* application recommended in the treatment of arthrosis. "" application recommended in the treatment of hypertension.
the multi-vitamines, other treatment strategies were used without the knowledge of the medicals.
Another meta-analysis published by Kiene (1989, 1996) scored 41 trials. Sixteen of these studies were reported to have solidity, nine had questionable solidity, and sixteen had no solidity at all. Twelve of the 16 studies with solidity (involving bronchus carcinoma, colorectal carcinoma, mamma carcinoma, gastric cancer, femal genital cancer, and liver metastases) showed better results for the mistletoe groups in regard of survival time, quality of life, or pleurodesis in cases of malignant pleural effusions.
Cancer patients receiving subcutaneous mistletoe treatment commonly report an increase of their well-being with a feeling of "inner warmth" and improvement of social activity. By all means, the psychological effects of being "non-abandoned" and the recovery of self-determination by injecting the "hopeful drug" to themselves is hardly to be ignored. Anyway, a recent study (Heiny and Beuth, 1994) enrolling 68 patients with breast cancer (TNM stages III-IV) reported a significant release of f-endorphin by subcutaneous application of a VA-E normed on ML I (Eurixor) in those patients responding with local skin reactions (redness, swelling) or increased peripheral lymphocyte counts, indicating a modulation of neuroendocrine functions by the treatment.
In a preclinical study with brain tumour patients (e.g. glioblastoma multiforme) (Lenartz et al., 1996), tumour destructive therapy (neurosurgery, perioperative dexa-methasone treatment, and local radiotherapy) resulted in a significant decrease of peripheral blood cell counts. As compared to patients receiving standard therapy only, those patients treated with standard therapy and VA-E (Eurixor) subcutaneously revealed a significant improvement of peripheral T lymphocyte numbers (i.e. CD4+ T-helper cells and CD8+ T-suppressor/cytotoxic cells) within 12 weeks; however, 3 month later, the T cell numbers did not differ between both groups (Lenartz et al., 1996). Furthermore, VA-E treatment resulted in an improved of quality of life (as measured by Spitzer's standard questionnaire) 6 month after surgery.
In a prospectively randomised clinical study (Heiny et al., 1998) enrolling 79 patients with advanced colorectal cancer treated with standard chemotherapy (5-fluorouracil and folinic acid), the patients receiving chemotherapy and VA-E (Eurixor) showed a significant increase of their quality of life (as measured by "Functional Assessment of Cancer Therapy Scale V 3.0" questionnaire) not earlier than 12 weeks after the treatment, indicating that this effect may not due to a placebo effect which should occur in the early phase of the treatment. Furthermore, the duration of severity of mucositis was significantly reduced (Heiny et al., 1998). However, the frequency and length of remission, relapse-free interval or overall survival did not differ between control group and those treated additionally with VA-E.
Similarly, another study involving 20 patients with advanced colorectal cancer receiving standard chemotherapy and 20 patients treated with standard therapy and VA-E (Helixor) was also unable to verify significant differences in respect to the number of patients in complete or partial remission (Douwes et al., 1986). Although the response rates of both groups did not differ, the mean survival time of the responder receiving chemotherapy and VA-E was higher as compared to the responder receiving chemotherapy alone (Douwes et al., 1986), indicating that VA-E may have a beneficial effect by improving the quality of life.
Although survival time and survival rate did not significantly differ between the treatment groups in a randomised and controlled study on the treatment of patients with non-small cell lung carcinoma published by Dold et al. (1991), the well-being of cancer patients significantly increased in the VA-E group (Iscador) as compared to the controls.
In a prospective comparative study (Gutsch et al., 1988), patients were treated after radical mastectomy by different adjuvant therapies: 177 breast cancer patients were treated with conventional chemotherapy (CMF—cyclophosphamide, methotrexate, 5-fluorouracil), 192 patients with subcutaneously applied VA-E (Helixor), and 274 patients without chemotherapy or VA-E therapy. Here, the 5 year survival rate of CMF (67.7%) or VA-E (69.1%) treated patients was significantly higher as compared to the patients treated by mastectomy alone (59.7%). The survival rates of all patients treated with CMF or VA-E did not differ significantly. As compared to CMF or controls, however, the survival rate of VA-E treated patients was higher especially in those patients with more than 4 tumour-positive lymph nodes.
Intrapleural administration of mistletoe extracts is reported to result in pleurodesis in cancer patients with malignant pleural effusions (Salzer, 1977; Böck and Salzer, 1980; Böck, 1983a, b; Stumpf and Schietzel, 1994). In a recent study (Stumpf and Schietzel, 1994), 20 cancer patients with malignant pleural effusions were treated intrapleurally with VA-E. Regarding pleurodesis, the overall response rate was 72%, displaying only 1.2% side effects of WHO classification I. The decline of tumour cells in the effusion liquid correlated negatively with the number of instillations. The efficacy was suggested to be due to the cytostatic and immunomodulatory properties of the intrapleurally applied VA-E. Salzer and Popp observed an increase of eosinophil granulocytes, CD4+ T helper cells, and NK cells in the effusions (Salzer, 1986; Salzer and Popp, 1990), while others described a transient increase of macrophages and eosinophils, and a constant increase of CD8+ T cells (Stumpf and Büssing, 1997). Thus, VA-E-mediated pleurodesis might be due to a stimulation of antitumour immunity rather than mechanical sclerosis.
After intratumoural injections of VA-E, Koch (1993) described in animals local inflammation and subsequent degeneration of epithelial carcinoma within 7 to 10 d. Regarding this application in cancer patients, only a few case reports are published (Drees et al., 1996; Stumpf et at., 1997a; Mathes, 1997; Scheffler et al., 1996). These reports describe effective reduction of tumour volume. To clarify whether tumour regression by an intratumoural injection of VA-E will be of benefit for the patients, controlled clinical studies especially in colorectal cancer patients with liver dissemination are required.
In conclusion, an increase of life quality and well-being was one of the most consistent effects of subcutaneous treatment with VA-E, while an improvement of survival (reported preferentially in older reports) may depend on several aspects such as individual responsiveness, tumour status, drug concentration, and route of application. Intrapleural and intralesional injection of potent VA-E may have beneficial effects as the tumour cells may be attacked directly, whether by the toxic proteins from Viscum album and/or by VA-E-activated immune cells.
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