18.7.2004 Internationales Forum zur Anwendung von Taheebo Osaka / Japan www.nosomi.at ZENTRUM NOSOMI ALLGEMEINMEDIZIN, ONKOLOGIE, NATURHEILVERFAHREN ÄRZTLICHE LEITUNG: Dr.Dr. HELMUT BACOWSKY 1200 Wien, Sachsenplatz 9/30 Tel.: +43 1 330 85 62, Fax: +43 664 507 81 82 E-Mail: [email protected] www.nosomi.at Short Report on Intratumoral Application of Taheebo Extract in Combination with ECT (Electro-Chemical-Therapy) in 18 Patients suffering from Cancer of the Prostate www.nosomi.at Bacowsky H. Cancer of the prostate Incidence: Austria 2000: 4.925 patients EU: 42,61 cases / 100.000 inhabitants Mortality: 14,65 /100.000 (Statistic Austria, Gesundheitsbuch 2002). www.nosomi.at Purpose of investigation: Are there side effects when Taheebo-extract is injected directly into the prostate? Are there risks for incontinence ? impotence ? reoccurrence ? metastasis ? Is prolongation of remission possible? Is there a positive influence on quality of life? www.nosomi.at This investigation is based on individual cases, no exclusions have been performed Each patient was informed thoroughly and in detail about risks concerning side effects, prognosis, relapse and possibility of metastasis compared with established therapies like operation, radiation, brachytherapy, hormonblockade. www.nosomi.at Methode: 18 patients, mean age 70,2 years (max.96 min. 51years ) with prostate cancer, verified by biopsy Gleason score, mean 5,1 ranging from 3 to 7 Bone metastasis present before treatment (3) Male hormone blockage before ECT+Taheebo application (3) being continued after treatment (3) male hormone blockage after ECT+Taheebo, new application (3) Chemotherapy, operation and radiation before ECT+Taheebo application (0). www.nosomi.at Status before treatment n = 18 Age Gleason mean 70,2 5,1 min. 51 3 max. 96 7 Hormon blockage 3 Meta stasis 3 Chemo therapy 0 Operation/ Radiation 0 www.nosomi.at ECT (Electro-ChemicalTherapy) ECT: In the case of initial or progressed cancer of the prostate ECT provides a possible effective minimal invasive treatment using electricity provided by a DCdevice. After local anaesthesia 2 electrodes made out of platin are inserted via the perineum into the prostate. Then a currency of 7-7.5 Volt is administered for about 40-50 minutes depending on the size of the prostate. At the end of treatment the electrodes are removed. Sideeffects like mild haematuria or impairment of urination can be possible, but as we have seen in more than 57 patients so far, these side effects happened only in 2 cases. www.nosomi.at Taheebo-extract was prepared by boiling down 30g Tabebuia av. powder (provided by Taheebo Japan Co.) with 500 ml water in a glass jar for 40 minutes. Decoct and sediment was transferred into 10 ml vials, which were then sterilised at 120ο C for 2 hours. Probes were tested on bacterial contamination (ARGE Graz) and analysed for content of Furan-Naphtochinon (Laboratories of Kyoto Prefectural University of Medicine). Each 10 ml vial contained 25mg Furan-Naphtochinon Immediately after ECT platin electrodes were removed and via syringe 5-10ml Tabebuia-extract was injected directly into the prostate PSA-levels were determined before treatment and every 6-8 months after therapy, sonographic and physical examination were done and Quality of life assessed by using a standard questionnaire (TOC) www.nosomi.at Results: side effects N=18 33% days after allergic Treatment reaction 0-1 0 1 to 2 0 ≥2 total 0 0 17% mild mild sensation fever 6 6 6% urination blockage 0 3 0 3 0 0 days of necessary inflammation treatment 1 10 0 1 10 www.nosomi.at Results/結果 30 months Observation/経過観察期間30ヶ月 3 patients out of 18 died, two patients due to additional chemotherapy performed in another clinic, 25 months and 30 months after ECT/Taheebo, one died of old age. 18 症例中3人死亡。そのうち2人は、他の病院で化学療法を受けたこ とが原因。通電治療とタヒボ注入後、25ヶ月と30ヶ月生存。もう1人は、 老衰による。 6 patients underwent therapy with male hormone blocking agent 6症例はホルモン遮断剤の治療を受けた。 3 already some time before treatment, because 2 out of 3 had bone metastasis 3症例は通電治療とタヒボ注入前にホルモン遮断剤を受けた。