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ORIGINAL ARTICLE
Nasal Saline for Chronic Sinonasal Symptoms
A Randomized Controlled Trial
Melissa A. Pynnonen, MD; Shraddha S. Mukerji, MD; H. Myra Kim, ScD; Meredith E. Adams, MD; Jeffrey E. Terrell, MD
Objective: To determine if isotonic sodium chloride
(hereinafter “saline”) nasal irrigations performed with
large volume and delivered with low positive pressure
are more effective than saline sprays at improving qual-
ity of life and decreasing medication use.
Design: A prospective, randomized controlled trial.
Setting: Community.
Participants: A total of 127 adults with chronic nasal
and sinus symptoms.
Interventions: Patients were randomly assigned to ir-
rigation performed with large volume and delivered with
low positive pressure (n=64) or spray (n=63) for 8 weeks.
Main Outcome Measures: Change in symptom se-
verity measured by mean 20-Item Sino-Nasal Outcome
Test (SNOT-20) score; change in symptom frequency
measured with a global question; and change in medi-
cation use.
Results: A total of 121 patients were evaluable. The ir-
rigation group achieved lower SNOT-20 scores than the
spray group at all 3 time points: 4.4 points lower at 2 weeks
(P=.02); 8.2 points lower at 4 weeks (P⬍ .001); and 6.4
points lower at 8 weeks (P = .002). When symptom fre-
quency was analyzed, 40% of subjects in the irrigation
group reported symptoms “often or always” at 8 weeks
compared with 61% in the spray group (absolute risk re-
duction, 0.2; 95% confidence interval, 0.02-0.38 (P=.01).
No significant differences in sinus medication use were
seen between groups.
Conclusion: Nasal irrigations performed with large vol-
ume and delivered with low positive pressure are more
effective than saline sprays for treatment of chronic nasal
and sinus symptoms in a community-based population.
Trial Registration: clinicaltrials.gov Identifier:
NCT00318006
Arch Otolaryngol Head Neck Surg. 2007;133(11):1115-1120
C
HRONIC NASAL AND SINUS
conditions are extremely
common in the general
population. Chronic
rhinosinusitis (CRS) alone
reportedly affects 36 millionAmericans each
year.
1,2
Allergic and nonallergic types of rhi-
nitis afflict millions more. Medications for
these conditions abound, and therapy is
usually directed at the underlying disease
process: antibiotics for rhinosinusitis and
antihistamine or anti-inflammatory drugs
for allergy and rhinosinusitis. Persistent
symptoms may be owing to a failure of
therapy, inability to treat disease process,
or failure of accurate diagnosis. For ex-
ample, nonallergic rhinitis frequently co-
exists with allergic rhinitis. Yet if the non-
allergic component of the patient’s rhinitis
is untreated, symptoms often persist, and
the antihistamine therapy may be deemed
a “failure.” Additional treatment may be pre-
scribed, including leukotriene inhibitors,
topical corticosteroids, mast cell stabiliz-
ers, decongestants, and/or anticholiner-
gics, yet many patients remain sympto-
matic. Isotonic sodium chloride (hereinafter
“saline”) irrigations may be useful adjunc-
tive therapy for patients with such chronic
sinonasal symptoms.
Otolaryngologists recommend the use
of nasal irrigations following sinus sur-
gery to cleanse the nasal passages and pro-
mote mucosal healing. Clinical experi-
ence and anecdotal reports of symptom
improvement have resulted in extension
of the use of nasal irrigations beyond post-
operative debridement. Many otolaryn-
gologists recommend use of irrigations for
a wide array of sinonasal conditions. Un-
til recently, evidence of their benefit re-
mained anecdotal. However, 2 recent clini-
cal trials have demonstrated the clinical
efficacy of nasal irrigations in nonsurgi-
cal patients, and nasal saline treatment is
becoming increasingly common.
3,4
Nasal saline sprays are often used as an
alternative to saline irrigations because sa-
line spray is often perceived to be equiva-
lent to and better tolerated than irriga-
Author Affiliations:
Departments of Otolaryngology
(Drs Pynnonen, Adams, and
Terrell) and Biostatistics and
Center for Statistical
Consultation and Research
(Dr Kim), University of
Michigan Health System, Ann
Arbor; and Department of
Pediatric Otolaryngology, Texas
Children’s Hospital, Houston
(Dr Mukerji).
