ArticlePDF Available

Nasal Saline for Chronic Sinonasal Symptoms: A Randomized Controlled Trial

Authors:

Abstract and Figures

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 quality of life and decreasing medication use. A prospective, randomized controlled trial. Community. A total of 127 adults with chronic nasal and sinus symptoms. Patients were randomly assigned to irrigation performed with large volume and delivered with low positive pressure (n = 64) or spray (n = 63) for 8 weeks. Change in symptom severity measured by mean 20-Item Sino-Nasal Outcome Test (SNOT-20) score; change in symptom frequency measured with a global question; and change in medication use. A total of 121 patients were evaluable. The irrigation 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 frequency 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 reduction, 0.2; 95% confidence interval, 0.02-0.38 (P = .01). No significant differences in sinus medication use were seen between groups. Nasal irrigations performed with large volume 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.
Content may be subject to copyright.
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).
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 133 (NO. 11), NOV 2007 WWW.ARCHOTO.COM
1115
©2007 American Medical Association. All rights reserved.
, on November 30, 2007 www.archoto.comDownloaded from
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
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 133 (NO. 11), NOV 2007 WWW.ARCHOTO.COM
1116
©2007 American Medical Association. All rights reserved.
, on November 30, 2007 www.archoto.comDownloaded from
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
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.
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 133 (NO. 11), NOV 2007 WWW.ARCHOTO.COM
1117
©2007 American Medical Association. All rights reserved.
, on November 30, 2007 www.archoto.comDownloaded from
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 16 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.
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 133 (NO. 11), NOV 2007 WWW.ARCHOTO.COM
1118
©2007 American Medical Association. All rights reserved.
, on November 30, 2007 www.archoto.comDownloaded from
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.
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 133 (NO. 11), NOV 2007 WWW.ARCHOTO.COM
1119
©2007 American Medical Association. All rights reserved.
, on November 30, 2007 www.archoto.comDownloaded from
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.
REFERENCES
1. Gliklich RE, Metson R. Economic implications of chronic sinusitis. Otolaryngol
Head Neck Surg. 1998;118(3, pt 1):344-349.
2. Anand VK. Epidemiology and economic impact of rhinosinusitis. Ann Otol Rhi-
nol Laryngol Suppl. 2004;193:3-5.
3. Rabago D, Zgierska A, Mundt M, Barrett B, Bobula J, Maberry R. Efficacy of daily
hypertonic saline nasal irrigation among patients with sinusitis: a randomized
controlled trial. J Fam Pract. 2002;51(12):1049-1055.
4. Rabago D, Pasic T, Zgierska A, Mundt M, Barrett B, Maberry R. The efficacy of
hypertonic saline nasal irrigation for chronic sinonasal symptoms. Otolaryngol
Head Neck Surg. 2005;133(1):3-8.
5. Keojampa BK, Nguyen MH, Ryan MW. Effects of buffered saline solution on na-
sal mucociliary clearance and nasal airway patency. Otolaryngol Head Neck Surg.
2004;131(5):679-682.
6. Adam P, Stiffman M, Blake RL Jr. A clinical trial of hypertonic saline nasal spray
in subjects with the common cold or rhinosinusitis. Arch Fam Med. 1998;7
(1):39-43.
7. Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity
of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg.
2002;126(1):41-47.
8. Wallman KK, Evinger S, Schechter S. Measuring our nation’s diversity: devel-
oping a common language for data on race/ethnicity. Am J Public Health. 2000;
90(11):1704-1708.
9. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics.
1982;38(4):963-974.
10. Colclasure JC, Gross CW, Kountakis SE. Endoscopic sinus surgery in patients
older than sixty. Otolaryngol Head Neck Surg. 2004;131(6):946-949.
11. Woodworth BA, Joseph K, Kaplan AP, Schlosser RJ. Alterations in eotaxin, mono-
cyte chemoattractant protein-4, interleukin-5, and interleukin-13 after systemic
steroid treatment for nasal polyps. Otolaryngol Head Neck Surg. 2004;131
(5):585-589.
12. Heatley DG, McConnell KE, Kille TL, Leverson GE. Nasal irrigation for the alleviation
of sinonasal symptoms. Otolaryngol Head Neck Surg. 2001;125(1):44-48.
13. Tomooka LTMC, Davidson TM. Clinical study and literature review of nasal irrigation.
Laryngoscope. 2000;110(7):1189-1193.
