SYNOPSIS
Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore
TOPIC:
A COMPARATIVE STUDY OF ROLE OF INTRANASAL CICLESONIDE SPRAY (CICLOSPRAY) AND SUBMUCOSAL DIATHERMY IN THE TREATMENT OF ALLERGIC RHINITIS .
Name of the candidate: Dr.Gauthama Shettigar
Postgraduate resident
Dept. of ENT
KIMS, Bangalore
Guide : Dr.K.G.Somashekar
professor
Dept. of ENT
KIMS, Bangalore.
Course & Subject : M.S. (E N T)
Date of Admission : 10-06-2008
College : Department of ENT
Kempegowda institute of Medical Sciences
Bangalore
2008
Brief resume of the intended work:
Need for the study:
Allergic rhinitis is a common &debilitating disease characterized by rhinorrhea,sneezing,nasal congestion, nasal itching.
It has considerable impact on quality of lifemeasures&social costs.
It is associated with rhinosinusitis,serous otitis media,nasal polypi,bronchial asthma,orthodontic prob lems in children especially.
The hallmark of allergic rhinitis is an IgE mediated type 1 hypersensitivity reaction to an inciting inhaled antigen or ingested food.
Treatment includes –allergen avoidance,pharmacotherapy,immunotherapy&surgical intervention.
Antihistamines were the first efficacious drugs used for symptomatic relief of allergic rhinitis. The main drawback of this drug is its sedative effect.However,newer molecules are less sedative but are expensive.
Effectiveness of steroid nasal spray in relieving nasal symptoms has been proved.one of the most recent corticosteroids, ciclesonide nasal spray has been shown to be effective in adults without any effect on HPA axis or adverse tissue changes in nasal mucosa
.
Ciclesonide which was approved by FDA in 2007, has systemic bioavailability below 1% and should therefore be less likely than older intranasal corticosteroids agents to promote systemic effects.
Submucosal diathermy leads to a dramatic fall in nasal resistance as well as allergic symptoms as a result of volume reduction and reduced sensitive receptor surface area of the inferior turbinates.
Hence ,this study is taken to clinically evaluate the efficacy of intranasal ciclosonide nasal spray and submucosal diathermy in treating this disease.
OBJECTIVES:
-To compare the effectiveness of medical & surgical line of management in treatment of allergic rhinitis.
-To clinically evaluate the efficacy of ciclesonide nasal spray and submucosal diathermy in relieving symptoms of allergic rhinitis.
REVIEW OF LITERATURE:
Historically, allergic reaction has been known for over 150 years.classical symptoms of allergic rhinitis were described as early as 1819 by John Bostock of England.
Beclomethasone –first topical corticosteroid for treatment of seasonal allergic rhinitis was introduced in 1973 as nasal spray.
Nasal physiology & functional anatomy:
Externally nose is shaped by cartilages ,skin & facial muscles.
Internally nose consists of bony & cartilaginous framework lined by mucosa.
Nasal cavity where inferior,middle & superior turbinates are located lined with pseudostratified columnar ciliated epithelium.
The turbinates increase mucosal surface of nasal cavity to about 150-200 sq.cm
And facilitate humidification,temperature regulation and filtration of inspired air.
There is an increased mucus discharge from inferior turbinate goblet cells of patients with perennial allergic rhinitis.
Nasal mucosa can shrink or expand rapidly by changing blood volume in response to neural ,mechanical,thermal or chemical stimuli.
ALLERGIC RHINITIS:
Allergic rhinitis is an IgE mediated hypersensitivity reaction of the mucous membrane of nasal airway characterized by sneezing,itching,watery nasal discharge and sensation of nasal obstruction.
Affects 10-25% of population globally.
Frequently encountered in young adulthood,
Allegic rhinitis with inferior turbinate hypertrophy serves one of the most common cause of nasal obstruction.Enlargement of inferior turbinate is almost always due to swelling of submucosa.this swelling is caused by dilatation of the submucosal venous sinusoids.
