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Comparison of intranasal hypertonic
Dead Sea saline spray and intranasal
aqueous triamcinolone spray in
seasonal allergic rhinitis
Scott Cordray, DO, FAOCO; Jim B. Harjo, DO; Linda Miner, PhD
Intranasal corticosteroids are well known to be efﬁca-
Symptoms of seasonal allergic rhinitis are usually caused
cious in the treatment of allergic rhinitis. Nasal irrigation
by tree, grass, and weed pollens. An important place to
with saline, including hypertonic saline, has long been
consider seasonal allergic rhinitis is Tulsa, Okla., which
recommended for the treatment of sinonasal disease,
is located in the northeast region of the state and is known
and it has been shown to have a positive effect on the
as “Green Country.” The city lies at the threshold of two
physiology of the nasal mucosa. Until now, no study of
distinct zones––a deciduous forest area and a grasslands
the clinical efﬁcacy of intranasal hypertonic Dead Sea
area––in which the population is exposed to a diversity
saline as a monotherapy for seasonal allergic rhinitis has
of allergenic vegetation.1 These two zones are populated
been reported. We conducted a prospective, randomized,
by vegetation that accounts for 70% (127 of 181) of all
single-blind, placebo-controlled comparison of intranasal
allergenic species and by 79% (26 of 33) of the most al-
hypertonic Dead Sea saline spray and intranasal aqueous
triamcinolone spray in 15 patients with seasonal allergic
The highest concentrations of airborne tree pollens are
rhinitis. Results were based on a 7-day regimen. Based
typically seen in the early spring. Genera include Quercus
on Rhinoconjunctivitis Quality of Life Questionnaire
(cedar), and Ulmus
scores, clinically and statistically signiﬁcant (
p < 0.0001)
the most abundant pollen during any season.2,3 Juniperus
improvements were seen in both active-treatment groups; ashei
(mountain cedar) pollen is carried upwind into the
as expected, the corticosteroid spray was the more effec-
Tulsa area from southwest Oklahoma and west Texas dur-
tive of the two treatments. No signiﬁcant improvement
ing the fall and through the winter.3,4
occurred in the control group. Our preliminary results
In the late spring and early summer, pollens are released
not only conﬁrm the efﬁcacy of intranasal corticosteroid
by other allergenic trees, such as Juglans regia
therapy in moderate-to-severe allergic rhinitis, they also
and Carya illinoensis
(pecan). Also, a number of grasses
suggest that the Dead Sea saline solution can be an ef-
pollinate from late spring through the summer; among
fective alternative in mild-to-moderate allergic rhinitis,
the most allergenic are Cynodon dactylon
particularly with respect to nasal and eye symptoms. The Phleum pratense
(timothy). Fall is typically the season
hypertonicity of the Dead Sea solution may have a positive
for Ambrosia triﬁda
(giant ragweed), which is the second
effect on the physiology of the nasal mucosa by improving
most abundant pollen in the Tulsa area; pollination usually
mucociliary clearance. In addition, the dominant cation
peaks in mid-September and ends in early October.
in the Dead Sea solution––magnesium––probably exerts
In addition to allergen avoidance, proven treatments for
anti-inﬂammatory effects on the nasal mucosa and on the
seasonal allergic rhinitis include intranasal corticosteroids,
oral and topical H receptor antagonists (antihistamines), in-
tranasal saline solutions, and occasionally immunotherapy;
Dr. Cordray is an otolaryngologist in private practice. Dr. Harjo is a recently, treatment with leukotriene receptor antagonists
family physician in private practice. Dr. Miner is director of aca-
has also been suggested. The superior effects of intranasal
demic programs at Southern Nazarene University. All are located corticosteroids in sinonasal diseases have been established
with respect to symptom resolution and quality of life.5-12
Reprint requests: Scott Cordray, DO, Hillcrest Physicians Bldg., 1145 S.
