Mao, J.J., Bowman, M.A., Xie, S.X., Bruner, D., DeMichele, A., & Farrar, J.T. (2015). Electroacupuncture versus gabapentin for hot flashes among breast cancer survivors: A randomized placebo-controlled trial. Journal of Clinical Oncology, 33, 3615–3620. 

DOI Link

Study Purpose

To evaluate the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo, using sham acupuncture (SA) and placebo pills (PP), and monitoring nocebo effects.

Intervention Characteristics/Basic Study Process

Participants were randomly assigned to receive eight weeks of EA or GP once per day within each group. Participants were then randomly assigned to receive either EA or sham control and GP or placebo. The primary end point in the hot flash composite score (HFCS) between SA and PP at week eight with secondary end points including group comparisons and additional evaluation at week 24 for durability of treatment effect. Two licensed nonphysician acupuncturists administered the EA and SA two times per week for two weeks, then one time per week for six more weeks. A total of 10 treatments were administered during this eight-week period.
 
A total of 900 mg of GP daily was prescribed. There was a six-day titration phase at the beginning and a tapering of the dose at the end of the study. Placebo capsules were used for the control group, and administration was identical.

Sample Characteristics

  • N = 120  
  • AGE RANGE: 31–79 years
  • MEAN AGE = 52.3 years (SD = 8.5 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: The study included women with breast cancer (stages I–III) who were free of disease and who have at least two hot flashes each day. Women could not be receiving active chemotherapy/radiation therapy and could be on hormonal therapy; however, the hormonal therapy could not have been initiated or changed within four weeks of starting the study.
  • OTHER KEY SAMPLE CHARACTERISTICS: Women who were pregnant, breastfeeding, or anticipated a change in hormonal therapy were not included, neither were women receiving coumadin, women who had a bleeding disorder, women who were receiving an anticonvulsant, women who had taken gabapentin in the past for hot flashes, or women who had renal failure in the prior 12 months. 74.2% of women were Caucasian; 22.5% were African American; 87.5% were postmenopausal; 25% had surgically induced menopause; 39.2% had chemotherapy-induced menopause; 67.5% were receiving hormonal therapy; and 25% were receiving an antidepressant.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Abramson Cancer Center of the University of Pennsylvania in Philadelphia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  • Randomized, placebo, controlled trial

Measurement Instruments/Methods

  • Daily hot flash diary

Results

By week eight, SA produced significantly greater reduction in HFCS than did PP (-2.39; 95% CI [-4.6, -0.17]). Among all treatment groups, the mean reduction of HFCS was greater in the EA group, followed by SA, GP, and PP (-7.4 vs -5.9 vs -5.2 vs -3.4; p = < 0.001). The pill groups had more treatment-related adverse effects than did the acupuncture groups; GP (39.3%), PP (20%), EA (16.7%), and SA (3.1 %), with p = 0.005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (-8.5 vs -6 vs -4.6 vs -2.8; p = 0.002).

Conclusions

EA resulted in the greatest reduction in hot flashes both at the end of the treatment and four months after the treatment. GP had similar effects while women received treatment, but not off treatment. Acupuncture (both SA and EA) elicited greater placebo and smaller nocebo effects than did GP or PPs for the management of hot flashes.

Limitations

  • Intervention expensive, impractical, or training needs
  • The training required to accurately administer EA is of concern and was not thoroughly addressed.
  • The sample size was small for a four-group study.

Nursing Implications

The EA group was found to have enhanced effects of reducing hot flashes in breast cancer survivors; however, SA also had better effects in reducing hot flashes than either GP or PPs. GP was associated with the most adverse effects, and the PP group reported more nocebo effects than did SA. This might be important information for nurses to be aware of as they provide education to patients.