14. Palmer KN. Reduction of sputum viscosity by a water aerosol in chronic bronchitis.
Lancet. 1960;1:91.
15. Georgitis JW. Nasal hyperthermia and simple irrigation for perennial rhinitis:
changes in inflammatory mediators. Chest. 1994;106(5):1487-1492.
16. Boek WM, Graamans K, et al. Physiologic and hypertonic saline solutions im-
pair ciliary activity in vitro. Laryngoscope. 1999;109(3):396-399.
17. Talbot AR, Parsons DS. Mucociliary clearance and buffered hypertonic saline
solution. Laryngoscope. 1997;107(4):500-503.
18. 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 study.
Ann Fam Med. 2006;4(4):295-301.
(REPRINTED) ARCH OTOLARYNGOL HEAD NECK SURG/ VOL 133 (NO. 11), NOV 2007 WWW.ARCHOTO.COM
1120
©2007 American Medical Association. All rights reserved.
, on November 30, 2007 www.archoto.comDownloaded from
... Other adverse events were rare, and included nasal drainage [57,60], epistaxis [41,62,84], bitter taste in mouth [62], pain [92] and nose dryness [50]. ...
... Other hypertonic saline preparations, such as Dead Sea salt, have also been proven as safe and effective in this indication [56]. While various application methods are used (mostly spray vs. low/large volume irrigation [46,60], the safety profile remains highly favourable across the various studies. ...
Article
Full-text available
The history of saline nasal irrigation (SNI) is indeed a long one, beginning from the ancient Ayurvedic practices and gaining a foothold in the west at the beginning of the 20th century. Today, there is a growing number of papers covering the effects of SNI, from in vitro studies to randomized clinical trials and literature overviews. Based on the recommendations of most of the European and American professional associations, seawater, alone or in combination with other preparations, has its place in the treatment of numerous conditions of the upper respiratory tract (URT), primarily chronic (rhino)sinusitis, allergic rhinitis, acute URT infections and postoperative recovery. Additionally, taking into account its multiple mechanisms of action and mounting evidence from recent studies, locally applied seawater preparations may have an important role in the prevention of viral and bacterial infections of the URT. In this review we discuss results published in the past years focusing on seawater preparations and their use in clinical and everyday conditions, since such products provide the benefits of additional ions vs. saline, have an excellent safety profile and are recommended by most professional associations in the field of otorhinolaryngology.
... These recommendations are in agreement with previous studies conducted in adults showing that large-volume low-pressure saline irrigation is preferable over low-volume high-pressure irrigation to maximize the efficacy of the procedure. 26,27 There are various devices that are used for nasal irrigation. In this study, 70% of the experts disagreed on the effectiveness of nasal spray while consensus was reached (94%) on the effectiveness of refillable squeeze bottle. ...
Article
Introduction Nasal irrigation is regularly used in infants to relieve upper airway symptoms. However, because there is no consensus on good practice, nasal irrigation in infants is described and applied heterogeneously among clinicians and between clinical trials. Objective The aim of this study was to establish consensus regarding the use of nasal irrigation in infants. Methods A panel of Belgian physiotherapists and physicians experienced in performing nasal irrigation in infants were surveyed using the Delphi technique. Three survey rounds were used. Participants rated their level of (dis)agreement to each statement in each round using a 6-point Likert scale. Consensus was defined for statements which collected at least 75% of responses in agreement or disagreement. The questionnaire of Round 1 was built on nasal irrigation practice habits previously collected from parents, childcare workers, and healthcare professionals. Questionnaires from rounds 2 and 3 were amended based on experts written feedback. Results Thirty experts (12 physicians and 18 physiotherapists) completed all 3 questionnaires. Consensus was achieved for 47 of 75 statements (63%) distributed over the following domains: “contraindications,” “indications and frequency of use,” “irrigation means,” “solution preparation,” “solution volume,” “realization of the technique,” and “assessment of the efficacy of nasal irrigation.” Conclusion This study provides the first well-constructed consensus on good practice on nasal irrigation in infants. Consensus on several statements across different domains were established but require validation in future trials. This study also proposes direction for future research focusing on statements that did not reach consensus.
... Various studies have reported that different types of equipment provide different volumes and pressures of nasal saline delivery, which may impact irrigation penetration into the paranasal sinuses [118][119][120][121][122][123][124][125]. Generally, the delivery technique of nasal irrigation can be categorized based on the volume and pressure of delivery into four groups [124]. ...
