Transcript Phase 1

Nasal irrigation for recurrent
rhinosinusitis and chronic sinus
complaints: a 3-part multi-method
study
UW Internal Medicine Primary Care Conference
David Rabago, MD
1-17-2007
http://www.fammed.wisc.edu/research/projects/nasalirrigation
.html
Objectives
Review basics of rhinosinusitis
Introduce nasal irrigation
Describe 3 studies
Discuss future directions
Rhinosinusitis: Why do we
care?
One of 10 most common ambulatory Dx’s,
26.7 million office/ED visits annually
5th leading cause of Abx Rx (13 million ‘92)
85-98% of dx get Abx
$5.8 billion direct & indirect costs
Patients care about RS
RS often refractory to treatment
Prevalence chronic RS 134/1000
Serious complications
Anatomy
Anatomy
Pathophysiology
Insult triggers inflammatory cascade
involving cytokines, macrophages,
mediators
Allergic response involves IgE, Eos
Blood vessels dilate
Capillary permeability increases
More mucus secretion
Coordinated ciliary action disrupted, slow
Sinus ostia occluded
Pathologic Sinus
infectious/allergic/
irritant
Ostial occlusion
Mucosal
Thickening/, 
further blockage
Bacterial infection,
viral infection
Secretions thicken,
pH changes
Ciliary damage
Bacterial or viral
growth
Inflammation
Predisposing conditions
URIs
Allergic rhinitis
Tobacco
Polyps
Dental infections
Swimming/diving
Cocaine abuse
Foreign body
Septal deviation
Hypertrophic turbinates
Abnl ostiomeatal complex
Cystic fibrosis
Diabetes
Immune deficiencies
Nasal Irrigation
Definition

Saline in the nasal cavity
Synonyms

Jala Neti, Neti Pot Therapy, Nasal Lavage,
Hypertonic Saline Lavage
Irrigant/Concentration/Volume: variable
Vessels

cupped hand, bulb syringe, spray bottle,
Water Pic™, Neti™ pot, Sinucleanse™,
Rhinomer™, Naso Cup…
Cultural and
Medical History
Used for centuries as part of Ayurvedic
tradition of Medicine
Medical References to nasal irrigation since
1890’s
Used as Post-Op adjunctive care for nasal
surgery
Anecdotal evidence for efficacy in sinusitis.
Ten RCTs
Nasal Irrigation cup
Where does the solution go?
Where does the solution go?
before irrigation
after irrigation
Biological Rationale
Sinus Disease 
Nasal Irrigation
thickens mucus
thins mucus
decreases CBF
increases CBF
decreases MCC
may increase MCC
increases inflam.
may decrease inflam.
Three studies
Phase 1: fastidious RCT in the short term
Phase 2: pragmatic prospective long-term
case series
Phase 3: qualitative study
Phase 1: Objective/Design
Does daily NI improve sinus symptoms and
quality of life, and decrease medication use
in adults with chronic sinus complaints and a
history of sinusitis compared to ‘standard of
care’?
Randomized Controlled Trial, Intention to
Treat, Primary Care and Specialty Clinics
Subject Participation in Phases 1, 2 and 3
76 subjects consented & randomized
Phase 1: Original
RCT (6 mos.)
Phase 2: Follow-up
study (12 mos.)
Phase 3: Qualitative
study
HSNI
n = 52
Opt out:
n = 12
Standard of Care
n = 24
Follow-up Study
n = 40
Follow up study:
n = 14
Single HSNI use group:
n = 54
All Subjects using HSNI in Phases 1 & 2:
n = 66
Qualitative Study:
28 Qualitative Interviews
Patients: Inclusion Criteria
18-65
2 ICD-9 diagnoses of acute sinusitis, or 1
of chronic sinusitis, per year for 2 years
not pregnant
not a nasal irrigation user
score of 3-6/6 ‘nasal symptoms impact’
question
able to perform nasal irrigation
Intervention:
Informational Meeting
Introduction
Personal Histories
Education
Consent/Randomization


