BACKGROUNDNigella sativa and its derivatives have been reported to have anti-inflammatory and bronchodilator effects, but the effects have been evaluated in only a few clinical studies.OBJECTIVESTo determine the effect of N sativa supplementation on inflammation of the airways and limitation of airflow in partly controlled asthma patients.DESIGNSingle-blind, placebo-controlled, randomized study.SETTINGAsthma and allergy clinic of a university hospital in eastern Saudi Arabia.PATIENTS AND METHODSPatients were divided into three groups. A control group (n=24) received the placebo, while NS-1 and NS-2 groups (n=26 each) received 1 and 2 g/day of N sativa, respectively, for 3 months along with maintenance inhaled therapy.MAIN OUTCOME MEASURE(S)Asthma control test (ACT) score, fractional exhaled nitric oxide (FeNO), peak expiratory flow (PEF) variability and other pulmonary function tests, IgE, serum cytokines, and frequency of exacerbations.RESULTSFEF25-75% and FEV1 (% predicted) increased significantly (P<.05) at both 6 and 12 weeks in the NS-2 group. PEF variability significantly improved in both NS-1 and NS-2 groups at 6 and 12 weeks as compared with the controls (P<.05). FeNO and serum IgE decreased significantly after 12 weeks in both the NS-1 and NS-2 groups vs baseline (P<.05). Both doses of N sativa produced a significant increase in the serum IFN-γ at 12 weeks vs baseline (P<.05) as well as a significant improvement in the ACT score at 6 and 12 weeks vs baseline (P<.001, <.01). Significantly fewer patients had exacerbations in the NS-1 group (P<.05).CONCLUSIONN sativa supplementation with inhaled maintenance therapy improves some measures of pulmonary function and inflammation in partly controlled asthma.LIMITATIONSNo bronchoalveolar lavage or sputum samples taken for measurement of asthma markers.
Our results indicate that goiter is endemic in this region of Sudan despite iodine sufficiency and that both anemia and vitamin A deficiency are health problems in the area. Moreover, consumption of millet, vitamin A deficiency, and protein-energy malnutrition are possible etiologic factors in this endemic area.
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