Prognosis following the use of complementary and alternative medicine in women diagnosed with breast cancer

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Summary

Objective

The purpose of this study was to assess whether CAM use affected breast cancer prognosis in those who did not receive systemic therapy.

Design

Secondary data analysis of baseline/survey data from the Women's Healthy Eating and Living (WHEL) study. 2562 breast cancer survivors participating in the study completed baseline assessments and a CAM use questionnaire. Cox regression models were conducted to evaluate the use of CAM modalities and dietary supplements on time to an additional breast cancer event (mean follow-up = 7.3 years).

Setting

A US-based multi-site randomized dietary trial.

Outcome

Time to additional breast cancer events.

Results

The women who did not receive any systemic treatment had a higher risk for time to additional breast cancer events (HR = 1.9, 95% CI: 1.32, 2.73) and for all-cause mortality (HR = 1.7, 95% CI: 1.06, 2.73) compared to those who had received systemic treatment. Among 177 women who did not receive systemic treatment, CAM use was not significantly related to additional breast cancer events. There were no significant differences between high supplement users (≥3 formulations per day) and low supplement users in either risk for additional breast cancer events.

Conclusion

The risk for an additional breast cancer event and/or death was higher for those who did not receive any systemic treatments; the use of dietary supplements or CAM therapies did not change this risk. This indicates that complementary and alternative therapies did not alter the outcome of breast cancer and should not be used in place of standard treatment.

Introduction

Improvements in breast cancer recurrence and survival have consistently been associated with the use of systemic cancer treatments (chemotherapy and anti-estrogen therapy) following surgery.1, 2, 3 Despite the effectiveness of these treatments, a significant proportion of women do not receive them.4, 5 A decision by the patient to decline treatment has been one of the primary reasons for the underuse of systemic treatment.5, 6 It is plausible that not all patients understand the impact of their decisions regarding treatment.5 Issues such as patient misunderstanding, or lack of information regarding the effectiveness of treatments, and fear of side effects have been associated with not pursuing these treatments.7, 8 Another potential factor is the untested belief that using alternative therapies and/or having a healthy lifestyle may be protective against cancer recurrence or death.9, 10, 11

Approximately 80% of breast cancer patients and survivors use some form of complementary and alternative medicine (CAM),12 which has been defined as a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine.13 Dietary supplements such as vitamins, minerals and herbals remain the most commonly used form of CAM.14, 15 Even though several studies have examined the prevalence and patterns of CAM use following a breast cancer diagnosis,16, 17, 18, 19, 20 few studies have reported the impact on breast cancer outcomes.21, 22 To date, the literature has suggested that there is insufficient evidence to determine the effect of CAM therapies on breast cancer prognosis.23 One small observational study (n = 33) that examined the use of biologically based CAM therapies as a primary treatment for breast cancer found that patients who used only CAM therapies had higher rates of recurrence and death than those who used standard treatment.24

Because the use of CAM therapies has been largely studied among breast cancer patients who have used conventional treatments, the impact of CAM use among women who have not received standard treatments is unknown. The Women's Healthy Eating and Living (WHEL) study provided a unique opportunity to investigate the potential risks or benefits of alternative therapies due to the extensive data collected on CAM use, including dietary supplements, as well as a large sample size and long follow-up. Since the WHEL dietary intervention did not affect prognosis,25 the trial participants were treated as a cohort of breast cancer survivors. The purpose of this study was to determine whether CAM use, including dietary supplements, was associated with risk for additional breast cancer events and death among those women who did not receive any systemic cancer therapies.

Section snippets

Study design and participants

This project was part of a large multisite clinical trial investigating the efficacy of a dietary intervention to reduce risk for breast cancer recurrence. The WHEL study enrolled participants at seven clinical sites between 1995 and 2000; the institutional review boards at each site approved the protocol and all participants provided written, informed consent. Details of the study protocol are described elsewhere.26 Major eligibility criteria included diagnosis within the past 4 years of

Results

The WHEL study included 177 participants who did not receive systemic therapy following a breast cancer diagnosis. As shown in Table 1, if participants did not get systemic therapy, then the risk of an additional breast cancer event increased by 90% (HR = 1.9, 95% CI: 1.32, 2.73), and the risk of death increased by 70% (HR = 1.7, 95% CI: 1.06, 2.73). Participant characteristics differed slightly depending on the receipt of systemic therapy. Women who did not receive systemic treatment were less

Discussion

Our results demonstrated that breast cancer events and death were more likely for those who did not receive any systemic treatment and using dietary supplements or additional CAM therapies did not change the risk for either outcome. Our first finding was in congruence with earlier studies that have shown that those who did not receive adequate systemic treatment were at a higher risk of recurrence.3, 32, 33 Studies have suggested that prognosis was better for women who had a combination of

Conflict of interest

All the authors declare that there are no conflicts of interest for this paper.

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    The Women's Healthy Eating and Living (WHEL) study was initiated with the support of the Walton Family Foundation and continued with funding from NCI grant CA 69375. Some of the data were collected from General Clinical Research Centers, NIH grants M01-RR00070, M01-RR00079, and M01-RR00827. Research related to the development of this paper was funded with support from NRSA National Center for Complementary and Alternative Medicine Fellowship Award 5F31AT004652-02.

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