52 Experimental Arm
24 Control Arm
Film/Demonstration/Practice
Interventions
Control: Routine care for sinus c/o
Experimental: Routine care for sinus c/o
plus daily nasal irrigation x 6 months
Concentration: ~ 2 X normal saline
pH:~8.0 buffered with baking soda
Volume: 135 ml per nostril
Primary Outcomes:
Quality of Life Measures
MOS-Short Form-12 (0-100)
Rhinosinusitis Disability Index (0-100)
Single Item Assessment (1-7)

“Please evaluate the overall severity of your
sinus symptoms since you enrolled in the study”
Each assessed at baseline,1.5, 3, and 6 mos
Reminder calls
Secondary Outcomes
Daily adherence log
Bi-weekly symptom and medication log
Side Effects
Satisfaction
Results: Randomization,
Compliance,Completion Rate
Effective randomization
69/76 (90.7%) subjects completed
study
Adherence to daily use 87%
96% questionnaire completion rate
80
Change in Rhinosinusitis
Disability Index (RSDI) score
75
Experimental
RSDI Score
70
Control
SE of change
in score
65
p<0.05
60
p<0.001
55
50
Baseline
6 weeks
3 months
6 months
Severe (7)
Moderate (4)
SE of change
in score
Control
Experimental
p<0.01
p<0.01
p<0.001
Normal (1)
Nasal-Sinus Symptom Severity (1-7 Likert scale)
Change in the Single-item Assessment
Baseline
6 weeks
3 months
6 months
Symptoms Medication use
Nasal sprays
Antibiotics
Nasal discharge
Nasal congestion
Frontal pressure
Frontal pain
Sinus headache
% 2 week intervals experienced
100.0%
Frequency of Sinus Symptoms
and Medication Use
80.0%
60.0%
Experimental
Control
40.0%
20.0%
0.0%
Clinical Relevance: Number
Needed To Treat



SIA and RSDI: “What % of subjects achieved
~ 15% improvement?”
Symptoms: “What % of subjects reported
symptoms or med use < 50% of 2-wk
periods?”
Meds: “What % of subjects reported
medication use >25% of 2-week blocks?”
NNT for Rhinosinusitis Index
and Single-Item Q
RSDI
SIA
Time (mos) Abs Fx Sz (%)
1.5
11.2
3
20.5
6
53.5
1.5
3
6
28.2
23.4
62.5
NNT
8.9
4.9
1.9
3.5
4.3
1.6
NNT for Symptoms
and Medications at 6 months
Sx
Meds
Abs Fx Sz
NNT
Headache
Pain
Pressure
Discharge
Congestion
11
25.5
29.5
0.8
19.5
9.1
3.9
3.4
125
5.1
Antibx
Nasal Sprays
13.2
8.5
7.6
11.8
Satisfaction and Side Effects
42/44 “will continue to use”
44/44 “would recommend”
10/44 reported side effects: burning,
tearing, h/a, nosebleed



