RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1.

Name

of

the

Candidate

and Dr. SHEREEF YAHIYA. M,

Address (in block letters)

POSTGRADUATE IN E.N.T,
DEPARTMENT OF E.N.T,
S. NIJALINGAPPA MEDICAL COLLEGE
& H. S. K HOSPITAL & RESEARCH
CENTRE, NAVANAGAR, BAGALKOT

2.

587102, KARNATAKA.
S. NIJALINGAPPA MEDICAL COLLEGE

Name of the Institution

& H. S. K HOSPITAL & RESEARCH

CENTRE, NAVANAGAR, BAGALKOT
3.
4.
5.

587102, KARNATAKA.
M.S. (E.N.T) [3 YEARS]
31/05/2011.
RANDOMIZED COMPARATIVE STUDY

Course of Study and Subject

Date of Admission to Course
Title of the Topic

TO

EVALUATE

HYPERTONIC
ISOTONIC

EFFICACY
SALINE

SALINE

OF

AGAINST
IN

THE

TREATMENT OF CHRONIC SINUSITIS

IN H. S. K HOSPITAL & RESEARCH
CENTRE , BAGALKOT.

6.

Brief Resume of the Intended Work:

6.1
Need for the study:

Chronic sinusitis has a higher prevalence and morbidity, but few

epidemiologic studies exist that help in designing treatment options for the
same. It is fairly well accepted that chronic sinusitis is one of the most
common ailment for an individual seeking medical care. Chronic sinusitis
results in high direct medical costs. Cost of antimicrobial therapy would be
expected to be escalating. Chronic sinusitis also results in losses in time away
from work or school with the associated decrease in productivity. If all the
costs were measured, chronic sinusitis costs in huge amount each year. Such
costs worldwide are higher than the gross national products of many of the
worlds nations. Recent appreciation that noninfectious causes predispose to
infectious sinusitis has revoked renewed interest in developing and
documenting efficacious ancillary therapies that could supplement or abrogate
antibiotic use. Chronic sinusitis also impact the quality of life, which will
affect their overall sense of well-being. Cleansing of the nasal passages are
described as an important method of treating different illnesses of nose and
paranasal sinuses.1 Nasal irrigation has been advocated since vedic times. In
Hatha Yoga, Jala-neti is described as a nasal cleansing technique for sinonasal
diseases.2 Nasal irrigations are often mentioned as adjunctive measures in
treating many sinonasal conditions. Despite their widespread use, much
mystique and uncertainty exist about their use. Anecdotal evidence and poorly
controlled studies add to the confusion and likewise, controversy exists
concerning irrigation tonicity.
Western medicine has adopted this practice since the 19th century
where nasal irrigation has been recommended for the treatment of sinonasal
pathology. Hypertonic saline improved clinical and radiological scores of
chronic sinusitis patients.3 Nasal irrigation has been shown to improve
symptoms and health status of patients with sinonasal disease.4
2

Nasal irrigation with isotonic or hypertonic saline can improve

mucociliary clearance time in various nasal pathologies. However controversy
exists regarding beneficial effects of hypertonic saline over isotonic saline in
reducing symptoms of chronic sinusitis.
In view of this, since no study of such kind is done in Bagalkot, the
present study will be undertaken for the first time in our institution,
S. Nijalingappa Medical College and H. S. K Hospital and Research Centre,
Bagalkot to evaluate the efficacy of hypertonic saline against isotonic saline in
the treatment of chronic sinusitis.

6.2

Review of Literature:
In a person having a painful spot in the head with intense headache,
pus or fluid running from the nose removes the disease said Hippocrates in
5th century B.C., referring to sinus infection.
Prospects for ancillary treatment of chronic sinusitis was revived in
19th century. Wingrave in 1902 discussed cleansing of the nasal passages as an
important method of treating different illnesses of nose and paranasal sinuses.1
Nasal irrigation has been advocated since Vedic times. In Hatha Yoga,
Jala-neti is described as a nasal cleansing technique for sinonasal disease.2
Shoseyov D et al. in 1998 studied 34 children in the age group of 3 to
16 years with chronic maxillary sinusitis. Males constituted 53.33% of the
study group. Each individual was treated with either hypertonic saline or
normal saline nasal drops for a period of 4 weeks and noticed a compliance of
88.24%. Discontinuation of the treatment was due to burning sensation in the
nose and throat in 8.82% of hypertonic saline group and 2.94% of the normal
saline group. Hypertonic saline group showed improvement in cough score
from 3.60.51 to 1.640.74, nasal secretion /PND score from 2.860.35 to
1.60.74 and radiological score from 8.061.28 to 2.661.04. The normal
3

