Effect of Nigella sativa supplementation on lung function and inflammatory mediators in partly controlled asthma: a randomized controlled trial

Abstract

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.

Effects of Nigella sativa oil on Th1/Th2, cytokine balance, and improvement of asthma control in children

“…14 Clinical study conducted by Salem et al reported that there was significant increase in the serum IFN-g and improvement in the ACT score after 12 weeks of Nigella sativa supplementation in asthmatic patients. 18 This study showed that NSO treatment increase of IFN-g and decrease of IL-4 serum level. It indicates that there was stimulatory effect on Th1 cells and inhibitory effect on Th2 cells.…”

The efficacy of Nigella sativa supplementation for asthma control: a meta-analysis of randomized controlled studies

“…Three hundred and fifteen potentially relevant articles are identified initially. Finally, four RCTs are included in the meta-analysis [20][21][22][23].…”

“…Screening Eligibility Included Figure 1. Flow diagram of the study search and selection process ies have found that Nigella sativa was well tolerated, and only mild and self-limited side effects were reported [21,22]. Several limitations exist in this meta-analysis.…”

“…Current evidence is insufficient for routine clinical use of Nigella sativa supplementation in asthmatic patients. Recently, several studies have investigated the efficacy of Nigella sativa supplementation for these patients, but the results are conflicting [21][22][23].…”

Efficacy and safety of HX 110-A and HX 110-B in promoting respiratory health: An 8-week, randomized, double-blind, parallel group, placebo-controlled trial

“…Previous studies have reported differences in total antioxidant capacity changes of 0.09 ± 0.10 mmol/L [12], and forced expiratory volume in 1 s (FEV1), FEV25-75%, peak expiratory flow variability, and fractional expired nitric oxide (FeNO) values of 7.70 ± 8.50%, 0.40 ± 0.45 L/s, 5.80 ± 6.30, and 4.60 ± 5.00 ppb, respectively, after control or test food intake [13]. Hence, the sample size per arm for the proposed study was calculated as 20 (60 in total), based on a power of 80% and an α = 0.05 level of significance.…”