doi: 10.1111/j.1472-8206.2007.00509.x
ORIGINAL
ARTICLE
The possible prophylactic effect of Nigella
sativa seed extract in asthmatic patients
Mohammad Hossein Boskabady*, H. Javan, M. Sajady, H. Rakhshandeh
Department of Physiology, Ghaem Medical Centre, Mashhad University of Medical Sciences, Mashhad 91735, Iran
Keywords
asthma,
Nigella sativa,
pulmonary function tests,
symptom score
Received 19 October 2006;
revised 5 December 2006;
accepted 23 April 2007
*Correspondence and reprints:
m-boskabady@mums.ac.ir,
mhboskabady@hotmail.com
ABSTRACT
In previous studies, the relaxant, anticholinergic (functional antagonism) antihistaminic, effects of Nigella sativa have been demonstrated on guinea-pig tracheal
chains. In the present study, the prophylactic effect of boiled extract of N. sativa on
asthmatic disease was examined. Twenty-nine asthmatic adults were randomly
divided into control group (14 patients) and study group (15 patients), and they were
studied for 3 months. In the study group 15 mL/kg of 0.1 g% boiled extract and in
the control group a placebo solution was administrated daily throughout the study.
Asthma symptom score, asthma severity, frequency of symptoms/week and wheezing
were recorded in the beginning (first visit), 45 days after treatment (second visit),
and at the end of the study (third visit). Pulmonary function tests (PFTs) were also
measured, and the drug regimen of the patients was evaluated at three different visits.
All asthma symptoms, frequency of asthma symptoms/week, chest wheezing, and
PFT values in the study group significantly improved in the second and third visits
compared with the first visit (P < 0.05 to P < 0.001). In addition, further
improvement of chest wheezing and severity of disease on the third visit were
observed compared with the second visit in this group (P < 0.05 for both cases). In
the third visit all symptoms in the study group were significantly different from those
of the control group (P < 0.01 to P < 0.001). However, in the control group, there
were only small improvements in some parameters in just the second visit. The usage
of inhaler and oral b-agonists, oral corticosteroid, oral theophylline and even inhaler
corticosteroid in the study group decreased at the end of the study while there were
no obvious changes in usage of the drugs in control subjects. The results of phase I
study generally suggest a prophylactic effect of N. sativa on asthma disease and
warrant further research regarding this effect.
INTRODUCTION
Nigella sativa is a grassy plant with green to blue flowers
and small black seeds, which grows in temperate and
cold climate areas. The seeds of N. sativa contain
thymoquinone, monoterpenes such as p-cymene and
a-pinene [1], the alkaloids nigellidine and nigellimine
[2,3] and a saponin [4]. All chemical composition of the
plant was summarized in a recent review [5].
Several therapeutic effects, including anti-asthma and
dyspnoea, have been described for the seeds of N. sativa
in ancient Iranian medical books [6]. In Arabian folk
medicine also, the whole black seeds alone or in
combination with honey are prompted for treatment of
bronchial asthma. There is evidence of relaxant effects of
the volatile oil from this plant on different smooth
muscle preparations including rabbit aorta [7], rabbit
jejunum [8], and guinea-pig isolated tracheal muscle
[9]. Mahfouz and El-Dakhakhny [10] reported that the
volatile oil from N. sativa protected guinea-pigs against
histamine-induced bronchospasm, but it did not
affect histamine H1 receptors in isolated tissues. However, in an in vivo study, increasing respiratory
rate and intratracheal pressure of guinea-pigs due to
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559
M. H. Boskabady et al.
560
i.v. administration of volatile oil from N. sativa has been
demonstrated [11].
