Research Article

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 3

Revised STRICTA checklist.

ItemDetail

(1) Acupuncture rationale(1a) Style of acupuncture
 (i) Manual acupuncture
(1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate
 (i) Through a previous study conducted by this research team, it was confirmed that AD patients could be treated with acupuncture twice a week for 4 weeks to improve symptoms. In addition, the Acupuncture and Meridian Science Research Center textbook was referenced. Optimal acupoints were selected through clinical experience and consensus by the experts in acupuncture and AD optimal acupoints.
(1c) Extent to which treatment was varied
 (i) No other interventions other than acupuncture.

(2) Details of needling(2a) Number of needle insertions per subject per session (mean and range where relevant)
(2b) Names (or location if no standard name) of points used (uni/bilateral)
 (i) Fixed points: 6 acupoints with 9 needles per participant per session:
 (ii) PC6, LI11, ST36 bilaterally, ST43, GB41, LI3 contralaterally
(2c) Depth of insertion, based on a specified unit of measurement or on a particular tissue level
from 5 to 30 mm, perpendicular to skin surface
(2d) response sought (e.g., de qi or muscle twitch response)
“De qi” sensation
(2e) Needle stimulation (e.g., manual, electrical),
manual stimulation, needle rotation with thumb and index fingers for the first 10–15 seconds
No other stimulation sensations.
(2f) Needle retention time
15 minutes
(2g) Needle type (diameter, length, and manufacturer or material)
A sterilized stainless steel needle (0.25 × 40 mm, Dong Bang Acupuncture Inc., Bundang, Seongnam, Korea)

(3) Treatment regimen(3a) Number of treatment sessions
 (i) 8 sessions
(3b) Frequency and duration of treatment sessions
 (i) Twice a week for 4 weeks, 15 minutes for each session
 (ii) Visit window: ± 5 days

(4) Other components of treatment(4a) Details of other interventions administered to the acupuncture group (e.g., moxibustion, cupping, herbs, exercises, lifestyle advice)
 (i) Lifestyle advice will be given to all participants
 (ii) Any other interventions will be prohibited during the study period
(4b) Settings and context of treatment, including instructions to practitioner and information and explanations to patients
 (i) Participants will be informed about acupuncture treatment in the study as follows: “In this study, you will be randomly allocated to the VA group or SA group. Acupoints will be selected as guided by traditional Korean medicine textbooks and AD-related reports.”

(5) Practitioner background(5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience)
 (i) Acupuncture treatment in this study will be performed by a KMD who is majoring under the guidance of a Korean medical dermatologist. The clinical experience of this KMD is more than 2 years. The practitioner KMD will have to undergone more than 10 hours of training and simulation workshopping to ensure that he is able to provide consistent acupuncture treatment in accordance with a predefined protocol.

(6) Control and comparator interventions(6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice
 (i) A control group (SA group) will be treated with sham acupuncture (SA) using park sham acupuncture Needles.
(6b) Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for items (1) to (3) above
 (ii) Park sham acupuncture needles and devices will be used in the same environment as in the VA group. However, acupoints will be different: a Point 1 to 2 cm proximal and 1 cm medial to PC6, a point 1 cm proximal and 1 cm medial to LI11, and a point 1 cm proximal and 1 cm lateral to ST36, each bilaterally.

STRICTA: Standards for Reporting Interventions in Clinical Trials of Acupuncture; AD: atopic dermatitis; VA: verum acupuncture; SA: sham acupuncture; KMD: Korean medicine doctor.