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Author (up) Balk, J.; Day, R.; Rosenzweig, M.; Beriwal, S. url  openurl
  Title Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue Type of Study RCT
  Year 2009 Publication Abbreviated Journal J Soc.Integr.Oncol.  
  Volume 7 Issue 1 Pages 4-11  
  Keywords Cancer-Related Fatigue; Neoplasms; Fatigue; RCT; Acu Versus Sham; Acupuncture; TCM Acupuncture Style; Fixed Acupuncture Protocol; Restricted Modalities, Acupuncture + Other; Heat Lamp; Sham Control; Non Penetrating Sham, Electrical; Non Penetrating Sham, Mechanical; Verum Acupoint Control; AcuTrials; Cancer;  
  Abstract 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  
  Address Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Hospital, University of Pittsburgh, PA 15213, USA  
  Language Number of Treatments 9  
  Treatment Follow-up 4 Weeks Frequency >1/WK Number of Participants 27  
  Time in Treatment 6 Weeks Condition Fatigue
  Disease Category Neoplasms OCSI Score  
  Notes Approved no  
  Call Number Serial 54  
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