The results of our studies have also shown differing
pharmacological effects of N. sativa on guinea-pig
tracheal chains, including: relaxant and functional
antagonistic effects on muscarinic receptors [12], inhibitory effect on histamine (H1) receptors [13], inhibitory
effect on calcium channels [14], opening effect on
potassium channels [15] and stimulatory effect on
b-adronceptors [16]. The antitussive effect of this plant
on the guinea-pig [17] was also demonstrated. Both
systemic and local administrations of essential oil from
this plant are showed to have anti-inflammatory activity
[18]. The therapeutic effect of N. sativa oil on patients
with allergic diseases (allergic rhinitis, bronchial asthma,
atopic eczema) was also demonstrated [19]. In addition,
Labib Salem in a recent review summarized the immunomodulatory and therapeutic properties of the N. sativa
L. seed and emphasized the potent immunomodulatory
effects of this plant [5].
Therefore, in the present study, the prophylactic effect
of boiled extract from N. sativa on asthmatic airways was
examined.
MATERIALS AND METHODS
Plant, extract and drugs
Nigella sativa was collected from Torbat Heydarieh (northeast Iran), and its seeds were dried at room temperature in
the absence of sunlight. The plant was identified by
botanists in the herbarium of Ferdowsi University of
Mashhad; and the specimen number of the plant is
293-0303-1. The boiled extract of the seeds of the plant
was prepared as follows: 10 g of the chopped, dried plant
was boiled with 100 mL distilled water for 15 min and
allowed to cool at room temperature. The extract was then
filtered with a clean cotton cloth, and the volume of extract
was adjusted to 100 mL by evaporation. Therefore, the
final extract concentration was 0.1 g%. The constituents
of the essential oil of N. sativa was assessed using HPLC
(Schimadzue (Tokyo, Japan), SSPD-10AVP) by a phytochemsit with ODS column [20].
Patients
Twenty-nine asthmatic patients were recruited from
the Asthma Clinic, Ghaem Medical Centre, Mashhad
University of Medical Sciences, and divided to control group (14 patients, 2 male, 12 female, aged
48.20 ± 11.91 years, height 157.80 ± 7.81 cm) and
study group (15 patients, 4 male, 11 female, aged
35.87 ± 12.79 years, height 161.50 ± 9.38 cm) in
random order. The researcher was unaware of the
allocation of patients in the two groups. All patients had
the following criteria: (1) previously diagnosed asthma
by a physician and having two or more of the following
symptoms: recurrent wheeze, recurrent cough or tightness at rest; wheeze, cough or tightness during the night
or early morning; wheeze or cough during exercise, (2)
having forced expiratory volume in 1 s (FEV1) and peak
expiratory flow (PEF) less than 80% of predicted values,
(3) had no history or symptoms of cardiovascular or
other respiratory diseases that required treatment (excluding the common cold). The studied patients had
moderate to severe asthma according to GINA guidelines
[21]. The protocol was approved by the Ethics Committee of our institution, and each subject gave informed
consent. The study was carried out during spring and
summer 2005.
Treatment duration and administered drugs
Each patient was treated for a period of 3 months and
was visited and controlled three times during treatment
duration. The treatment regimen of all studied patients
included inhaled corticosteroid, mostly beclomethasone
dipropionate (400–1400 lg depending on the severity of
the disease) and in some cases fluticasone dipropionate
(500 lg), inhaler and oral b-agonists, oral corticosteroid
and oral theophylline. In addition, the patients of the
study group were given 15 mL/kg of 0.1 g% boiled
extract (containing 10 g% glucose) daily; and those of the
control group were given a semi-roasted glucose solution
(10 g% in saline) as a placebo for N. sativa extract
throughout the study. The placebo solution did not
contain any chemical that could affect asthma disease.
The study was performed in the double-blind manner.
Protocol
Medical examination was performed and asthma symptoms were taken in all patients at the beginning, in the
middle (45 days after starting the study on each patient),
and at the end of the study. Asthma symptom score was
counted according to Table I [22]. The degree of wheezing was considered between 0 and 3 as follows: no
wheezing ¼ 0, barely heard wheezing ¼ 1, moderate
wheezing ¼ 2, and loud wheezing ¼ 3. Pulmonary
function tests were also measured in the beginning and
at the end of the study using a spirometer with a
pneumotachograph sensor (Model ST90; Sangyo Co.,
Ltd, Fukuda, Japan). Prior to the pulmonary function
testing, the required manoeuvre was demonstrated by
ª 2007 The Authors Journal compilation ª 2007 Blackwell Publishing Ltd. Fundamental & Clinical Pharmacology 21 (2007) 559–566
Prophylactic effect of Nigella sativa on asthma disease
Table I The criteria for asthma severity
score.