saline treatment group showed significant improvement only in the PND score
from 2.660.49 to 1.530.83 but no significant change in cough score (from
3.530.52 to 3.330.49) and radiological score (from 8.131.25 to 7.860.91).
In this study hypertonic saline group improved significantly in clinical and
radiological scores.3
Study conducted by Tomooka LT et al. of USA in July 2000 revealed
that nasal irrigation was effective in improving symptoms and health status of
patients with sinonasal disease. Study was conducted on 211 patients and 20
disease free control subjects. Patients irrigated their nasal cavities using
hypertonic saline delivered by a waterpik

device using a commercially

available nasal adapter twice daily for 3 to 6 weeks. Patients rated nasal disease
specific symptoms and completed a self-administered quality of well being
questionnaire before intervention and at follow-up. 76% of patients reported
symptomatic improvement and 24% reported adverse side effects or no
beneficial effects from nasal irrigation. Adverse side effects included nasal
irritation, nasal discomfort, otalgia and pooling of saline in paranasal sinuses
with subsequent drainage. Compliance reported after 6 weeks was 92% among
patients who came for follow-up.4
Study conducted by Homer JJ et al. of UK in December 2000
evaluated the effect of the tonicity of saline nasal douching solutions on
mucociliary clearance in order to ascertain whether hypertonicity conferred
any advantage. They conducted a randomized double-blind crossover trial.
Saline douching solutions of 0.9%, 3% and 5% tonicity were used and
mucociliary clearance were measured by the saccharin clearance time (SCT).
The resultant SCT after administration of 5% saline was significantly reduced
compared to both 0.9% (P = 0.005) and 3% saline (P = 0.04). Thus hypertonic
saline solutions improved mucociliary clearance.5
4

Study conducted by Daviskas E et al. of Sydney, Australia in 2002 Fall

showed that long-term treatment with hypertonic saline(HS) or mannitol may
benefit patients with mucociliary dysfunction.6
Wabnitz DA, Wormald PJ of Adelaide, South Australia in May 2005
conducted study on 80 healthy volunteers and they were randomized to receive
0.9% saline spray to one nostril and 3.0% saline spray to the other. They
collected ciliated cells and Ciliary Beat Frequency was calculated using
computerized microphotometry. Although neither solution significantly altered
the Ciliary Beat Frequency from baseline measurements, there was a
significant difference between the Ciliary Beat Frequencies of the two
solutions at 5 minutes post administration (9.1 Hz with 0.9% saline, 10.1 Hz
with 3.0% saline. (P < .05).7
Multimethod study by Rabago D et al. of Wisconsin, USA, in JulyAugust 2006 after conducting semi structured, in-depth interviews with 28
participants who recently used nasal irrigation for studies assessing Hypertonic
Saline Nasal Irrigation. They revealed that : (1) Hypertonic Saline Nasal
Irrigation improved self-management of sinus symptoms, creating a sense of
empowerment; (2) Hypertonic Saline Nasal Irrigation produced rapid and
long-term improvement in quality of life; (3) participants identified discomfort,
time, and mild side effects as barriers to Hypertonic Saline Nasal Irrigation
use; and (4) participants identified aspects of training and at-home use that
overcame these barriers. They concluded that

Hypertonic Saline Nasal

Irrigation is a safe, well-tolerated, inexpensive, effective, long-term therapy

that patients with chronic sinonasal symptoms can and will use at home with
minimal training and follow-up. Success with Hypertonic Saline Nasal
Irrigation will likely be improved by patient education.8
Randomized double-blind trial conducted on 80 patients with
5

rhinosinusitis by Hauptman G, Ryan MW of Texas, USA in November 2007

compared the effect of two saline nasal sprays on nasal patency and
mucociliary clearance. Nasal patency and mucociliary clearance measurements
were taken before and after the treatment. Both solutions improved saccharine
clearance times (P < 0.0001). Buffered physiological saline significantly
affected nasal airway patency (P = 0.006). Both solutions improved symptoms
of nasal stuffiness (P < 0.0001) and nasal obstruction (P < 0.0001). Buffered
hypertonic saline caused increased nasal burning/irritation compared with
buffered physiological saline (P < 0.0001). They concluded that buffered
physiological and buffered hypertonic saline nasal sprays both improve
mucociliary clearance, which is beneficial for treatment of rhinosinusitis. Both
solutions provided symptomatic relief.9
Chronic sinusitis refers to a group of disorders characterized by
inflammation of the mucosa of the paranasal sinuses of duration of 12 weeks.
Many factors play a role in the development of chronic sinusitis, including
both host and environmental factors. Antimicrobial resistance appears to be
increasing for the common pathogens in rhinosinusitis, particularly for H.
influenzae and S. pneumoniae. Increasing resistance is largely related to the use
of antibiotics.10
Study conducted by Ural A et al. of Ankara, Turkey in May 2009 on
132 adults to investigate the impact of nasal irrigation with isotonic or
hypertonic sodium chloride solution on mucociliary clearance time in patients
with allergic rhinitis, acute sinusitis and chronic sinusitis revealed that nasal
irrigation can improve mucociliary clearance time in various nasal pathologies.
Mucociliary clearance time was measured using saccharine clearance test on
132 adults before and after 10 days application of intranasal isotonic or
hypertonic saline. They also suggested that further studies should be conducted
6

