cough syrup

TRANSLATION
NaturaMed
Offprint
Efficacy and tolerance of ivy extract in patients
suffering from respiratory tract diseases
M. Hecker
KIRCHHEIM
OFFPRINT FROM NATURAMED 14 (1999) NR.2, S. 28-33, © KIRCHHEIM-VERLAG MAINZ, TEL. (06131) 9 60 70 16
„
BRONCHITIS
Efficacy and tolerance of ivy extract
in patients suffering from
respiratory tract diseases
M. Hecker
In 2 post-marketing observation trials the efficacy and tolerance of a special dried ivy leaf
extract (Prospan®) in various forms of administration (cough syrup and effervescent cough
tablets) were determined in a total of 248 patients who were suffering from inflammatory
diseases of the respiratory tract. Therapy proved to be effective and very well tolerated,
whereby the results of controlled clinical studies with a larger range of administration were
confirmed.
nary function in patients
product
an
suffering from bronchial
anti-
asthma, to be clinically
has
The dried ivy leaf extract,
expectorant
manufactured
obstructive effect due to
clearly
to a special procedure,
its
and
significantly better than
used for the studies is an
bronchspasmolytic
pro-
placebo (5). Furthermore,
expectorant, which has
perties. The efficacy and
it
been on the market for
very good tolerance of the
aqueous preparations for
more than 25 years. This
various
oral administration have
expectorant is adminis-
administration has been
to
tered
proved
mately 2.5 higher than
to
according
adults
and
and
secretolytic
forms
of
through
the
and
was
be
statistically
proved
dosed
that
approxi-
children of every age with
results of clinical studies
ethanolic
the
(1-5). In a double-blind,
administration (2,4,6).
catarrh of the respiratory
placebo-controlled
The
tract
the
indication
“acute
accompanied
by
special
trial,
extract
forms
recommended
dosages
for
coughing,
symptomatic
proved, with regard to an
corresponding
treatment
of
improvement in pulmo-
rations
chronic
bronchial diseases“. The
adjusted.
of
were
the
prepatherefore
„
BRONCHITIS
Far-reaching findings as
Efficacy was assessed by
included
to
the doctor and noted on a
documentation.
the
efficacy
and
4-level
scale
from
tolerance
of
these
dosages
from
daily
“symptom-free“ to “wor-
medical practice should
sened“, with reference to
be documented in the
symptoms
and
signs.
in
the
Inclusion criteria
• Patients of both sexes
suffering from inflammatory
and /or ob-
structive diseases of
the respiratory tract.
Fig. 1: Overall assessment of efficacy by physician
100
85,9
90
1: very good / good
2: moderate
3: poor
4: no information
Nr. of assessments (%)
80
70
• Effervescent
cough
tablets: age ≥ 4 years
• Cough syrup: age 0-9
years
60
Exclusion criteria
50
• Treatment
with
an-
40
other expectorant or
30
antitussive
• Known fructose into-
20
6,2
6,1
10
5
lerance (due to the
0
content of sorbitol)
1
2
3
4
• Intolerance to one of
the components
present
post-marketing
Individual
dosages
as
well as the duration of
observation trials.
treatment were recorded
Methods
The open, multicentrically
as additional parameters.
designed post-marketing
The
observation trials, without
tolerance resulted from
control
the occurrence of adverse
groups,
were
assessment
tract
(bronchial
asthma,
mucoviscidosis, quinsy
angina, bronchopneumonia).
events
the requirements of the
general
German Drug Law, the
made by the individual
The dosage and duration
declaration
doctor.
of treatment were based
Helsinki/
from
respiratory
carried out according to
of
and
of
• Severe diseases of the
a
assessment
on the recommendations
Tokyo and the principles
of good clinical practice
on medicinal products.
Medication
stated
Patients
248 patients at an age of
0
to
79
years
were
in
information
the
patient
leaflet
and
were adapted according
to each individual clinical
picture
and
course
of
(45%)
"respiratory
disease.
Evaluation
Qualitative characteristics
were described in detail
by means of a descriptive
process;
quantitative
characteristics by means
of descriptive parameters.
The
chitis"
evaluation
of
tolerance took place with
the
Intention-to-treat
Population
(ITT),
tract
and
in the individual symp-
infec-
toms (coughing, expec-
tion" (29%). All patients
toration,
apart from one suffered
breath, respiratory pain)
from cough, more than
and
half (63%) expectorated,
assessment made by the
in 16% and 23% of the
treating
patients,
of
respect to the general
and
respiratory
assessment, efficacy was
were
diagnosed
documented as very good
respectively
(multiple
to good in 86% of the
breath
pain
shortness
entries were possible).
Duration of therapy
carried out with the Per-
The mean duration of
Protocol-Treatment Popu-
therapy lay at 7.3 (± 2.4)
(PPT).
Missing
values remained as such.
a
of
general
doctor.
With
patients (fig. 1). In the
of
changes
individual
analysis of efficacy was
lation
on
case
the
shortness
in
symptoms,
cough and expectoration
days in the case of cough
was either cured or had
improved
mately
in
approxi-
90%
of
all
syrup and at 8.2 (± 2.5)
patients; the curing or
days
effervescent
improvement of shortness
cough tablets within the
of breath and respiratory
Patients
range recommended by
pain
A total of 248 patients
the manufacturer.
approximately 60% of all
Results
for
(138 female, 110 male)
were
admitted
to
the
was
obtained
in
(fig. 2).
