Reporting Quality of Randomized Controlled Trials for the Treatment of Eczema with Chinese Patent Medicine Based on the CONSORT‐CHM Formulas 2017

Abstract

Objective. Chinese patent medicine (CPM) has been widely used to treat eczema in mainland China for decades. This study aims to investigate circulating CPM for eczema in mainland China and to evaluate the reporting quality of randomized controlled trials (RCTs) of them by using the CONSORT-CHM formulas 2017 (Consolidated Standards of Reporting Trials for Chinese herbal medicine formulas 2017). Methods. Circulating CPM with the indication for eczema was selected by searching three drug databases and confirmed by contacting the manufacturers. RCTs for the treatment of eczema with CPM were selected in four Chinese literature databases and four English literature databases from their inception to August 31, 2019. The reporting quality of included RCTs was assessed based on the CONSORT-CHM formulas 2017. A univariate analysis was conducted to identify the factors associated with the reporting quality. Results. A total of 70 circulating CPMs had the indication for eczema. Among them, 21 CPMs with 144 RCTs reached the eligible criteria. The mean overall quality score (OQS) of 144 RCTs was 19.85 ± 2.73, which was much less than the maximum score of 38. Of the 38 items, 12 items were reported in over 70% of the trials, 6 items were reported in 50%–70% of the trials, and 16 items were reported in less than 50% of the trials. Publication after 2015 (P<0.001) and the first author from a university hospital (P=0.010) were associated with the better reporting quality. Conclusion. There are a lot of circulating CPMs with the indication for eczema in mainland China, but both the quantity and the reporting quality of RCTs regarding those CPMs are suboptimal. It is necessary that authors and journal editors learn and adhere to the CONSORT-CHM formulas 2017 to enhance the reporting quality of RCTs for the treatment of eczema with CPM.

Reporting characteristics and quality of randomized controlled trial protocols in traditional Chinese medicine: a cross-sectional study

“…The documentation about the quality of herbal medicine formulas was poor according to the CONSORT checklist in 2006 ( Bian et al, 2006 ) 4 . In addition, a systematic review ( Li et al, 2020 ) of Chinese patent medicine for eczema showed the mean overall quality score was not good with reference to the CONSORT-CHMF 2017 statement.…”

The reporting quality of randomized controlled trials in Chinese herbal medicine (CHM) formulas for diabetes based on the consort statement and its extension for CHM formulas

“…We also conducted multivariate regressions and prespecified subgroup analyses ( Liu et al, 2023b ) to investigate factors that influence the quality of reporting. These factors included: (1) type of journal (integrative and complementary medicine versus non-integrative and complementary medicine journals, definition according to Journal Citation Reports, https://jcr.clarivate.com/jcr/browse-journals ), (2) year of publication (2009 and earlier versus 2010 and later for the CONSORT statement; 2016 and earlier versus 2017 and later for the CHM formula extension), (3) sample size (below median versus above median), (4) number of authors (below median versus above median), (5) multicenter (yes versus no), (6) type 2 diabetes mellitus (T2DM) studied only (yes versus no), (7) TCM patterns studied (yes versus no), and (8) positivity of primary outcome (yes versus no).…”

Evaluation of compliance of CONSORT-CHM formula 2017 in randomized controlled trials of Chinese herbal medicine formulas: protocol of a five-year review

“…However, recent systematic reviews on various conditions, including eczema, essential hypertension, stroke, acute upper respiratory infection in children, prostate cancer, and male infertility, have highlighted the disappointing reporting quality of RCTs involving CHMF (Li et al, 2020;Xu et al, 2020;Tian et al, 2022;Yu et al, 2022;Yan et al, 2023;Zhang et al, 2023). Specific flaws identified include: 1) inadequate reporting on study design (such as the method of randomization), which easily arise a risk of bias that could impact the reliability and validity of the findings (Li et al, 2020;Zhang et al, 2023). 2) a lack of awareness among authors regarding the detail description of CHMF interventions.…”