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tion.
5
The clinical efficacy of saline sprays is unproven.
6
The present study was designed to compare the efficacy
of saline spray with saline irrigation with respect to disease-
specific quality of life change in a general population of
patients with chronic nasal and sinus complaints.
METHODS
STUDY PARTICIPANTS
Potential study participants were recruited from the general popu-
lation between December 2005 and May 2006 through several
mechanisms: (1) an electronic posting at the Engage bulletin
board, which is sponsored by the University of Michigan Cen-
ter for the Advancement of Clinical Research to advertise active
clinical trials at the University of Michigan Health System; (2)
an electronic posting at clinicaltrials.gov; (3) flyers posted in the
public corridors of the University of Michigan Hospital; (4) study
brochures distributed to local allergists, pulmonologists, and pri-
mary care physicians; and (5) flyers posted in public places
throughout the local community, such as libraries, grocery stores,
pharmacies, housing complexes, and other sites. Eligible par-
ticipants were adults 18 years or older who self-reported 1 or
more of the following symptoms 4 or more days each week in
the preceding 2 weeks: nasal stuffiness (blocked sensation in the
nose), nasal dryness or crusting, nasal congestion (this term was
left open to the individual patient’s interpretation), discolored
nasal discharge, or thick nasal discharge (including postnasal dis-
charge). In addition to the presence of symptoms at least 4 days
each week, the symptoms must have been present at least 15 of
the preceding 30 days. Participants were excluded if they had
recent sinus surgery, respiratory infection within the preceding
2 weeks, or had used either of the study interventions within the
preceding month. Subjects with recent (2 week) upper respira-
tory tract infections, whether viral or bacterial, were excluded.
However, subjects with at least 4 weeks of symptoms were in-
cluded. As a result, our subjects may have had acute rhinosinu-
sitis or CRS.
STUDY DESIGN
The study was a randomized controlled trial comparing 2 meth-
ods of nasal saline use: nasal irrigation and nasal spray. The study
protocol was reviewed and approved by the University of Michi-
gan Health System institutional review board and the General Clini-
cal Research Center (GCRC). Financial support for the study was
provided by NeilMed Pharmaceuticals, Santa Rosa, California, who
is the manufacturer of the saline product, Sinus Rinse.
A brief telephone survey was used to screen subjects and to
confirm eligibility of potential study participants. Eligible study
participants met with the study coordinator at 1 of 3 outpatient
clinical research GCRC sites: University of Michigan Hospital, Ann
Arbor; Domino’s Farms, Ann Arbor; and Ypsilanti Health Cen-
ter, Ypsilanti, Michigan. Written informed consent was obtained
from all study participants at the time of meeting with the study
coordinator prior to the conduct of any study-related procedures.
SURVEY INSTRUMENTS
Baseline and follow-up surveys consisted of the 20-Item Sino-
Nasal Outcome Test (SNOT-20)
7
measure of symptom sever-
ity, a global question regarding symptom frequency, and a medi-
cation diary. The SNOT-20 is a validated, self-administered, quality
of life instrument specific for patients with symptoms of rhino-
sinusitis. The instrument measures physical problems, func-
tional limitations, and emotional consequences of sinusitis by
asking subjects to score 20 items, including the need to blow the
nose, sneezing, runny nose, cough, postnasal discharge, thick
nasal discharge, ear fullness, dizziness, ear pain, facial pain/
pressure, difficulty falling asleep, waking up at night, lack of a
good night’s sleep, waking up tired, fatigue, reduced productiv-
ity, reduced concentration, frustrated/restless/irritable, and being
sad and embarrassed. The SNOT-20 gives a summary measure
that is usually scored from 0 to 5. For ease of interpretation, we
have used a multiple of 20, giving a summary score ranging from
0 to 100, with 100 indicating worse symptoms.
