Table 1 Extract from Acupuncture Protocol, presented in accordance with STandards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA)⁶⁸

1

Acupuncture rationale

Rationale for selection of points and literature sources

The acupuncturist needled four energy-associated acupuncture points on all patients.⁶⁹

2

Acupuncture rationale

Individualization and literature sources

Based on clinical experience and TCM theory,⁶⁹ the study acupuncturist [name] developed a system of classifying patients into one of four symptom pattern subgroups that may contribute to the development of fatigue symptoms: (A) gastrointestinal symptoms and signs, (B) emotional symptoms and signs, (C) sleep dysfunction symptoms and signs, and (D) myofascial muscle pain. Classification took account of patient's physiological dysfunctions as recognized by current state of health, previous disease conditions, and treatment history.

3

Needling details

Points used

For each patient, the study acupuncturist administered acupuncture at 4 energy-associated points (Li4, Sp6, ST36, Ki3) and then additionally needled acupuncture points he considered beneficial primarily in light of symptom pattern classification. Those in the gastrointestinal symptom pattern also received acupuncture on P6 and Sp4. Those in the emotional symptom pattern also received acupuncture on Lu7, Ki4, Liver3, Yintang, and Gv20. Those in the sleep symptom pattern also received acupuncture on H7, Ki4, and Ub62. Those in the pain symptom pattern also received acupuncture on Gb20, Te5, Gb43, SI3, Ub62, Gb29, Gb30, Gb40, and selected points related to specific sites of somatic pain. All points were administered bilaterally.

4

Needling details

Depths of insertion

Points were needled perpendicularly to a depth of 0.5-1.5, with exact depth varying by location of acupuncture point, ease with which patient achieved the "de qi" ("twitch") sensation, patients' size, sensitivity, and their state of health.

5

Needling details

Responses elicited

The study acupuncturist sought to achieve the "de qi" (twitch) response by employing needling techniques such as lifting, thrusting, and rotating.

6

Needling details

Needle retention time

Needles were inserted over the course of approximately 10 minutes, retained in place for about 30 minutes, and removed over the course of about 10 minutes (50 minutes total)

7

Needling details

Type of needles

LEKON^™ sterile disposable acupuncture needles of the following sizes: 34G (gauge) × 1.5 (0.22 mm × 40 mm diameter); 34G× 1.0 (0.22 mm × 25 mm); 32G× 1.5 (0.25 mm × 40 mm); and 38G× 0.5 (0.18 mm × 13 mm); needle types were chosen according to acupuncture point location and patients' size, sensitivity, and state of health.

8

Practitioner background

Duration of relevant training

The clinician delivering acupuncture [Jie-Jia Li] earned a medical degree from the Southern Medical University in Guangzhou, China, a Master's degree in Traditional Chinese Medicine from Shanghai University of Traditional Chinese Medicine, and a Ph.D. in Traditional Chinese Medicine at American Liberty University in California.

9

Practitioner background

Length of clinical experience

JJL has over 20 years of experience in providing acupuncture and has worked at the UCLA Center for East-West Medicine for over 15 years.

10

Practitioner background

Expertise in specific condition

JJL has been treating patients with breast and other types of cancer for nearly 10 years; he has been collaborating with [Name] in researching breast cancer for more than five years.