Acupuncture Treatment for Symptom Management in Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial

Abstract

Atopic dermatitis (AD) is a chronic inflammatory skin disease with persistent itching, which impairs quality of life (QoL). Although various conventional treatments for AD exist, patients with AD often seek complementary and alternative therapies when conventional therapy has failed to relieve their AD symptoms or has had adverse effects. Acupuncture treatment may relieve AD symptoms, but controlled trials are needed to confirm this. Following our pilot study, which found that acupuncture treatment improves AD symptoms in mild-to-moderate AD patients, we will assess the effect of acupuncture treatment for symptom relief of AD using a trial with a complemented protocol. This is a two-arm, randomized, participant- and assessor-blinded, sham-controlled trial. A total of 36 mild-to-moderate AD patients will be randomly assigned in a 1:1 ratio to receive eight sessions twice weekly of either verum acupuncture (VA) or nonpenetrating sham acupuncture (SA) over four weeks. The primary outcome measured will be the change in the total Scoring Atopic Dermatitis (SCORAD) score. Secondary outcomes will be (1) changes in AD symptoms, QoL, dyspepsia symptoms, and electroencephalography (EEG) between baseline and week 4 and (2) changes in AD symptoms and QoL at baseline and at weeks 2, 4, and 8. This study will assess acupuncture treatment for the alleviation of AD symptoms in patients with mild-to-moderate AD. This clinical trial gas been registered in Korean Clinical Trial Registry (registration number: KCT0002796; date of registration: April 13, 2018).

Effect of Acupuncture on Gut-Brain Axis Parameters in Patients with Atopic Dermatitis: A Study Protocol for a Randomized, Participant- and Assessor-Blind, Sham-Controlled Trial

“…is is not a confirmative study to evaluate the effectiveness of acupuncture. In our previous study [8], we have already confirmed the effectiveness of acupuncture treatment on patients with mild to moderate AD. e aim of this study is to discover the response determinants and the mechanism of action of acupuncture treatment for AD, mainly focusing on the gutbrain axis.…”

“…Our research team has conducted previous randomized controlled trials (RCTs) addressing AD-related topics [7,8].…”

Effect of acupuncture treatment in patients with mild to moderate atopic dermatitis: a randomized, participant- and assessor-blind sham-controlled trial

“…This trial was approved by the Institutional Review Board at Kyung Hee University Korean Medicine Hospital and registered with the Clinical Research Information Service on April 13, 2018 (identifier: KCT0002796). The protocol of this clinical trial was in accordance with the Consolidated Standards of Reporting Trials [ 16 ] and Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines and has been previously published [ 17 ]. We obtained written informed consent from all study participants before enrollment.…”

“…Acupuncture treatments were based on the revised STRICTA 2010 recommendations [ 21 ] (Supplementary Table 1 ) and a predefined protocol [ 17 ]. All acupuncture treatments were conducted by one KMD with more than 2 years of clinical experience in Korean Medicine dermatology who had undergone more than 10 h of education about this trial protocol.…”

“…APPT was measured to quantitatively assess abdominal symptoms using a new algometer developed at the Korea Institute of Oriental Medicine [ 26 ]. The detailed procedure has been described previously [ 17 ]. The credibility test was used to evaluate the reliability and expectations of the acupuncture treatment [ 27 ].…”