Article
The Korean Society of Otorhinolaryngology-Head and Neck Surgery and Korean Rhinologic Society appointed a guideline development group (GDG) to establish a clinical practice guideline, and the GDG developed a guideline for nasal irrigation for adult patients with chronic rhinosinusitis (CRS). The guideline focuses on knowledge gaps, practice variations, and clinical concerns associated with nasal irrigation. Nasal irrigation has been recommended as the first-line treatment for CRS in various guidelines, and its clinical effectiveness has been demonstrated through a number of studies with robust evidence. However, no guidelines have presented a consistent nasal irrigation method. Several databases, including OVID Medline, Embase, the Cochrane Library, and KoreaMed, were searched to identify all relevant papers using a predefined search strategy. When insufficient evidence was found, the GDG sought expert opinions and attempted to fill the evidence gap. Evidence-based recommendations for practice were ranked according to the American College of Physicians grading system. The committee developed 11 evidence-based recommendations. This guideline focuses on the evidence-based quality improvement opportunities deemed the most important by the GDG. Moreover, the guideline addresses whether nasal lavage helps treat CRS, what type of rinsing solution should be used, and the effectiveness of using additional medications to increase the therapeutic effect.
Article
Background Topical sinus irrigation plays a critical role in the management of sinonasal diseases. Yet, the penetration of irrigant to targeted sinuses may be highly variable and difficult to predict. Here, we investigate the use of 3D printing as a planning tool to optimize outcomes. Methods Eight post-operative models were 3D printed with a FormLabs Form3 printer based on individual CT scans. Irrigations were performed and video recorded with a squeeze bottle attached via silicon water-tight seal, in 4 head positions: 45° to-the-side, 90° to-the-side, 45° forward and 45° to-the-side, and 90° forward, with irrigation fluid entering the upper (conventional) or lower (backfill) nostrils. Results Significant individual variations were observed in sinus penetration as a function of head position. In general, the maxillary sinus was the easiest to irrigate in most head positions ( P < .05), followed by frontal and ethmoid, with sphenoid being the most difficult. Both the 90°-to-the-side and the 90°-forward positions were significantly more effective than the others ( P < .05), with 90°-forward better for frontal sinuses and 90°-to-the-side superior for all other sinuses. The backfill was significantly superior to conventional technique in head positions involving a side tilt ( P < .05). Conclusion Variations in technique and position significantly impacted irrigation outcome. Backfill irrigation that pushes fluid against gravity to pool around the ostium, seems to provide overall better outcomes. This study demonstrates the advantage of 3D printing as a rapid planning tool to guide irrigation strategies.
Article
Full-text available
Objective Corticosteroid irrigation (CSI) is commonly used for management of chronic rhinosinusitis (CRS) with nasal polyps; however, such use is not approved by the US Food and Drug Administration (FDA). This review analyzes published reports on the efficacy and safety of CSI in CRS and evaluates clinical implications of current gaps in evidence. Data Sources Publications obtained through PubMed searches through January 2022. Study Selection Searches were conducted using two terms: “chronic rhinosinusitis” or “nasal polyps” as the first term and “corticosteroid irrigation,” “steroid nasal lavage,” or “sinus rinse” as the second term. We reviewed relevant, peer-reviewed literature (19 original research [9 controlled, 10 uncontrolled trials], 7 reviews, and 1 meta-analysis) reporting safety and/or efficacy of CSI in patients with CRS. Results Studies were difficult to compare because they used a variety of solution volumes (60 mL to 125 mL per nostril), corticosteroid agents (budesonide, betamethasone, mometasone, or fluticasone), corticosteroid doses, preparation protocols (by compounding pharmacy or by patient), and administration (frequency, time of day, body positioning). It is difficult to determine which parameters might substantially influence clinical effects because studies were generally small, showed marginal benefits, and rarely assessed safety. To date, no studies evaluating CSI have shown statistically significant differences in a type-I error–controlled primary endpoint over any comparator, possibly owing to small sample sizes. Conclusion Designing more robust clinical trials may help determine if CSI is a valid treatment option. Until more evidence supporting CSI use exists, health care professionals should strongly consider choosing FDA-approved therapies for the treatment of CRS.