Though allergic rhinitis is not life threatening, morbidity is significant.
Often co-exists with asthma,otitis media,eustacian tube dysfunction,sinusitis,nasal polypi,allergic conjunctivitis and atopic dermatitis.
Allergic rhinitis can be classified in to persistant(perennial) allergic rhinitis and intermittent(seasonal) allergic rhinitis.
Aetiology:
Principle cause is sensitivity to inhalant allergens. House dust and dust mites, pollens, fungal allergens are important precipitating factors.
Relevant laboratory tests to be considered are –allergy skin test, RAST, total serum IgE, Total blood eosinophils count, nasal smear cytology, and nasal provocation test.
MATERIALS AND METHODS:
Source of data:
For this study, 60 subjects who are aged between 14-60 years with moderate to severe symptoms of allergic rhinitis will be chosen among the out patients attending dept. of ENT, KIMS, Bangalore from December 2008 to December 2010
Patients who are willing to participate will be evaluated by means of history taking, clinical examination and laboratory investigations.
Written informed consent will be taken.
Study type:
Randomized prospective clinical study-a Comparative study
Sampling technique:
Participants with 2 or more symptoms-sneezing, nasal obstruction, nasal discharge, itching of nose, itching of eyes, palatal itching, watering of eyes will be selected
Inclusion criteria:
Age: 14-60
Both males and females
Patients with 2 or more symptoms.
Those with AEC>400 cells/cu.mm, nasal smear study showing >15% eosinophils
Exclusion criteria:
Subjects will be excluded from the study if they have any of the following-
Co-existing illness-URI, sinusitis
Pregnant and lactating women
Co-existing systemic illness
Those who underwent turbinectomy
Allergic rhinitis with polyp
Use of antihistamines or intra nasal/oral corticosteroids within one month of presentation to OPD
Plan for data analysis:
Baseline symptoms score will be recorded in the symptoms’ diary and will be provided to subjects and taught how to record data on daily basis
Subjects are to be randomized to receive either intranasal ciclesonide 2puffs in each nostril once daily for 12 weeks (GROUP1) OR selected for submucosal diathermy under general anaesthesia using unipolar electrocautery (GROUP2)
Group1 and 2 will be evaluated at the end of each month for 3 months.
Statistical methods:
Chi-square and Fischer exact
Paired proportion test will be used to find significance proportion of symptoms before and after treatment
Mann-Witney U test-to find significance of total symptoms score between group1 & 2
Wilcoxon Signed rank test to find the significance of total symptoms before and after treatment
Does the study require any investigations or interventions to be conducted on patients or other human?
Yes.
AEC, nasal smear cytology, skin prick test are to be done, before starting the treatment.
In case of patients who are selected for SMD, electrocauterisation of inferior turbinate will be done under GA, using unipolar electrode with the help of 22 gauge spinal needle. and they will be under observation in the hospital post operatively for 1-2 days
Has ethical clearance been obtained from your institution in the above case?
YES.
List of references:
1) John H Krouse; USA otolaryngologic clinics of north America, April 2008 volume .41 page no: 347-358
2) Jones A, Wight, R.G. Kabil yand Beckingham (1989) Predicting the outcome of diathermy to the inferior turbinates, clinical otolaryngology 14, 41-44
3) Jones A S, Lancer J (1987) does submucosal diathermy to the inferior turbinate reduces nasal resistance to airflow in the long term? Journal of laryngology and otology; 101,448-451
4) Kafle P ,Maharajan,Shrestha,Toran K C ; comparison of chemical cautery and steroid spray against SMD IN the treatment of symptomatic ITH ; Kathmandu university medical journal(2007),vol.5,no:3,issue 19 ,335-338
5) Charles W. Cummings, John M Fredicson,Lee A Harker et al .Allergic rhinitis, otolaryngology head & neck surgery. 3 rd edition vol.2 904-905
6) Mettzaar E O, Berger WE ; A dose ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis.J.Allergy clin immunol 1999; 104(1); 107-114
7) S.R.Durham; mechanisms and treatment of allergic rhinitis, scott-brown’s otolaryngology; 6 th edition.vol.4; 1997 4/6/1
8) Nielsen L P, Mygind N, Dahl R; Intranasal corticosteroids for allergic rhinitis-superior relief; Drugs; Dept. of clinical pharmacology, university of Aarhus, Denmark; 2001;61(11);1563-79(ISSN:0012-6667)
9) Richard L Mabry, allergy for rhinologists, otolaryngol clin North America 1998; 31(1); 175-187
10) Mathew J Dyes, David M G Halpin and Ken Stein; Inhaled ciclesonide versus inhaled budesonide/beclomethasone/fluticasone in chronic asthma in adults-a review;BMC family practice;2006;7:34;
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Signature of the candidate :
Name & designation of the guide: Dr.K.G.Somashekar
professor
Dept. of ENT, KIMS B’lore.
