Abstract
Background and aims
Allergic rhinitis is the most common chronic and allergic disease, especially in children. This study aimed to investigate the anti-inflammatory effects of Nigella sativa and its effects on inflammatory factors in patients with allergic rhinitis symptoms and the process their clinical study charges.
Setting
The present study is a clinical trial that conducted as prospective and double blind with descriptive analytic.
Materials and methods
The sample included 66 patients (case and placebo) with allergic rhinitis exposed to N. sativa oil. Individual characteristics, including age and sex, and characteristics of the disease, including nasal congestion, runny nose, itchy nose, and sneezing attacks, were evaluated. From the start of the study, that is, day 0, up to the end of the study, that is, day 30, an observer completed the symptoms severity questionnaire.
Statistical analysis
Data were presented as means ± SEM. Comparisons between groups were performed by using paired Student t test. Differences were considered significant if P values are less than .05 and .01.
Results
In the present study, 66 patients with allergic rhinitis, including 22 males (33.3%) and 44 females (66.7%) with a mean age of 47.19 years, were included. Immunoglobulin E total of more than 100 was reported in 38 patients before treatment. Immunoglobulin E in nasal wash from 7 patients was observed and was not measurable in 59 cases. Only 6.1% of the study population had nasal mucosal eosinophil.
Conclusion
The results show that N. sativa could reduce the presence of the nasal mucosal congestion, nasal itching, runny nose, sneezing attacks, turbinate hypertrophy, and mucosal pallor during the first 2 weeks (day 15). The present findings are consistent with evidence that the antiallergic effects of N. sativa components could be attributed to allergic rhinitis. Moreover, N. sativa should be considered for treating allergic rhinitis when the effects of other antiallergic drugs need to be avoided.
1
Introduction
Allergic rhinitis is the most common chronic and allergic disease, especially in children, and its prevalence in the communities is increasing due to industrialization . The prevalence has been reported from 1.4% to 39.7% in different Western countries, and in England, it increased 4 times during the previous 30 years, in which the cause is not clearly known . The reported prevalence in our country includes the wide spectrum ranging from 7.2% to 23.6% . The disease develops due to increased inflammatory cells such as neutrophil, eosinophil, and basophil and mast cell . The signs and symptoms of this disease include stimulation of mucous glands, vasodilatation, increased vascular permeability, and stimulated mucus that themselves are responsible for creating typical symptoms such as itching, sneezing, rhinorrhea, and nasal congestion . Allergens that usually caused allergic rhinitis include 2 seasonal and permanent categories that divided mainly to the pollen group, and the second group includes plants Mayt, mold, animal particles, and cockroach particles . Treatment of seasonal allergic rhinitis usually is done by a histamine receptor antagonist, sympathomimetic, and corticosteroids .
Considering the growing importance of research that works on the effects of treatment plants and stuck them in the treatment of the diseases, this study aimed to investigate the anti-inflammatory effects of Nigella sativa and its effects on inflammatory factors in patients with allergic rhinitis symptoms and the process their clinical study charges.
2
Materials and methods
2.1
Study design and population
The present study is a clinical trial that conducted as prospective and double blind with descriptive analytic. The sample included 66 patients (case and placebo) with allergic rhinitis referred to ear nose and throat clinic of Imam Khomeini Hospital, Ahwaz, during the years 2007 to 2009 and were exposed to N. sativa oil. The study was approved by the University Hospital and Ahvaz Jundishapur University of Medical Sciences Ethics Committees, and all subjects provided informed consent to participate.
2.2
Exclusion criteria
All patients who had a previous history of major psychiatric illness, current dependence on drugs like sedatives or hypnotics, as well as cardiac and liver diseases were excluded.
2.3
Patient evaluation and data collection
Individual characteristics, including age and sex, and characteristics of the disease, including nasal congestion, runny nose, itchy nose, and sneezing attacks, were evaluated. Laboratory features including nonspecific serum IgE, IgE from nasal mucosa wash, serum eosinophil, and nasal mucosa before and after treatment were observed. The selected patients were enrolled, and data and progress of patients were recorded. From the start of the study, that is, day 0, up to the end of the study, that is, day 30, an observer completed the symptoms severity questionnaire.
2.4
Clinical evaluation
Before treatment, patients symptoms including nasal congestion, sneezing attacks, and nasal itching in 4 levels (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe) were evaluated and recorded in a questionnaire . The patient’s condition was evaluated every 2 weeks and at end of treatment (after 4 weeks) and recorded in the same questionnaire. The eosinophil measurement from nasal mucosa epithelium with eosinophil to calm lower frontal turbinate and then to be collected by a swap method was performed. Nasal smear for eosinophil classification–based method was set. Methods used are as follows: 0 = no cells, + = low eosinophil or small clump, 2+ = average or large clump, 3+ = much larger but all fields are not filled, and 4+ = all fields are filled. When the number of eosinophil cells in the 2 high-powered field is considered, 10 or more cells positive for these cells are seen (<+2) . Nasal mucosa IgE measurement is as follows: nasal mucosa epithelium was washing by 10-mL syringe washing and 40 mL of solution in test tube to collect the wash by normal saline solution; serum 9/0% is done .