Objectives /Hypothesis: The aim of this study was to compare the efficacy and outcome of daily hypertonic saline irrigation versus saline/xylitol for treating pediatric chronic rhinosinusitis (CRS). Study design This was a prospective, randomized, single-blinded study. Methods One hundred and twenty-five children diagnosed with CRS were enrolled in this study. The patients were randomized to twice-daily hypertonic irrigations with saline or saline/xylitol for 6 weeks. The treatment outcomes were measured using: Sinonasal Quality of Life Survey (SN-5) completed at baseline and after 6 weeks of irrigation. Results There were statistically significant improvements in the hypertonic nasal saline group's (reduction in SN-5 domain scores) four domains and an increase in the overall QoL score within each group after 6 weeks of treatment compared to baseline; however, there were no differences in the activity limitation (p = 0.1803). The xylitol solution groups had no differences between the two groups in the SN-5 scores in any of the domains or the overall score at baseline, and post irrigation treatment. Conclusions Due to low tolerance, compliance, and the side effects, xylitol irrigation is not recommended as a first-line treatment for pediatric CRS. The use of a large volume of low pressure, twice-daily intranasal hypertonic irrigation for 6 weeks is safe and effective in the treatment of pediatric CRS; therefore, it can be used as a baseline treatment for pediatric CRS before considering surgical interventions.
Article
Background: The effects of endoscopic sinus surgery (ESS) on the symptom burden of Eustachian tube dysfunction (ETD) in chronic rhinosinusitis (CRS) patients were investigated. Methods: Ninety-two patients with CRS following ESS were prospectively enrolled and followed up every 3 months for 1 year. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) and 22-item Sino-Nasal Outcome Test (SNOT-22) were administered before ESS and at each visit following ESS. Results: Before surgery, 25% patients reported ETDQ-7 scores ≥ 14.5, indicating the presence of ETD. The mean preoperative ETDQ-7 and SNOT-22 scores were 13.3 and 40.0, respectively. The mean ETDQ-7 and SNOT-22 scores were significantly decreased to 8.2 and 17.0 at 1-year following ESS, respectively. Most patients reported alleviation of their symptoms within the first 3 months, and the prevalence of ETD had decreased to 3.3% at 1 year. Patients who received revision surgery had higher ETDQ-7 scores during the follow-up period. Additionally, 5.4% of patients reported worsening of their symptoms. Conclusion: ETD symptoms can be effectively alleviated in most patients within 3 months following ESS. However, 5.4% of patients reported worsening of their symptoms at the 1-year follow-up. Additional objective studies should be conducted to evaluate Eustachian tube function thoroughly in CRS patients.Supplemental files will be available at http://links.lww.com/JCMA/A148.
Chapter
Full-text available
Prior to 2005, our existing knowledge of inflammatory patterns in CRS came nearly exclusively from studies with Western patients, and those studies indicated that nasal polyps were “eosinophilic” and characterized by the expression of interleukin (IL)-5 and other type 2 cytokines, whereas CRSsNP resembled a type 1 disease with expression of IFN-gamma [1, 2]. However, less eosinophilic and more neutrophilic inflammation was found in patients with CRSwNP in Asia, when compared with Europe and North America [3]. Chinese patients with CRSwNP demonstrated neutrophil-biased inflammation as compared to their Caucasian counterparts [4]. Approximately 80% of CRSwNP patients in the Western world display a type 2 signature [5, 6], whereas between 20% and 60% display that signature in China, Korea, and Thailand, respectively [3]. By measuring the value of ECP/MPO, Wang et al. [7] found that cases of CRSwNP in regions of Europe, Japan, and Australia showed an eosinophilic dominance (eosinophilic > 50%) rather than a non-eosinophilic dominance (eosinophilic < 50%) such as cases found in Beijing and Chengdu in China. Another study found that <50% of CRSwNP cases in Beijing showed eosinophilic inflammation [8]. The results from different geographic regions indicated that the immunological patterns of CRS were not the same in all ethnic populations [9].
Article
Full-text available
Objectives/hypothesis: Nasal disease, including chronic rhinosinusitis and allergic rhinitis, is a significant source of morbidity. Nasal irrigation has been used as an adjunctive treatment of sinonasal disease. However, despite an abundance of anecdotal reports, there has been little statistical evidence to support its efficacy. The objective of this study was to determine the efficacy of the use of pulsatile hypertonic saline nasal irrigation in the treatment of sinonasal disease. Study design: A prospective controlled clinical study. Methods: Two hundred eleven patients from the University of California, San Diego (San Diego, CA) Nasal Dysfunction Clinic with sinonasal disease (including allergic rhinitis, aging rhinitis, atrophic rhinitis, and postnasal drip) and 20 disease-free control subjects were enrolled. Patients irrigated their nasal cavities using hypertonic saline delivered by a Water Pik 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. Results: Patients who used nasal irrigation for the treatment of sinonasal disease experienced statistically significant improvements in 23 of the 30 nasal symptoms queried. Improvement was also measured in the global assessment of health status using the Quality of Well-Being scale. Conclusions: Nasal irrigation is effective in improving symptoms and the health status of patients with sinonasal disease.
