Balk, J., Day, R., Rosenzweig, M., & Beriwal, S. (2009). Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. Journal of the Society for Integrative Oncology, 7, 4–11.
To obtain feasibility and effect size data for the intervention of true acupuncture on cancer-related fatigue (CRF) in patients receiving radiation therapy.
Participants were randomized to receive acupuncture or sham acupuncture; there were three real intervention assignments for every two sham assignments. Needles were in place for 30 minutes per session, and participants had treatments once or twice per week during the four to six weeks of the trial. Needle placement for true and sham interventions were specifically described in the report.
The study was a double-blind, placebo-controlled, randomized trial.
FACIT-F scores in the true acupuncture group improved more over time than those in the sham group, but the differences were not significant. QOL and depression scores improved in both groups over time significantly but were not different between the groups. Observations regarding feasibility during the study included: there was difficulty getting patients enrolled; changes in staff, staffing, and procedures made protocol use difficult; and due to procedures to maintain blinding and use of sham procedures, therapists felt that there was less needle manipulation possible with the protocol used for true acupuncture and felt it was difficult to determine the actual depth of needle insertion. It was also felt that the sham procedure was actually more than sham, although less than true acupuncture, due to skin and pressure stimulation.
It was concluded that feasibility to conduct this type of trial in a large group of patients was low. Findings of this study did not support the use of acupuncture to reduce fatigue in patients receiving radiation therapy.