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Table 1 Checklist for items in STRICTA 2010*

From: The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial

Item

Detail

1. Acupuncture rationale

1a) Style of acupuncture:

According to systematic reviews and clinical experiences of our principal investigator and co-investigators. Manual and electro-acupuncture based on traditional Chinese medicine theory

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

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):

14 needles

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

Bilateral:

Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26),

Zusanli (ST-36), Fenglong (ST-40), Sanyinjiao (SP-6)

Unilateral:

Qihai (CV-6), Zhongwan (CV-12)

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

10–25 mm

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

De qi

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

Manual and electrical — dense-disperse waves at 50 Hz and 10 V

2f) Needle retention time:

30 min

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

Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 × 0.30 mm matching the Streitberger sham needles)

3. Treatment regimen

3a) Number of treatment sessions: 16 sessions

3b) Frequency and duration of treatment sessions:

2/week for 8 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):

Auricular acupressure with Semen Vaccariae embedded adhesive tape.

Unilateral auricular points: Hunger, Shen men, Spleen and Stomach

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 weight control 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 experience):

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 predefined 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 body acupuncture and auricular 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 + Semen Vaccariae embedded tape pressure on non-acupoints at auricular helix

Table 1 Click here to download Table Table 1.docx

- Number of needle insertions per subject per session:

14 sham needles at the same acupoints as the treatment group, and 4 auricular helix points with embedded tape pressure

- Depth of insertion:

Needles are only adhered to the skin.

- Needle retention time:

30 min

- Needle type

Streitberger’s non-invasive acupuncture needles (Gauge 8 × 1.2”/0.30 × 30 mm)

- Number of treatment sessions:

16 sessions

- Frequency and duration of treatment sessions:

2/week for 8 consecutive weeks

  1. *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