そのうち の2人は既に骨転移が認められていた。 www.nosomi.at Results/結果 3 received hormone blockade immediately after ECT/Taheebo. 3症例は、通電治療とタヒボ注入直後、予防としてホルモン療法を行った。 15 patients are still alive, no relapse or bone metastasis in those patients who had none before treatment, no marked progression in those 2 patients with bone metastasis who were treated by hormone blockade and biphosphonate infusion at regular interval. One patient with bone metastasis before ECT/Taheebo therapy is stable with only slow progress observed, neither treated with a hormone blocking agent nor receiving biphosphonate infusions. 15症例 全て生存中、治療前に再発、骨転移のなかった患者は、その 状態を保っている。骨転移のあった2人の患者は治療後、顕著な進行を 認めていない。 12 patients without new metastasis during 30 months of observation. 12症例では、新たな骨転移は認められない。 www.nosomi.at Results: psa Mean PSA level before/after ECT+Taheebo injection 25,00 20,00 15,00 10,00 5,00 0,00 PSA m 30 m 24 r te af r te af r te af r te af m 12 6m re fo be t=months www.nosomi.at Results: Individual PSA-levels differ in a wider range, elevation can be observed 4-6 months after treatment, due to manipulation of the prostate, dropping then or also rising again after 6-8 months, though no visible metastasis are detectable in bones by szintigraphy. In those cases an examination by PET and molecular genetic evaluation of minimal residual cancer cells in peripheral blood will be done in a next step. www.nosomi.at Results: Individual PSA level performance ECT/Taheebo 10ml 11.12.01 Androgenblockage since 5/02 17,00 14,80 15,30 12,00 t 5,00 t www.nosomi.at Mai 04 Mrz 04 Jan 04 Nov 03 Sep 03 Jul 03 Mai 03 Mrz 03 Jan 03 Nov 02 0,00 Sep 02 11,29 Jul 02 10,10 Mai 02 0,10 1,40 5,15 Mrz 02 0,10 Jan 02 0,19 11,00 10,00 Nov 01 psa 51,50 40,00 34,10 32,70 20,00 0,00 18,00 15,00 Au g0 Ok 1 t De 01 z F e 01 b0 Ap 2 r0 Ju 2 n Au 02 g0 Ok 2 t De 02 z F e 02 b0 Ap 3 r0 Ju 3 n Au 03 g0 Ok 3 t De 03 z F e 03 b0 Ap 4 r0 Ju 4 n0 4 PSA 60,00 20,00 68,00 Sep 01 80,00 ECT/Taheebo 5ml 19.11.01 Results: ml ECT/Taheebo 10ml 11.12.01 Change in Prostate-Volume 60 50 40 30 20 10 0 47 48 39 24 02 z 02 i 02 l 02 02 02 03 z 03 i 03 l 03 03 03 04 z 04 i 04 n r a Ju ep ov an r a Ju ep ov an r a Ja M M J M J M M M N N S S t www.nosomi.at Summery/結論 ECT/Taheebo を 手術、化学療法、放射線治療と比較 ECT/Taheebo 利点 Nearly pain free treatment No severe side effects No allergic reactions No impairment of libido and sexual function No incontinence No hospitalisation Patient is mobile immediately after treatment able to work within the next day low cost compared to operation, radiation ほとんど痛みを伴わない治療 ほとんど副作用を伴わない アレルギー反応なし 性欲、性機能を損なわない 失禁がない 外来治療のみ 治療後、即、動ける 翌日から仕事 復帰可能 治療費が安価 www.nosomi.at Summery/結論 ECT/Taheebo を 手術、化学療法、放射線治療と比較 ECT/Taheebo 考慮点 Not yet approved method Too small number of patients with only 30 months of observation Further investigations necessary 公に認可された治療法で はない 症例が少なく、経過観察の 期間も短い、30ヶ月のみ 今後も研究が必要 www.nosomi.at Conclusion: Prospective follow ups of patients of this pilot study are planned Data will be compared with patient´s treated with other methods Future investigations are planned to see, wether a combination of one or multiple injections in a certain interval combined with oral administered Taheebo can be helpful to suppress cancer growth in the prostate. Further Investigations will be directed using Taheebo extract in cell cultures on different wild type human cancer cell strains to show a possible direct cytostatic effect To elucidate the potential of Taheebo extract as an apoptosis inducing agent on a moleculargenetic level enhancing BAX protein reducing Bcl2 gene expression reducing MDR-RNA levels in vivo, minimising drug resistance, implementing the possibility of lower dosage of toxic chemo therapeutics. www.nosomi.at ZENTRUM NOSOMI ALLGEMEINMEDIZIN, ONKOLOGIE, NATURHEILVERFAHREN ÄRZTLICHE LEITUNG: Dr.Dr. HELMUT BACOWSKY 1200 Wien, Sachsenplatz 9/30 Tel.: +43 1 330 85 62, Fax: +43 664 507 81 82 E-Mail: [email protected], www.nosomi.at
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