to develop a protocol for standardized use of saline solution irrigation in

various nasal pathologies.11

6.3

Objectives of the Study:

Objectives:
1. To evaluate the effect of hypertonic saline nasal drops against isotonic
saline nasal drops in the treatment of chronic sinusitis with respect to
pre and post treatment radiological scores of X-ray of paranasal sinuses
(Waters view), Saccharin Clearance Time (SCT), symptoms using
visual analogue score.
2. To assess the tolerance to hypertonic saline nasal drops with respect to
scores given after querying the patients.
3. To know the impact of hypertonic nasal drops on the quality of life.

7.

Materials and Methods:

7.1
Source of Data:
This is a one year study of all cases of chronic sinusitis attending the
Department of E.N.T (In Patients and Out Patients) to all the units in S.
Nijalingappa Medical College and H. S. K Hospital and Research Centre,
Bagalkot. All those patients who responded for follow-up will be our sample
size.
Type of study: Randomized comparative study. Randomization by simple
random table. All odd numbers from simple random table will be treated with
isotonic saline nasal drops and all even numbers will be treated with 3.5%
hypertonic saline nasal drops.

7.2

Method of Collection of Data:

All cases of chronic sinusitis attending the Department of E.N.T (In patients
and Out Patients) to all the units in S. Nijalingappa Medical College and
H. S. K Hospital and Research Centre, Bagalkot from 1 st January 2012 to 31st
December 2012 and follow-up till 31st January 2013 will be included in the
study. Detailed clinical history will be obtained followed by clinical
examination. Data will be analyzed from findings recorded in pre-tested semistructured proforma after entering the data into the computer after coding.
7

Analysis of data will take 2 months, Typing and printing will also take 2
months. So, total duration of study will take 17 months.
Informed consent will be obtained from the patients
A) Inclusion criteria:
1. All cases of chronic sinusitis in the age group of 18 - 50 years will be
included.
2. Both sexes will be included.
B) Exclusion criteria:
1. Patients with known anatomical defect that obstructs the sinuses.
2. Patients with polyp and mucocele that obstructs the sinuses.
Sampling frame: All cases of chronic sinusitis attending the Department of
E.N.T (In patients and Out Patients) to all the units in S. Nijalingappa Medical
College and H. S. K Hospital and Research Centre, Bagalkot fulfilling the
eligibility criteria will be our sample size. Depending on last 2 years data from
medical records department expected sample size would be 60-80 patients.
Statistical analysis: Chi-Square test will be used to find the independence of
groups at 5% level of significance. Unpaired t test will be used to find
significant difference between the groups.
Study design: Single blind randomized comparative study

7.3

Does the study require any investigations or interventions to be

conducted on patients or other humans or animals? If so, please
describe briefly.
The study requires investigation and intervention of cases of chronic
sinusitis. The details are as follows.
A) Investigation:
X-ray of Paranasal Sinuses (Waters view).
Saccharin Clearance Time (SCT).
B) Intervention:
8

Cases of chronic sinusitis will be treated with isotonic saline nasal

drops for one group of patients and 3.5% hypertonic saline nasal drops
for another group of patients.

7.4

Has ethical clearance been obtained from your institution in

case of 7.3? YES. Ethical clearance has been obtained from Ethical
committee of the institution

8.

List of References:
1.
2.

Wingrave. The Nature of Discharges and Douches. The Lancet 1902.

Instruction Manual and General Information on Yogic Saline Nasal Cleansing
Technique. The Jala-neti Booklet [cited 2005 Dec 30]: [41screens]. Available

3.

from: URL:http://www.yoga-age.com/asanas/jala.pdf.
Shoseyov D, Bibi H, Shai P, Shoseyov N, Shazberg G and Hurvitz H.
9

Treatment with hypertonic saline versus normal saline nasal wash of pediatric
4.

chronic sinusitis. J Allergy and Clin Immunol 1998; 101:602-5.

Tomooka LT, Murphy C and Davidson TM. Clinical study and literature review

5.

of nasal irrigation. Laryngoscope 2000 July; 110(7): 1189-93.

