Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 125–6
To evaluate the therapeutic efficacy and safety of long-term adjuvant therapy of early stage breast carcinoma patients with the standardised mistletoe extract Iscador administered concurrently with conventional oncological treatment (test group), and compared with conventional therapy alone (control group).
In a multicentre, comparative, retrolective, epidemiological cohort study in randomly selected centres, Iscador was subcutaneously administered in addition to conventional chemo-, radio-, or hormone therapy with a follow-up of at least 3 years or until death. The endpoint criteria were: adverse drug reactions (ADR) attributed to conventional therapy, disappearance of treatment and disease-associated symptoms, adjusted tumour-specific survival, and time to distant metastases. Safety was assessed by the number of patients with Iscador-attributed ADRs. All results were adjusted for baseline imbalances and potential confounders.
A total of 1442 patients, (710 vs. 732) from 16 centres were eligible. At baseline, the test group had a more advanced disease and worse prognostic factors profile. After a mean follow up of 72 vs. 67 months, and 56 months of Iscador treatment, 16.2% of the test patients and 54.0% of the control patients developed ADRs attributed to the conventional therapy (adjusted odds ratio 0.47 (0.32–0.67), P = 0.000). The test group was significantly superior with respect to complete symptom relief, improvement of Karnofsky-index (P < 0.01), showed a longer tumour-specific survival (adjusted hazard ratio = 0.2 (0.04–0.90), P = 0.036), and no significant difference in the time to metastatic disease. In the test group, 0.8% experienced mostly mild systemic and 17.3% local Iscador-attributed ADRs that all resolved.
In the present study the adjuvant Iscador therapy was associated with significantly fewer ADRs caused by the concurrent conventional therapy, better quality of life, significantly longer tumour-specific survival and no difference in the time to metastatic disease. Iscador treatment was well tolerated with more local than systemic ADR that all resolved. These results suggest clinically relevant efficacy and safety of adjuvant Iscador in the therapy of early stage breast carcinoma.
