
Treatment o
iver
isease
ffects w
th regard to a certa
n therapeut
ca
m. Thus
n terms of the licensing regulations, the efficacy of a
dru
, includin
“liver thera
eutics”, ma
be defined a
t
ea
stract qua
ity o
me
icine to ac
ieve t
erapeuti
success with proper use, accidental and placebo success
avin
been excluded
K.J.
ennin
1978
T
eUSFoo
,
rug and Cosmet
c Act def
nes the term “eff
cacy”
n
imilar manner. • Mere proof of quality and safety i
ufficient for medicine that does not have be licensed
but onl
re
stered; no
roof of eff
cac
sre
u
red. Th
ppl
es to homoeopath
c remed
es, for example.
(
.) The eff
cacy of med
c
nal remed
es,
nclud
ng “l
ve
therapeutics”, may be regarded as a
ontinuum, i
fr
ver
wea
ig
potent
.
hus, efficac
is also
roven when the substance
s shown to be onl
sl
htl
effect
ve or
s only effect
ve
n some pat
ents (
nd
v
dual
ases). Principally (
xceptions are possible), proof o
efficac
is to be
rovided b
controlled clinical studies
No
roof of su
er
or
t
of the dru
under
nvest
at
o
over the standard preparat
on
s requ
redbylaw.No
oes the licensing procedure check whether there is
otential need for the dru
in
uestion
hus the aim of clinical studies is to provide proof o
sa
et
and a
ro
riate e
icac
. • However, it is essen-
a
to ensure t
e
ua
t
o
t
eran
om
ze
, contro
e
rials in every respect
(9
Principles of liver therap
3.1 Bas
c cons
derat
ons
First of all, two terms need rectif
in
, since th
su
erficial
et incorrect use of the desi
nation
r
herapy” an
protective therapy of the liver
have
rendered
t fundamentally more d
ff
cult to make
r
m
n
Th
rm
r
r
li
fr
m
h
e
ochs of s
eculative or em
irical thera
and con
t
tute the or
g
n of the catchword “therapeut
cn
h
l-
sm”. (s. tab. 40.1)
3.1.1 L
ver thera
here has never been and there st
ll
s not any “l
ve
thera
” in the true sense ⫺
nd no such thera
will
exist in future either. The liver as the lar
est biochemica
erformance centre of the bod
s constantl
act
ve
ome 11 ma
or metabol
c areas w
th 60
0
ntegrated
artial functions. In order to accom
lish the man
tasks, about 300 billion liver cells undertake a
rox. 50
b
omolecular react
ons da
l
ndeed an unbel
evable
eat. Consequently,
t
s not poss
ble for drugs to have
n
ff
n
h
liv
r
wh
l
hera
ies fo
l
v
r
rt
erapies
or
epato
ogica
symptoms are
W
th th
sl
ngu
st
c correctness, our therapeu-
75
t
c efforts
n hepatology become
ealistic
nd objectifi
able
There are far more than 100 liver diseases plus
ariants and diverse com
lications. A lar
e number of
hem can be treated successfull
w
th
harmacolo
cal
eg
men
somet
mes w
th str
k
ngly good result
ell as, of course, by invasive and surgical therapy
.1.2 L
ver thera
eut
ca
ents
n the str
ct l
ngu
st
c and hepatolog
cal sense, there
o such thing as liver therapeutic agents. How
v
hi
n
ortunate ter
sfre
uentl
and indeed deliberatel
used rhetor
call
n
ubl
cat
ons or for adm
n
strat
v
easons. Here, the express
o
“hepatic agents”
analo-
gous to cardiac, otologic and diuretic agents, etc.) woul
e more correct and not so
romisin
in the
o
ular
sense as the des
nat
on “l
ver thera
eut
ca
ents”. •
any case, one ought to be aware of the possible psycholog
ical e
ect o
such a term, especiall
with regard to
ace
o
.
s.
. 874
.1.3 Protect
ve thera
of the l
ve
imilarly, there is no generally protective therapy of the
liver. Liver “
rotection” as such ma
include active
acc
nat
on a
a
nst v
ral he
at
t
s A or B, for exam
le
and,
naw
der sense, also pass
ve
mmun
zat
on after
xposure or general avoidance of typical liver noxae
This can “
rotect” the liver from diseases
(16
n
n-v
tro
n
n-v
vo ex
er
ments
certa
n substance
can be stud
ed for the
r protect
ve effect on the hepato-
c
tes or endothelial cells
includin
biomembranes an
or
anelles
under the influence of various noxae or
tox
ns. Many su
stances
ave
een s
own to
isp
ay
is
tinct protective properties experimentall
under various
nvesti
ative con
itions.
uch studies are not
h
w
v
admissible in humans. • These ex
erimental
rotectiv
ropert
es may also be of therapeut
c value
n
nd
v
dual
cases (e.g. appl
cat
on o
ilibini
n Aman
ta po
son
ng)
A“l
ver-protect
ve preparat
on” must therefore be cap
able of
rotectin
the he
atoc
tes
as well as the sinu
ndothelium
from a
articular liver toxin, or from tw
to three clearly def
ned (or,
n the opt
mal case, all obl
gate) l
ver tox
ns
b
administration be
ore or, at the lat
st, w
en t
e
ama
e occurs. Th
f
n
i
xistin
cellular dama
e would be classified as “ther-
apy” and no longer “protect
on”. The term protect
ve
l
ver therapy clearly
mpl
es prophylax
h
ch, apar
from the above exce
tions
e.
. vaccination
, is usuall
ot feasible under the
rovisions of the res
ective health
nsurance system.
(16
3.2 Precond
t
ons
he
uestion of
rovabilit
of a certain thera
is als
de
endent on various
r
in he
atolo
:
1
now-
ledge of the spontaneous course of a l
ver d
sease (not