Folie 1 - nosomi.at

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Transcript Folie 1 - nosomi.at

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).
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Purpose of investigation:
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Are there side effects
when Taheebo-extract
is injected directly
into the prostate?
Are there risks for
incontinence ?
impotence ?
reoccurrence ?
metastasis ?

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Is prolongation of
remission possible?
Is there a positive
influence on quality of
life?
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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.
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Methode:
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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)
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being continued after
treatment (3)
male hormone blockage
after ECT+Taheebo, new
application (3)
Chemotherapy, operation
and radiation before
ECT+Taheebo application
(0).
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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
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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.
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Taheebo-extract

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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)
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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
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Results/結果
30 months Observation/経過観察期間30ヶ月

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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。
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Results/結果

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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。
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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
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Results:

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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.
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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
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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
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Summery/結論
ECT/Taheebo を
手術、化学療法、放射線治療と比較
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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
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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
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Summery/結論
ECT/Taheebo を
手術、化学療法、放射線治療と比較

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ECT/Taheebo 考慮点
Not yet approved method
Too small number of
patients with only 30
months of observation
Further investigations
necessary

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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
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Conclusion:
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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