Utica Ave., #513, Tulsa, OK 74104. Phone: (918) 582-8217; fax: Intranasal corticosteroids also have a signiﬁcant effect on
(918) 582-8219; e-mail: email@example.com
inﬂammatory mediators in allergic rhinitis.13,14 In fact, when
ENT-Ear, Nose & Throat Journal
■ July 2005
COMPARISON OF INTRANASAL HYPERTONIC DEAD SEA SALINE SPRAY AND
INTRANASAL AQUEOUS TRIAMCINOLONE SPRAY IN SEASONAL ALLERGIC RHINITIS
compared with oral antihistamines and with leukotriene neck cancer, human immunodeﬁciency virus-related nasal
receptor antagonists (with intranasal saline typically used disease, cystic ﬁbrosis, and renal, hepatic, pulmonary, and
as a control) for the treatment of seasonal allergic rhinitis, cardiovascular disease.
corticosteroids have been shown to be superior.5,7,9,11,12
During the study, 6 of the 21 patients withdrew. Two
The effects of intranasal hypertonic saline solutions patients withdrew because of adverse reactions, 2 did
are less clear. Some studies have shown that they exert not return for the second of two scheduled visits, 1 was
beneﬁcial effects on nasal physiology, mucociliary clear- disqualiﬁed for antihistamine use during the study period,
ance in particular,15-18 and that they help relieve symptoms and 1 had stopped treatment prematurely. The ﬁnal data
and improve quality of life in patients with sinonasal analysis, therefore, was based on ﬁndings in the 15 pa-
disease.19-21 Other studies, however, have shown that they tients––3 men and 12 women, aged 20 to 74 years (mean:
have a negative effect on nasal physiology and no effect 35.2 ± 16.05)––who completed both visits.
Written informed consent was obtained from all patients.
One such hypertonic saline solution is made from Dead The research protocol and the informed consent form were
Sea salts. The Dead Sea is the world’s most saline lake approved by the Institutional Review Board of Family
body, and it contains proportionately more magnesium, Medical Care of Tulsa, Inc.
calcium, bromine, and potassium and less sodium, sulfate,
This randomized, single-blind, placebo-
and carbonate than any ocean.25 Magnesium is the dominant controlled study was conducted during 6 weeks of the
cation, accounting for approximately 35% of the composi- spring allergy season in Tulsa, Okla. All patients were
tion of Dead Sea salts. This chemical composition makes required to comply with the study protocol at two ofﬁce
Dead Sea salt unlike any other sea salt in the world.26
visits. The treatment protocol was explained to them with
Treatment with Dead Sea salts has been shown to have both oral and written instructions.
positive effects on skin conditions such as psoriasis27 and
Patients were randomized into 3 groups of 5 each to
contact eczema.28 The magnesium ion is believed to be receive either intranasal hypertonic Dead Sea saline spray
primarily responsible for these positive effects.27-30 Also, (2 sprays into each nostril 3 times daily), aqueous triam-
it is well established that magnesium in its intravenous,31,32 cinolone spray (110 µg into each nostril once daily), or
inhaled and nebulized,33-35 and dietary36,37 forms plays a a placebo nasal saline spray (2 sprays into each nostril 3
role in treating acute asthma, which is known to cause a times daily) for 7 days.
At the ﬁrst visit, each patient underwent skin-prick
A report from Italy revealed that intranasal hypertonic allergen testing for tree pollen (American elm, post oak,
saline was beneﬁcial in reducing the amount of as-needed and mountain cedar), grass pollen (bermuda and timothy),
antihistamines in a pediatric population with seasonal al- short ragweed pollen, and Alternaria
mold extract. Patients
lergic rhinitis.38 Until now, no study has been published also completed the standardized version of the Rhinocon-
regarding the effects of hypertonic saline as a monotherapy junctivitis Quality of Life Questionnaire (RQLQ), once
for seasonal allergic rhinitis. In this article, we describe at the ﬁrst visit and again at the completion of treatment.
what we believe is the ﬁrst such preliminary study.
The RQLQ is a reliable, validated instrument with strong
discriminative properties.39,40 The survey contains 28
Patients and methods
questions regarding 7 domains: activities, sleep, practical
Our study population was originally problems, nasal symptoms, eye symptoms, other symp-
made up of 21 patients who had presented to the family toms, and emotional status. For each domain, patients rate
practice ofﬁce of one of the authors (J.B.H.) seeking treat- themselves as to how much their symptoms have affected
ment for symptoms of seasonal allergic rhinitis. In order them during the previous week on a scale of 0 (no effect)
to be eligible for this study, patients had to be at least 18 to 6 (great effect).
