Prophylactic acupuncture treatment during chemotherapy with breast cancer: a randomized pragmatic trial with a retrospective nested qualitative study
This study investigated the effect of additional prophylactic acupuncture during chemotherapy on quality of life and side effects compared to standard treatment alone in breast cancer patients.
In a pragmatic trial, newly diagnosed breast cancer patients were randomized to additional acupuncture treatments over 6 months or standard care alone (control group). The primary outcome was the disease-specific quality of life (FACT-B). Twenty qualitative semi-structured interviews were conducted with ten patients from each group regarding their subjective experiences.
A total of 150 women (mean age 51.0 (SD 10.0) years) were randomized. For the primary endpoint, FACT-B total score after 6 months, no statistically significant difference was found between groups (acupuncture: 103.5 (95%, CI 88.8 to 107.2); control (101.4 (− 97.5 to 105.4); difference 2.0 (− 3.4 to 7.5) p = 0.458)). Qualitative content analyses showed that patients in the acupuncture group described positive effects on psychological and physical well-being. For both patient groups, coping strategies were more important than reducing side effects.
Breast cancer patients receiving prophylactic acupuncture during chemotherapy did not show better quality of life in the questionnaires in contrast to the reported positive effects in the qualitative interviews. Coping strategies for cancer appear to be important.
clinicaltrials.gov; NCT01727362. Prospectively registered 11 July 2012; https://clinicaltrials.gov/ct2/show/NCT01727362. The manuscript adheres to CONSORT guidelines.
KeywordsAcupuncture Breast cancer Quality of life Complementary medicine Pragmatic trial Comparative effectiveness research
All authors participated in developing the study design and protocol and in revising the manuscript. Specific tasks and responsibilities: study conventionalization and general trial coordination (CW, BB), statistical expertise and analysis (SR, SB), data management (SB), study intervention (BK), and overall medical responsibility (MC). All authors read and approved the final manuscript.
The study was kindly funded by a grant of the Dorit & Alexander Otto Foundation, Hamburg, Germany. The funder asked for a trial to explore the effectiveness of acupuncture in patients with breast cancer while receiving chemotherapy. The funder had no influence on the trial design, methodology, data analysis, or interpretation of the results.
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflicts of interest.
All procedures performed in the study were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards and with the local ethics review board (Ethic Committee of Medical Association Hamburg, Reference Number PV4002; June 2012). Because guidelines for chemotherapy treatment regime changed during the study and because of the inclusion of nested qualitative study, amendments were submitted and were approved in February 2014 and June 2016, respectively.
Research involving animal rights
This article does not contain any studies with animals performed by any of the authors.
Informed consent was obtained from all individual participants included in the study.
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