Symptom frequency was measured with the question “Over
the past 2 weeks, how much have you been bothered by your
nasal and/or sinus symptoms?” offering the following 5-point
multiple-choice Likert response scale: “never,” “rarely,” “sel-
dom,” “often,” or “always.” Symptom chronicity was mea-
sured with the questions: “Of the preceding 12 months, how
many months have you had these symptoms?”
A medication diary was used to document treatment com-
pliance and use of prescription or nonprescription medica-
tions for nasal and sinus-related symptoms (including but not
limited to antihistamines, nasal steroid sprays, decongestants,
and antibiotics).
RANDOMIZATION
Randomization was stratified by GCRC site; and within each
stratum, blocked randomization with random block size was
performed to further enhance the balancing of the patients. The
biostatistician (H.M.K.) generated the computerized random-
ization codes, and sequentially numbered, opaque envelopes
with random assignments were prepared beforehand and given
to site coordinators at each site.
INTERVENTION
A study visit was scheduled on day 0. On day 0, according to ran-
domization, subjects were instructed in the technique of nasal la-
vage (irrigation group) or nasal saline spray (spray group) and were
asked to do the assigned treatment twice daily for 8 weeks. They
were provided with an 8-week supply of materials (Sinus Rinse
irrigations from NeilMed Products Inc, and Deep Sea nasal sa-
line spray distributed by Major Pharmaceuticals, Livonia, Michi-
gan). Both the saline solution (irrigation) and saline spray used
in our study were isotonic sodium chloride solutions. Subjects
were allowed to continue their usual medications.
END POINTS AND FOLLOW-UP
Outcomes were measured at 2, 4, and 8 weeks after random-
ization using a mail-in survey composed of the SNOT-20, the
global question of symptom frequency, and the medication di-
ary. Data on adverse effects were collected prospectively with
an open-ended question. The study coordinator, who was not
blinded to treatment group, telephoned each subject 1 week
after enrollment to answer any participant questions and en-
courage compliance. Telephone calls thereafter were used to
collect missing survey data.
DEMOGRAPHIC MEASURES
Demographic measures consisted of age, sex, race, and high-
est educational status attained. Subjects self-reported their race/
ethnicity, and options were defined according to the 2-tier ques-
tion used by the US Census Bureau.
8
STATISTICAL ANALYSIS
Baseline characteristics, including baseline values of the out-
come measures, were compared between the 2 study groups using
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a
2
test for categorical variables and a 2-sample t test for con-
tinuous variables. The SNOT-20 mean scores and mean change
scores relative to baseline were calculated by group at each fol-
low-up point. Trends over time and between groups were first
graphically explored. The analysis was done to test for signifi-
cant improvement in outcome after randomization within each
study group using paired t tests. Between-group outcome dif-
ferences at each follow-up time were done using 2-sample t tests.
Finally, we compared outcomes between 2 study groups aver-
aged over the follow-up times using mixed-effect model analy-
sis.
9
The global symptom question was dichotomized to com-
pare frequent symptoms (often or always) with infrequent
symptoms (seldom, rarely, or never), and between-group com-
parisons were made using
2
tests. Symptom frequency during
follow-up was compared between the 2 groups using a logistic
regression model with robust standard error estimates to adjust
for within-patient correlation from having repeated measures of
symptom severity data. Odds ratios were used as a summary mea-
sure comparing differences in symptom burden between groups.
RESULTS
PARTICIPANTS
A total of 193 potential subjects were screened, of whom
127 eligible patients were enrolled and randomized to
either the irrigation or spray group (
Figure 1). Of those
randomized, 6 patients withdrew before they reached the
first follow-up measurement time (4.7%), and thus were
not included in the analysis. A total of 121 subjects were
observed for at least 2 weeks (60 in the irrigation group
and 61 in the spray group), and 113 subjects had com-
plete data (93%) at all 4 planned measurement times.
Demographic and baseline characteristics of study par-
ticipants were similar between the 2 groups (
Table 1).
PRIMARY OUTCOMES
Baseline mean SNOT-20 scores (35.5 for spray, 37.6 for
irrigation) were similar in the 2 groups and comparable
to the mean SNOT-20 scores reported in patients with CRS.
