Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus u

1: Eur J Med Res. 2008 Mar 31;13(3):107-20. Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus uteri cancer patients with a mistletoe preparation (Iscador). Grossarth-Maticek R, Ziegler R. Institute for Preventive Medicine, Heidelberg, Germany. BACKGROUND: Mistletoe preparations such as Iscador are in common use as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. Efficacy of this complementary therapy is still discussed controversially. OBJECTIVE: Does the long-term therapy with Iscador show any effect on survival or psychosomatic self-regulation of patients with corpus uteri cancer? PATIENTS AND METHODS: Prospective recruitment and long-term follow-up in the following 4 controlled cohort studies. (1) Two randomized matched-pairs studies: corpus uteri cancer patients without (30 pairs) and with distant metastases (26 pairs) that never used any kind of mistletoe therapy were matched for prognostic factors. By pairwise random allocation, one of the patients was suggested mistletoe therapy to be applied by the attending physician. (2) Two non-randomized matched-pairs studies: corpus uteri cancer patients without (103 pairs) and with distant metastases (95 pairs) that already received mistletoe (Iscador) therapy were matched by the same criteria to control patients without Iscador therapy. RESULTS: Concerning overall survival in the randomized studies, a significant effect in favour of Iscador therapy was present only in the first study, the second showed no evidence for an effect: estimate of the hazard ratio and 95% confidence interval: 0.36 (0.16, 0.82) and 1.00 (0.46, 2.16) respectively. In the non-randomized studies, the results that adjusted for relevant prognostic variables were: 0.41 (0.26, 0.63), and 0.61 (0.39, 0.93). The effect of therapy with Iscador within 12 months on psychosomatic self-regulation as a measure of autonomous coping with the disease shows a significant rise in the Iscador group against the control group in the randomized as well as in the non-randomized study on patients with corpus uteri cancer without metastases: estimate of the median difference and 95% confidence interval: 0.40 (0.15, 0.70) and 0.70 (0.25, 1.15) respectively. CONCLUSION: The mistletoe preparation Iscador in these studies has the effect of prolonging overall survival of corpus uteri cancer patients. Psychosomatic self-regulation as a measure of autonomous coping with the disease, rises significantly more under Iscador therapy than under conventional therapy alone.