Bokmand, S., & Flyger, H. (2013). Acupuncture relieves menopausal discomfort in breast cancer patients: A prospective, double blinded, randomized study. The Breast, 22, 320–323. 

DOI Link

Study Purpose

To investigate the therapeutic effect of acupuncture on hot flashes and disturbed sleep in patients with breast cancer, the possible side effects of this treatment, and the effect on plasma estradiol levels

Intervention Characteristics/Basic Study Process

Two experienced acupuncturists provided either true acupuncture or sham acupuncture in the predetermined points. Group 1 had manual acupuncture in pre-determined bilateral points for 15–20 minutes once a week for five consecutive weeks. These points were Hc6, Ki3, Sp6, and Lr3, which are located on the wrist, ankle, and foot. Group 2 had sham acupuncture in four predetermined bilateral non-acupuncture points outside the meridian but within the same region as the true points. The treatment was given once a week for five weeks. Group 3 received no acupuncture. All groups completed a log book. Plasma estradiol levels were measured in blood samples obtained just prior to the first treatment and 30 minutes after. It was measured again at five weeks later and 30 minutes after the final treatment. Group 3 had plasma estradiol levels obtained at allocation and five weeks later.

Sample Characteristics

  • N = 94
  • MEAN AGE = 61 years (45–76 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Self-estimation of troublesome hot flashes and disturbed night sleep

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient area   
  • LOCATION: Denmark

Phase of Care and Clinical Applications

  • PHASE OF CARE: Post-surgical and survivorship
  • APPLICATIONS: Elder care

Study Design

  • Double-blinded, randomized (double-blind only applied to Groups 1 and 2 for the investigator and participants)

Measurement Instruments/Methods

  • Completion of a logbook using a subjective visual analog scale to rate extent of symptoms
  • Obtained plasma estradiol levels prior to first treatment, 30 minutes after that treatment, at five weeks and 30 minutes after final treatment
  • The control group had the levels drawn at allocation and five weeks later.
  • Analysis performed using Roche Modular Immunochemistry, Electrochemical Luminescent Immuno Assay

Results

The researchers reported that a significant relief occurred in the acupuncture group after the second treatment, lasting until 6 weeks post-treatment (p < 0.05), as compared to the sham acupuncture and no treatment groups, which lasted for at least 12 weeks. A decrease in sleep disturbance also was noted in the same group as compared to the others. Side effects were reported as mild and temporary. Reported side effects included fatigue, pruritus, and nausea. No effect on the plasma estradiol levels in all groups occurred. Eleven women from all groups reported using concurrent treatments including clonidine and/or venlafaxine, mirtazapine with clonidine, and hormone replacement.

Conclusions

The acupuncture group reported a decrease in hot flashes versus the other groups. No formal validation of the visual analog scale occurred. The concurrent use of other therapies may influence the reported outcomes. Restrictions of concurrent therapies for hot flashes during participation and validation of the self-reporting tool were needed.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: 11 participants used other forms of treatment in conjunction with their study participation to control hot flashes. Participants were Caucasian. No other groups were included in the sample.

Nursing Implications

A large randomized trial exploring acupuncture versus placebo is needed that restricts concurrent therapy usage during trial participation and includes women with breast cancer having similar hot flash interventions such as tamoxifen or aromatase inhibitors with hot flash occurrence. True acupuncture may benefit, but further study is indicated.