8/10 indicated they were “insignificant”
2/10 “significant” but did not change overall
satisfaction
most were able to improve side effects by
dilution or alternating days of therapy
Phase 1 Conclusions
In a controlled setting, daily nasal
irrigation:
 Improved quality of life
 Decreased sinus symptoms
 Decreased antibiotic use
 Decreased nasal spray use
 Well-tolerated
 High satisfaction
Phase 2: Objective
To assess nasal irrigation usepatterns adherence, efficacy, sideeffects, and satisfaction in a long-term
(12 mos) standard clinical setting
Subject Participation in Phases 1, 2 and 3
76 subjects consented & randomized
Phase 1: Original
RCT (6 mos.)
Phase 2: Followup study (12 mos.)
Phase 3: Qualitative
study
HSNI
n = 52
Opt out:
n = 12
Standard of Care
n = 24
Follow-up Study
n = 40
Follow up study:
n = 14
Single HSNI use group:
n = 54
All Subjects using HSNI in Phases 1 & 2:
n = 66
Qualitative Study :
28 Qualitative Interviews
Ph 2 Inclusion Criteria/Intervention
All 76 subjects from Phase I invited
to participate
54 (71%) consented
Former control subjects trained in
nasal irrigation
Both groups used nasal irrigation
as desired
Ph 2 Primary Outcomes:
Quality of Life Measures
Rhinosinusitis Disability Index (0-100)
Single Item Assessment (1-7)
Sino-Nasal Outcomes Test (SNOT-20)
Each assessed at 6 and18 mos
Ph 2 Secondary Outcomes
Frequency and Pattern of Nasal
Irrigation Use
Sinus Symptom Severity and
Frequency
Side Effects
Satisfaction
Results:
Similar Baseline Characteristics
Age
QoL Scores
Gender
Race/Ethnicity
Education
Allergy Hx
Nasal Surgical
Hx
ICD-9 Code
Clinic Type
Results: Compliance and
Completion Rates
54/54 (100%) subjects completed
study
85% questionnaire completion rate
Results:
Primary Outcomes
Intervention
“Control”
RSDI: Improved
SIA: Improved
SNOT-20: Stable
RSDI: Improved 22.5%
SIA: Improved 38%
SNOT-20:Improved 36%
85
Change in Rhinosinusitis
Disability Index (RSDI) score
80
Experimental
75
RSDI Score
Control
70
SE of change
in score
p<0.05
65
p<0.001
60
55
Baseline
6 weeks
3 months
6 months
18 months
Severe (7)
Moderate (4)
SE of change
in score
Experimental
Control
p<0.01
p<0.01
p<0.001
Normal (1)
Nasal-Sinus Symptom Severity (1-7 Likert scale)
Change in the Single-item Assessment
Baseline
6 weeks
3 months
6 months
18 months
Sino-Nasal Outcomes Test (SNOT-20) Scores
55
50
45
Scores
40
Experimental
35
Control
30
25
20
15
Baseline/6-months
18/12 months
Results:
Secondary Outcomes
Frequency

2.4 irrigations/week
Pattern
35% Scheduled
 65% When Symptomatic
 5%
Not at all

Results:
Secondary Outcomes
Side effects: (9% nasal irritation
and burning)
Satisfaction: 96% overall will
continue to use and recommend
Phase 2: Overall results
Initial Control Subs: Matched gains by
initial nasal irrigation users
Initial Experimental Subs: Continued
stable improvement
Both groups stable use 2-3x per week
Continued satisfaction
Phase 3: Objective
Qualitatively assess attitudes and
practices regarding use of saline
nasal irrigation


(How did they do it?)
(How can we help our pts do it?)
Subject Participation in Phases 1, 2 and 3
76 subjects consented & randomized
Phase 1: Original
RCT (6 mos.)
Phase 2: Follow-up
study (12 mos.)
Phase 3:
Qualitative study
HSNI
n = 52
Opt out:
n = 12
Standard of Care
n = 24
Follow-up Study
n = 40
Follow up study:
n = 14
Single HSNI use group:
n = 54
All Subjects using HSNI in Phases 1 & 2:
n = 66
Qualitative Study :
28 Qualitative Interviews
Methods: Phase 3
Inclusion Criteria: Nasal irrigation use
in either Phase 1 or Phase 2
Willing to be interviewed
Methods: Phase 3
Recruitment


Phase 2 subjects queried semi-randomly
Interested subjects consented/enrolled
Intervention

