Trial of Essiac to ascertain its effect in women with breast cancer (TEA-BC).

BACKGROUND Breast cancer is a major cause of morbidity, mortality, and medical expenditures among women in Canada. Essiac (Resperin Canada Limited, Waterloo, Ontario, Canada), a blend of at least four herbs (burdock root [Arctium lappa], Indian rhubarb [Rheum palmatum], sheep sorrel [Rumex acetosella], and the inner bark of slippery elm [Ulmus fulva or U. rubra]), has become one of the more popular herbal remedies for breast-cancer treatment, secondary prevention, improving quality of life, and controlling negative side-effects of conventional breast-cancer treatment. OBJECTIVES Our primary objective was to determine the difference in health-related quality of life (HR-QOL), as assessed by the Functional Assessment of Cancer Therapy Breast Cancer Version, between women who are new Essiac users (since breast cancer diagnosis) and those who have never used Essiac. Secondary endpoints included differences in depression, anxiety, fatigue, rate of adverse events, and prevalence of complications or benefits associated with Essiac during standard breast-cancer treatment. Additionally, we described the pattern of use of Essiac in this cohort of women. METHODS We performed a retrospective cohort study in 510 women, randomly chosen from the Ontario Cancer Tumour Registry, with a diagnosis of primary breast cancer in 2003. RESULTS With the exception changes in a Physical well-being subscale and a relationship with doctor subscale, Essiac did not have a significant effect on HR-QOL or mood states. Even for Physical well-being and relationship with doctor, Essiac seemed to have a negative effect, with Essiac users doing worse than the non-Essiac users. This might be attributed to the fact that the group of users comprised younger women with more advanced stages of breast cancer, and both of these subgroups of patients have been shown to be at a significantly increased risk for negative mood states and/or a decreased sense of well-being. The women were taking low doses (total daily dose 43.6 +/- 30.8 mL) of Essiac that corresponded to the label directions found on most Essiac products. Friends were the most common source of information, and most women were taking Essiac to boost their immune systems or increase their chances of survival. Only 2 women reported minor adverse events, whereas numerous women reported beneficial effects of Essiac. CONCLUSIONS Essiac does not appear to improve HR-QOL or mood states. Future studies are needed to determine whether other clinical outcomes, such as cancer reoccurrence, are affected by Essiac.