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    Tumorous Diseases
      • Human Investigations
        - Prostate Tumor
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Prostate Tumor

In order to investigate the anticancer effect of DDW in humans a four-month long double-blind phase II placebo controlled clinical trial was conducted on prostate cancer. The primary outcome was the best response, and the agent’s safety was also assessed. Forty-four patients were evaluated in the Intention-to-Treat analysis (ITT Population), 22 patients were involved in the treated and 22 patients in the placebo group, both groups received the same forms of conventional treatment. In addition, beside the 44 evaluated patients in the phase II clinical trial, the course of the disease was also retrospectively evaluated in 91 patients consuming DDW parallel with the conventional forms of treatments.

Summarizing the changes in prostate volume during the 4 months’ period of the trial in the treated group a net decrease of 160.3 cm3 was achieved, on the contrary, the result was 54 cm3in the control group. Urination complaints ceased in 8 patients of the treated group, but none of the patients experienced changes in their complaints in the placebo group (p=0.0041).

During the extended follow-up of the 44 patients, in the first year (from the date of entering the trial), 2 patients (9.1%) died in the treated group and 9 patients (40.9%) in the placebo group (significantly lower mortality in the treated group; Fisher’s Exact Test, p=0.034).
Investigating the patients with distant metastasis developed within one year after the diagnosis, the median survival time (MST) was 5.4 year compared to other studies with progressive metastatic prostate cancer showing 15-20 months long MST.

The results suggest that DDW might reduce the mortality of prostate cancer, since it was able to delay progression as well as to prolong MST in patients with histologically confirmed prostate cancer.

References:
Somlyai G., Molnár M., Laskay G., Szabó M., Berkényi T., Guller I., Kovács A. (2010) Orvosi Hetilap 151(36):1455-1460
G. Somlyai, A. Kovács, I. Guller, Z. Gyöngyi, K. Krempels, I. Somlyai, M. Szabó, T. Berkényi, M. Molnár (2010) European Journal of Cancer 8(5):208
G. Somlyai (2001) Komplementer Medicina/Journal of Complementary and Alternative Medicine V(4):28-31
G. Somlyai, G. Jancsó, Gy. Jákli, T. Berkényi, Z. Gyöngyi, I. Ember (2001) Anticancer Research 21:1617
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