Journal Reading

Does Oral Prednisolone Increase

The Efficacy of Subsequent Nasal
Steroids in Treating Nasal
Polyposis?
Presented by:
Cindy Dewinta S 11 2013 254
Melissa Trixiana 11 2013 249
Margareth S.Pereira 11 2013 259
Ricardo C. Amalo 11 2013 314

Backgrou
nd

Conclusi
on

Discussi
on

Methods

Results

Background
To evaluate whether oral prednisolone
produces any additive effects on
subsequent nasal steroid therapy
To evaluate if any clinical variables can
predict therapeutic outcome

Nasal
polyposis

Chronic inflammatory disesase of the

sinonasal mucosa of unknown etiology

Nasal steroids
are
Mainstay
treatment,
but some
patients do
not respond

Systemic steroid is well known for reduction

the symptoms and polyp size
Long term used

side effects

The optimum usage without side effects

important to improve medical treatment
Data to confirm the additive effects of oral
steroids on long term efficacy are lacking.

Allergy
Sinusitis

Multifactori
al disease

Predisposin
g factors

Asthma

Comorbid
disorders

Aspirin
intolerance
Size of
polyps

Poor
response
to steroid
therapy
and higher
recurrence
rate after
surgery

Knowledge of the effects of these possibly predicative

variables would be useful in treatment planning and
identifying patients to benefit from early surgical
intervention.

Evaluated the efficacy of a 14 day

course of 50 mg of oral
prednisolone

Evaluated the short term effects of

systemic steroid at 14 days posttrial
in nasal polyposis

Showed the positive effects of a

short course of corticosteroids on
improvement in nasal symptoms,
polyps size, nasal airflow

Patients with large polyp size and/or

mucoid or mucopurulent discharge
from the meatus middle and superior
were predisposed to a poorer
treatment outcome.

Inclusion and
Exclution Criteria

Statistical
Analysis

METHODS

Clinical Assessment

Data
Collection

METHODS
117 patients with
nasal polyposis

at the Allergy and

Rhinology Clinic,
Department of
Otolaryngology,
Faculty of Medicine

between May 1,
2007 and
September 30,
2010

Songklanagarind Hospital,
Prince of Songkla
University, Songkhla,
Thailand

Inclusio
n

Exclusi
on

Benign
bilateral nasal
polyps
diagnosed
clinically and
confirmed by
nasal
endoscopy

Symptoms or
physical signs of
renal, hepatic, DM

cataract, glaucoma,
cardiovascular,
unstable asthma,
cystic fibrosis

mucociliary
disorders,
immunocompromise
d, severe septal
deviation, acute
infection

Data Collection

nasal
symptom
s
sex

age

Medic
al
Histor
y

concomit
ant
diseases

medicati
on use

of
y
r
o
hist

ma
h
t
a,
s
e
t
A
h
n
n
g
p
e
r
u
s
r
o
y
recu zing, d ss, or c ,
e
)
e
whe tightn t night ray.
a
st
x
che icularly chest
l
t
(par norma
a
and

The criteria for diagnosis of rhinosinusitis

rhinitis
symptom
s

positive
sinus
radiograp
hy

positive
meatal
discharge

Skin-prick test ommon

Bermuda
grass

Johnson
grass

Careless
weed

Alternaria
species

Penicillium
mix

18 c lergens
al
aero

Acacia

Fusarium

Dermatophagoides
pteronyssinus

Positif
control

Aspergillus
mix

Candida
albicans

cat pelt

Dog
epithelium

American
cockroach

Mixed
feathers

Dermatophagoides
farinae

Histamine phosphate
2.75 mg/mL

kapok
pyrethrum

Negative
control

Cladosporium
sphaerospermum

aline
s
n
i
r
lyce

t
s
e
t
k
c
i
r
p
n
i
k
S

Skin wheal diameters were determined

at 20 minutes
posit
iv

e rea
ction

Patients were randomly assigned

at a 3:2 ratio to receive 50 mg of
prednisolone or placebo,
respectively, daily for 14 days
and were blinded to their
treatment regimen.
The dosage and duration of prednisolone were
selected as the maximum safe dose.

At the end of
this preliminary
stage

 All patients were instructed to return

their remaining drug at the 2-week
follow-up visit and then record carefully
each nasal steroid dose taken on a diary
card, which they would bring at their 7and 12-week follow-up visits.

Clinical assesment

Evaluations of the patients symptoms

First visit before beginning treatment (week 0)
At the end of the oral prednisolone phase (week 2)
At the middle of the MFNS treatment phase (week 7)
At the end of the MFNS treatment (week 12)

blocked nose, runny nose, sneezing, nasal itching,

hyposmia, postnasal drip, cough, and sinonasal
pain.

The severity of each individual symptom assesment

Score 0

No symptoms

Mild symptoms (steady

Score 1-2
symptoms but easily tolerable)
Score 3-4

Score 5-6

Moderate symptoms
(symptoms
hard to tolerate, might
interfere
with activities of daily living,
sleep,
both)
Severeor
symptoms
(symptoms
so bad that the person could
not function virtually all the
time

TNSS

The patient was instructed to keep their lips

tightly closed while performing the maximal
total expiratory effort through the nose after
a maximal inspiration.

