Acupuncture as an integrative approach for the treatment of hot flashes in women with breast cancer: A prospective multicenter randomized controlled trial (AcCliMaT)

Grazia Lesi, Giorgia Razzini, Muriel Assunta Musti, Elisa Stivanello, Chiara Petrucci, Benedetta Benedetti, Ermanno Rondini, Maria Bernadette Ligabue, Laura Scaltriti, Alberto Botti, Fabrizio Artioli, Pamela Mancuso, Francesco Cardini, Paolo Pandolfi

Research output: Contribution to journalArticle

34 Citations (Scopus)

Abstract

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 selfcare 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-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P <.05). Conclusion: Acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.

Original languageEnglish
Pages (from-to)1795-1802
Number of pages8
JournalJournal of Clinical Oncology
Volume34
Issue number15
DOIs
Publication statusPublished - May 20 2016

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Hot Flashes
Acupuncture
Self Care
Randomized Controlled Trials
Breast Neoplasms
Quality of Life
Therapeutics
Acupuncture Therapy
Acupuncture Points
Pamphlets
Intention to Treat Analysis
Menopause
Safety
Health

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Acupuncture as an integrative approach for the treatment of hot flashes in women with breast cancer : A prospective multicenter randomized controlled trial (AcCliMaT). / Lesi, Grazia; Razzini, Giorgia; Musti, Muriel Assunta; Stivanello, Elisa; Petrucci, Chiara; Benedetti, Benedetta; Rondini, Ermanno; Ligabue, Maria Bernadette; Scaltriti, Laura; Botti, Alberto; Artioli, Fabrizio; Mancuso, Pamela; Cardini, Francesco; Pandolfi, Paolo.

In: Journal of Clinical Oncology, Vol. 34, No. 15, 20.05.2016, p. 1795-1802.

Research output: Contribution to journalArticle

Lesi, G, Razzini, G, Musti, MA, Stivanello, E, Petrucci, C, Benedetti, B, Rondini, E, Ligabue, MB, Scaltriti, L, Botti, A, Artioli, F, Mancuso, P, Cardini, F & Pandolfi, P 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, vol. 34, no. 15, pp. 1795-1802. https://doi.org/10.1200/JCO.2015.63.2893
Lesi, Grazia ; Razzini, Giorgia ; Musti, Muriel Assunta ; Stivanello, Elisa ; Petrucci, Chiara ; Benedetti, Benedetta ; Rondini, Ermanno ; Ligabue, Maria Bernadette ; Scaltriti, Laura ; Botti, Alberto ; Artioli, Fabrizio ; Mancuso, Pamela ; Cardini, Francesco ; Pandolfi, Paolo. / Acupuncture as an integrative approach for the treatment of hot flashes in women with breast cancer : A prospective multicenter randomized controlled trial (AcCliMaT). In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 15. pp. 1795-1802.
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abstract = "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 selfcare 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-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P <.05). Conclusion: Acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.",
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T2 - A prospective multicenter randomized controlled trial (AcCliMaT)

AU - Lesi, Grazia

AU - Razzini, Giorgia

AU - Musti, Muriel Assunta

AU - Stivanello, Elisa

AU - Petrucci, Chiara

AU - Benedetti, Benedetta

AU - Rondini, Ermanno

AU - Ligabue, Maria Bernadette

AU - Scaltriti, Laura

AU - Botti, Alberto

AU - Artioli, Fabrizio

AU - Mancuso, Pamela

AU - Cardini, Francesco

AU - Pandolfi, Paolo

PY - 2016/5/20

Y1 - 2016/5/20

N2 - 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 selfcare 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-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P <.05). Conclusion: Acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.

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