ABSTRACT
BACKGROUND: This systematic review evaluated the Chinese herbal medicine (CHM) for treating atopic dermatitis (AD). METHODS: PubMed, EMBASE, the Cochrane library, the Wanfang database, and China National Knowledge Infrastructure (CNKI) were searched for relevant randomized controlled trials (RCTs) from inception to December 2021. Overall recovery rate, disease/symptom severity scoring, quality of life (QoL), recurrence rate, and incidence of adverse events (AEs) were evaluated. STATA SE 14.0 software was used for statistical analysis. RESULTS: 17 RCTs involving 1624 patients were eligible. CHM was associated with a higher overall recovery rate (risk ratio [RR] = 1.15, 95% confidence interval [CI]: 1.05, 1.26, p = .003) and decreased recurrence rate (odds ratio [OR] = 0.19, 95% CI: 0.07, 0.55, p = .002), both confirmed by sensitivity analyses. CHM could decrease scoring atopic dermatitis index (MD = -0.61, 95% CI: -1.12, -0.11, p = .017), however, sensitivity analysis revealed non-robustness. No significant differences were found between the CHM and the control group in Eczema Area and Severity Index, QoL, and the incidence of AEs. CONCLUSIONS: CHM was effective for treating AD as it could improve the overall recovery rate and decrease the recurrence rate. More studies are required to validate the potential of CHM on disease/symptoms severity and QoL.
Subject(s)
Dermatitis, Atopic , Drugs, Chinese Herbal , Humans , Drugs, Chinese Herbal/adverse effects , Dermatitis, Atopic/drug therapy , China , Quality of Life , Research DesignABSTRACT
Atopic eczema (AE), or atopic dermatitis, is a common inflammatory skin disease. As conventional medicines for moderate and severe AE patients have been reported to be associated with unwanted side effects, many patients with AE have sought other therapies. Chinese herbal medicine (CHM) is one of the most commonly used complementary therapies with a long history of being applied for the treatment of AE. Clinical evidence for CHM for AE in systematic reviews and randomised controlled trials (RCTs) published from 2013 to 2016 was reviewed. Findings from the Cochrane systematic review suggested that oral use of a CHM formulation may improve health-related quality of life (HRQoL) of children with moderate or severe AE. The benefit on improvement of AE requires further high-quality clinical studies.
Subject(s)
Dermatitis, Atopic/drug therapy , Drugs, Chinese Herbal/therapeutic use , Child , Clinical Trials as Topic , Dermatitis, Atopic/pathology , Drugs, Chinese Herbal/adverse effects , Humans , Myocardium/metabolism , Myocardium/pathology , Quality of Life , Severity of Illness Index , Spleen/metabolism , Spleen/pathologyABSTRACT
BACKGROUND: Atopic 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/DESIGN: We 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 REGISTRATION: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.
