Nigella sativa supplementation and non-alcoholic fatty liver disease: A systematic review of clinical trials | ||
| Avicenna Journal of Phytomedicine | ||
| دوره 13، شماره 1، فروردین و اردیبهشت 2023، صفحه 18-33 اصل مقاله (578.74 K) | ||
| نوع مقاله: Review Article | ||
| شناسه دیجیتال (DOI): 10.22038/ajp.2022.20060 | ||
| نویسندگان | ||
| Abbas Mohtashamian1؛ Armin Ebrahimzadeh1؛ Zahra Shamekhi2؛ Nasrin Sharifi* 1 | ||
| 1Research Center for Biochemistry and Nutrition in Metabolic Diseases, Basic Science Research Institute, Kashan University of Medical Sciences, Kashan, Iran | ||
| 2Sepidan Bagherololoom Higher Education College, Shiraz University of Medical Sciences, Shiraz, Iran | ||
| چکیده | ||
| Objective: Based on the results of previous studies, the effects of N. sativa on some of the non-alcoholic fatty liver disease's (NAFLD) biomarkers were positive; however, there were conflicting results regarding other variables. Therefore, the present systematic review of clinical trials was designed to clarify whether N. sativa effectively prevents the progression of NAFLD. Materials and Methods: A search of four databases (Scopus, PubMed, Medline, and Google scholar) was conducted to identify the clinical trials that assessed the effects of N. sativa supplementation on NAFLD. The outcome variables of interest were biomarkers of hepatic steatosis, liver enzymes, insulin resistance, and inflammation. Results: Overall, four randomized clinical trials (RCTs) were included. In three studies, hepatic steatosis grade decreased significantly after N. sativa supplementation. Serum levels of liver enzymes reduced significantly in three of four included trials. In the only study that examined the effect of N. sativa on insulin resistance parameters, all variables related to this factor were significantly reduced. In two included studies that measured biomarkers of inflammation, the serum levels of tumor necrosis factor α (TNF-α), high-sensitive C-reactive protein (hs-CRP), and interleukin 6 (IL-6) decreased significantly after intaking N. sativa supplements. Conclusion: Although the efficacy of N. sativa on liver enzymes and the grade of hepatic steatosis was reported in some of the included studies, more well-designed clinical trials are needed to determine the definitive effects of N. sativa on NAFLD. The present study provides suggestions that help to design future studies in this field. | ||
| کلیدواژهها | ||
| Nigella Sativa؛ Non-alcoholic fatty liver disease؛ Clinical trials؛ Systematic review | ||
| مراجع | ||
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Abbasnezhad A, Hayatdavoudi P, Niazmand S, Mahmoudabady M. 2015. The effects of hydroalcoholic extract of Nigella sativa seed on oxidative stress in hippocampus of STZ-induced diabetic rats. Avicenna J Phytomed, 5: 333-340. Al-Naqeeb G, Ismail M. 2009. Regulation of apolipoprotein A-1 and apolipoprotein B100 genes by thymoquinone rich fraction and thymoquinone in HEPG2 cells. J Food Lipids, 16: 245-258. Amizadeh S, Rashtchizadeh N, Khabbazi A, Ghorbanihaghjo A, Ebrahimi AA, Vatankhah AM, Malek Mahdavi A, Taghizadeh M. 2020. Effect of Nigella sativa oil extracts on inflammatory and oxidative stress markers in Behcet's disease: A randomized, double-blind, placebo-controlled clinical trial. Avicenna J Phytomed, 10: 181-189. Argo CK, Northup PG, Al-Osaimi AM, Caldwell SH. 2009. Systematic review of risk factors for fibrosis progression in non-alcoholic steatohepatitis. J Hepatol, 51: 371-379. Asgharzadeh F, Bargi R, Beheshti F, Hosseini M, Farzadnia M, Khazaei M. 2017. Thymoquinone restores liver fibrosis and improves oxidative stress status in a lipopolysaccharide-induced inflammation model in rats. Avicenna J Phytomed, 7: 502-510. Bai T, Yang Y, Wu YL, Jiang S, Lee JJ, Lian LH, Nan JX. 2014. Thymoquinone alleviates thioacetamide-induced hepatic fibrosis and inflammation by activating LKB1-AMPK signaling pathway in mice. Int Immunopharmacol, 19: 