Miconazole nitrate compared with chlordantoin in the treatment of vaginal candidiasis


Morris, D.F.; Sugrue, D.L.

British Journal of Venereal Diseases 51(2): 123-124

1975


In a double-blind study of the treatment of vaginal candidiasis, miconazole nitrate gave a cure-rate of 88 per cent. (29 out of 33) compared with 58 per cent. (21 out of 36) using chlordantoin. Although approximately two-thirds of the patients who responded did so to a 10-day course of treatment, the different rates of cure with these preparations at this stage were not statistically significant. However, when a second course of treatment was given to those women who still had proven candidiasis, the overall cure-rate with miconazole was significantly greater than that with chlordantoin.

Brit.
J.
vener.
Dis.
(1975)
51,
123
Miconazole
nitrate
compared
with
chlordantoin
in
the
treatment
of
vaginal
candidiasis
DELIA
F.
MORRIS
AND
DENIS
L.
SUGRUE
From
the
Special
Treatment
Centre,
Shelton,
Stoke-on-Trent
This
paper
reports
the
results
of
a
double-blind
study
of
miconazole
nitrate
compared
with
chlordantoin
for
the
treatment
of
vaginal
candidiasis.
Material and
methods
All
female
patients
who
attended
the
Special
Treatment
Centre
for
sexually-transmitted
diseases
at
Stoke-on-
Trent
for
the
first
time
between
January
and
mid-
December,
1973,
were
questioned
and
examined
accord-
ing
to
a
defined
protocol.
Those
with
evidence
of
vaginal
candidiasis
were
included
in
this
trial.
Vaginal,
cervical,
and
urethral
swabs
were
collected
for
laboratory
tests
and
a
urine
specimen
was
examined.
The
swabs
were
examined
by
direct
microscopy
of
wet
films
and
Gram-stained
smears;
for
culture
they
were
transported
in
Stuart's
transport
medium
with
added
charcoal
and
examined
by
standard
microbiological
techniques.
Vaginal
candidiasis
was
diagnosed
if
blasto-
spores
or
mycelia
were
seen
in
direct
films
of
vaginal
secretion
or
if
Candida
albicans
was
cultured.
After
treatment
patients
were
considered
to
be
cured
if
their
symptoms
were
absent
and
Candida
could
not
be
demon-
strated
in
direct
films
or
by
culture
over
a
mean
period
of
6.5
weeks
(range
2
to
14
weeks).
Of
569
new
patients,
99
showed
evidence
of
vaginal
candidiasis;
twelve
of
the
99
had
no
symptoms.
Each
was
treated
with
a
cream
containing
an
antifungal
agent,
the
identity
of
which
was
unknown
to
the
investigators
until
all
the
clinical
data
had
been
collected.
The
creams
and
their
containers
appeared
identical
but
they
con-
tained
either
2
per
cent.
miconazole
nitrate
or
1
per
cent.
chlordantoin.
Each
patient
was
given
a
tube
of
antifungal
cream
sufficient
for
ten
nightly
treatments,
each
of
5
gm.
A
plastic
applicator
for
intravaginal
use
was
supplied.
The
patients
were
asked
to
record
how
many
applications
of
cream
were
necessary
before
they
experienced
relief
of
symptoms;
they
were
re-examined
4
to
6
days
after
completing
the
course
and
then
2
weeks
and
4
weeks
later.
When
Candida
persisted,
a
second
10-day
course
of
the
same
cream
(as
identified
by
its
code
number)
was
given
and
the
patient
re-examined
as
before.
Sixteen
patients
defaulted
so
that
the
results
here
apply
only
to
the
83
women
who
completed
their
course
of
treatment
and
who
