Nigella Abstracts 5

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Effect of Nigella sativa seed administration on prevention of febrile neutropenia during chemotherapy among children with brain tumors.
            (Mousa et al., 2017)  Download
PURPOSE:  Seeds of Nigella sativa (NS) are used to combat various disease conditions through their antibacterial effects. To evaluate the seeds' potential, we studied their effect on the prevention of febrile neutropenia (FN) in children with brain tumors. METHODS:  A randomized pretest-post-test control group study including 80 children (2-18 years) with brain tumors undergoing chemotherapy were equally allocated into two groups. Intervention group received 5 g of NS seeds daily throughout treatment while controls received nothing. CBC with differentials, incidence of FN, and LOS were noted on each follow-up. RESULTS:  The majority of children 38/40 (95%), of the intervention group, took the seeds for 3-9 consecutive months. Eight out of 372 (2.2%) FN episodes were experienced by children of intervention group compared to controls 63/327 (19.3%) (p = 0.001) and a shorter LOS (median = 2.5 days) vs 5 days in the control group (p = 0.006). Children in both groups belonged to almost same geographical area with similar socio-economic background. Weights of children were almost equal at diagnosis. CONCLUSION:  NS seeds showed a decrease in incidence of FN in children with brain tumors with shortening of subsequent LOS which may improve their outcome and thereby quality of life. Larger scale studies are needed to further evaluate the seeds' potential.

Effect of Nigella sativa Seed Extract for Hypertension in Elderly: a Double-blind, Randomized Controlled Trial.
            (Rizka et al., 2017)  Download
BACKGROUND:  Nigella sativa (NS) seed extract shows diuretic activity, inhibits sympathetic nervous system overactivity and increases the production of Nitric Oxide in in vivo studies, thus it has a potential use as an adjuvant antihypertensive for elderly population. This study aimed to determine the effect of Nigella sativa seed extract to systolic blood pressure (SBP) and diastolic blood pressure (DBP) of elderly patients with hypertension. METHODS:  a double-blind, randomized controlled trial was conducted on elderly subjects with hypertension in three outpatient clinics in Cipto Mangunkusumo National Hospital Jakarta Indonesia from June to September 2011. Subjects were divided into intervention group given 300 mg Nigella sativa seed extract twice daily for 28 days and into another group which was given placebo. Blood pressure were measured on day 1 and 28. Intention to treat analysis using unpaired t-test to compare blood pressure after intervention between the two groups was performed. RESULTS:  of a total of 85 patients, 76 subjects fulfilled the study criteria and were randomized into 2 groups, with 38 subjects in each group. Both groups were comparable in all important prognostic factors. The mean systolic blood pressure of the NS group was decreased from 160.4 (SD 15.7) mmHg to 145.8 (SD 19.8) mmHg, and from 160.9 (16.3) mmHg to 147.53 (SD 22.0) mmHg in the placebo group (p=0.36). The mean diastolic blood pressure in the NS group was decreased from 78.3 (SD 11.9) to 74.4 (SD 8.2) mmHg, and from 79.0 (SD 12.4) to 78.2 (SD 8.9) in the placebo group (p=0.35). Reported adverse events include dyspepsia in 6 subjects (15.7%), nausea in 3 subjects (7.8%), and constipation in 2 subjects (5.2%). No electrolyte abnormalities, liver and renal toxicities, or orthostatic hypotension were observed. CONCLUSION:  although a trend towards a slight decrease in blood pressure was observed, Nigella sativa has not been proven to be effective in reducing blood pressure in elderly patients with hypertension.

Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.
            (Salimzadeh et al., 2017)  Download
AIM:  Osteoarthritis is a global health problem, especially for the elderly. A good replacement for non-surgical treatments is the use of traditional medicines. We selected a revere plant (Nigella sativa L.), a widely utilized medicinal herb for the treatment of inflammatory conditions, from the Iranian traditional medicine (ITM) pharmacopoeia with proven anti-inflammatory and analgesic actions. METHODS:  We performed a prospective, randomized, double-blind, and placebo-controlled clinical trial, in order to investigate whether the herb is useful in alleviating the symptoms of knee osteoarthritis. American College of Rheumatology clinical criteria were the basis of diagnosis, while the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire was considered as the main outcome measure. One hundred and ten eligible patients were assigned to receive a placebo or an active intervention (2 g/day of processed N. sativa seed powder in divided doses). Acetaminophen tablets were the rescue medicine. Finally, 40 patients in the placebo group and 37 patients in the active group completed the trial and were included in the statistical analysis. RESULTS:  Both cohorts demonstrated statistically significant within-group differences (P < 0.05) in some subscales that were more prominent in the active group without any considerable adverse effects. Nevertheless, KOOS score results and the mean number of acetaminophen tablets used by patients showed no statistically significant between-group differences. CONCLUSIONS:  It can be concluded that future programmed studies with larger sample sizes, longer follow-up periods, and other forms of N. sativa seeds as an active intervention is necessary to evaluate its efficacy in relieving the symptoms of knee osteoarthritis.