20-30 minute semi-structured, in-depth taped
interviews
Analysis


Consensus-based interview discussion
Theme identification
Methods:
Open-ended talking points
1. Character of sinus problems like before/after NI
2. Experience any problems from NI?
3. How did NI fit into daily life?
4. Social reactions about using NI from those
around you?
5. What about NI now?
6. What worked in teaching process?
7. Anything else to say?
Results: Sample similar to
Phase 1 & 2 NI users
Age
Baseline Scores
Past Medical History





Seasonal Allergies
Asthma
Nasal Surgery
Nasal Polyps
Deviated Septum
End Phase 2 scores
Results: Themes
Empowerment
Quality of Life
Barriers to use of HSNI
Strategies for overcoming barriers
Results: Empowerment
“I’ve learned that I can take care of a lot of
this by myself, so I do.”
“It’s…truly wonderful… makes me feel
more in control of my own health and my
own sinus condition.”
Results: Quality of life
“ … almost instant relief of the
congestion…”
“When you suffer from a chronic illness for
so long and then you don’t…it’s such a big
relief,…such a big change when you can
enjoy things that [other] people take for
granted.”
Results: Barriers to NI use
“It was [initially] uncomfortable and it kind
of burned.” “ …felt a bit like drowning.”
“Pure and simple: it was gross. It took a
while to get used to it. It felt really funky.”
“The hardest part was creating a habit of
doing it and doing it all the time.
Overcoming barriers
“It helped to hear that there were other
people going through this…I didn’t realize
that I was feeling isolated until I met some
of the other people.”
Teaching, teaching teaching
“The actual instruction when we went to
the [sink] and you showing us directly how
to use it made all the difference in the
world.”
“making it part of my daily routine.”
Conclusions: Ph 3
Confirmed positive results from two prior studies.
Effective, safe, well-tolerated, inexpensive therapy
Patients with frequent RS and chronic sinus
symptoms can learn in the office and use at home
Clinical success HSNI will likely be improved by
brief patient education, HSNI demonstration, inperson coaching, and the ability to tailor HSNI use
to individual needs.
Limitations of 3 studies
Small
Specific population
Use/participation bias in second and third
phases
Self-report, recall bias
Should you be recommending
Nasal Irrigation?
Those who meet criteria of these studies and are
receptive
Pts with less dz who are more proactive
Pts who want a ‘natural’ therapy
Special populations


Pregnant women with sinus complaints
Pts with multiple Abx allergies/intolerances
Be aggressive, suggest ‘full trial’ min q day x 1
month
?Allergic rhinitis, ?URI-triggered asthma
Future Work
Systematic Reviews/Practice Guidelines

Clinical review, Cochrane review
Teaching paper
Bigger, better study?
Clinic integration study
4th clinical paper, pilot data on NI for:



Seasonal allergy
Asthma
ENT/anatomical variants
Publications
Rabago D, Zgierska, A, Mundt, MP, Barrett, B, Bobula J,
Maberry R. Efficacy of daily hypertonic saline nasal irrigation
among patients with sinusitis: A randomized controlled trial.
Journal of Family Practice 2002;51(12):1049-1055.
Rabago D, Pasic T, Zgierska A, Mundt M, Barrett B, Maberry
R. The efficacy of hypertonic saline nasal irrigation for chronic
sinonasal symptoms. Otolaryngology: Head and Neck
Surgery 2005 133(1):3-8.
Rabago D, Barrett B, Marchand L, Maberry R, Mundt M.
Qualitative aspects of nasal irrigation use by patients with
chronic sinus disease in a multi-method study Annals of
Family Medicine 2006; 4: 295-301.
Guerard E, Rabago D, Bukstein D; Nasal irrigation for chronic
sinus symptoms in patients with asthma, allergic rhinitis, and
nasal polyposis: a pilot study; In preparation
Thanks!
Co-authors

Bruce Barrett, Emily Guerard, Rob
Maberry, Lu Marchand, Marlon Mundt
Tom Pasic, Aleksandra Zgierska
Mentors

Mike Fleming, Jim Bobula
UW-DFM, AAFP, NIH-NCCAM