561
Symptom
Frequency
Night wheezing
None
Night cough
Exercise cough and wheezing
Morning cough, tightness and wheezing
Day time cough, tightness and wheezing
1
Waking once at night
2
Waking most of night
3
None
0
Sleeping well with a little cough
1
Waking once at night
2
Waking most of night
3
Non-existent during strong exercise
0
Existence only during strong exercise
1
Existence during climbing stairs
2
Existence during ordinary activity
3
None
0
Existence in case of exertion
1
Mild symptoms without exertion
2
Waking in the morning due to symptoms
3
None
0
Once a day
1
Two or more times a day
2
Total score
Data analysis
The data of asthma symptom score, chest wheeze,
frequency of occurrence of symptoms/week and PFT
values were expressed as mean ± SEM because the
variability of these data among asthmatic subject were
considerable; but those of height and age were expressed
as mean ± SD because there were small differences in
these data between subjects. The percentage change in
the asthma symptom score, chest wheeze, frequency of
occurrence of symptoms/week and PFT values in the
middle (second visit) and at the end of the study (third
visit) were calculated as follows: [data of the second or
third visit ) data of the first visit (baseline values)]/data
of the first visit · 100.
0
Sleeping well with a little wheezing
Affecting day-time activity
the operator, and subjects were encouraged and supervised throughout test performance. Pulmonary function
testing was performed using the acceptable standards
outlined by the American Thoracic Society with subjects
in a standing position and wearing nose clips [23]. All
tests were carried out between 10:00 and 17:00 h. Lung
function tests were performed three times in each subject
by an acceptable technique [22]. The highest level for
forced vital capacity (FVC), FEV1, PEF, maximal expiratory flow at 75%, 50%, and 25% of the FVC (MEF75,
MEF50, and MEF25 respectively) was taken independently
from the three curves.
Score
3
16
All data were compared between the beginning, the
middle and the end of the study (three visits) using oneway analysis of variance (ANOVA) with Tukey–Kramer
multiple post hoc test. The data of control and study
groups were compared using unpaired ‘t’ test. The
difference of percentage of patients using each type of
drug between each two visits was tested by chi-square
testing on 2 · 2 contingency tables. Significance was
accepted at P < 0.05.
RESULTS
Constituents of the essential oil of N. sativa
The main constituents of the essential oil of N. sativa
included thujene a (8.2%), pinene a (2%), pinene b
(2.9%), terpinene a (1.8%), cymenen P (41.7%), limonene (3%), terpinene G (12.8%), campholenel a (9.7%),
carvacrol (2.2%) and thymoqunone (2%) [20].
Asthma symptoms
All symptom scores, according to GINA guidelines,
improved after even 45 days treatment of asthmatic
patients in the study group. In the control group only
night wheezing, exercise wheeze and cough, and morning wheeze and cough in the second visit were
significantly lower than in the first visit (P < 0.05 to
P < 0.01). However, there was no significant improve-
ª 2007 The Authors Journal compilation ª 2007 Blackwell Publishing Ltd. Fundamental & Clinical Pharmacology 21 (2007) 559–566
M. H. Boskabady et al.
562
NS
2.0
NS
*
NS
NS
NS
NS
1.5
3.0
NS
1.0
2.5
2.0
0.0
**
*
***
NS
NS
Night wheezing
Daily wheeze & cough
0.0
Morning wheeze & cough
***
NS
NS
NS
NS
1.0
0.5
Night coughing
***
*
NS
1.5
0.5
Night wheezing
***
*
Daily wheeze & cough
NS
Visit 3
**
Morning wheeze & cough
NS
Excercise wheeze & cough
*
Night coughing
**
2.5
3.5
Visit 2
NS
Asthma symptom score
NS
Asthma symptom score
(b)
Visit 1
3.0
Excercise wheeze & cough
(a)
Figure 1 Comparison of symptom score of control (a) and study (b) groups of asthmatic patients at the beginning (fine filled bars),
middle (medium filled bars) and at the end of 2-month study (coarse filled bars). Statistical difference in different parameter between three
visits: NS, non-significant difference, *P < 0.05, **P < 0.002, ***P < 0.001.