7
Both study groups showed significant improvement in
SNOT-20 scores after randomization (
Figure 2) at each
of weeks 2, 4, and 8 (P⬍.001 for each week, paired t test).
However, the SNOT-20 scores were consistently lower (bet-
ter) in the irrigation group than in the spray group.
The change in mean SNOT-20 scores over the study
period in both groups is summarized in
Table 2. When
SNOT-20 scores over the 8-week period were modeled,
the time-averaged decrease (improvement) in SNOT-20
scores from baseline was 6.7 (P ⬍ .001) for the spray
group, and the irrigation group had additional de-
creases of 4.4 (P = .02) at week 2, 8.2 ( P ⬍ .001) at week
4, and 6.4 (P = .002) at week 8 (data not shown). The
analysis was adjusted for baseline scores of SNOT-20,
smoking status, baseline symptom frequency, and age.
The frequency of sinus or nasal symptoms in the pre-
ceding 2 weeks at each measurement time as assessed with
the global question is summarized in
Table 3. At base-
193 Potential subjects screened
66 Excluded
31 Refused randomization
35 Did not meet eligibility
criteria
64 Irrigation group
127 Randomized
4 Lost to follow-up before first
time measurement
60 Subjects included in
analysis at week 2
63 Spray group
2 Lost to follow-up before first
time measurement
61 Subjects included in
analysis at week 2
Figure 1. Randomization of the study cohort.
Table 1. Baseline Characteristics of Study Groups
After Randomization
a
Characteristic
Spray
(n=63)
Irrigation
(n=64)
P
Value
Age, mean (SD), y 48.1 (17.1) 45.1 (14.6) .29
Men 18 (29) 24 (38) .29
ⱖ College degree 52 (83) 51 (80) .68
White 47 (75) 48 (75) .72
Smoking status .61
Current smoker 7 (11) 11 (17)
Quit smoking 22 (35) 20 (31)
Never smoked 34 (54) 33 (52)
Symptom burden .77
Rarely 0 1 (2)
Seldom 3 (5) 4 (6)
Often 29 (46) 29 (45)
Always 31 (49) 30 (47)
Symptom duration, mo ⬎.99
1-2 0 0
3-6 5 (8) 5 (8)
7-12 58 (92) 57 (92)
b
a
Unless otherwise indicated, data are reported as number (percentage) of
subjects.
b
Missing data for 2 subjects in the irrigation group.
10
20
30
40
50
0 2 4
6 8
SNOT-20 Score, Mean
Time Since Randomization, wk
Saline irrigation
Saline spray
Figure 2. Scores from the 20-Item Sino-Nasal Outcome Test (SNOT-20)
7
determined at baseline and weeks 2, 4, and 8 after randomization by
irrigation and spray study group.
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line, 95% of the spray group (n = 58) and 93% of the ir-
rigation group (n=56) reported having been bothered by
frequent nasal or sinus symptoms. However, at week 8,
40% of the irrigation group (n = 24) vs 61% of the spray
group (n=37) reported having frequent symptoms. When
symptom frequency was dichotomized and modeled, fre-
quent symptoms (often or always vs seldom, rarely, or
never) were significantly less likely among the irriga-
tion group. During the follow-up period, the odds of fre-
quent symptoms for the irrigation group relative to the
spray group were 0.49 (P= .01) after adjusting for smok-
ing status, patient age, and baseline SNOT-20 score.
The absolute risk reduction in symptom frequency with
saline irrigations was 0.2 (95% confidence interval 0.02-
0.38) (P=.01) with the number needed to treat equal to 5.
The absolute risk reduction of symptom severity, measured
by a clinically significant improvement in SNOT-20 scores
(corresponding to ⱖ16 points), was 15% with the number
needed to treat equal to 7.
As depicted in
Figure 3 using data from both groups,
there was good correlation between mean SNOT-20 scores
(symptom severity) and global question (symptom fre-
quency) answers.