years of age, had to have experienced at least two of six
Statistical analysis was performed
symptoms (nasal stufﬁness, watery/itchy eyes, rhinorrhea, with the assistance of the Excel statistical package (Mi-
sneezing, postnasal drainage, and itchy throat/cough) at crosoft; Redmond, Wash.) and conﬁrmed by the Statistica
presentation, and had to have had a positive skin puncture 2003 package (StatSoft; Tulsa). Values analyzed were the
test for seasonal allergens. Exclusion criteria included the mean RQLQ scores in each of the 7 domains and the overall
presence of chronic sinusitis, nasal polyposis, a deviated composite scores. The Student’s t
test was ﬁgured from
nasal septum or history of nasal septal perforation, and the composite scores. A one-sided hypothesis was used in
recent nasal or sinus surgery; the use of an antihistamine, anticipation of an expected reduction in composite scores
cromolyn, decongestant, or a topical or systemic corti- after treatment; this helped obviate a type II error, which
costeroid within the preceding 2 weeks or an immuno- likely would have occurred in view of the small number
therapeutic agent within the preceding 2 years; pregnancy of patients in this study.
and/or lactation; and chronic conditions such as head and
Volume 84, Number 7
on any RQLQ domain. Juniper et al, who developed the
Following treatment, clinically and statistically signiﬁcant RQLQ, deﬁned a clinically signiﬁcant difference as “the
improvements in mean composite RQLQ scores were seen smallest difference in score in the domain of interest which
in both the Dead Sea saline group and the corticosteroid patients perceive as beneﬁcial and would mandate a change
group; no signiﬁcant improvement occurred in the control in management,” and they provided evidence that this dif-
ference is 0.5.40 Based on this interpretation, the placebo in
The Dead Sea saline group experienced a signiﬁcant our study did lead to a clinically signiﬁcant difference in
reduction in the mean composite RQLQ score, which fell three domains: sleep, eye symptoms, and emotional status.
from 3.38 to 2.02, a difference of 1.36 (p
This ﬁnding supports the idea that although nasal saline is
As expected, the corticosteroid group experienced the typically used as a control in studies of allergic rhinitis, it
most marked overall improvement, as its mean composite is not a genuine placebo. Ratner et al have suggested that
RQLQ score declined from 3.24 to 1.03, a difference of oral nonsedative antihistamines have been shown to be
no more effective than placebo aqueous nasal sprays in
In the control group, the mean composite RQLQ score placebo-controlled studies in which the active comparator
was 2.60 prior to treatment and 2.44 afterward, a difference was an intranasal corticosteroid, but they have been shown
of 0.16. The difference was not statistically signiﬁcant to be superior to placebo tablets when the active comparator
= 0.6483). Likewise, there was no signiﬁcant difference was another oral antihistamine.11 In light of the ﬁndings by
in any of the 7 domain scores pre- and posttreatment.
Ratner et al and their belief that intranasal saline washes
In both active-treatment groups, improvements were seen the nasal mucosa of allergens and mucus, we suggest that
in all 7 individual domains. The greatest improvements in the efﬁcacy of intranasal saline might be equal to that of
the Dead Sea saline group involved nasal symptoms (from oral H receptor antagonists for some patients with mild
3.83 to 2.17, a difference of 1.66) and eye symptoms (from symptoms. Nasal saline may indeed play a role in the
3.00 to 2.04, a difference of 0.96). In the corticosteroid treatment of allergic rhinitis when it is delivered as a true
group, the greatest improvements involved eye symptoms irrigation agent rather than as just a simple moisturizer. One
(from 3.75 to 0.85, a difference of 2.90) and nasal symptoms Tulsa allergist, Jane Purser, MD, recommends nasal saline
(from 3.65 to 1.40, a difference of 2.25).
irrigation with a minimum of 5 sprays in each nostril every
morning, and she has observed some clinically signiﬁcant
improvements among her patients with chronic sinonasal
Our expected ﬁnding that triamcinolone disease (oral communication, February 2001). We believe
resulted in a statistically signiﬁcant alleviation of severe that nasal saline spray as a placebo is probably adequate
symptoms and improvement in quality of life is consistent for research purposes, but it does provide some actual
with the large body of evidence that intranasal corticoste- clinical beneﬁt as an irrigant in some patients.
roids are not only efﬁcacious but superior for the treatment
Dead Sea saline.
