Acupuncture As an Integrative Approach for the Treatment of Hot Flashes in Women With Breast Cancer: A Prospective Multicenter Randomized Controlled Trial (AcCliMaT)

作者：Lesi Grazia, Giorgia Razzini, Muriel Assunta Musti, Elisa Stivanello, Chiara Petrucci, Benedetta Benedetti, Ermanno Rondini, Maria Bernadette Ligabue, Laura Scaltriti, Botti Alberto, Fabrizio Artioli, Pamela Mancuso, Francesco Cardini, Paolo Pandolfi · 发表于：Journal of Clinical Oncology · 年份：2016 · DOI：10.1200/jco.2015.63.2893 · 被引用次数：121 · 研究领域：Menopause: Health Impacts and Treatments、Acupuncture Treatment Research Studies、Cancer survivorship and care

PURPOSE: To determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer. PATIENTS AND METHODS: We conducted a pragmatic, randomized controlled trial comparing acupuncture plus enhanced self-care versus enhanced self-care alone. A total of 190 women with breast cancer were randomly assigned. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints. The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses. RESULTS: Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P < .001) and at 3- and 6-month post-treatm...