SECONDARY OUTCOMES
The numbers and percentages of participants who re-
ported medication use for treatment of their nasal or si-
nus symptoms are summarized in
Table 4. Participants
in both groups were more likely to use oral medications
than nasal medications at all time points. Within each group,
over the duration of the study, there was no difference in
the number of participants who reported medication us-
age. Since there was no within-group difference, we com-
bined the 2 groups to assess any change in medication use
over time. When data across time and groups were com-
bined, the number of participants reporting any medica-
tion use was found to be significantly less, both for oral medi-
cations (P=.002) and nasal medications (P=.04), relative
to baseline. However, the duration of medication use (mea-
sured in days) did not differ significantly from baseline
(P=.39 for oral medication duration; P=.57 for nasal medi-
cation duration). When the analysis of SNOT-20 was fur-
ther adjusted for the duration of nasal medication use in
the past 2 weeks, the irrigation group still showed greater
symptom reduction at each of the 3 follow-up times com-
pared with the spray group, and each additional day of na-
sal medication use was associated with a 0.54-point lower
SNOT-20 score (P=.01).
Compliance (defined as using the assigned interven-
tion for at least 11 days in the past 2 weeks) was higher
in the spray group (97%, 93%, and 93%) than in the ir-
rigation group (92%, 81%, and 79%) at weeks 2, 4, and
8, respectively (P=.03).
Adverse effects were common in both groups (25%
in the spray group, 43% in the irrigation group). Forty-
one subjects reported a total of 67 occurrences of ad-
verse effects over the duration of the study (32%). Post-
treatment nasal drainage (an expected adverse effect) was
the most common adverse effect (n = 14) in each group.
There was no statistically significant difference (P= .21)
in the overall rate of adverse effects reported between the
2 groups, and no participants discontinued treatment ow-
ing to adverse effects.
Table 2. Change From Baseline in SNOT-20 Scores at 2, 4, and 8 Weeks After Randomization
a
Week
Spray
Irrigation
P Value
b
Subjects, No. SNOT-20 Score Subjects, No. SNOT-20 Score
2 61 6.7 (14.5) 59 12.2 (16.1) .05
4 60 7.4 (14.3) 57 16.2 (16.4) .002
8 59 8.5 (15.2) 55 15.0 (17.6) .04
Abbreviation: SNOT-20, 20-Item Sino-Nasal Outcome Test.
7
a
Unless otherwise indicated, data are reported as mean (SD) SNOT-20 scores. Within spray and irrigation groups, the changes were statistically significantly
greater than 0 based on paired t test at P⬍.001 for every week.
b
For comparison of irrigation with spray group using the 2-sample t test.
Table 3. Study Participants Who Reported Symptoms Often
or Always
a
Week Spray Irrigation P Value
b
0 58 (95) 56 (93) .68
2 42 (69) 32 (53) .08
4 38 (62) 28 (47) .08
8 37 (61) 24 (40) .02
a
Unless otherwise indicated, data are reported as number (percentage) of
subjects.
b
Based on
2
test.
0
5
10
15
25
20
30
35
40
SNOT-20 Score, Mean
Global Question Answer
Always
Seldom
Never
Figure 3. Relationship between mean 20-Item Sino-Nasal Outcome Test
(SNOT-20)
7
scores and global question scores.
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COMMENT
To our knowledge, this is the first randomized controlled
trial showing greater efficacy of saline irrigation vs saline
spray for providing short-term (8 week) relief for chronic
nasal symptoms. The result demonstrated substantially
greater benefit with irrigation than with spray, both in terms
of symptom severity (SNOT-20) and symptom fre-
quency. The irrigation group achieved a clinically signifi-
cant improvement in quality of life as measured by the
SNOT-20 instrument, whereas the spray group did not. Fur-
thermore, the irrigation group experienced 50% lower odds
of frequent nasal symptoms compared with the spray group.
The baseline severity of nasal and sinus symptoms of
the subjects enrolled in this study and the magnitude of
symptom improvement achieved with irrigation can best
be appreciated when compared with other studies that
have used the SNOT-20. In the study by Piccirillo et al,
7
the work that validated the instrument, comparable
SNOT-20 scores for subjects with presumed CRS and
healthy subjects, were 38 and 12, respectively.
7
Al-
though the patients in our study did not undergo clini-
cal evaluation to discern the underlying cause of their
chronic nasal and sinus complaints, the severity of their
symptoms, as measured by baseline mean SNOT-20 scores
(35.5, spray group; 37.6, irrigation group), and the chro-
nicity of their symptoms (⬎6 months for most sub-
jects), were comparable to those with presumed CRS.
