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Pure Sesame Oil vs Isotonic Sodium Chloride Solution as Treatment for Dry Nasal Mucosa
Jörgen Johnsen, MD;
Britt-Marie Bratt, MD;
Oskar Michel-Barron, MD;
Christer Glennow, PhD;
Björn Petruson, MD, PhD
Arch Otolaryngol Head Neck Surg. 2001;127:1353-1356.
ABSTRACT
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Objective To evaluate whether there was any difference in efficacy when nasal
mucosa dryness was treated with pure sesame oil (Nozoil) compared with isotonic
sodium chloride solution (ISCS).
Design In a randomized, crossover study, 79 subjects with nasal mucosa dryness
were enrolled. Half the subjects received pure sesame oil for 14 days followed
by ISCS for 14 days, and the other half received ISCS for 14 days followed
by pure sesame oil for 14 days. During the test period from March 13 to May
30, 2000, the outdoor absolute humidity was low. Nasal mucosa dryness, stuffiness,
and crusts were scored every evening with a visual analog scale.
Setting The County Hospital, Skellefteå, Sweden.
Results Nasal mucosa dryness improved significantly when pure sesame oil was
used compared with ISCS (P<.001). The improvement
in nasal stuffiness was also better with pure sesame oil (P<.001) as was improvement in nasal crusts (P<.001). Eight of 10 subjects reported that their nasal symptoms
had improved with pure sesame oil compared with 3 of 10 for ISCS (P<.001). Adverse events were few and temporary.
Conclusion When nasal mucosa dryness due to a dry winter climate was treated, pure
sesame oil was shown statistically to be significantly more effective than
ISCS.
INTRODUCTION
MANY PEOPLE have nasal mucosa dryness without being aware of it. They
feel an irritation in the nose, such as itching and burning or smarting pain,
and they often have to remove dehydrated mucus and crusts. These complaints
increase when the humidity is low, as it is in air-conditioned rooms and during
long journeys by airplane. During the winter months in the northern part of
the world, it is cold and the absolute humidity is low. Proetz1
was the first to report that "with approaching winter, there was a wave of
dry-nose patients appearing in the office."1(p377)
He observed that this occurred when the absolute humidity fell below 5 g H2O of water per cubic meter of air (g/m3).
In the city of Skellefteå in the north of Sweden (latitude 65°),
daily registrations of the humidity between 1952 and 1957 were made by the
local ear, nose, and throat specialist Folke Lindwall.2
He found that the absolute humidity was below 5 g/m3 from December
to May and noted that many of the inhabitants had problems with dry noses
and throats during this period.
The usual way to treat dry nasal mucosa has been to administer isotonic
sodium chloride solution (ISCS) in different ways, such as a nasal spray,
nose drops, a rinsing cane, or a humidifier.3
In the treatment of dry nasal mucosa, pure sesame oil has also been used.3-4
The aim of this study was to compare ISCS with pure sesame oil in subjects
with dry nasal mucosa living in the city of Skellefteå during the dry-air
winter period.
SUBJECTS AND METHODS
SUBJECTS
An advertisement in the daily Skellefteå newspaper asked inhabitants
who had problems with dry nasal mucosa to contact the ear, nose, and throat
department at the County Hospital. Almost 300 persons answered, and 79 subjects
were enrolled in the study (25 men and 54 women, aged 26-79 years [median
age, 60 years]). Excluded were subjects with ongoing upper respiratory tract
infections (common cold and acute sinusitis), present symptoms of allergic
rhinitis, unilateral symptoms, and marked deviation of the nasal septum, and
those undergoing treatment with nasal steroids, nasal decongestants, or antiallergic
medication.
All subjects had a low-grade chronic inflammation due to dry nasal mucosa.
On average, the subjects had had problems with dry nasal mucosa for 13 years
(range, 2-41 years). All 79 subjects completed the trial. No financial incentive
was given to the subjects, who wanted to participate in the study because,
for years, they had had problems with nasal dryness during the winter.
TEST PERIOD
During the study period (March 13 to May 30, 2000), the outdoor absolute
humidity varied between 1.9 and 7.6 g/m3; on 55 (70%) of 79 days,
the value was less than 5 g/m3 (Figure 1).
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Figure 1. The absolute humidity (grams of
water per cubic meter of air) in the outdoor air during the test period from
March 13, 2000, to May 30, 2000.
