Liljegren, A., Gunnarsson, P., Landgren, B. M., Robeus, N., Johansson, H., & Rotstein, S. (2012). Reducing vasomotor symptoms with acupuncture in breast cancer patients treated with adjuvant tamoxifen: a randomized controlled trial. Breast Cancer Research and Treatment, 135, 791-798.

The study evaluated the value of true acupuncture in management of hot flashes in women with breast cancer receiving tamoxifen.

Patients  on tamoxifen who experienced vasomotor symptoms were randomly assigned to true acupuncture or control acupuncture groups.  All patients were treated for 20 minutes twice weekly for 5 weeks in an outpatient clinic.  In the true acupuncture group, 8 needles were inserted at defined points.  In the control group, needles did not penetrate the skin, but were rotated until the patient felt a superficial sensation on the skin.  In the control group, the needles were placed at 8 sites, as well.   Study data were collected at baseline, week 6, and week 18.

The study enrolled 74 women with a mean age of 58 years. 

• KEY DISEASE CHARACTERISTICS: All had breast cancer  and were receiving tamoxifen.
• OTHER KEY SAMPLE CHARACTERISTICS:
  • 70% were post menopausal
  • 69% had received previous estrogen replacement therapy
  • 22% were also receiving SSRIs
  • 41% in the treatment group and 38% in the control group had received previous acupuncture therapy

The study was conducted in an outpatient clinic in Sweden.

PHASE OF CARE: Transition phase after active treatment

The study was a single-blind, randomized, sham-controlled trial.

Instruments/measures included:

• Vasomotor symptom intensity – 5 point self-report scale
• Hot flush diary

There were no significant differences between groups in frequency of hot flushes and sweating over time.  The acupuncture group reported less severity of symptoms of sweating at night ( p = .03).    Both groups demonstrated significant improvement in symptoms over time.  Of those who received true acupuncture, 69.4% thought they had receiving true acupuncture, while 63.9% of those in the control group thought they had received true acupuncture, suggesting that patient blinding was accomplished.  One adverse event of bleeding and bruising was reported in 1 control patient.

Findings suggest little difference in symptoms between those who received acupuncture versus those who received sham acupuncture.  Acupuncture may have some benefit, but it is unclear if this also reflects a placebo effect from the intervention.

Study limitations included:

• Small sample (< 100)
• Risk of bias (no blinding)
• Measurement/methods not well described 
• Measurement validity/reliability questionable 
• It is unclear how a control patient could have experienced the adverse event of bleeding at a sham acupuncture site when the sham needles did not puncture the skin.  This raises questions about fidelity to the sham procedure used. 
• Investigators who collected the data were not blinded. 
• It is unclear how the frequency of night sweatings was actually measured and what was used for the analysis – the measurement method described does not specify frequency of episodes and does not specify time of day of episodes. There was no analysis of significance of  baseline symptom differences between groups, or correction of changes over time with baseline symptom levels

This study provides limited evidence regarding the effect of acupuncture for vasomotor symptoms in women with breast cancer treated with tamoxifen.  It does demonstrate questions regarding potential placebo effects of acupuncture or placebo effects of sham acupuncture procedures that complicate research design in this area. Appropriate placebo or comparison control groups for this type of research need to be identified.