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 | |
- 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 |