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TEST PRODUCTS
The products used in the study included a nasal spray containing pure
sesame oil in accordance with the European Pharmacopeia in a 10 mL medical
glass bottle sealed with a snap closure and with a dosage pump (Nozoil; Pharmacure
AB, V Frölunda, Sweden). No preservatives were added.
The other product was a nasal spray with ISCS containing 0.9% sodium
chloride in a 30 mL medical glass bottle sealed with a snap closure and with
a dosage pump. The ISCS was buffered with disodium phosphate dihydrate and
potassium dihydrophosphate to a pH of 7.4. It was preserved with 0.08% metergin
(Renässans; Mirwana AB, Gällivare, Sweden).
DURATION OF TREATMENT
Half the subjects were randomized to receive pure sesame oil for 14
days followed by ISCS for 14 days, and the other half received ISCS for 14
days followed by pure sesame oil for 14 days. Both treatments were administered
with 1 to 3 sprays in each nostril 3 times daily and presented to the subjects
as active therapies.
CRITERIA FOR EVALUATION
Every evening, each subject evaluated the efficacy of the treatment
that day by using visual analogue scale (VAS) scores. The following 3 symptoms
were graded: (1) Nasal mucosa dryness (itching, irritation, and smarting pain):
0, no nasal dryness; and 100, worst imaginable nasal dryness. (2) Nasal stuffiness:
0, no nasal stuffiness; and 100, the nose completely blocked. (3) Nasal crusts
(dehydrated mucus): 0, no crusts; and 100, the nose filled with crusts.
After each 14-day treatment period, the subjects answered questions
about overall assessments of symptoms and adverse events.
STUDY DESIGN
The planning and monitoring procedures were performed in compliance
with good clinical practice, including essential documents being archived
by Clinical Data Care AB, Lund, Sweden, and the study was approved by the
Umeå Independent Ethics Committee. The subjects were given oral and
written information about the study, and all consented to participate.
STATISTICAL METHODS
The VAS measurements were analyzed using the analysis of variance technique
for repeated measures. The model allowed for variations due to subjects within
sequence, treatment, day, and period. The results are expressed as least-square
means and are presented with 95% confidence intervals to estimate the magnitude
of any treatment effect. No imputations were performed. All tests were 2-tailed,
and P values less than .05 were considered statistically
significant. Differences in the proportion of adverse events between treatments
were tested using McNemar test. The statistical analyses were performed using
SAS statistical software, version 6.12 (SAS Institute Inc, Cary, NC).
RESULTS
For subjects treated with pure sesame oil, the mean pretreatment VAS
value for nasal mucosa dryness was 51 and it decreased to 24 after 14 days
of treatment, while the corresponding values for subjects treated with ISCS
were 46 decreasing to 42. The difference between these scores for pure sesame
oil and ISCS was highly significant (P<.001).
After 10 days of treatment, the difference started to reach statistical significance,
as the confidence intervals then did not overlap (Figure 2).
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Figure 2. Nasal mucosa dryness improvement
expressed as a visual analog scale (VAS) score, where 0 indicates no nasal
dryness at all and 100, worst imaginable nasal dryness. The mean values for
each day of treatment are presented, as well as the 95% confidence intervals.
The difference between pure sesame oil and isotonic sodium chloride solution
(ISCS) is significant (P<.001).
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When nasal stuffiness was scored, the mean VAS value for subjects treated
with pure sesame oil decreased from 46 to 24, compared with 43 to 37 for those
treated with ISCS (P<.001). A statistically significant
difference was seen on day 14, when the confidence intervals did not overlap
(Figure 3).
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Figure 3. Nasal stuffiness improvement expressed
as a visual analog scale (VAS) score, where 0 indicates no nasal stuffiness
and 100, the nose completely blocked. For each day of treatment, the mean
values and 95% confidence intervals are presented. The difference between
pure sesame oil and isotonic sodium chloride solution (ISCS) is significant
(P<.001).
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The mean VAS value for nasal crusts for subjects treated with pure sesame
oil decreased from 45 to 19, and from 40 to 37 for subjects treated with ISCS
(P<.001). After 9 days of treatment, the confidence
intervals did not overlap, showing that pure sesame oil is a significantly
better treatment than ISCS (Figure 4).