The use of the intranasal hypertonic
of seasonal allergic rhinitis.5,7,9,11,12 It is interesting that of Dead Sea saline solution in our study resulted in some
the 7 RQLQ domains, intranasal triamcinolone’s greatest moderate but clinically and statistically signiﬁcant improve-
effect was on reducing eye symptoms (i.e., conjunctivitis). ment in posttreatment RQLQ scores. It was most effective
This suggests that allergic rhinitis is a disease of systemic in treating nasal symptoms. It was also signiﬁcantly more
immunologic response and that intranasal corticosteroids effective than the placebo in all 7 domains. We believe ours
have a global effect rather than just a local effect.
is the ﬁrst study to demonstrate the possible efﬁcacy of
According to our analysis, nasal saline as intranasal hypertonic Dead Sea saline solution in alleviating
the control preparation had no statistically signiﬁcant effect symptoms and improving overall quality of life in patients
Table. Mean composite RQLQ scores pre- and posttreatment in the
action is unclear, but we can offer some
possible explanations. Like the nasal saline
placebo, it may act as a mild irrigant and
physically clear mucus and inﬂammatory
cells. It may also have positive effects on
mucociliary clearance.15,16 Finally, in view
of its beneﬁcial effect on eye symptoms, it
may have global anti-inﬂammatory proper-
ties and affect the systemic immunologic
ENT-Ear, Nose & Throat Journal
■ July 2005
COMPARISON OF INTRANASAL HYPERTONIC DEAD SEA SALINE SPRAY AND
INTRANASAL AQUEOUS TRIAMCINOLONE SPRAY IN SEASONAL ALLERGIC RHINITIS
Regarding the latter explanation, magne- cell degranulation and histamine release. Through a number
sium is the dominant cation in the Dead Sea saline solution, of mechanisms, this activity causes symptoms of sneezing,
and it is reasonable to postulate that magnesium exerts some rhinorrhea, nasal and ocular itchiness, eye watering, and
effect on inﬂammatory cells or inﬂammatory mediators. cough. Chemotactic factors presumably modulate the inﬂux
Asthma is known to be associated with increased amounts of eosinophils, one of which is histamine. Magnesium
of eosinophils and has long been believed to cause a reac- administered intranasally via Dead Sea saline solution
tion similar to an allergy. Intravenous magnesium has been may inhibit eosinophil release of major basic protein and
shown to be beneﬁcial in the treatment of acute asthma,31,32 mast cell release of histamine, thereby inhibiting the local
and nebulized magnesium in combination with albuterol immune response and probably creating the anti-inﬂam-
was shown to exert beneﬁcial effects in a pediatric popula- matory effect of the systemic response.
tion in an emergency department in Detroit.35 In another
Our data suggest that the use of intranasal hypertonic
study, 36.8% of asthma patients who were treated for 4 Dead Sea saline solution in a spray form results in a moder-
weeks at the Dead Sea itself were able to discontinue their ate reduction of symptoms and a moderate improvement
medications; even those who continued inhalation treat- in overall quality of life in patients with seasonal allergic
ment were able to reduce the frequency of their puffs by rhinitis, and that it is probably useful in patients with
43%.34 Dietary magnesium has positive effects, as well. mild-to-moderate symptoms. The Dead Sea solution also
Researchers in the United Kingdom found that a dietary appears to be signiﬁcantly better than nasal saline placebo
regimen high in magnesium signiﬁcantly improved lung in reducing symptoms and improving quality of life, and
function and lowered asthma symptom scores.36,37 The role it probably exerts antiinﬂammatory effects on the nasal
of magnesium in lung function is probably twofold: (1) mucosa and the systemic inﬂammatory response. Patients
Magnesium relaxes bronchial smooth muscle and thereby with moderate-to-severe symptoms should probably be
dilates airways, and (2) it may exert some inﬂuence on treated with an intranasal corticosteroid, with or without
inﬂammatory cells and their subsequent release of inﬂam- a nasal wash with Dead Sea saline solution. It is possible
that a different delivery system––namely irrigation––may
Evidence of the positive effect that magnesium in enhance the positive effects of the Dead Sea solution, and
Dead Sea salts has on some skin diseases was reported we hope that such a study can be undertaken.
by Greiner and Diezel in Germany.30 They administered
In conclusion, it appears that the intranasal hypertonic
water with a high concentration of magnesium ions to mice Dead Sea saline solution is superior to plain saline solution
with allergenic contact dermatitis that had been induced in the treatment of seasonal allergic rhinitis. However, in
by 1-chloro-2, 4-dinitrobenzene (DNCB). Mice that were view of the small number of patients in our study, these
challenged by DNCB plus magnesium chloride experienced results are only preliminary. Fortunately, several studies
signiﬁcantly less inﬂammation than did mice that were are under way to help conﬁrm or refute our conclusion.
challenged by DNCB alone and by DNCB plus sodium
chloride. Greiner and Diezel conﬁrmed these ﬁndings in References
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ENT-Ear, Nose & Throat Journal
■ July 2005
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