Conference Paper
Rhinosinusitis is highly prevalent in the United States, affecting an estimated 16% of the adult population annually. The prevalence of the illness is increased in women and, relative to other US regions, in individuals living in the South. The direct costs associated with chronic rhinosinusitis are higher than the background costs in managed care patients because of increased office visits and medication prescriptions, and the indirect costs due to restricted activity days are enormous. Rhinosinusitis poses an immense economic burden in the United States. Data concerning the epidemiology and economic impact of the disease are reviewed.
Article
An approach to cost analysis useful in understanding the economic implications of surgical intervention on chronic sinusitis is break-even time analysis. The break-even time is the time until cost savings associated with improved health status after surgery equal the up-front costs of the operation itself. Data from 100 consecutive patients undergoing sinus operation were obtained by survey before surgery and at quarterly intervals for 1 year with statistically validated outcome measures (Medical Outcome Study Short Form 36-Item Health Survey, Chronic Sinusitis Survey). Direct and indirect costs were obtained or derived for this cohort. The cost of sinus medications, including over-the-counter remedies, nasal steroid sprays, and antibiotics, averaged $1220 per patient per year before surgery and $629 after surgery (p < 0.0001), which is a 48% reduction. Surgical costs averaged $6490 per patient. Economic modeling predicted a break-even time of approximately 7 years assuming a 3% surgical revision rate per year, a 3% decrease in sickness-related disability, and a 5% discount rate. The model was sensitive to changes in the total cost of operation, the surgical revision rate, and the anticipated disability benefit. We conclude that significant direct and indirect medical cost savings may be achieved after surgical intervention for chronic sinusitis and these savings eventually break even with the total cost of surgery itself.
Article
Models for the analysis of longitudinal data must recognize the relationship between serial observations on the same unit. Multivariate models with general covariance structure are often difficult to apply to highly unbalanced data, whereas two-stage random-effects models can be used easily. In two-stage models, the probability distributions for the response vectors of different individuals belong to a single family, but some random-effects parameters vary across individuals, with a distribution specified at the second stage. A general family of models is discussed, which includes both growth models and repeated-measures models as special cases. A unified approach to fitting these models, based on a combination of empirical Bayes and maximum likelihood estimation of model parameters and using the EM algorithm, is discussed. Two examples are taken from a current epidemiological study of the health effects of air pollution.
Article
Local nasal hyperthermia or inhalation of heated water vapor is often recommended as a home remedy for various rhinitis disorders such as the common cold and allergic rhinitis. Inhaled heated vapor treatments and simple saline solution nasal irrigation were investigated for their effect on inflammatory mediator production in nasal secretions. Three treatments were given for nasal irrigation: heated water particles (large particle water vapor) at 43 degrees C, heated molecular water vapor (molecular water vapor) at 41 degrees C, and simple saline solution nasal irrigation. Nasal washes were done before each treatment (baseline), immediately after treatments, and at 30 min, 2, 4, and 6 h. Histamine, prostaglandin D2, and leukotriene C4 (LTC4) concentrations were measured in nasal secretions and compared with baseline values. Thirty symptomatic patients with active perennial allergic rhinitis underwent three treatments at weekly intervals. Nasal histamine concentrations fell substantially with the nasal irrigation (p < 0.01 immediately posttreatment and at 30 min; p < 0.05 at 2, 4, and 6 h). Large particle vapor also reduced histamine concentrations for up to 4 h posttreatment compared with baseline values (p < 0.05). Alternatively, molecular water vapor did not alter nasal histamine concentrations. Surprisingly, the three treatments did not alter prostaglandin D2 concentrations over the 6 h. Leukotriene C4 concentrations fell briefly after the large particle treatment but did not with the molecular water vapor. With saline solution irrigation, LTC4 concentrations in nasal secretions were lower than baseline at 30 min to 4 h after a treatment (p < 0.05). This study demonstrated the usefulness of large particle vapor treatment and saline solution irrigation in reducing inflammatory mediators in nasal secretions and indirectly supports the clinical efficacy of these treatments for chronic rhinitis.