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Figure 4. Nasal crusts improvement expressed
as a visual analog scale (VAS) score, where 0 indicates no crusts and 100,
the nose filled with crusts. For each day of the two 14-day treatment periods,
the mean values and 95% confidence intervals are presented. The difference
between the 2 therapies is significant (P<.001). ISCS indicates
isotonic-sodium chloride solution.
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In the overall assessments of symptoms after each 14-day treatment period,
it was shown that pure sesame oil produced a statistically significantly more
efficacious treatment effect compared with ISCS (P<.001).
Most subjects (58 [73%]) reported that their symptoms improved after the pure
sesame oil treatment, 6 (8%) reported that their symptoms had disappeared,
8 (10%) reported that their symptoms were unchanged, and 2 (3%) reported that
their symptoms had worsened. The question was not answered by 5 subjects.
For the ISCS group, symptoms improved for 26 subjects (33%), did not disappear
for 0%, remained unchanged for 26 (34%), and worsened for 23 (29%). The question
was not answered by 4 subjects.
During the study, 6 subjects (8%) in the pure sesame oil group and 4
(5%) in the ISCS group reported adverse events (no difference between groups
[P = .30]). In the pure sesame oil group, 4 subjects
(5%) contracted an upper respiratory tract infection compared with 2 (3%)
subjects in the ISCS group; 2 (3%) subjects in the pure sesame oil group contracted
rhinitis compared with 1 (1%) subject who developed sinusitis and 1 (1%) who
had nosebleeds in the ISCS group. Two of 4 subjects who contracted an upper
respiratory tract infection when using pure sesame oil were cured while continuing
this treatment.
COMMENT
In many parts of the world, the outdoor climate during the winter is
characterized by low humidity. When the absolute humidity falls below 5 g/m3, the inhabitants have problems with dry nasal mucosa.1-2
In this study, we compared the effect of pure sesame oil with that for ISCS
for people with nasal problems due to dry outdoor air. We found that the efficacy
of pure sesame oil was statistically significantly better than that for ISCS.
It is clear that nasal problems due to dry outdoor air are a common complaint
in the northern part of Sweden during the winter, as almost 300 of 30 000
inhabitants wanted to participate in our study.
During the study period, the outdoor humidity was measured every day
and the mean value was below 5 g/m3 of air on 70% of the days.
During the last 2 weeks in May, the humidity increased somewhat.
When the subjects rated their nasal complaints, it was found that nasal
mucosa dryness produced the highest score, followed by nasal stuffiness and
nasal crusts. During the treatment period, we noted that there was a significant
decrease in complaints about nasal crusts after 9 days of treatment with pure
sesame oil, about nasal dryness after 10 days, and about nasal stuffiness
after 14 days. When pure sesame oil was used, a confirmed improvement was
seen from day to day. This was not observed for ISCS.
After 14 days of treatment with pure sesame oil, more than 8 of 10 subjects
reported that their symptoms had disappeared or improved. When ISCS was used,
this was seen in only about 3 of 10 subjects. In the ISCS group, one third
of the subjects reported that their problems were unchanged and about the
same number reported that their problems had worsened. When pure sesame oil
was used, only 2 subjects reported that their symptoms had worsened; both
had contracted an upper respiratory tract infection.
The subjects were informed before they started the study that pure sesame
oil and ISCS were both active therapies. Isotonic sodium chloride solution
has long been the most commonly used therapy for nasal dryness. It has been
shown that ISCS results in little interference with the nasal mucosa or mucociliary
clearance.5
As ISCS is inert, with the main purpose of humidifying the mucosa, we
have chosen to regard ISCS as a kind of placebo therapy against which we wanted
to test the efficacy of pure sesame oil on nasal mucosa dryness.
The adverse effects from using the pure sesame oil were few in number
and mild. Six of 79 subjects experienced signs of upper respiratory tract
infections, which is to be expected in a community where these infections
are common at this time of year. Two of the subjects were cured while continuing
to use the pure sesame oil. There was no difference in the frequency of these
infections between the periods with pure sesame oil and ISCS.
In a review by Spencer,6 the risk of
lipoid pneumonia and paraffin granuloma was mentioned when mineral oils like
paraffin are used as drops or sprays in the nose. Mineral oils that remain
in the lung will eventually cause fibrosis. For the body, there is, however,
a great difference between mineral oils and vegetable oils such as pure sesame
oil. Both are substances that can be digested and not encapsulated, as paraffin
is. Vegetable oils are not hydrolyzed by the lung lipases, but "they are mainly
expectorated, causing little or no damage to the lung."6(p518)
When the mucociliary movements were measured in nasal biopsy specimens
from 8 healthy volunteers, it was shown that the ciliary beat frequency was
the same before and after 1-hour exposure to pure sesame oil (Herbert Riechelmann,
MD, PhD, written communication, March 19, 1995). Therefore, the ciliary movements
are unaffected by pure sesame oil, and any small amounts of pure sesame oil
that reach the bronchi can be transported away.
