After approval of the protocol by the institutional review board, patients were identified and screened by an Integrative Medicine Service research assistant. After obtaining informed consent and following approval from the beast cancer physicians at the Memorial Sloan-Kettering Cancer Center (MSKCC), patients were accrued to the study. Inclusion criteria were women aged 18 years or older; lymphoedema in an arm as a result of surgery and/or radiation therapy for breast cancer; clinical diagnosis of lymphoedema for at least 6 months and no more than 5 years; and affected arm with >2 cm circumference than the unaffected arm. Previous acupuncture treatment for lymphoedema and the current use of diuretics were the sole exclusion criteria.
Upper extremity measurements were performed in a standard fashion: the circumference of the patient's upper arms and forearms was measured, in both the affected and unaffected limbs, before and after each treatment. The upper arm was measured at 10 cm above the olecranon process; the forearm was measured at 5 cm below the olecranon process. The site with the greater difference between affected and unaffected arms (either the forearm or the upper arm) was used to determine baseline and outcome assessment for each patient. Changes in each patient's arm circumference were compared against her baseline measures.
Response was defined as at least a 30% reduction in the difference in size between the affected and unaffected arms after 4 weeks of treatment.
Traditional Chinese Medicine acupuncture treatment was given by certified acupuncturist members of the MSKCC Integrative Medicine Service. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSKCC. They selected the point prescription by consensus, based on historical context plus their relevant professional experience. The same point prescription was used for all patients; needle stimulation was a manual gentle rotation with lift and thrust. Needles were inserted bilaterally, in the affected as well as the unaffected limb. The acupuncturists were not intentionally seeking de qi sensation.
Alcohol swabs were applied prior to insertion of sterile, filiform, single-use needles (Tai Chi Brand, 32-36 gauge, 1 or 1.5 inch needles; made in China and distributed by Lhasa OMS, Weymouth, Massachusetts, USA) that penetrate 5–10 mm into the skin. The acupoint prescription is given in .
Study patients received acupuncture twice a week for 4 consecutive weeks at the MSKCC Integrative Medicine Outpatient Center. Thereafter, patients were asked to contact the research assistant should any side effects occur, and monthly follow-up calls were made to study the subjects for 6 months to obtain information about any side effects.
The study design was a Simon's two-stage minimax design with a null and alternative hypotheses of 5% and 20%, respectively. We planned to enroll 13 patients in the first stage of the study; if there was at least one response, we planned to accrue an additional 14 patients, declaring acupuncture worthy of further study if a total of four or more responses occurred in the total of 27 patients.