2.5
Preparation of N. sativa extract
N. sativa oil from a Gorgan plant extract was purchased from Gorgan Co Ltd (Gorgan, Iran). The obtained oil (0.5 mL) was filled in the empty capsules and was kept in the refrigerator for short time before consumption.
2.6
Statistical analysis
Data were presented as means ± SEM. Comparisons between groups were performed by using paired Student t test on a Statistical Software Package (SPSS, Chicago, IL). Differences were considered significant if P values are less than .05 and .01.
2
Materials and methods
2.1
Study design and population
The present study is a clinical trial that conducted as prospective and double blind with descriptive analytic. The sample included 66 patients (case and placebo) with allergic rhinitis referred to ear nose and throat clinic of Imam Khomeini Hospital, Ahwaz, during the years 2007 to 2009 and were exposed to N. sativa oil. The study was approved by the University Hospital and Ahvaz Jundishapur University of Medical Sciences Ethics Committees, and all subjects provided informed consent to participate.
2.2
Exclusion criteria
All patients who had a previous history of major psychiatric illness, current dependence on drugs like sedatives or hypnotics, as well as cardiac and liver diseases were excluded.
2.3
Patient evaluation and data collection
Individual characteristics, including age and sex, and characteristics of the disease, including nasal congestion, runny nose, itchy nose, and sneezing attacks, were evaluated. Laboratory features including nonspecific serum IgE, IgE from nasal mucosa wash, serum eosinophil, and nasal mucosa before and after treatment were observed. The selected patients were enrolled, and data and progress of patients were recorded. From the start of the study, that is, day 0, up to the end of the study, that is, day 30, an observer completed the symptoms severity questionnaire.
2.4
Clinical evaluation
Before treatment, patients symptoms including nasal congestion, sneezing attacks, and nasal itching in 4 levels (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe) were evaluated and recorded in a questionnaire . The patient’s condition was evaluated every 2 weeks and at end of treatment (after 4 weeks) and recorded in the same questionnaire. The eosinophil measurement from nasal mucosa epithelium with eosinophil to calm lower frontal turbinate and then to be collected by a swap method was performed. Nasal smear for eosinophil classification–based method was set. Methods used are as follows: 0 = no cells, + = low eosinophil or small clump, 2+ = average or large clump, 3+ = much larger but all fields are not filled, and 4+ = all fields are filled. When the number of eosinophil cells in the 2 high-powered field is considered, 10 or more cells positive for these cells are seen (<+2) . Nasal mucosa IgE measurement is as follows: nasal mucosa epithelium was washing by 10-mL syringe washing and 40 mL of solution in test tube to collect the wash by normal saline solution; serum 9/0% is done .
2.5
Preparation of N. sativa extract
N. sativa oil from a Gorgan plant extract was purchased from Gorgan Co Ltd (Gorgan, Iran). The obtained oil (0.5 mL) was filled in the empty capsules and was kept in the refrigerator for short time before consumption.
2.6
Statistical analysis
Data were presented as means ± SEM. Comparisons between groups were performed by using paired Student t test on a Statistical Software Package (SPSS, Chicago, IL). Differences were considered significant if P values are less than .05 and .01.
3
Results
In the present study, 66 patients with allergic rhinitis, including 22 males (33.3%) and 44 females (66.7%) with a mean (SD) age of 20.81 (7.27) years, were included. From the total sample, 3 patients from the case group and 4 subjects from placebo were excluded from the study because they refused to complete the study. The age distribution of the patients in the study group is shown in Fig. 1 . Immunoglobulin E total of more than 100 was reported in 38 patients before treatment. Immunoglobulin E in nasal wash from 7 patients was observed and was not measurable in 59 cases. Only 6.1% of the study population had nasal mucosal eosinophil.
The total serum IgE means before treatment in the study and placebo groups were 201.9890 and 179.0392, and in the end of the treatment, they were 205.30212 and 194.42408, respectively. The individual differences in the study and placebo groups were not statistically significant ( P = .828, P = .608; Fig. 2 ). The averages of IgE from nasal wash in the study group before treatment and at the end of treatment were 0.45 and 0. 06, respectively, which shows no statistically significant difference ( P = .0017; Fig. 3 ). The averages of IgE from nasal wash in the placebo group before treatment and at the end of treatment were 0.51 and 0.23, respectively, which also shows no statistically significant difference ( P = .455; Fig. 3 ).
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