|
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
|
