Abstract
This study aims to test the feasibility of a randomised clinical trial to evaluate how acupuncture affects atopic dermatitis (AD) symptoms and quality of life and to explore potential biomarkers that may be associated with AD. It is a sham-controlled trial in which 30 eligible patients will be randomly allocated in a 1 : 1 : 1 ratio to one of three groups: verum acupuncture (VA) group 1 (3 times weekly for 4 weeks); VA group 2 (twice weekly for 4 weeks); or sham acupuncture group (SA; twice weekly for 4 weeks). SA will consist of nonpenetrating acupuncture. Outcome measures will include the Visual Analogue Scale for itch, SCORing Atopic Dermatitis, and Eczema Area and Severity Index to evaluate AD symptoms improvement along with the Patient Oriented Eczema Measure and Dermatology Life Quality Index to assess quality of life. Measures will be collected at baseline, once weekly during the treatment period, and after a 4-week follow-up period. Blood collection will be at baseline and 4 and 8 weeks after treatment and compared with healthy controls. Illumina sequencing will be used to profile microRNA expression in each group to explore candidate microRNA biomarkers for specific effects of acupuncture in patients with AD. This trial is registered via US National Institutes of Health Clinical Trials registry (ClinicalTrials.gov) on 15 July 2016, identifier: NCT02844452.
Highlights
The prevalence of atopic dermatitis (AD), a chronic relapsing inflammatory skin disease characterized by eczematous and intensely pruritic skin lesions [1, 2], is increasing worldwide [3, 4]
First-line therapy of AD is based on the use of emollients and other systemic and/or topical treatments: topical corticosteroid (TCS) and calcineurin inhibitors are recommended as topical management; antimicrobials, systemic immune-modulators, allergen-specific immunotherapy, and phototherapy are used for systemic management [8,9,10,11]
The aims of this study are (1) to investigate the feasibility of a large-scale randomised clinical trial to test the antipruritic effect of acupuncture treatment compared with a sham acupuncture in patients with AD; (2) to identify the optimal dose and schedule of acupuncture treatment and to identify outcome measures that will reflect symptoms changes; and (3) to discover biomarkers that may be associated with the therapeutic effects of acupuncture
Summary
The prevalence of atopic dermatitis (AD), a chronic relapsing inflammatory skin disease characterized by eczematous and intensely pruritic skin lesions [1, 2], is increasing worldwide [3, 4]. In Korea, patients with AD have frequently used Traditional Korean Medicine, such as acupuncture and herbal medicine, for symptom management [13]; there have been only a small number of clinical studies of AD treatment with acupuncture and herbal medicine and even fewer studies investigating the therapeutic effect of acupuncture alone [12, 14]. This may explain why a recent systematic review failed to include any randomised clinical trials (RCTs) of acupuncture as treatment of AD [15]. Considering its potential antipruritic effect, this highlights the need for rigorously designed and conducted trials in acupuncture field [15]
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