Table 1 Checklists for items in STRICTA 2010

• 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) Reason 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

• Details of needling

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

28 needles

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

he gu 合谷(LI4), nei guan 內關(PC6), qu chi 曲池(LI12), ba xie 八邪(EX-UE9), zu san li 足三里(ST36), san yin jiao 三陰交(SP6), tai chung 太衝(LV3), ba feng 八風(EX-LE10)

2c) Depth of insertions, 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 - continuous waves at 2 Hz

2f) Needle retention time:

25 min

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

Disposable acupuncture needles

(verum acupuncture needles Hwato 0.25 × 0.25 mm matching the Streiterger sham needles)

• Treatment regimen

3a) Number of treatment sessions: 12 sessions

3b) Frequency and duration of treatment sessions:

Acupuncture will start after the day of 1st chemotherapy cycle

1/week for 12 consecutive weeks even if the chemotherapy is stopped

• Other components of treatment

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

No other intervention

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

Chinese Medicine Clinic cum Training and Research Centre

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

• Practitioner background

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

Hong Kong registered Chinese medicine practitioners with at least 3 years of clinical experience and scholarship training in Chinese medicine oncology of Hong Kong Hospital Authority, who have undergone training and are able to provide identical acupuncture treatment in accordance with a predefined protocol

• Control or comparator interventions

6a) Rationale for the control or comparator in the context of the research question, with source 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

Number of needle insertions per subjects per session:

28 Sham needles at the same acupoints as the treatment group

Depth of insertion:

Needles are only adhered to the skin

Needle retention time:

25 min

Needle type

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

Number of treatment sessions:

12 sessions

Frequency and duration of treatment sessions:

1/week for 12 consecutive weeks