Even though the majority of breast cancer patients in the United States use complementary therapies, there has been a lack of evidence-based resources to help guide both clinicians and patients about their safety and effectiveness.
The Society for Integrative Oncology (SIO) has now published the first clinical practice guidelines on integrative therapy in breast cancer, which allow specific therapies to be recommended as evidence-based supportive care options.
The guidelines have been published in the Journal of the National Cancer Institute Monographs.
The multidisciplinary team of authors evaluated more than 80 different types of therapies and 30 interventions for safety and efficacy, including acupuncture, food supplements, yoga, and meditation. A modified version of the US Preventive Services Task Force (USPSTF) grading system was used to develop and grade recommendations.
"This allowed us to use a standard tool to measure the strength of the data," said guideline first author Heather Greenlee, ND, PhD, assistant professor of epidemiology at Columbia's Mailman School of Public Health in New York City and president of the Society for Integrative Oncology.
Few Score Grade A or B
Only meditation, yoga, and relaxation with imagery got top marks with grade A recommendations for routine use for common conditions such as anxiety and mood disorders.
These therapies also received a B grade for reducing stress, depression, and fatigue, as did acupuncture for controlling chemotherapy-induced nausea and vomiting. Music therapy and massage also got B recommendations for reducing anxiety and mood disturbances.
Many of the interventions (n = 32), including laser therapy for lymphedema, acupuncture for hot flashes, and Qigong for improving quality of life, had weaker evidence of benefit (grade C), primarily owing to small study sizes or conflicting evidence in the literature.
A few interventions (n = 7), such as aloe vera gel to prevent or treat acute skin reaction to radiation and guarana as an herbal for the treatment of fatigue, were deemed unlikely to provide any benefit and received a grade of D and are not recommended.
In addition, one therapy was found to be harmful and was given a grade H. "We found that acetyl-l-carnitine, which is marketed to prevent chemotherapy-related neuropathy, was shown to actually increase the risk," Dr Greenlee told Medscape Medical News.
A number of interventions did not have sufficient evidence to support any specific recommendations. They require further investigation through well-designed controlled clinical trials, she explained. "We were also unable to assess most dietary supplements and herbs, as there's not much evidence available. So we could not make any recommendations on those."
The only botanicals included in the guideline were ginseng for fatigue, ginger for chemotherapy-related nausea/vomiting, and mistletoe to improve quality of life (all grade C). Even though some of the natural products had sufficient efficacy data, they lacked long-term safety information and could not be given a higher grade.
The authors note that grade C interventions represent areas in which there is a greater need for additional study, and as such, the use of these modalities require "shared decision making between patients and providers, a discussion of the risk-benefit for all available treatments, and monitoring for efficacy, futility, and harm and balanced against the availability of conventional treatments."
Table. Grade A and B Recommendations
|Modality||Clinical Application||Strength of Evidence|
|Meditation||Recommended for treating mood disturbance and depressive symptoms in patients undergoing radiation therapy||A|
|Recommended for improving quality of life||A|
|Recommended for reducing anxiety in breast cancer patients and in those undergoing radiation therapy||B|
|Relaxation||Recommended for improving mood and depressive symptoms when added to standard care||A|
|Yoga||Recommended for improving mood in women undergoing radiation therapy and/or chemotherapy, and for fatigue in addition to standard care||A|
|Recommended for improving anxiety in the same group of patients (see above)||B|
|Massage||Recommended for improving mood disturbance posttreatment||B|
|Music therapy||Recommended for improving mood in newly diagnosed patients||B|
|Recommended for reducing anxiety during radiation and chemotherapy||B|
|Stress management||Recommended for reducing anxiety during treatment||B|
|Energy conservation||Recommended for treatment of fatigue||B|
|Acupressure||Can be considered for patients receiving chemotherapy as an addition to antiemetics to help control nausea and vomiting||B|
|Electroacupuncture||Can be considered for patients as an addition to antiemetics to control vomiting during chemotherapy||B|
This is the third guideline that the SIO has published, but it is different from the others, explained Dr Greenlee. "This one is organized by the clinical application, which makes it much more useable for patients and clinicians," she told Medscape Medical News. "You can go look for a symptom, such as depression or nausea, and then see what has been shown to be the most effective treatment."
To prepare the guidelines, Dr Greenlee and her coauthors conducted a systematic review to identify randomized controlled trials that studied the use of integrative therapies for supportive care in patients receiving breast cancer treatment. They identified 4900 research articles from 1990 through 2013, and of those, 203 met the criteria for inclusion.
The patient populations in the studies were undergoing a variety of cancer treatments, including surgery, chemotherapy, radiation therapy, and hormonal therapy. Specific considerations that can affect the recommendation of complementary and integrative therapies include the stage of disease, the overall goal of anticancer therapy, whether integrative therapies are given concurrently with anticancer therapy, and whether there is potential for interactions and known toxicity of specific anticancer therapy, the authors note.
"A challenge in assessing the safety and effectiveness of complementary therapies was the lack of standardization of interventions across trials using similar therapeutic approaches," said guideline coauthor Debu Tripathy, MD, professor and chair of breast medical oncology at MD Anderson Cancer Center in Houston, Texas, in a statement. "In addition, some integrative therapies are applied in a variety of settings ― early vs advanced stages of disease and a spectrum of symptom severity ― such that the clinical criteria for using some therapies may not be straightforward."
Funding was provided by the Society for Integrative Oncology. The authors report no relevant financial relationships.
J Natl Cancer Inst Monogr. 2014;50:346–358. Full text
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Cite this: First Guidelines on Integrative Therapy in Breast Cancer - Medscape - Nov 06, 2014.