Homer JJ, Dowley AC, Condon L, El-Jassar P, Sood S. The effect of
hypertonicity on nasal mucociliary clearance. Clin Otolaryngol Allied Sci 2000

6.

December; 25(6): 558-60.

Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase
clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med

7.

2002 Fall; 15(3): 331-41.

Wabnitz DA, Wormald PJ. A blinded, randomized, controlled study on the
effect of buffered 0.9% and 3% sodium chloride intranasal sprays on ciliary

8.

beat frequency. Laryngoscope 2005 May; 115(5): 803-5.

Rabago D, Barrett B, Marchand L, Maberry R, Mundt M. Qualitative aspects
of nasal irrigation use by patients with chronic sinus disease in a multimethod

9.

study. Ann Fam Med 2006 July-August; 4(4): 295-301.

Hauptman G, Ryan MW. The effect of saline solutions on nasal patency and
mucociliary clearance in rhinosinusitis patients. Otolaryngol Head Neck Surg

10.

2007 November; 137(5): 815-21.

Benninger MS. Rhinosinusitis. Chapter 113 in: Gleeson M, Browning GG,
Burton MJ, Clarke R, Hibbert J, Jones NS et al. Scott browns
otorhinolaryngology head and neck surgery. 7th ed. Hodder Arnold: Edward

11.

Arnold Publishing; 2008, 1439-1441.

Ural A, Oktemer TK, Kizil Y, Ileri F, Uslu S. Impact of isotonic & hypertonic
saline solutions on mucociliary activity in various nasal pathologies: clinical
study. J Laryngol Otol 2009 May; 123(5): 517-21.

9.

Signature of the Candidate

10.

Remarks of the Guide

RECOMMENDED. THIS STUDY CAN BE

CARRIED OUT SATISFACTORILY IN
THIS INSTITUTE. THIS SYNOPSIS IS
FORWARDED TO UNIVERSITY FOR
KIND ACCEPTANCE.

11.
11.1

Name & Designation of

(In Block Letters)
Guide

Dr. MALLIKARJUN REDDY M.S.,

10

PROFESSOR AND HEAD,

DEPARTMENT OF E.N.T,
S. NIJALINGAPPA MEDICAL COLLEGE,
BAGALKOT.

11.2

Signature

11.3

Co-Guide (if any)

Dr. SANGAPPA. S .DODDAMANI M.S.,

PROFESSOR,
DEPARTMENT OF E.N.T,
S. NIJALINGAPPA MEDICAL COLLEGE,
BAGALKOT.

11.4

Signature

11.5

Head of the Department

Dr. MALLIKARJUN REDDY M.S.,

PROFESSOR AND HEAD,
DEPARTMENT OF E.N.T,
S. NIJALINGAPPA MEDICAL COLLEGE,
BAGALKOT.

12.

11.6

Signature

12.1

Remarks of the Chairman

and the Principal

12.2

Signature

11

B. V. V. Sanghas
S. NIJALINGAPPA MEDICAL COLLEGE & H. S. K HOSPITAL & RESEARCH CENTRE,
NAVANAGAR, BAGALKOT 587102, KARNATAKA.
Department of E.N.T
ANNEXURE I
RESEARCH INFORMED CONSENT FORM
Study Title: RANDOMIZED COMPARATIVE STUDY TO EVALUATE EFFICACY OF
HYPERTONIC SALINE AGAINST ISOTONIC SALINE IN THE TREATMENT OF CHRONIC
SINUSITIS IN H. S. K HOSPITAL & RESEARCH CENTRE , BAGALKOT.
Principal Investigator/ PG Guides Name: Dr. Shereef Yahiya. M / Dr. Mallikarjun Reddy
Name of the subject:
Age/Sex:
1. I have been informed that this study requires use of Isotonic saline nasal drops / Hypertonic saline nasal
drops & the procedure may cause discomfort to the nose & throat.
2. I understand that my participation in the study may not have a direct benefit to me.
3. I understand that medical information produced by this study will become part of institutional record & will
be kept confidential by the said institute.
4. I understand that my participation is voluntary & may refuse to participate or may with draw my consent &
discontinue participation at any time without prejudice to my present or future care at this institution.
5. I agree not to restrict the use of any data or results that arise from this study provided such a use is only for
scientific purpose (s)
I confirm that
(Chief researcher/ Name of the PG
guide) has explained to me the purpose of research & the study procedure that I will undergo and the
possible risks & discomforts as well as benefits that I may experience, in my own language. Therefore I
agree to give consent to participate as a subject in this research project.

Participants signature

Date:

I have explained to
research, the possible risks and benefits to the best of my ability.

Investigator/ PG (Guide) signature

(Subject) the purpose of the

Date:

12