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Table 1 Checklist for items in STRICTA 2010

From: Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial

Item

Detail

1. Acupuncture rationale

1a) Style of acupuncture

Manual and electro-acupuncture base on traditional Chinese medicine theory and evidences from previous clinical trials.

1b) Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references where appropriate

According to systematic reviews and clinical experiences of our principal investigator and co-investigators.

1c) Extent to which treatment was varied

Standard treatment is used. No variation of treatment among patients.

2. Details of needling

2a) Number of needle insertions per subject per session (mean and range where relevant)

15 needles.

2b) Names (or location if no standard name) of points used (uni/bilateral)

Bilateral—Tianshu (ST25), Zusanli (ST36), Sanyinjiao (SP6), Toulinqi (GB15), Taichong (LR3), and Zhangmen (LR13).

Unilateral—Baihui (GV20), Guanyuan (CV4), and Zhongwan (CV12).

2c) Depth of insertion, based on a specified unit of measurement, or on a particular tissue level

10–30 mm.

2d) Response sought (e.g., de qi or muscle twitch response)

De qi.

2e) Needle stimulation (e.g., manual, electrical)

Manual.

Electrical—dense-disperse waves with 50 Hz at 10 volts.

2f) Needle retention time

30 min.

2g) Needle type (diameter, length, and manufacturer or material)

Disposable stainless steel acupuncture needles (Dong Bang acupuncture needles, 0.25 mm in diameter and 40 mm in length with guide tube, manufactured by Dong Bang Acupuncture Inc. Korea).

3. Treatment regimen

3a) Number of treatment sessions

12 sessions.

3b) Frequency and duration of treatment sessions

2/week for 6 consecutive weeks.

4. Other components of treatment

4a) Details of other interventions administered to the acupuncture group (e.g., moxibustion, cupping, herbs, exercises, lifestyle advice)

None.

4b) Setting and context of treatment, including instructions to practitioners and information and explanations to patients

University clinics.

Participants will be informed about acupuncture treatment in the study as follows: “In this study, acupoints for IBS will be used based on related reports and clinical experience of our investigators.”

5. Practitioner background

5) Description of participating acupuncturists (qualification or professional affiliation, years in acupuncture practice, other relevant experiences)

Hong Kong-registered Chinese medicine practitioners having at least 3 years of clinical experience, who have undergone training and are able to provide identical acupuncture treatment in accordance with a pre-defined protocol.

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

To assess the efficacy and safety of electro-acupuncture compared to sham acupuncture.

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

- Style of acupuncture: sham acupuncture (needling at sham acupoints).

- Number of needle insertions per subject per session: 15 needles.

- Depth of insertion: 10–30 mm.

- Needle retention time: 30 min.

- Needle type: the same as the treatment group.

- Number of treatment sessions: 12 sessions.

- Frequency and duration of treatment sessions: 2/week for 6 consecutive weeks.

  1. Note: This checklist, which should be read in conjunction with the explanations of the STRICTA items, is designed to replace CONSORT 2010’s item 5 when reporting an acupuncture trial