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 significanlty reduced persistant signs/symptoms of the disease/treatment during the validated aftercare period of approximately five years.