Investigation of the effect of black cumin oil on pain in osteoarthritis geriatric individuals.
            (Tuna et al., 2018)  Download
PURPOSE:  This study has been carried out to investigate the analgesic effect of black cumin oil on individuals with knee pain. METHOD:  The experimental group (n = 30) and control group (n = 30) have been randomly selected. The control group patients have continued their routine prescription. For the experimental group, black cumin oil has been applied by rubbing to their knees 3 times a week for 1 month. FINDINGS:  As a result of the study, the mean VAS values of the patients in the experimental group has changed to 7.50 ± 0.97 on the 1st day and 6.30 ± 1.14 on the 30th day and there has been a significant decrease in pain severity in this group (p < 0.001). RESULTS:  This study has shown that the pain relieving properties of black cumin oil is effective on geriatric individuals living with knee pain.

Safety and efficacy of a polyherbal formulation for the management of dyslipidemia and hyperglycemia in patients with advanced-stage of type-2 diabetes.
            (Zarvandi et al., 2017)  Download
The present clinical trial was designed to evaluate the safety and efficacy of a polyherbal formulation (PHF) consisted of Allium sativum, Aloe vera, Nigella sativa, Plantago psyllium, Silybum marianum and Trigonella foenum-graecum for controlling dyslipidemia and hyperglycemia in patients with advanced-stage of type-2 diabetes. An open-label phase I trial was carried out on 30 patients who had hyperlipidemia and hyperglycemia before the beginning of the trial in spite of receiving statins and oral hypoglycemic drugs. Patients were given one PHF sachet two times daily for 40 consecutive days. All subjects also continuously received their statins and oral hypoglycemic agents. Clinical assessments and laboratory findings were evaluated before starting treatment and at day 40. Treatment with PHF had no significant effects on serum biochemical parameters related to liver and kidney functions, on hematological parameters related to erythrocytes, leukocytes, and platelets, and on body weight and blood pressure. After consumption of PHF, 2 patients complained of mild nausea, and 2 patients reported diarrhea. PHF significantly decreased fasting blood glucose and HbA1c from 162±40mg/dL to 146±37mg/dL and from 8.4±1.5% to 7.7±1.1%, respectively. Also, it significantly decreased the level of LDL from 138±25mg/dL to 108±36mg/dL, and the level of triglycerides from 203±47mg/dL to 166±58mg/dL. In conclusion, the present results demonstrated that the PHF was safe and efficacious in lowering the levels of blood glucose and serum lipids in patients with advanced-stage of type-2 diabetes.

 


References

Mousa, HFM, et al. (2017), ‘Effect of Nigella sativa seed administration on prevention of febrile neutropenia during chemotherapy among children with brain tumors.’, Childs Nerv Syst, 33 (5), 793-800. PubMed: 28349493
Rizka, A, et al. (2017), ‘Effect of Nigella sativa Seed Extract for Hypertension in Elderly: a Double-blind, Randomized Controlled Trial.’, Acta Med Indones, 49 (4), 307-13. PubMed: 29348380
Salimzadeh, A, et al. (2017), ‘Effect of an orally formulated processed black cumin, from Iranian traditional medicine pharmacopoeia, in relieving symptoms of knee osteoarthritis: A prospective, randomized, double-blind and placebo-controlled clinical trial.’, Int J Rheum Dis, 20 (6), 691-701. PubMed: 28378356
Tuna, HI, et al. (2018), ‘Investigation of the effect of black cumin oil on pain in osteoarthritis geriatric individuals.’, Complement Ther Clin Pract, 31 290-94. PubMed: 29705470
Zarvandi, M, et al. (2017), ‘Safety and efficacy of a polyherbal formulation for the management of dyslipidemia and hyperglycemia in patients with advanced-stage of type-2 diabetes.’, Biomed Pharmacother, 89 69-75. PubMed: 28214690