Table II Asthma symptoms and severity in control and study groups of patients in the beginning, and their percentage decrease in the
middle and at the end of the study.
Beginning
Symptoms
Control group
Middle
Study group
End
Control group
Study group
Control group
Study group
Night wheezing
2.36 ± .25
2.20 ± 0.20 NS
55.94 ± 10.13
34.44 ± 5.97 NS
5.99 ± 8.50
65.56 ± 0.12***
Night coughing
2.00 ± 0.30
1.87 ± 0.27 NS
41.67 ± 11.15
33.32 ± 6.90 NS
33.33 ± 11.59
74.45 ± 7.78**
Exercising W and C
2.43 ± 0.17
2.47 ± 0.163 NS
40.47 ± 9.03
28.87 ± 5.00 NS
15.46 ± 8.97
53.32 ± 7.49**
Morning W and C
1.79 ± 0.28
2.27 ± 0.23 NS
32.14 ± 10.26
32.21 ± 4.73 NS
14.29 ± 8.35
51.11 ± 7.54**
Daily W and C
2.00 ± 0.3
2.13 ± 0.19 NS
41.74 ± 14.48
35.55 ± 5.11 NS
7.14 ± 9.48
60.00 ± 10.26*
Weekly W and C
6.07 ± 0.74
4.47 ± 0.45 NS
24.31 ± 4.74
40.06 ± 4.36*
10.48 ± 9.97
58.45 ± 5.25***
Chest wheezing
2.57 ± 0.17
2.6 ± 0.13 NS
26.17 ± 4.85
23.32 ± 4.54 NS
22.61 ± 7.74
Asthma severity
3.20 ± 0.19
3.27 ± 0.18 NS
29.20 ± 5.25
23.32 ± 3.27 NS
5.36 ± 3.87
44.43 ± 3.12*
49.45 ± 3.50***
W, wheezing; C, coughing. All values were quoted as mean ± SEM. Statistical difference in different parameter between control and study group:
NS, non-significant difference, *P < 0.01, **P < 0.005, ***P < 0.001.
ment in symptoms between the third (end of 3-month
study) and the first visits (Figure 1a). In the study group,
all asthma symptoms were improved significantly in the
second (P < 0.05 to P < 0.001) and third visits
(P < 0.001 for all symptoms) than in the first visit
(baseline values) except night cough in the second visit
(Figure 1b). In addition, there was no significant difference in symptoms between the third and second visit in
the study group. While at the beginning of the study
there were no significant differences in asthma symptoms between control and study groups; in the third
visit, there was significantly more reduction in all
symptoms in the study subjects compared with the
control group (P < 0.01 to P < 0.001) (Table II).
Severity of asthma and wheezing
Asthma severity score, frequency of occurrence of
asthma symptoms/week, and chest wheezing were also
improved at the end of the study (after 3-month
treatment) in study groups. In the control group only
chest wheezing and severity of asthma in the second visit
were significantly lower than the first visit (P < 0.05 for
ª 2007 The Authors Journal compilation ª 2007 Blackwell Publishing Ltd. Fundamental & Clinical Pharmacology 21 (2007) 559–566
Prophylactic effect of Nigella sativa on asthma disease
(a)
7
NS
Visit 1
Visit 2
Visit 3
NS
Asthma severity, ferquency of symptoms/week and wheezing
6
563
NS
5
4
NS
* NS
3
NS
**
NS
2
1
5
(b)
***
*
4
3
NS
***
**
*
*
***
*
2
1
Chest wheezing
Asthma severity
Weekly wheeze & cough
0
Figure 2 Comparison of severity of asthma according GINA
guideline, frequency of asthma symptoms/week and chest wheeze of
control (a) and study (b) groups of asthmatic patients at the
beginning (fine filled bars), middle (medium filled bars) and at the
end of 2-month study (coarse filled bars). Statistical difference
in different parameter between three visits: NS, non-significant
difference, *P < 0.05, **P < 0.002, ***P < 0.001.
