title: Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial.
abstract: The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.
authors.affiliation: Institute for Complementary and Integrative Medicine, University Hospital Zurich and University Zurich, Sonneggstr. 6, 8091, Zurich, Switzerland, claudia.witt@uzh.ch.
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
authors.forename: Oskar
authors.initials: O
authors.lastname: Außerer
authors.forename: Susanne
authors.initials: S
authors.lastname: Baier
authors.forename: Herbert
authors.initials: H
authors.lastname: Heidegger
authors.forename: Katja
authors.initials: K
authors.lastname: Icke
authors.forename: Oswald
authors.initials: O
authors.lastname: Mayr
authors.forename: Manfred
authors.initials: M
authors.lastname: Mitterer
authors.forename: Stephanie
authors.initials: S
authors.lastname: Roll
authors.forename: Gilbert
authors.initials: G
authors.lastname: Spizzo
authors.forename: Arthur
authors.initials: A
authors.lastname: Scherer
authors.forename: Christian
authors.initials: C
authors.lastname: Thuile
authors.forename: Anton
authors.initials: A
authors.lastname: Wieser
authors.forename: Lena
authors.initials: L
authors.lastname: Schützler
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis / Q000628:therapy*; D003131:Combined Modality Therapy; D000529:Complementary Therapies / Q000009:adverse effects / Q000379:methods; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011788:Quality of Life; D012307:Risk Factors; D016896:Treatment Outcome