Remarks :
Signature of the guide :
Name of the HOD : Dr.B.V.Chandregowda
HOD, Dept.of ENT, KIMS B’lore.
Signature of the HOD :
PROFORMA
DEPT. OF OTORHINOLARYNGOLOGY, KIMS, Bangalore
Case no.: O.P.no. :
Name : Occupation:
Age : Address :
Sex :
Chief Complaint:
Duration Severity
Nose:
*Sneezing
*Nasal Obstruction
*Discharge (watery/mucoid/purulent)
*Impaired Smell
*Itching
Eyes:
Itching
Watering
Others:
Palatal Itching
Ear Itching
Headache
Cough
Wheezing
Postnasal drip
Fatigue
Sleep disturbances
Depression
Past History:-
History of Previous medical / surgical treatment.
History of allergy.
Systemic Illness – Asthma / DM/ HTN /TB / Cardiac Illness / Epilepsy/Psychiatric Illness.
Family history of allergy:
Personal history:
Diet:
Sleep:
Appetite:
Bowel bladder:
Habits:
General physical examination
Built: nourishment:
Pallor/ icterus/ cyanosis/ clubbing/ lymphadenopathy/ koilonychia/oedema
CVS:
RS :
CNS: PULSE:
P/A : B.P. :
RR :
ENT Examination:
NOSE:
External appearance
Vestibule
Ant.rhinoscopy:
Nasal mucosa-pale/oedematous
Septum
Lateral wall-turbinate
Post.rhinoscopy:
Examination of PNS: Tenderness of maxillary/frontal/ethmoidal
Test for olfaction:
COLD SPATULA TEST:
COTTON WISP TEST:
THROAT: Oral cavity
Oropharynx
Laryngopharynx
EAR: Pinna
EAC
TM
TFT –Rinne
- Weber
- ABC
EYES: Lids
Conjunctiva
Investigations:Hb, TC ,DC ,ESR AEC
Urine-Albumin
Sugar
Micro
X-Ray-PNS
Smear cytology of nasal mucosa for eosinophils
TREATMENT:
Dept of ENT, Kempegowda Institute of Medical SciencesAllergic Rhinitis Symptoms diary
Name: / Date of starting Treatment / Date of Surgery:
Age / Sex: / O.P. No.:
Symptoms / 1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9 / 10 / 11 / 12 / 13 / 14 / 15 / 16 / 17 / 18 / 19 / 20 / 21 / 22 / 23 / 24 / 25 / 26 / 27 / 28
1 / Sneezing
2 / Nasal Obstruction
3 / Nasal Discharge
4 / Itching of Nose
5 / Itching of Eyes
6 / Palatal Itching
7 / Watering of Eyes
8 / Cough
9 / Headache
10 / Wheezing
11 / Loss of smell
12 / Sleep disturbance
13 / Depression
14 / Others
0– Absent
1 - Symptoms present, but not troublesome
2-symptoms frequently troublesome but not disturbing daily activity or sleep
3-symptoms disturbing daily activity or sleep.