both cases). However, there was no significant difference
in the above parameters between the third and first visits
(Figure 2a). In the study group, the asthma severity
score, frequency of asthma symptoms/week, and chest
wheezing were significantly lower in the second and
third visits than in the first visit (P < 0.05 and
P < 0.001 for all cases in second and third visits
respectively), (Figure 2b). In addition, there was signifi-
cant improvement in the asthma severity score and chest
wheezing in the third visit compared with the second
visit in the study group (P < 0.05), (Figure 2b). While at
the beginning of the study there was no significant
difference in the asthma severity score, frequency of
asthma symptoms/week, and chest wheezing between
control and study groups, in the third visit, there was
significantly more reduction in all symptoms in study
subjects compared with the control group (P < 0.05 to
P < 0.001) (Table II).
Pulmonary function tests
All PFT variables were abnormally low in both control
and studied asthmatic patients at the beginning of the
study (33.00 ± 4.85% to 62.27 ± 4.50%). PFT variables
were improved after 45 days of treatment in study group;
and there was further improvement in PFTs at the end of
the study. In the control group, there were only significant increases in FEV1 and MMEF in visit 2 compared to
visits 1 and 3 (P < 0.05 to P < 0.001) (Figure 3a). In the
study group, in the second visit most PFT values (except
MEF75 and MEF50) and the third visits all PFT values
were significantly improved compared with first visits
(P < 0.001 for all cases) (Figure 3b). The values of FVC
and MMEF also significantly increased in the third visit
compared with the second visit in the study group
(P < 0.01 for both cases). Although at the beginning of
the study PFF in the control group was lower than in the
study group (P < 0.05), in the second and third visits all
PFT variables in the study group increased; and in the
third visit, there was significantly more increase in all
PFT values (except MEF25) in study subjects compared
with the control group, and they were more significantly
different than in the control group (P < 0.05 to
P < 0.001) (Table III).
Treatment regiment and inhaler using technique
The usage of inhaler and oral b-agonists, oral corticosteroid, oral theophylline and even inhaler corticosteroid
of the study group was decreased at the end of the
study while there were no obvious changes in usage of
these types of drugs in control subjects (P < 0.01 to
P < 0.001) (Table IV).
DISCUSSION
The results of the present study showed improvement in
symptom score, asthma symptom/week, chest wheeze,
and especially in PFT values in patients receiving extract
of N. sativa compared with the control group. Although
ª 2007 The Authors Journal compilation ª 2007 Blackwell Publishing Ltd. Fundamental & Clinical Pharmacology 21 (2007) 559–566
M. H. Boskabady et al.
564
(a)
35
***
NS NS
Visit 1
Visit 2
Visit 3
30
NS
(b)
Increase in pulmonary function tests (precent of base line values)
