Beuth, J., Schneider, B., & Schierholz, J. M. (2008). Impact of complementary treatment of breast cancer patients with standardized mistletoe extract during aftercare: a controlled multicenter comparative epidemiological cohort study. Anticancer Research, 28, 523–527.

Intervention Characteristics/Basic Study Process

Data were acquired by the 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 cancer disease and treatment, disease-related symptoms and adverse effects experienced by the patients, and the course of the disease. Outcomes were assessed at yearly intervals until the end of the observation or treatment period.

Sample Characteristics

A total of 681 women with primary breast cancer were included.

Study Group

  • N = 167
  • Mean age was 55.11 years.
  • Statistically significant tendency to more severe diseases and higher disease stages
  • Most patients were receiving hormone therapy (71.9%), which was significantly more than the control group.

Control Group

  • N = 514
  • Mean age was 54.63 years.
  • The majority of patients were receiving hormone therapy (48.2%).

Patients were excluded if they received other mistletoe products except the study medication, if they suffered from a relapse or metastatic disease at the beginning of the postoperative treatment, or if a secondary malignancy was detected.

Setting

The study was conducted in 53 randomly selected hospitals or practices representatively distributed in Germany, including oncologists, gynecologists, and general practitioners.

Phase of Care and Clinical Applications

Unclear

Study Design

This was a controlled, multicenter, comparative, epidemiological, cohort study.

Measurement Instruments/Methods

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

Results

The complementary standardized mistletoe extract study group reported a statistically significant lower number of fatigue or tiredness symptoms compared to the control group during an aftercare period of about five years, with 0.6% versus 1.0% reporting fatigue symptoms for the study and control groups, respectively.