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Journal Reading

DINA NURHAYATI
Pembimbing :
30101306918 dr. Shelly Tjahyadewi, M.Kes, Sp.THT-KL
Efficacy of Hypertonic
Saline and Normal Saline in
the Treatment of Chronic
Sinusitis
Journal identity
Tittle
◦Efficacy of Hypertonic Saline and Normal Saline in the Treatment of
Chronic Sinusitis
Author
◦Ramabhadraiah Anil Kumar, Borlingegowda Viswanatha, Nisha
Krishna, Niveditha Jayanna, Disha Ramesh Shetty
Publisher
◦International Journal of Otolaryngology and Head & Neck Surgery
Publication year
◦2013
Introduction

The common modalities of


absenteeism from work, frequent treatment for chronic sinusitis
Paranasal sinus disease is a revisits to the doctor and also a cause include the use of antibiotics,
common illness seen in the for significant expenditure of money decongestants, mucolytics and
general population. on over-the-counter medications. steroids.
Nasal Irrigation
This is also
important in the
Nasal irrigation Use of normal
postoperative
aids in the saline and
period to reduce
clearance of hypertonic saline
the risk of
secretions, debris for nasal irrigation
adhesions and to
and intranasal is an inexpensive
promote
crusts technique.
osteomeatal
patency.
Goals
This study was designed to compare the efficacy of
hypertonic saline nasal drops over that of normal
saline nasal drops in the treatment of chronic
sinusitis.

As per the null hypothesis it was assumed that there


is no difference between the two groups and finally
the results were compared which showed a
statistically significant result.
Materials and Methods
Methods Location Time

Victoria Hospital,
A double Department of
Otorhinolaryngol
blinded ogy, Bangalore From July
randomized Medical College 2009 to
and Research August 2011.
comparative Institute,
study Bangalore,
Karnataka, India
Study Design
Fifty patients who were diagnosed with chronic sinusitis in
the age group of 18 - 45 years were selected.

They were randomized into two groups. Group A included


twenty-five cases treated with normal saline (solution A)

The remaining twenty-five cases in Group B were treated


with 3.5% hypertonic saline (solution B)

Ten drops three times a day in both nostrils for a period


of 4 weeks
Normal saline which is
commercially available as 0.9%
Sodium chloride solution was
used as solution A.

Hypertonic solution of 3.5% Sodium


chloride was prepared by dissolving
3.5 g of sodium chloride in 100 ml
of double distilled water and was
used as solution B
Inclusion criteria

Patients who had been treated with antibiotics, β2


agonists, topical steroids and systemic steroids
were included in the study, but the treatment was
stopped one month prior to the beginning of the
study.
Those with any known
anatomical defect or
Exclusions mucocele that obstructs
the sinuses were
excluded from the study.
Diagnosis of Chronic Sinusitis
Two major One minor
criteria criteria

nasal
headache
discharge

Post
nasal drip
Chronic Sinusitis Criteria
The diagnosis was
confirmed by x-ray
of paranasal sinus
(Water’s view).

Post treatment x-ray of the


paranasal sinuses (Water’s
view) was taken at the end of
4 to 6 weeks and compared
with the pretreatment x-ray.

The pre and post treatment


x-rays were graded
according to Berg et al.
X RAY GRADING
Informed Consent

The patients were informed about the


mode of treatment and asked to
report every week for a period of one
month to assess symptoms
The research project was
approved by the Ethics
Committee of the Institution
under the protocol Good
Clinical Practices.
TECHNIQUE

The drops were instilled


Patients advised fast upward in a sitting
to instill ten or standing position with They were immediately
drops the head pulled back to removed from the nose
in order to minimize the
intranasally allow secretions to flow salty taste and burning
three times a downwards from the sensation that may occur.

day. nose without the patient


breathing them in.
Study Outcome
nasal
congestion

nasal
headache
discharge

sense of
facial pain
smell
Study Outcome
nasal
congestion

nasal
headache
discharge

sense of
facial pain
smell
Study Outcome
Tolerance for
the nasal
solution

3 = Moderate 4 = Severe
1 = No burning 2 = Mild burning
burning burning
sensation sensation
sensation sensation.
Data Analysis

DATA

CHI
SQUARE
TEST

UNPAIRED
“T” TEST
Result and Analysis
The following
observations were made
in fourty two patients Eight patients (16%)
General
who completed the defaulted from the study
Result
treatment schedule group of fifty patients.
proposed in the study.
Patients in group B had significant
improvement in nasal congestion
by the end of fourth week when
compared to group A.
Patients reported relief of
headache in both groups but
comparison between the two
groups showed significant
improvement in group B
Facial pain subsided in both the
groups by the end of second or
third week of treatment and the
difference was found to be
statistically insignificant between
the two groups
Loss of smell was reported by
eight patients in group A and in
eleven patients in group B and
in both the groups it improved The difference was
with treatment. found to be
statistically
insignificant between
the two groups
Patients reported clear nasal secretions
and reduction in the quantity of
secretions by the end of fourth week in
both the groups. group B showed
significant improvement by the end of
fourth week.
It was observed that both groups
showed improvement in their
overall symptoms but, group B
showed significant improvement
when compared to group A.
X-rays were graded and given scores accordingly. There was no
Figure 1. shows radiological statistical significance in distribution of cases between the two groups.
improvement in one of the
patients, after treatment In group B, highly significant downgrading in radiological score was
with hypertonic saline 3.5% noticed (from 5.67 ± 1.32 to 3.62 ± 1.43); whereas in group A there was
nasal drops. no such improvement (from 5.38 ± 1.43 to 4.71 ± 1.42) (p = 0.001)
In group A 85.7% patients did not complain
of any burning sensation.
Mild burning sensation was reported by
14.3% in group A and 57.1% in group B.
Moderate burning sensation was reported
None of the patients
by 19% of patients in group B. None of the in both the groups
patients in both the groups reported severe reported severe
burning sensation burning sensation
Discussion
Discussion
•Hypertonic VS 3.5 % hypertonic
Normal Salin saline solutions
nasal solution
• It is the concentration of sea
used to reduce water and is considered
symptoms of harmless and better tolerated by
chronic sinusitis the patients, even children.
mechanism action of hypertonic saline
nasal solutions
decreases mucosal
improves
edema and mechanically clears
mucociliary
inflammatory inspissated mucus
function
mediators