Peak flow rate was read

from a cursor in liters per
minute, with the best of
three readings with a
variation of 10%
considered as the true peak
flow, which was then
recorded as the result.

The PEFI was calculated

as the nasal PEF divided
by the oral PEF to
compensate for changes
in lung function.

Nasal polyps size was assessed by nasal endoscopy at each visit

scored on a scale of 0
Score
No polyps
3 as follows:
0
Score mild polyposis (small polyps, causing only slight
obstruction)
1
Score
2
Scor
e3

moderate polyposis (mediumsized polyps, causing

troublesome obstruction)
severe polyposis (large-sized polyps, causing total or almost
total obstruction)

(TNPS)
re
o
c
s
s
p
ly
o
p
l
a
s
a
The total n
the polyps
f
o
m
su
e
th
as
d
te
la
u
was calc
scores for each nostril.

Patient
Characteris
tic
Potentially
Predictive
Factors on
Treatment
Outcome

Adver
se
Effect
s

Resul
ts

Nasal
Sympto
ms

PEFI and
Nasal Polyp
Size

Assesed for
eligibility

Excluded (n=4)
- Not meeting inclusion criteria (n=0)
- Declined to participate (n=4)
- Other reasons (n=0)
Randomized
3:2 ratio
(n=117)
Allocated to intervention (n=69)
- Received allocated intervention (n=69)
-Did not receive allocated intervention (n=0)

-Lost to follow up (logistical

problems) (n=2)
- Discontinued intervention
(n=0)
Analyzed (n=67)
-Excluded from
analysis (give reasons)
(n=0)

Allocated to intervention (n=48)

- Received allocated intervention
(n=48)
-Did not receive allocated
intervention (n=0)

-Lost to follow up (logistical

problems) (n=1)
-Discontinued intervention (n=0)

Analyzed (n=47)
-Excluded from
analysis (give
reasons (n=0)

Nasal
Symptoms
Oral Prednisolone
significantly more improvements of all
nasal symptoms (Prednisolon Group)

Nasal Steroids (MFNS)

Maintained improvement in Prednisolone
group
Continuing improvement in Placebo group
End of the Nasal Steroid Phase:
no significant differences in the improvements
of most nasal symptoms between the two groups,
except in hyposmia

PEFI AND NASAL POLYP SIZE

PEFI scores and nasal polyp

size in the prednisolone
group were significantly
higher than in the placebo
group

Throat
irritation

Adverse
Effects

Gastrointestinal
disturbance,
dyspepsia (oral
steroid)

Headache

Nasal
irritation

No patient reported
significant adverse
symptoms immediately
after cessation of oral
prednisolone

Adverse Event

Gastrointestinal
disturbance
Dyspepsia
Throat irritation
Headache
Nasal irritation
Increased appetite
Fatigue
Acne
Insomnia

Prednisol
one
Group

Placebo
Group

11
5
4
3
2
1
1
1
1

1
1
3
3
2
0
0
0
0

Potentially Predictive Factors on

Treatment Outcome
Patients with polyp grade 3 positive meatal
discharge showed less improvement in all
treatment outcomes than patients with
polyp grades 1 and 2 and negative meatal
discharge

In this analysis, both polyp grade and nasal

endoscopy were significant predictors of
treatment outcome

Increasing polyp size or positive meatal

discharge predicted poorer therapeutic
response

DISCUSSION

Effect of initial oral prednisolone administration on

subsequent nasal steroid treatment in patient with nasal
polyposis

The measures is in the subjective assessment and

objective

This study showed that in subjective and objective

have been improved after oral steroid treatment
after 2 weeks and maintained with the nasal steroids

Other factor beside

steroid resistance that
can cause poor
treatment outcome is
chronic sinus
inflammation

Nasal polyps with

positive meatal
discharge, showed a
worse therapeutic
response,

An abnormal sinus
radiography could be
the result of
noninfectious
inflammation and/or
infection.,

Allergy and asthma are

frequently associated
with nasal polyps, and
patient with these
condition may have
poor outcome in
treatment

And potent antiinflammatory action

with the initial oral
prednisolone, might be
highly effective in
control of asthma,
allergic, and
inflammation of sinus

Limitation in this study

There is False positive and negative of conventional sinus
radiography, abnormal sinus radiography should be
interpreted in the clinical examination, nasal endoscopy

A CT Scan is the imaging modality to provide more objective

information; however CT imaging is limited by cost and
consideration of radiation

This study represent an examination of short-term effect of

initial oral steroid followed by topical steroid in patient with
nasal polyps, and need the longer clinical trials to examine
the long-term therapeutic effect and identify reliable clinical
predictors.

CONCLUSION

The main findings of

this study

Nasal steroid therapy alone effectively

improved nasal symptons

Combined therapy oral steroid and nasal

steroid was more effective than nasal steroid
alone in improving hyposmia, polyps size,
and nasal airflow.

Massive polyposis and/or positive meatal

discharge can be considered as major risk
factors for steroid insensitivity.