Article
Nasal irrigations have been used for centuries without any scientific data to determine efficacy. For 10 years, the senior author has used buffered hypertonic saline nasal irrigation for patients with acute/chronic sinusitis and for those having undergone sinus surgery. A simple study was undertaken using volunteers without any significant sinonasal disease. Patients served as their own control using a saccharin clearance test before any nasal irrigation was used. Patients then used one of two solutions to irrigate their nose-buffered normal saline or buffered hypertonic saline-and were then retested. On a separate day, the control test was repeated, followed by irrigation with the alternate solution and a second saccharin clearance test. The outcome showed buffered hypertonic saline nasal irrigation to improve mucociliary transit times of saccharin, while buffered normal saline had no such effect.
Article
To determine whether hypertonic saline nasal spray relieves nasal symptoms and shortens illness duration in patients with the common cold or acute rhinosinusitis. Randomized trial with 2 control groups. Two family practice clinics. One hundred forty-three adult patients with a cold or sinus infection. Patients with allergic rhinitis, symptoms for more than 3 weeks, or other respiratory diagnoses were excluded, as were those who had used topical decongestants. Hypertonic saline or normal saline spray 3 times a day or observation. Subjects completed a 7-day symptom checklist that included a well-being question ("Do you feel back to normal?"). Nasal symptom score (sum of scores for nasal congestion, rhinorrhea, and headache) on day 3 and day of well-being (day of symptom resolution). Data were collected for 119 subjects. No difference was found in either primary outcome when hypertonic saline was compared with either normal saline or observation. Mean day of well-being was 8.3 (95% confidence interval [CI], 6.9-9.7), 9.2 (95% CI, 6.9-11.43), and 8.0 (95% CI, 6.7-9.3) days in the hypertonic saline, normal saline, and observation groups, respectively. Day 3 mean nasal symptom score was 3.8 (95% CI, 3.0-4.5) for hypertonic saline, 3.7 (95% CI, 2.9-4.5) for normal saline, and 4.1 (95% CI, 3.5-4.7) for observation. Only 44% of the patients would use the hypertonic saline spray again. Thirty-two percent noted burning, compared with 13% of the normal saline group (P = .05). Hypertonic saline does not improve nasal symptoms or illness duration in patients with the common cold or rhinosinusitis.
Article
Physiologic saline (NaCl 0.9%) is commonly used in treating acute and chronic rhinosinusitis. Moreover, physiologic saline is used as a control medium, vehicle, or solvent in studies on ciliary beat frequency (CBF). Hypertonic saline (NaCl 7% and 14.4%) has been applied in attempts to enhance mucociliary transport in patients with cystic fibrosis or asthma and in healthy subjects. Therefore the objective of this study is to document in vitro effects of saline solutions in different concentrations on CBF. Experimental, in vitro. The effects on CBF of cryopreserved mucosa of the sphenoidal sinus was measured by a photoelectrical method. Initial frequencies, measured in Locke-Ringer's solution (LR), were compared with CBF after exposure to NaCl in concentrations of 0.9%, 7.0%, and 14.4% (w/v). NaCl 0.9% has a moderately negative effect on CBF. The 7% solution leads to a complete ciliostasis within 5 minutes, although this effect turns out to be reversible after rinsing with LR. A hypertonic solution of 14.4% has an irreversible ciliostatic effect. LR is an isotonic solution that has no effect on CBF. Therefore it is probable that this solution is more appropriate than saline for nasal irrigation and nebulization or antral lavage. Moreover, the results of this study suggest that mucolytic effects induced by hyperosmolarity should be attained preferably with hypertonic saline 7% in patients with cystic fibrosis or asthma. At this concentration, the ciliostatic effect is reversible, whereas irreversible changes are to be expected at higher concentrations.
Article
During the 4-year period 1993 through 1997, the Office of Management and Budget (OMB) undertook a comprehensive review of the statistical standards that are used throughout the federal government to gather and publish data on race and ethnicity. The primary objective of this review was to ensure that our standards provide a common language that reflects the increasing diversity of the US population and maintains our ability to monitor compliance with civil rights laws. The review culminated with the October 1997 issuance of OMB's "Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity." In this article, we describe key aspects of the process that was undertaken to review and revise the 1977 standards. We also attempt to dispel some myths and misunderstandings that have been associated with these standards.