had
subsequent
tests
of
cure.
Received
for
publication
July
3,
1974
Address
for
reprints:
D.
L.
Sugrue,
Special
Treatment
Centre,
Wellesley
Street,
Shelton,
Stoke-on-Trent,
ST1
4NF
Results
Some
characteristics
of
the
patients
are
given
in
Table
I
:
these
include
factors
such
as
pregnancy
and
the
recent
taking
of
antibiotics
and
oral
contraceptives
which
might
have
helped
to
predispose
the
patient
to
vaginal
candidiasis.
No
patient
had
glycosuria.
TABLE
I
Relevant
personal
and
medical
details
of
patients
and
defaulters
Treatment
Miconazole
Chlordantoin
Defaulters
Total
patients
42
41
16
Mean
age
(yrs)
26
24
25
Marital
status
Single
26 28
12
Married
16
13
4
Previous
history
of
Candida
infection
16
14
4
Pregnancy
0
0
1
Diabetes
mellitus
0
0
0
Oral
contraceptives
22
21
7
Tetracycline
recently
4
1
1
Other
antibiotics
recently
15
9
3
Concomitant
treatment*
9
9
3
*This
included
penicillin,
metronidazole,
nalidixic
acid,
topical
podophyllin,
and
idoxuridine
The
response
to
treatment
in
patients
with
culture-
proven
candidiasis
is
summarized
in
Tables
II
to
IV.
Cure
was
more
common
in
women
treated
with
miconazole
nitrate
than
in
those
with
chlordantoin.
After
a
single
course
of
treatment
twenty
of
33
women
using
miconazole
and
fifteen
of
36
women
using
chlordantoin,
became
culture-negative,
a
difference
which
was
not
statistically
significant
(Table
II).
TABLE
II
Response
after
one
course
of
treatment
in
patients
with
C.
albicans
isolated
before
treatment
Response
after
one
course
of
treatment
Treatment
Total
Miconazole
Chlordantoin
Success
20
15
35
Failure
13
21
34
Total
33
36
69
1.771
Two
courses
of
cream
were
required
by
nine
of
the
29
women
successfully
treated
with
miconazole
and
by
six
of
the
21
successfully
treated
124
British
Journal
of
Venereal
Diseases
with
chlordantoin
(Table
III).
Thus,
after
one
or
two
courses
of
treatment,
only
four
of
33
women
failed
to
be
cured
by
miconazole
compared
with
fifteen
of
36
women
who
were
still
culture-positive
after
two
courses
of
chlordantoin.
This
difference
is
statistically
significant
(P
<
0.02).
TABLE
III
Response
after
one
or
two
courses
of
treatment
in
patients
with
C.
albicans
isolated
before
treatment
Treatment
Response
Miconazole
Chlordantoin
Total
Success
Failure
29
4
21
15
50
19
Total
33
36
69
=
6.12
P<0.02
Fourteen
patients
initially
had
positive
direct
smears
but
negative
cultures.
They
are
included
in
Table
IV
together
with
those
who
initially
had
positive
cultures.
The
cure-rate
then
becomes
higher
for
both
fungicides.
However,
direct
microscopical
appearances
can
be
misleading,
as
when
only
blasto-
spores
are
seen
these
could
be
commensal
yeasts
and
not
necessarily
C.
albicans.
All
fourteen
patients
responded
satisfactorily
to
treatment,
a
proportion
which
would
be
unlikely
if
the
yeasts
had
been
predominantly
C.
albicans.
TABLE
IV
Response
among
all
patients
including
those
initially
positive
by
smear
only
Treatment
Response
Miconazole
Chlordantoin
Total
Success
Failure
38
4
26
15
64
19
Total
42
41
83
x
2
=
7.14
P<0.01
Most
patients
showed
some
subjective
improve-
ment
with
each
treatment
and
pruritus
was
usually
relieved
within
the
first
few
days.
Side-effects
were
minimal;
three
patients
on