Sesame oil of pharmaceutical quality has been used for many years as
a solvent for drugs that are given intramuscularly, such as testosterone,
and no adverse effects have been observed.7-8
It has also been used when bronchographies have been performed since the sesame
oil is stable, neutral, nonirritating, and inert.9
A few subjects have been reported to be allergic to sesame seed. However,
when they received oral 1-mL doses of pharmaceutical quality sesame oil, no
allergic reactions were observed.9 The reason
is that the pure sesame oil contains no proteins that can cause allergic reactions.
When pure sesame oil was studied in patients who had previously undergone
nasal irradiation and outpatients who were experiencing problems with dryness
of the nose, it was found that the nasal problems decreased significantly
during treatment with pure sesame oil.4
It is well-known that many vegetable oils contain vitamin E, and sesame
oil is one with a high concentration. The batch of pure sesame oil used for
the study comprised 35 mg/kg of  -tocopherol and 308 mg/kg of ß
+  – tocopherol. One potential mechanism of action of pure sesame
oil might be as a scavenger. The tocopherols might neutralize oxidants such
as ozone and oxides of nitrogen in the inhaled air and prevent tissue damage
and inflammation that would otherwise occur. When tocopherols are incorporated
into the cell membranes, a carryover effect might be expected.
The present study underlines the fact that the best way to treat nasal
mucosa dryness is to use pharmaceutical quality sesame oil and not ISCS. The
test was conducted in the winter when it is known that the humidity is low.
There are, however, other situations with low humidity when complaints of
nasal mucosa dryness occur. These include long journeys by airplane, air-conditioned
rooms, and areas with a warm, dry inland climate or deserts. The aging nose
is also sensitive to drying and crust formation. As shown here, half the test
subjects were older than 60 years.
AUTHOR INFORMATION
Accepted for publication June 20, 2001.
Corresponding author and reprints: Björn Petruson, MD, PhD,
Department of Otorhinolaryngology, Sahlgrenska University Hospital, S-413
45, Göteborg, Sweden (e-mail: carin.zettervall{at}vgregion.se).
From the Departments of Otorhinolaryngology, County Hospital, Skellefteå
(Drs Johnsen, Bratt, and Michel-Barron), Clinical Data Care, Lund (Dr Glennow),
and Otorhinolaryngology, Sahlgrenska University Hospital, Göteborg (Dr
Petruson), Sweden.
REFERENCES
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1. Proetz AW. Humidity, a problem in air-conditioning. Ann Otol Rhinol Laryngol. 1956;65:376-384.
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in Diseases of Northern Sweden. Umeå, Sweden: Tika Pharmaceutical; 1967:13-22.
3. Cody DTR, Kern EB, Pearson BW. Diseases of the Ear, Nose and Throat. Chicago, Ill: Year Book Medical Publishers Inc; 1981:220, 251-253.
4. Björk-Eriksson T, Gunnarsson M, Holmström M, Nordkvist A, Petruson B. Fewer problems with dry nasal mucous membranes following local use
of sesame oil. Rhinology. 2000;38:200-203.
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5. Boek WM, Romeijn SG, Graamans K, Verhoef JC, Merkus FWHM, Huizing EH. Validation of animal experiments on ciliary function in vitro, II:
the influence of absorption enhancers, preservatives and physiologic saline. Acta Otolaryngol (Stockh). 1999;119:98-101.
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6. Spencer H. Pathology of the Lung. 4th ed. Oxford, England: Pergamon Press; 1985:517-525.
7. Stenrich F. Sesam körner – Allergie. Pneumonologie. 1989;43:710-714.
8. Brown WE, Wilder VM, Schwartz P. A study of oils used for intramuscular injections. J Lab Clin Med. 1944;29:259-264.
9. Théon AP, Pascoe JR, Carlson GP, Krag DN. Intratumoral chemotherapy with cisplastin in oily emulsion in horses. J Am Vet Med Assoc. 1993;202:261-267.
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