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 Dxs,
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

Ostialocclusion
Mucosal
Thickening/,
furtherblockage
Bacterialinfection,
viralinfection

Secretionsthicken,
pHchanges
Ciliarydamage
Bacterialorviral
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
1890s
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

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

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

NNT for Symptoms

and Medications at 6 months

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%

Results:
Secondary Outcomes
Frequency

2.4 irrigations/week

Pattern
35%

65%

5%

Scheduled
When Symptomatic
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
Ive learned that I can take care of a lot of
this by myself, so I do.
Itstruly 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 dontits 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 thisI didnt 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