Table 1 Acupuncture treatment details based on the STRICTA 2010 checklist
Item | Detail |
|---|---|
1. Acupuncture rationale | 1a) Style of acupuncture - EA based on traditional meridian theory. |
1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate - Partially individualized manual EA treatments based on the traditional meridian theory, literature review, consensus by the experts in GERD and acupuncture, and clinical experience of Korean medicine gastroenterologist. | |
1c) Extent to which treatment was varied - Partially individualized EA treatment, i.e., fixed points plus optional points according to pattern identification of the participant. | |
2. Details of needling | 2a) Number of needle insertions per subject per session (mean and range where relevant) - From 18 to 20. |
2b) Names (or location if no standard name) of points used (uni/bilateral) - Eighteen fixed points: ST36, a point 0.5 cun below ST36, PC6, LI4, LR3, SP4, SP9, GB34 (bilateral), CV10, and CV13 (unilateral). - Optional points according to individual pattern identification (1) “Liver qi invading the stomach” type: SP11, LR2 (Rt. side) (2) “Spleen-stomach weakness” type: CV12 (one point), ST41 (Rt. side) (3) “Spleen-stomach dampness-heat” type: LR13, SP3 (Rt. side) (4) “Stomach yin deficiency” type: CV12 (one point), ST44 (Rt. side) | |
2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level - From 5 to 30 mm. | |
2d) Response sought (e.g., de qi or muscle twitch response) - none | |
2e) Needle stimulation (e.g., manual, electrical) - Electrical stimulation: 2/6 Hz mixed (ITO ES-160, Japan) - Acupoints with electrical stimulation: ST36, a point 0.5 cun below ST36, PC6, LI4 (bilateral), CV10, and CV13 (unilateral). | |
2f) Needle retention time - 20 minutes. | |
2g) Needle type (diameter, length, and manufacturer or material) - Park sham device with real and sham needle, i.e., sterilized stainless steel needle (0.25 x 40 mm, Dongbang Acupuncture Inc., Bundang, Sungnam, Korea). | |
3. Treatment regimen | 3a) Number of treatment sessions - Twelve treatment sessions in both EA and sham EA groups. |
3b) Frequency and duration of treatment sessions - Twice weekly for 6 weeks, 20 minutes for each session. | |
4. Other components of treatment | 4a) Details of other interventions administered to the acupuncture group (e.g., moxibustion, cupping, herbs, exercises, lifestyle advice) - Except for lifestyle modification and rescue medicine, other interventions during the study period will not be allowed. |
4b) Setting and context of treatment, including instructions to practitioners, and information and explanations to patients - Korean Medicine Clinical Trial Center in University hospitals - Participants will be informed about acupuncture treatment in the study as follows: “In this study, classic and nonclassic acupuncture treatment for GERD will be used based on traditional Korean medicine textbook and GERD- related literature.” | |
5. Practitioner background | 5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experience) - Two Korean Medicine Doctors who have licenses and at least 5 years of experience in gastrointestinal disorders. They went through training and simulation to ensure that they are able to provide identical EA treatment on the ground of predefined protocol and standard operating procedure. |
6. Control or comparator interventions | 6a) Rationale for the control or comparator in the context of the research question, with sources that justify this choice - A sham EA group using Park sham device with sham needle will be adopted. |
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. - Participants in the sham EA group will receive acupuncture treatment after randomization twice weekly for 6 weeks. - Sham EA group: nonpenetrating, nonacupoint, nonelectric current (1) Device: Park sham device with sham needle (2) Acupoint: Eighteen acupoints. Each acupoint is 2 cm apart from the acupoints of EA group to the medial side. (The optional points in accordance with pattern identification will not be included) (3) Duration of treatment sessions: 20 minutes |