Table 1 Checklists for items in STRICTA 2010

1.Acupuncture rationale

1a) style of acupuncture

Our previous study found that the combination of electroacupuncture and auricular massage significantly reduced weight and BMI compared to sham controls.

1b) reasoning for treatment provided, based on clinical experience, literature sources, and /or consensus methods, with references where appropriate

1c) extent to which treatment was varied:

Use standard processing. No difference in treatment between 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)

Tianshu (ST-25,Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12),Zusanli (ST-36),Fenlong (ST 40),Sanyinjiao (SP-6),^.

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

inserted at a depth of 10–25 mm into the points

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

De qi

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

Electrical stimulation with dense-disperse waves with 50 Hz at 100 V will be delivered through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points.

2f) needle retention time:

30mins

2 g) 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)

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

3.Treatment regimen

3a) number of treatment sessions:

The number of treatment sessions is 16 sessions.

3b) frequency and duration of treatment sessions:

The frequency and duration of treatment sessions is twice in a week over 8 consecutive weeks, every session will take 30 min.

4.Other components of treatment

4a) details of other interventions administered to acupuncture group (e.g. moxibustion, cupping, herbs, exercise, lifestyle advice):

Participants be told not to eat other snacks, meat or starchy foods in addition to meals, etc.

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

Hong Kong Baptist University Chinese Medicine Clinics

Participants will be informed about acupuncture treatment in the study as follows: “in this study, acupoints for central obesity 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):

Registered TCM Physician with at least 3 years of clinical experience and trained to treat participants in accordance with study protocols.

6.Control or comparator interventions

6a) The primary outcome is the change in waist circumference at the beginning of the study and at the end of the study. The secondary outcomes include

changes in hip circumference, waist-to-hip circumference ratio, Body Mass Index (BMI), body fat percentage, total cholesterol (TC), triglyceride (TG), fasting blood glucose (FBG) during treatment and follow up period.

6b)

-style of acupuncture

Sham acupuncture

-number of needle insertions per subjects per session:

14 sham needles at the same acupoints as the treatment group

-Depth of insertion:

Needles are only adhered to the skin of insertion.

-needle retention time:

30 min

-needle type

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

-frequency and duration of treatment sessions:

2 sessions per week over 8 consecutive weeks.