25
***
** NS
20
NS
NS NS
NS
NS
NS
15
NS
*
* NS
10
NS NS
NS
NS
5
0
NS
50
45
NS
40
35
30
***
***
***
*
NS
*
***
NS
NS
NS
***
***
25
20
NS
NS
***
***
NS
***
NS
***
15
10
5
*
0
FVC
FEV1
MMEF
PEF
MEF75
MEF50
MEF25
Figure 3 The percentage increase in pulmonary function tests in
proportion to the baseline values of control (a) and study (b) groups
of asthmatic patients at the middle (fine filled bars) and the end of
3-month study (medium filled bars). FEV1: forced expiratory volume
in 1 s; FVC: forced vital capacity; PEF: peak expiratory flow; MEF75,
MEF50 and MEF25: maximal expiratory flow at 75%, 50% and 25%
of the FVC, respectively. All values of PFTs were quoted as
percentage predicted. Statistical difference in different parameter
between three visits: NS, non-significant difference, *P < 0.05,
**P < 0.002, ***P < 0.001.
in the present study asthmatic patients were treated for a
short period of time, there were significant improvements
in PFT values in the studied group. The PFT values in the
studied group were increased more than 20% at the end
of the study period (3 months) and became close to
normal values. The asthma symptom scores were also
improved in the study group, and patients were almost
symptom-free at the end of the study. The asthma
severity was also improved from moderate persistent to
severe persistent and achieved intermittent to mild
persistent according to the GINA guideline [21]. The
chest wheeze of patients in the study group was
significantly reduced after 3 months of treatment. The
amount and types of drugs in the treatment regimen
of this group of patients were also decreased due to
improvement of asthma severity. All patients in the
study group were able to do almost normal activity at the
end of the study. However, there were minimal changes
in symptom score, asthma symptom/week, chest wheeze
and PFT values in the control group.
The PFT values in the control group were lower than
in the study group; and their symptoms score, asthma
severity and chest wheeze were non-significantly greater.
These differences indicated more severe disease and
expectation of more pronounced response to treatment,
but the response to the same treatment regiment without
the extract of N. sativa was less than that of the study
group. In fact, in the second visit (after 45 days of
treatment) there were some improvements in the different parameter of the control group which support their
treatment response. However, their treatment response
was much lower than in the study group and returned to
baseline values at the third visit. Although the patients
employed in the study used different types of corticosteroid, they were divided randomly into two groups.
Therefore, the treatment regiment of the patients does
not influence the outcome of the therapy.
The smaller effect of the extract from N. sativa on some
PFTs, especially on MEF25, may indicate that this plant
has little effect on small airways. In fact, this finding is
supported by our previous study indicating that this
plant has a minimum effect in this value of PFT. The
results of this study confirm those of previous studies
indicating a relaxant effect of this plant on airway
smooth muscle [12].
The main pathological feature of asthmatic patients is
airway inflammation, and all prophylactic drugs used in
treatment of this disease are aimed to reduce this
phenomenon. Therefore, the mechanism of prophylactic
effect of this plant on asthma is perhaps due to its
suppressing effect on airway inflammation. In fact, the
inhibitory effects of the essential oil of N. sativa and
thymoquinone have been shown on both cyclooxygenase and 5-lipooxygenase pathways of arachidonic
acid metabolism and also on membrane lipid peroxidation [24]. In addition, the inhibitory effect of this plant
on histamine (H1) receptor seen in our previous study
[13] can contribute to its anti-inflammatory effect. The
antitussive effect of N. sativa has been shown in our
previous study [17]. Furthermore, it was shown that
both systemic and local administrations of the essential
oil from this plant have an anti-inflammatory activity
[18]. The therapeutic effect of N. sativa oil on patients
with allergic diseases (allergic rhinitis, bronchial asthma, atopic eczema) was also demonstrated [19]. In
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Prophylactic effect of Nigella sativa on asthma disease
565
Table III Pulmonary function tests (PFTs) in control and study groups of asthmatic patients at the beginning and their percentage increase
in middle and the end of the study.
