Schumacher, K., Schneider, B., Reich, G., Stiefel, T., Stoll, G., Bock, P. R., . . . Beuth, J. (2003). Influence of postoperative complementary treatment with lectin-standardized mistletoe extract on breast cancer patients. A controlled epidemiological multicentric retrolective cohort study. Anticancer Research, 23, 5081–5087.

Data were retrieved by investigators from the patients’ medical records at each of the study centers and were transferred to a standardized case report form (CRF). Data collected included patient demographics, characteristics of the tumor disease, treatments, signs, symptoms, side effects experienced by patients, and the course of the disease. For each symptom, a patient was included in the analysis if the symptom was present either at the beginning and/or the end of postoperative treatment, and if an assessment was available for both time points. The primary target criterion was the change in symptom score between the start and end of postoperative treatment.

• The sample was comprised of 689 women with primary breast cancer.
• The therapy group was comprised of 219 patents (mean age = 60 years [range 33–92]). The majority had stage IIa (26.5%).
• The control group was comprised of 470 patients (mean age = 64 years [range 35–90]). The majority had stage IIa (29.4%).
• Patients were excluded if they were taking any other complementary medication except standardized mistletoe extract, suffered from a relapse or developed metastasis at the beginning of the postoperative treatment, or if a secondary malignancy was detected.

The study included seven study centers randomly identified in Germany (hospitals and general or specialized practitioners).

Patients were undergoing the active treatment phase of care.

This was a controlled, epidemiologic, multicentric, retrolective, cohort study with parallel groups.

Data were collected on CRFs in which, prior to data collection, the data elements required for the study were identified and defined.

The mean change in fatigue symptom scores during the postoperative study period was significantly larger (beneficial) in the therapy group compared to the control group (p < 0.0001). The adjusted odds ratios for fatigue in treatment/control was 7.33. A multivariate analysis of the combined symptom score was calculated in accordance to Wei-Lachin and proved a significant superiority of the therapy group (p = 0.0001).