As for the magnitude of symptom improvement, Pic-
cirillo et al
7
suggested a clinically meaningful SNOT-20
change score that would correspond to 16 in our current
study. For comparison, SNOT-20 scores of patients who
undergo sinus surgery have improved 19 to 22 points,
10
and patients with severe nasal polyposis treated with oral
prednisone improved 10 points.
11
Our mean SNOT-20 im-
provement (range, 12.2-16.2 points) over the 8-week study
is similar to a clinically meaningful threshold. This find-
ing is even more remarkable given the nominal cost and
minimal risk of this saline intervention.
The benefits derived from nasal saline use are likely
due to 1 or more local effects,
12,13
including decreased vis-
cosity of nasal secretions,
14
decreased edema of the na-
sal mucosa, and removal of debris, bacteria, allergens, and
inflammatory mediators by the mechanical “lavage” ac-
tion of saline irrigation.
15
Enhanced mucociliary clear-
ance has also been hypothesized as a possible mecha-
nism of action, although the data are conflicting.
16,17
The
greater efficacy of irrigation over saline spray may be due
to greater volume, increased delivery pressure, and me-
chanical debridement achieved with irrigations. (A dem-
onstration of nasal irrigation can be viewed at http://www
.salineirrigation.com/instructions.html.)
In the present study, although overall compliance in
both groups was high, participants in the spray group were
more compliant than those in the irrigation group (P=.04).
Nonetheless, the compliance of patients in the irriga-
tion group (79%) was still quite high and comparable to
the 87% compliance rate at 6 months reported by Rabago
et al.
4
It also suggests that our results are a conservative
estimate of the true benefit of irrigation therapy.
Adverse effects were frequent in both groups, although
most were minor, and none resulted in discontinuation of
therapy. The most commonly reported adverse effect in each
group was posttreatment drainage. Others occurred more
sporadically, and included symptoms common to pa-
tients with chronic nasal and sinus conditions (eg, dry-
ness in the nose and pressure in the ears). Overall, the types
and rates of these effects were comparable to those re-
ported in other clinical trials.
4,13
Although subjects in the
irrigation group were more likely to have these adverse ef-
fects, no subject in the study found the adverse effects se-
vere enough to stop treatment. A 2006 study by Rabago et
al
18
reports that patients not only continue to use irriga-
tion long term but also are able to self-adjust their irriga-
tion schedule and technique to minimize any possible ad-
verse effects.
18
The positive sense of satisfaction among
irrigation users is associated with clinical improvement as
well as improvement in quality of life.
We did not find decreased medication use with adju-
vant saline treatments. This was somewhat surprising and
contrasts with findings from other prospective studies of
saline irrigation, which have shown decreased medica-
tion use overall
12
and specifically less antibiotic use.
3
There
are several possible explanations for our negative result.
Rabago et al
3
required a prior diagnosis of recurrent acute
rhinosinusitis or CRS and thus may have selected for sub-
jects with greater antibiotic or other medication use. Since
our study was designed to recruit patients without any spe-
Table 4. Medication Use by Study Groups
Week
Spray
Irrigation
Participants, No. (%) Days Used, Mean (SD)
a
Participants, No. (%) Days Used, Mean (SD)
a
Oral
0 29 (48) 8.7 (8.9) 30 (50) 5.4 (6.3)
2 18 (30) 6.3 (5.1) 19 (32) 6.3 (5.1)
4 19 (31) 7.8 (5.4) 21 (35) 9.9 (5.1)
8 19 (31) 8.6 (5.0) 17 (28) 9.9 (5.3)
Nasal
0 13 (21) 6.5 (5.5) 11 (18) 8.5 (5.6)
2 6 (10) 4.8 (3.4) 9 (15) 8.9 (6.1)
4 7 (11) 3.3 (1.8) 6 (10) 7.3 (6.0)
8 12 (20) 5.9 (4.1) 10 (17) 10.3 (5.3)
a
In the past 2 weeks.