Beginning
Middle
PFTs
Control group
Study group
FVC
End
Control group
Study group
Control group
54.21 ± 3.30
62.27 ± 4.50 NS
30.5 ± 10.25
14.53 ± 2.10 NS
9.26 ± 5.47
FEV1 (L)
52.1 ± 4.50
58.8 ± 5.00 NS
19.1 ± 8.37
16.00 ± 1.66 NS
3.30 ± 6.50
PEF (L/s)
38.8 ± 3.70
53 ± 5.21*
8.23 ± 5.56
20.00 ± 6.01 NS
)0.66 ± 7.20
MMEF
Study group
27.71 ± 4.15*
29.47 ± 5.04**
31.18 ± 3.80***
37.7 ± 5.30
42.13 ± 5.70 NS
8.19 ± 8.70
16.10 ± 2.27 NS
2.80 ± 10.23
31.74 ± 4.44**
MEF75 (L/s)
33 ± 4.85
50 ± 7.40 NS
21.60 ± 7.98
16.10 ± 6.25 NS
7.71 ± 8.52
31.74 ± 11.00***
MEF50 (L/s)
37.71 ± 5.18
41.67 ± 5.45 NS
6.95 ± 9.34
24.74 ± 4.36 NS
1.26 ± 9.93
42.00 ± 7.06***
MEF25 (L/s)
45.9 ± 7.45
49.87 ± 5.70 NS
9.34 ± 10.44
13.75 ± 4.58 NS
3.64 ± 11.30
20.95 ± 5.40 NS
FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; PEF: peak expiratory flow; MEF75, MEF50 and MEF25: maximal expiratory flow at 75%, 50% and
25% of the FVC, respectively. All values of PFTs were quoted as mean ± SEM of percentage predicted. Statistical difference in different parameter between
control and study groups: NS, non-significant difference, *P < 0.05, **P < 0.005, ***P < 0.001.
Table IV Different type of drugs in treatment regimen in control and study groups of asthmatic patients at the beginning, middle and the end
of the study (percentage of total patients in each group).
Beginning
Middle
End
Type of drugs
Control group
Study group
Control group
Study group
Control group
Study group
Inhaler salbotamol
80
73
86.6 NS
70 NS
93.3* ns
68 NS ns
Oral salbotamol
26.5
15
13.3*
12.5 NS
26.6 NS
0***,
Salmetrol inhaler
0
0
20***
0 NS
6.6*
Inhaler corticosteroids
26.5
32
80***
21 NS
53.3***,
Oral corticosteroid
26.6
30
26.6 NS
14**
20 NS ns
Oral theophylline
53.3
68.5
86.6***
47.5**
46.6 NS
6.6
0
33.3***
0 NS
6.6 NS
Antihistamine
0 NS ns
15** ns
6.25*** ns
23***,
0 NS ns
Statistical difference in the percentage of patients using each type of drug between beginning with middle and the end of the study: NS, non-significant
difference, *P < 0.05, **P < 0.002, ***P < 0.001. Statistical difference in the percentage of patients using each type of drug between middle and the end of
the study: ns, non-significant difference, P < 0.05,
P < 0.001. Inhaler corticosteroids included beclomethasone dipropionate and fluticasone dipropionate.
Oral corticosteroid drug of the treatment regimen of patients was prednisolone. Antihistamine drugs were included in treatment regimen of allergic asthmatic
patients to prevent allergic symptoms.
addition, Labib Salem in a recent review summarized
the immunomodulatory and therapeutic properties of
the N. sativa L. seed and emphasized on potent
immunomodulatory effects of this plant [5]. In addition
Ali and Blunden also summarized different pharmacological effect of N. sativa including effect on asthma
disease, inflammation and immune system and indicated its different constituents [25]. Therefore, as indicated
in ancient Iranian medical books this plant could have
therapeutic effects on respiratory diseases. However,
more studies are required revealing the different therapeutic effect, effective substance(s) and mechanism(s) of
action of N. sativa.
Regarding the safety of this remedy, many in vivo
studies including the study of Kalus et al. [19] were done
on this plant and there is no any report on adverse
reaction of N. sativa. In addition, hepato-protective effect
of this plant also was shown [26,27]. Furthermore, in a
comprehensive review, the safety properties of the
N. sativa L. seed was emphasized [5].
In conclusion, the results of phase I study generally
suggest a prophylactic effect of N. sativa on asthma disease
and warrant further research regarding this effect.
ACKNOWLEDGEMENTS
This study was financially supported by Research
Department of Mashhad University of Medical sciences.
The author also would like to thank Dr Hoseinzade for
his HPLC analysis of the essential oil of the plant.
ª 2007 The Authors Journal compilation ª 2007 Blackwell Publishing Ltd. Fundamental & Clinical Pharmacology 21 (2007) 559–566
M. H. Boskabady et al.
566
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