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

Table 1

Study schedule for the AD patient group.

Outcome values and intervention		Baseline assessment	Treatment period								Final assessment
			1-week		2-week		3-week		4-week
AD symptoms	SCORAD assessment	●				●					●
	EASI assessment	●				●					●
	DLQI assessment	●				●					●
GI symptoms	Abdominal examination	●				●					●
	GSRS assessment	●				●					●
	TDS assessment	●				●					●
	Bristol stool scale	●				●					●
	AR assessment			●	●	●	●	●	●	●	●
Gut-brain axis	BDI STAI-X1, 2	●
	fMRI image (tasks 1 and 3)	●									●
	Stool collection	●									●
	Blood collection	●									●
	Acupuncture treatment		●	●	●	●	●	●	●	●
	Investigate for adverse events		●	●	●	●	●	●	●	●	●

BDI, Beck Depression Inventory; STAI, State-Trait Anxiety Inventory; SCORAD, Scoring Atopic Dermatitis; VAS, Visual Analog Scale; EASI, Eczema Area and Severity Index; DLQI, Dermatology Life Quality Index; GSRS, Gastrointestinal Symptom Rating Scale; TDS, Total Dyspepsia Symptom Scale; AR, adequate relief of functional dyspepsia pain and discomfort; AD, atopic dermatitis. Except for the fMRI session, the baseline assessment will take between 30 minutes and 1 hour. An fMRI session, performed at the first and last evaluations, will take about an hour and a half to two hours. Each acupuncture session will take about 15 to 20 minutes. And a total of 30 to 45 minutes will be required for the questionnaires administered in the intermediate and final evaluations. Visit window is ±5 days. Baseline assessment—first acupuncture treatment and eighth acupuncture treatment—Endpoint assessment will be performed within 7 days. The visit window period is ±5 days.