSORI-CM01 when added to topical calcipotriol cream.

methodsPeople with moderate psoriasis vulgaris were randomized to receive oral PSORI-CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants' satisfaction and willingness to repeat were also assessed.

resultsThe pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow-up. Participants' baseline basic characteristics were comparable. No between-group statistical significance was found on pre-defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI-CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported.

conclusionsThe design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add-on effects of oral CHM PSORI-CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full-scale RCT.

Indexed as

Administration, TopicalAdultCalcitriolDermatologic AgentsDouble-Blind MethodDrugs, Chinese HerbalDrug Therapy, CombinationFemaleHumansMalePilot ProjectsPsoriasisTreatment OutcomecalcipotrieneCalcitriolDermatologic AgentsDrugs, Chinese HerbalPSORI-CM01calcipotriolChinese herbal medicineclinical trialpilotplacebopsoriasis

Identifiers

PMID33463052
PMCPMC7809599

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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.