miconazole
and
one
on
chlordantoin
experienced
slight
vaginal
irritation
but
it
was
not
necessary
to
stop
treatment.
Both
prepara-
tions
were
acceptable
to
the
patients.
Discussion
Both
miconazole
nitrate
and
chlordantoin
can
be
used
successfully
to
treat
vaginal
candidiasis.
In
the
present
series
miconazole
gave
a
higher
rate
of
cure.
With
both
preparations
it
was
common for
a
second
10-
day
course
to
be
needed
before
a
satisfactory
result
could
be
obtained.
Proost,
Maes-Dockx,
Nelis,
and
van
Cutsem
(1972)
obtained
negative
cultures
in
54
of
57
patients
at
least
4
days
after
completion
of
treatment
with
once
daily
application
of
2
per
cent.
miconazole
nitrate
for
2
weeks.
Breen
(1961)
cured
only
69
per
cent.
of
his
patients
with
twice-daily
applications
of
chlordantoin
for
2
weeks,
but
95
per
cent.
were
cured
if
this
regimen
was
maintained
for
6
weeks.
In
the
trial
reported
by
the
General
Practitioner
Research
Group
(1974),
41
of
fifty
women
were
found
to
be
culture-negative
after
a
single
daily
application
of
2
per
cent.
miconazole
nitrate
for
10
days,
when
re-examined
on
the
fourteenth
day;
this
figure
dropped
to
38
when
they
were
re-examined
on
the
28th
day.
These
observations
indicate
that
a
10-day
course
of
miconazole
nitrate
is
probably
too
short
and
that
better
results
can
be
obtained
if
treatment
is
continued
for
at
least
2
weeks.
Miconazole
nitrate
used
according
to
this
regimen
has
a
useful
place
in
the
treatment
of
this
often
dis-
tressing
condition.
Summary
In
a
double-blind
study
of
the
treatment
of
vaginal
candidiasis,
miconazole
nitrate
gave
a
cure-rate
of
88
per
cent.
(29
out
of
33)
compared
with
58
per
cent.
(21
out
of
36)
using
chlordantoin.
Although
approxi-
mately
two-thirds
of
the
patients
who
responded
did
so
to
a
10-day
course
of
treatment,
the
different
rates
of
cure
with
these
preparations
at
this
stage
were
not
statistically
significant.
However,
when
a
second
course
of
treatment
was
given
to
those
women
who
still
had
proven
candidiasis,
the
overall
cure-rate
with
miconazole
was
significantly
greater
than
that
with
chlordantoin.
We
should
like
to
thank
Dr.
H.
C.
Masheter
and
Mrs.
A.
Hewitt
of
Janssen
Pharmaceutical
Ltd.
for
their
co-
operation
in
this
study.
References
BREEN,
J.
L.
(1961)
Obstet.
and
Gynec.,
17,
112
GENERAL
PRACTITIONER
RESEARCH
GROUP
(1974)
Report
No.
187
Practitioner,
212,
254
PROOST,
J.
M.,
MAEs-Docia,
F.
M.,
NELIS,
M.
0.,
and
VAN
CUTSEM,
J.
M.
(1972)
Amer.
J.
Obstet.
Gynec.,
112,
688
Le
nitrate
de
Miconazole
compare
it
la
Chlordan-
toine
dans
le
traitement
de
la
candidose
vaginale
SOMMAIFtE
Dans
une
etude
a
double
insu
du
traitement
de
la
candidose
vaginale,
le
nitrate
de
Miconazole
a
donne
un
taux
de
guerison
de
88
pour
cent
(29
sur
33)
compare
a
58
pour
cent
(21
sur
36)
lorsque
l'on
utilisait
la
Chlordantoine.
Quoiqu'approximativement
deux
tiers
de
malades
qui
repondirent
au
traitement
le
firent
en
dix
jours,
les
taux
de
guerison
avec
ces
preparations
ne
furent
pas
significatifs
ce
moment.
Cependant,
lorsqu'une
deuxiCme
serie
de
traitement
fut
prescrite
aux
femmes
qui
conservaient
une
candidose
prouvee,
le
total
du
taux
de
guerison
avec
le
Miconazole
fut
significativement
plus
grand
qu'avec
la
Chlorantoine.