Mao, J.J., Farrar, J.T., Bruner, D., Zee, J., Bowman, M., Seluzicki, C., . . . Xie, S.X. (2014). Electroacupuncture for fatigue, sleep, and psychological distress in breast cancer patients with aromatase inhibitor-related arthralgia: A randomized trial. Cancer, 23, 3744–3751. 

DOI Link

Study Purpose

To examine electroacupuncture (EA) compared to sham acupuncture (SA) and a waitlist control (WLC) group to determine effectiveness on fatigue, sleep disturbance, depression, and anxiety in postmenopausal breast cancer survivors who reported joint pain, or arthralgia, related to aromatase inhibitors (anastrazole, letrozole, exemestane)

Intervention Characteristics/Basic Study Process

Acupuncture interventions were administered by two licensed acupuncturists (not physicians). Ten treatments were administered over eight weeks with two treatments during each of the first two weeks followed by one treatment per week for the following six weeks. The EA and SA treatments were administered by the same two acupuncturists. Procedures for the two groups differed in the placement of the acupuncture needles and actual versus sham electrical stimulation using a transcutaneous electrical nerve stimulation (TENS) unit. The same timing and duration of treatments was used for each group.

Sample Characteristics

  • N = 67 (159 were screened; 76 were enrolled; 9 were excluded during the next round of evaluations; 4 were lost to follow-up by time 2 [4 weeks] and 4 more were lost to follow-up by time 3 [12 weeks])  
  • MEAN AGE: 59.7 years (range = 41–76 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer survivors being treated with aromatase inhibitors (AIs) for 3–56 months. 66% of participants were being treated with an AI at the time of the study. At baseline, there were significant correlations between baseline pain (as measured by the Brief Pain Inventory) and fatigue, sleep, and depression, but there was no correlation with anxiety. Most participants (71.6%) were white and 23.9% were black; greater than 75% reported college education. Disease: 48%–50% were at disease stage I, 30–36 % were at disease stage II, and 14%–22 % were at disease stage III.  
  • OTHER KEY SAMPLE CHARACTERISTICS: Most participants (71.6%) were white and 23.9% were black; greater than 75% held some college education. Inclusion criteria: Women with histories of stages I–III breast cancer currently taking an AI, current complaints of joint pain times three months, attributes pain to AI, current-week pain rating of 4 or greater on an 11-point rating (0–10), complaints of pain at least 15 days within the last 30 days. 

Setting

  • SITE: Single-site    
  • SETTING TYPE: Not specified    
  • LOCATION: The Abramson Cancer Center of the Hospital of the University of Pennsylvania

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS:  Elder care, palliative care 

Study Design

Three-group randomized controlled trial comparing EA, SA, and WLC.

Measurement Instruments/Methods

Four measurement tools were used: the Brief Pain Inventory (BPI); the Brief Fatigue Inventory (BFI); the Pittsburgh Sleep Quality Index (PSQI); and the Hospital Anxiety and Depression Scale (HADS). A priori primary outcome reported pain intensity and interference. A priori secondary outcome reported fatigue, sleep, and psychological distress (anxiety, depression).

Results

Measurements were repeated at weeks 4, 8, and 12. There was significant (p = 0.0095) improvement in the fatigue score after EA, no improvement with SA, and greater reduction in fatigue than the WLC group. There were nonsignificant improvements in sleep in the EA and SA groups compared to the WLC group. There was significant (p = 0.04) improvement in the EA group but the SA group on the HADS anxiety score compared to the WLC group; a nonsignificant improvement continued in the EA group at week 8, whereas week 12 showed a significant (p = 0.006) improvement in the EA and WLC groups. EA and SA group improvements in depression scores were significant (p = 0.015 and p = 0.0088, respectively) compared with the WLC group; EA and SA significantly (p = 0.0031m and p = 0.0056, respectively) improved scores at week 8, and scores did not change at week 12.

Conclusions

EA produced improvements by reducing fatigue, anxiety, and depression scores. SA produced improvements in depression scores only. Acupuncture with electronic stimulation may be an effective treatment for pain and the nonpain symptoms of fatigue, sleep disturbance, and depression associated with AIs. Additional research is encouraged.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding). There was no blinding but the risk of bias is low because each arm of the study required specific treatment limited to administration by just two acupuncturists.

 

Nursing Implications

Acupuncture with electrical stimulation should be considered a viable treatment option for patients with breast cancer taking AIs who complain of joint pain. Large, randomized, controlled research studies are needed to develop evidence for the efficacy of EA in breast and other cancers. Drug and symptom cluster correlations must be deconstructed.