Lesi, G., Razzini, G., Musti, M.A., Stivanello, E., Petrucci, C., Benedetti, B., . . . Artioli, F. (2016). Acupuncture as an integrative approach for the treatment of hot flashes in women with breast cancer: A prospective multicenter randomized controlled trial (AcCliMaT). Journal of Clinical Oncology, 34, 1795–1802.

To evaluate the effectiveness of acupuncture plus self-care versus self-care alone on hot-flashes control in patients with breast cancer

Assignment to either the acupuncture or control group was 1:1. Both groups received an informational booklet about climacteric syndrome and its management and was followed for at least 12 weeks. The acupuncture group also received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints. Quality of life and climatic symptoms were measured at week 12, 3 months, and 6 months.

• N = 190 (105 self-care and 85 self-care plus acupuncture), allocation ratio 1:1 by hormonal therapy (final—completed treatment was 163 with 88 self-care and 83 acupuncture)
• AGE: 31–65 years
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Breast cancer, age 18–65 years, receiving hormone therapy, amenorrhea in a minimum of the last six months, presenting six episodes or more of hot flashes per day
• OTHER KEY SAMPLE CHARACTERISTICS: Accept and sign the informed consent, score greater than 15 on the Greene Climacteric Scale (GCS), PS > 1, active physical activities or relaxation techniques or diet control in group or self-management, not exclusion criteria as chemotherapy or radiotherapy, concomitant drugs for menopause or previous acupuncture in last year

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Five cancer hospitals and one primary care hospital in northern Italy

PHASE OF CARE: Transition phase after active treatment

A phase III, multicenter, randomized, controlled trial with acupuncture and self-care versus self-care alone

• The primary outcome was hot flashes measured with hot flash score (HFS), recorded daily in diaries.
• Symptoms related to menopause and quality of life were the secondary outcomes and were evaluated with the Greene Climacteric and Menopause Quality of Life (MenQoL) scale, consisting of 29 items on a Likert-type scale ranging from 0 (not bothered) to 6 (maximum impact). 
• Adherence to self-care assignment was evaluated in the control visits.
• Different investigators for clinical data collection and acupuncture administration

Mean HFS at week 12, finalizing the treatment, was 22.7 for the control group and 11.3 in the acupuncture group. Differences in mean HFS were 9.3 (95% confidence interval [214.2, 24.4], p < 0.001). A greater reduction in HFSs were observed in the acupuncture group during the basal, third, and sixth month controls for hot flashes, and a similar reduction was found on the GCS-Greene Climacteric Scale. Twelve patients in the acupuncture arm reported mild adverse events (i.e., muscle pain, headache, and one menstrual bleed). No serious adverse events were reported in either group.

The authors demonstrated that acupuncture plus the self-care intervention during 12 weeks was more effective to decrease the hot flashes than self-care alone. All health-related quality of life dimensions were ameliorated except for sexual dimension. The positive affect persisted for six months after intervention.

• Risk of bias (no blinding)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• The intervention was applied in a research context that may be difficult to extend to clinical practice.
• Lost to follow-up in control group was ≥ 10%

Because many women with breast cancer are reluctant to take drugs for hot flashes, nurses can give educational and advice about the effectiveness of acupuncture. The self-care booklet may be a useful tool, but additional investigation of its validity in use with women taking medication for hot flash management is needed.