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cific diagnosis or cause for their symptoms, differences in
inclusion criteria may have contributed to the inability to
demonstrate a reduction in medication use with initiation
of nasal irrigations. Heatley et al
12
reported decreased medi-
cation use, but it is not clear whether they found fewer sub-
jects using any medication or fewer medication days among
all subjects. Finally, our study was slightly underpowered
to detect change in medication use (the study had 78%
power to detect reduction in medication use compared with
99% to detect a clinically significant change in SNOT-20
score). Further studies focused on recruiting subjects with
high rates of antibiotic use for sinusitis could be designed
to evaluate the potential cost savings of this intervention.
The generalizability of this study is one of its greatest
strengths. The results of this study are applicable to the large
number of patients with assorted nasal and sinusitislike
symptoms seen by primary care providers on a daily basis.
This study was specifically designed to recruit subjects from
the general community with self-reported chronic nasal and
sinus symptoms. Other strengths of our study design in-
clude prospective recruitment, patient-oriented primary and
secondary outcomes, an intention-to-treat analysis, and a
very low dropout rate. However, this study was not blinded
and did not have adequate power to evaluate the potential
heterogeneous subgroups of patients with nasal symp-
toms, such as those patients with allergic rhinitis, nasal pol-
yposis, cystic fibrosis, or those with nasal congestion that
complicates nasal continuous positive airway pressure use.
In addition, the nature of our study did not allow blind-
ing, although we were diligent in our efforts to prevent any
experimenter bias. Finally, despite efforts to document com-
pliance through the use of self-report diaries, there is the
possibility for patient overreport of compliance. How-
ever, given the positive findings of our study, we do not
believe this was a notable problem.
In conclusion, our study suggests that nasal irrigations
performed with a large volume and delivered with low posi-
tive pressure are more effective than saline sprays over an
8-week period for treatment of chronic nasal and sinus
symptoms among a community-based population with self-
reported symptoms. Our findings also suggest that the ben-
efit of saline irrigations as adjunctive therapy for chronic
nasal and sinus-related symptoms could be expanded be-
yond the otolaryngologist’s armamentarium and incorpo-
rated into the general practice of other clinical health care
providers who frequently evaluate patients with such symp-
toms. Primary care physicians and physician extenders may
prove to be essential in explaining the benefits and useful-
ness of saline irrigations to patients in the community.
Submitted for Publication: February 5, 2007; final re-
vision received April 25, 2007; accepted May 7, 2007.
Correspondence: Melissa A. Pynnonen, MD, Department
of Otolaryngology, University of Michigan Health Sys-
tem, 1904 Taubman Center, 1500 E Medical Center Dr,
Ann Arbor, MI 48109-0312 (pynnonen@umich.edu).
Author Contributions: Dr Pynnonen had full access to
all the data in the study and takes responsibility for the
integrity of the data and the accuracy of the data analy-
sis. Study concept and design: Pynnonen, Mukerji, Kim,
Adams, and Terrell. Acquisition of data: Pynnonen,
Mukerji, and Terrell. Analysis and interpretation of data:
Pynnonen, Mukerji, Kim, and Terrell. Drafting of the
manuscript: Pynnonen, Mukerji, Kim, and Terrell. Criti-
cal revision of the manuscript for important intellectual con-
tent: Pynnonen, Mukerji, Kim, Adams, and Terrell. Sta-
tistical analysis: Mukerji, Kim, and Terrell. Obtained
funding: Pynnonen, Kim, and Terrell. Administrative, tech-
nical, and material support: Pynnonen, Mukerji, and
Terrell. Study supervision: Pynnonen, Mukerji, and Terrell.
Financial Disclosure: None reported.
Funding/Support: Financial support was provided by
NeilMed Pharmaceuticals, Santa Rosa, California.
Role of the Sponsor: The sponsor had no role in design
or conduct of the study; collection, management, analy-
sis, or interpretation of the data; or in preparation, re-
view, or approval of the manuscript.
Additional Contributions: Jay F. Piccirillo, MD, shared
the SNOT-20 instrument with us. Karen A. Chartier, AAS,
helped design the study flyer and brochure. Dr Adams
assisted with approval by the institutional review board.
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