mild
antibacterial
vasoconstrictive
property
effect
Discussion
causes an increase
Hypererosmolarity in Ca2+ release stimulate the ciliary
of the airway fluids from intercellular beat frequency
stores

possibly by regulating the use or


availability of adenosine
triphosphate by ciliary
axoneme.
Discussion
Radiological analysis in group A showed that there were nine
patients with right maxillary sinus haziness; eight with left sided
haziness and four with bilateral haziness.
In group B there were eleven patients with right maxillary sinus
haziness; seven with left sided haziness and three had bilateral
haziness.
The analysis of pre-treatment and post-treatment radiological
scores revealed highly significant improvement in group B (from 5.67
± 1.32 to 3.62 ± 1.43) compared to group A (from 5.38 ± 1.43 to 4.71
± 1.42) (p = 0.001).
Conclusion

Hypertonic saline nasal


The study showed that
solution was well tolerated
3.5% hypertonic saline
by the patients and the
nasal solution was more
treatment of patients with
efficacious than 0.9%
chronic sinusitis with 3.5%
normal saline solution in
hypertonic saline nasal
the treatment of patients
solution improved their
with chronic sinusitis.
quality of life.
Critical appraisal
Critical Appraisal
No Kriteria Ya (+), Tidak (-)
1 Jumlah kata dalam judul, < 12 kata +

2 Deskripsi Judul Menggambarkan isi utama


penelitian dan tanpa singkatan
3 Daftar penulis sesuai aturan jurnal +
4 Korespondensi penulis +
5 Tempat & waktu penelitian dalam Tempat (+), Waktu (+)
judul
Abstract
No Kriteria Ya (+), Tidak (-)

1 Abstrak 1 paragraf +

2 Mencakup IMRC +

3 Secara keseluruhan informatif +

4 Tanpa singkatan selain yang baku +

5 Kurang dari 250 kata +


Pendahuluan
No Kriteria Ya (+), Tidak (-)
1 Terdiri dari 2 bagian atau 2 paragraf -

2 Paragraf pertama mengemukakan alasan +


dilakukan penelitian
3 Paragraf ke 2 menyatakan hipotesis atau tujuan +
penelitian
4 Didukung oleh pustaka yang relevan +
5 Kurang dari 1 halaman +
Bahan dan Metode
No Kriteria Ya(+), Tidak (-)
1 Jenis dan rancangan penelitian +
(Eksperimental)
2 Waktu dan tempat penelitian Waktu +/tempat +
3 Populasi Sumber +
4 Teknik sampling +
5 Kriteria inklusi +
6 Kriteria eksklusi +
7 Perkiraan dan perhitungan besar sempel -
8 Perincian cara penelitian +
9 Blind -
10 Uji Statistik +
11 Program komputer +
12 Persetujuan subjektif +
Hasil Penelitian
No. Kriteria Ya (+) Tidak (+)
1 Jumlah Subjek +
2 Tabel Karakteristik -
3 Tabel Hasil Penelitian +
4 Komentar dan Pendapat Penulis +
tentang hasil
5 Tabel Analisis data dengan Uji +
Kesimpulan dan Daftar Pustaka
No. Kriteria Ya (+) Tidak (+)

1 Pembahasan dan kesimpulan terpisah +


2 Pembahasan dan kesimpulan di paparkan +
dengan jelas
3 Pembahasan mengacu dari penelitian +
sebelumnya
4 Pembahasan sesuai dengan landasan teori +

5 Keterbatasan Penelitian -
6 Simpulan berdasarkan penelitian +
7 Saran Penelitian -
8 Penulisan Daftar Pustaka sesuai aturan +
PICO Analysis

PATIENT INTERVENTION

Pasien dengan Sinusitis • Irigasi Larutan Hipersaline


Kronis 3,5%

COMPARISON OUTCOME

Irigasi Larutan Normal Saline • VAS


0,9% • Efektifitas pengobatan
Bukti valid
Pertanyaan Jawaban
Apakah alokasi pasien pada penelitian ini dilakukan secara Ya
acak?
Apakah pengamatan pasien dilakukan secara cukup panjang Ya
dan lengkap?

Apakah semua pasien dalam kelompok yang diacak, Ya


dianalisis?
Apakah pasien dan dokter tetap blind dalam melakukan Ya
penelitian, selain dari terapi yang diuji?
Apakah ada kelompok kontrol ? Ya
Aplikasi
Pertanyaan Jawaban
Apakah pada pasien kita terdapat perbedaan bila Tidak
dibandingkan dengan yang terdapat pada penelitian
sebelumnya sehingga hasil tersebut tidak dapat
diterapkan pada pasien kita?
Apakah penelitian tersebut mungkin dapat Ya
diterapkan pada pasien kita?

Apakah pasien memiliki potensi yang Ya


menguntungkan apabila penelitian diterapkan?
Kesimpulan

Hasil penelitian valid

Hasil penelitian penting

Hasil penelitian dapat diterapkan

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