JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue

Judith Balk, Richard Day, Margaret Rosenzweig, Sushil Beriwal
Journal of the Society for Integrative Oncology 2009, 7 (1): 4-11
19476729
Cancer-related fatigue is a substantial problem for cancer patients and their caregivers, but no effective treatment exists. Acupuncture has been suggested to improve cancer-related fatigue, but no randomized clinical trials have been conducted. We hypothesized that true acupuncture, compared with sham acupuncture, would reduce cancer-related fatigue in cancer patients receiving external radiation therapy. The aim of this study was to determine effect size and feasibility. A modified, double-blind, randomized, placebo-controlled trial was conducted. The subject, clinical staff, and assessor were blinded, but the acupuncturist was not. Subjects received acupuncture once to twice per week during the 6-week course of radiation therapy. Data were collected at baseline, 3 weeks, 6 weeks, and 10 weeks, which was 4 weeks after that last radiation session. Twenty-seven subjects enrolled, and 23 completed the last data collection. Both true and sham acupuncture groups had improved fatigue, fatigue distress, quality of life, and depression from baseline to 10 weeks, but the differences between the groups were not statistically significant. The true acupuncture group improved 5.50 (SE, +/- 1.48) points on the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F), whereas the sham acupuncture group improved by 3.73 (SE +/- 1.92) points. This difference was not statistically significant (p = .37). All subjects guessed that they were in the true acupuncture group. Our study was underpowered to find a statistically significant difference. To demonstrate a statistically significant improvement between true and sham acupuncture would require 75 subjects per group in a future study. Owing to poor recruitment, the feasibility of a larger trial using the same methodology is low. Despite being underpowered, it appears that subjects receiving true acupuncture may benefit more than subjects receiving sham acupuncture. In the discussion section, we review our experience with using a sham-needle controlled study.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
19476729
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"