Mistletoe Extract

Mistletoe Extract

PEP Topic 
Fatigue
Description 

Mistletoe extracts have been applied to patients with cancer for claimed cytotoxic effects. Mistletoe has been discussed for its potential effect on fatigue.

Effectiveness Not Established

Research Evidence Summaries

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.

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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.

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.

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Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

Patients were undergoing the active treatment phase of care.

Study Design:

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

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 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).


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