Dosage
study; 176 (71%) thereof
76%
were younger than 15
received doses according
years. 120 patients were
to
treated with cough syrup
recommendations.
and 128 with effervescent
of the patients were given
cough tablets. 13 patients
less
and
12%
more
were excluded from the
medication
than
was
analysis of efficacy due to
recommended.
of
the
the
patients
manufacturer’s
12%
Tolerance
Tolerance of therapy was
judged as very good to
good
in
98%
of
all
patients
(fig.
3).
adverse
event
(allergic
exanthema)
mented
and exclusion criteria.
patient, the connection of
indications
were
"bron-
only
docu-
violation of the admission
The most frequently cited
in
was
An
one
Efficacy
which to the medication
Efficacy was recorded on
was
the basis of both changes
specified.
however
not
„
BRONCHITIS
dosage recommendations
Fig. 2: Curing or improvement of symptoms
or Prospan® take these
findings into account.
During the present post-
Nr. of patients (%) with cure or
improvement
100
marketing
80
studies, the medication
91,3
87,5
observation
was given to 76% of all
60
patients according to the
60,9
57,7
manufacturer’s
40
recom-
mendations. The results
20
prove the efficacy and
tolerance
0
Expectoration
Cough
hereby
Resp. Pain
to whether higher doses
Discussion
The
Dyspnoea
examined
of ethanol-free adminis-
leaf
tration forms of the active
extract has been used for
ingredient are eventually
more than 25 years in
necessary, in order to be
varying
of
special
dried
ivy
forms
of
therapeutic
equiva-
administration. A positive
lence, when compared to
monograph
an
on
the
oral,
ethanolic
substance was published
preparation.
in 1988 by the Federal
controlled clinical trial (2)
Public Health Department
as well as in a post-
(BGA), in which a daily
marketing
dosage of 300 mg of drug
study
was considered sufficient.
demonstrated,
This
approximately 2.5 times
monograph
was
higher
ethanolic
aqueous
a
observation
(6),
based on results using an
preparation
In
it
dose
that
of
was
an
the
administration
(47% ethyl alcohol) of the
form was needed for oral
active
application, so as to be
ingredient.
ethanol
is
known
as
As
commonly
able
being
comparable effect to the
a
to
achieve
a
resorption mediator, the
ethanolic
administration
issue is to be settled, as
form. The manufacturer’s
of
these
dosages
in
patients
suffering
from
inflam-
matory diseases of the
respiratory
tract.
documentation
The
on
effi-
cacy is of significance
especially with respect to
the
symptoms
“cough“
and “expectoration“, as
practically
all
patients
were suffering from cough
and more than 60% from
expectoration
(whereas
shortness of breath and
respiratory
pain
was
diagnosed in only 16%
and
23%
respectively)
of
patients
before
treatment.
Tolerance of therapy was
very good. An adverse
event (allergic exanthema) was documented in
only
one
patient,
the
connection of which to the
ance of therapy
Pädiatrie 10, S. 155-157
(1997)
5. Mansfeld H.-J., Höhre
H., Repges R., Dethlefsen
U.: Therapie des Asthma
bronchiale
mit
Efeublättertrockenextrakt. MMW
140/3,
S.
32/26-36/30
(1998)
6. Hecker, M.: Prospan®
Hustentropfen mit Ethanol deutlich besser wirksam als
ethanolfreie
Vergleichspräparate. T&E Pädiatrie 10,
S. 648-650 (1997)
Fig. 3: Tolerance of therapy
100
Nr. of patients (%)
80
77,6
60
40
20
20,8
1,6
0
0
very good
good
average
poor
medication was however
not
specified.
Furthermore, the patient
was being simultaneously
Correspondence to:
Dr. Martina Hecker,
Katharina-Schackey-Str.
5a, D-61169 Friedberg
treated with the active
ingredient
paracetamol,
for which there have been
reports of rare cases of
allergic skin reactions.
Conclusion:
These
post-marketing
observation
studies
demonstrate
that
the
different dosages of the
various
administration
forms of dried ivy leaf
extract
established
in
clinical trials are also valid
in wide medical practice,
with regard to the efficacy
and excellent tolerance of
Prospan®.
Literature
1. Gulyas A., Lämmlein
M.M.: Zur Behandlung von
Kindern mit chronischobstruktiver
Bronchitis.
Sozialpädiatrie 8, S. 632634 (1992)
2. Gulyas A., Repges R.,
Dethlefsen U.: Konsequente
Therapie
chronischobstruktiver
Atemwegserkrankungen bei Kindern.
Atemw.-Lungenkrkh. 5, S.
291-294 (1997)
3. Lässig W., Generlich H.,
Heydolph F., Paditz E.:
Wirksamkeit und Verträglichkeit
efeuhaltiger
Hustenmittel. TW Pädiatrie
9, S. 489-491 (1996)
4. Mansfeld H.-J., Höhre
H., Repges R., Dethlefsen
U.:
Sekretolyse
und
Bronchospasmolyse.
TW
Citation reference:
Hecker M.: Wirksamkeit
und Verträglichkeit von
Efeuextrakt bei Patienten
mit Atemwegserkrankungen.
Naturamed 14 Nr. 2: 28.33;
1999