Impact of complementary treatment of breast cancer patients with standardized mistletoe extract during aftercare: a controlled multicenter comparative epidemiological cohort study.

OBJECTIVES To investigate the safety and efficacy of complementary treatment of breast cancer patients with the standardized mistletoe extract (sME) HELIXOR in routine practice during aftercare through a multicenter comparative epidemiological cohort study with 53 randomly selected hospitals/practices representatively distributed in Germany, including oncologists, gynaecologists and general practitioners. PATIENTS AND METHODS Data from 741 screened patients fulfilling the inclusion/exclusion criteria were checked. Of these, 681 patients were eligible for the final analysis of the study group (with sME n = 167) and the control group (n = 514). Efficacy (development of disease/therapy-induced signs and symptoms; quality of life) and safety (number and severity of adverse events) of complementary treatment in breast cancer patients treated with sME in the aftercare period were determined. RESULTS Complementary treatment of breast cancer patients with sME during the aftercare period of approximately 5 years after terminating recommended standard therapies resulted in significantly fewer (p < 0.001) complaints of patients (56.3% study group versus 70.0% control group). The reduced number of disease/therapy-related sign/symptoms (e.g. mucositis, fatigue, pain, headache) correlated to a significantly improved quality of life. Adverse drug reactions to the sME treatment were mostly mild and self limiting. CONCLUSION Complementary treatment with the sME HELIXOR proved to be beneficial for breast cancer patients since it significantly improved quality of life and significantly reduced persistant signs/symptoms of the disease/treatment during the validated aftercare period of approximately five years.