351-357. Balbaa M, Abdulmalek SA, Khalil S. 2017. Oxidative stress and expression of insulin signaling proteins in the brain of diabetic rats: Role of Nigella sativa oil and antidiabetic drugs. PLoS One, 12: e0172429. Ben El Mostafa S, Abdellatif M. 2020. Herbal Medicine in Chronic Diseases Treatment: Determinants, Benefits and Risks. pp. 85- 95. Benhaddou-Andaloussi A, Martineau L, Vuong T, Meddah B, Madiraju P, Settaf A, Haddad PS. 2011. The in vivo antidiabetic activity of Nigella sativa is mediated through activation of the AMPK pathway and increased muscle Glut4 Content. Evid Based Complement Alternat Med, 2011: 538671. Biddinger SB, Hernandez-Ono A, RaskMadsen C, Haas JT, Aleman JO, Suzuki R, Scapa EF, Agarwal C, Carey MC, Stephanopoulos G, Cohen DE, King GL, Ginsberg HN, Kahn CR. 2008. Hepatic insulin resistance is sufficient to produce dyslipidemia and susceptibility to atherosclerosis. Cell Metab, 7: 125-134. Mohtashamian et al. AJP, Vol. 13, No. 1, Jan-Feb 2023 30 Brufau G, Canela MA, Rafecas M. 2008. Phytosterols: physiologic and metabolic aspects related to cholesterol-lowering properties. Nutr Res, 28: 217-225. Catena C, Bernardi S, Sabato N, Grillo A, Ermani M, Sechi LA, Fabris B, Carretta R, Fallo F. 2013. Ambulatory arterial stiffness indices and non-alcoholic fatty liver disease in essential hypertension. Nutr Metab Cardiovasc Dis, 23: 389-393. Chartampilas E. 2018. Imaging of nonalcoholic fatty liver disease and its clinical utility. Hormones (Athens), 17: 69-81. Chen Z, Wang L, Yang G, Xu H, Liu J. 2015. Chinese herbal medicine combined with conventional therapy for blood pressure variability in hypertension patients: a systematic review of randomized controlled trials. Evid Based Complement Alternat Med, 2015: 582751. Cicero AF, De Sando V, Izzo R, Vasta A, Trimarco A, Borghi C. 2012. Effect of a combined nutraceutical containing Orthosiphon stamineus effect on blood pressure and metabolic syndrome components in hypertensive dyslipidaemic patients: a randomized clinical trial. Complement Ther Clin Pract, 18: 190-194. Cicero AFG, Colletti A, Bellentani S. 2018. Nutraceutical approach to non-alcoholic fatty liver disease (NAFLD): The available clinical evidence. Nutrients, 10: 1153. Darakhshan S, Bidmeshki Pour A, Hosseinzadeh Colagar A, Sisakhtnezhad S. 2015. Thymoquinone and its therapeutic potentials. Pharmacol Res, 95- 96: 138-158. Darand M, Darabi Z, Yari Z, Hedayati M, Shahrbaf MA, Khoncheh A, HosseiniAhangar B, Alavian SM, Hekmatdoost A. 2019a. The effects of black seed supplementation on cardiovascular risk factors in patients with nonalcoholic fatty liver disease: A randomized, doubleblind, placebo-controlled clinical trial. Phytother Res, 33: 2369-2377. Darand M, Darabi Z, Yari Z, Saadati S, Hedayati M, Khoncheh A, HosseiniAhangar B, Alavian SM, Hekmatdoost A. 2019b. Nigella sativa and inflammatory biomarkers in patients with non-alcoholic fatty liver disease: Results from a randomized, double-blind, placebocontrolled, clinical trial. Complement Ther Med, 44: 204-209. Dowman JK, Tomlinson JW, Newsome PN. 2011. Systematic review: the diagnosis and staging of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Aliment Pharmacol Ther, 33: 525-540. Fallo F, Dalla Pozza A, Sonino N, Federspil G, Ermani M, Baroselli S, Catena C, Soardo G, Carretta R, Belgrado D, Fabris B, Sechi LA. 2008. Nonalcoholic fatty liver disease, adiponectin and insulin resistance in dipper and nondipper essential hypertensive patients. J Hypertens, 26: 2191-2197. Gandhi CR. 2017. Hepatic stellate cell activation and pro-fibrogenic signals. J Hepatol, 67: 1104-1105. Goyal SN, Prajapati CP, Gore PR, Patil CR, Mahajan UB, Sharma C, Talla SP, Ojha S K. 2017. Therapeutic potential and pharmaceutical development of thymoquinone: A multitargeted molecule of natural origin. Front Pharmacol, 8: 656. Hadi V, Kheirouri S, Alizadeh M, Khabbazi A, Hosseini H. 2016. Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial. Avicenna J Phytomed, 6: 34-43. Hamaguchi M, Kojima T, Takeda N, Nakagawa T, Taniguchi H, Fujii K, Omatsu T, Nakajima T, Sarui H, Shimazaki M, Kato T, Okuda J, Ida K. 2005. The metabolic syndrome as a predictor of nonalcoholic fatty liver disease. Ann Intern Med, 143: 722-728. Hasani-Ranjbar S, Nayebi N, Larijani B, Abdollahi M. 2009. A systematic review of the efficacy and safety of herbal medicines used in the treatment of obesity. World J Gastroenterol: WJG, 15: 3073-3085. Hasani-Ranjbar S, Nayebi N, Moradi L, Mehri A, Larijani B, Abdollahi M. 2010. The efficacy and safety of herbal medicines used in the treatment of hyperlipidemia; a systematic review. Curr Pharm Des, 16: 2935-2947. Hashempur MH, Heydari M, Mosavat S H, Heydari ST, Shams M. 2015. Complementary and alternative medicine Nigella Sativa supplementation and NAFLD AJP, Vol. 13, No. 1, Jan-Feb 2023 31 use in Iranian patients with diabetes mellitus. J Integr Med, 13: 319-325. Higgins JP, Thompson SG, Deeks JJ, Altman DG. 2003. Measuring inconsistency in meta-analyses. Bmj, 327: 557-560. Hosseini B, Saedisomeolia A, Wood LG, Yaseri M, Tavasoli S. 2016. Effects of pomegranate extract supplementation on inflammation in overweight and obese individuals: A randomized controlled clinical trial. Complement Ther Clin Pract, 22: 44-50. Hosseini S, Razmgah G, Nematy M, Esmaily H, Yousefi M, Kamalinejad M, Mosavat SH. 2018. Efficacy of black seed (Nigella sativa) and lemon balm (Melissa officinalis) on non-alcoholic fatty liver disease: A randomized controlled clinical trial. Iran Red Crescent Med J, 20: e59183. Hosseinian S, Hadjzadeh MA, Roshan NM, Khazaei M, Shahraki S, Mohebbati R, Rad AK. 2018. Renoprotective effect of Nigella sativa against cisplatin-induced nephrotoxicity and oxidative stress in rat. Saudi J Kidney Dis Transpl, 29: 19-29. Hrebicek J, Janout V, Malincikova J, Horakova D, Cizek L. 2002. Detection of insulin resistance by simple quantitative insulin sensitivity check index QUICKI for epidemiological assessment and prevention. J Clin Endocrinol Metab, 87: 144-147. Hussain M, Tunio AG, Akhtar L, Shaikh GS. 2017. Effects of nigella sativa on various parameters in Patients of non-alcoholic fatty liver disease. J Ayub Med Coll Abbottabad, 29: 403-407. Katsiki N, Mikhailidis DP, Mantzoros CS. 2016. Non-alcoholic fatty liver disease and dyslipidemia: An update. Metabolism, 65: 1109-1123. Keating SE, Hackett DA, George J, Johnson N A. 2012. Exercise and non-alcoholic fatty liver disease: a systematic review and meta-analysis. J Hepatol, 57: 157-166. Khaldi T, Chekchaki N, Boumendjel M, Taibi F, Abdellaoui M, Messarah M, Boumendjel A. 2018. Ameliorating effects of Nigella sativa oil on aggravation of inflammation, oxidative stress and cytotoxicity induced by smokeless tobacco extract in an allergic asthma model in Wistar rats. Allergol Immunopathol (Madr), 46: 472-481. Khonche A, Huseini H F, Gholamian M, Mohtashami R, Nabati F, Kianbakht S. 2019. Standardized Nigella sativa seed oil ameliorates hepatic steatosis, aminotransferase and lipid levels in nonalcoholic fatty liver disease: A randomized, double-blind and placebocontrolled clinical trial. J Ethnopharmacol, 234: 106-111. Lindenmeyer CC, McCullough AJ. 2018. The natural history of nonalcoholic fatty liver disease-an evolving view. Clin Liver Dis, 22: 11-21. Lomonaco R, Ortiz-Lopez C, Orsak B, Webb A, Hardies J, Darland C, Finch J, Gastaldelli A, Harrison S, Tio F, Cusi K. 2012. Effect of adipose tissue insulin resistance on metabolic parameters and liver histology in obese patients with nonalcoholic fatty liver disease. Hepatology, 55: 1389-1397. Lopez-Suarez A, Guerrero JM, ElviraGonzalez J, Beltran-Robles M, CanasHormigo F, Bascunana-Quirell A. 2011. Nonalcoholic fatty liver disease is associated with blood pressure in hypertensive and nonhypertensive individuals from the general population with normal levels of alanine aminotransferase. Eur J Gastroenterol Hepatol, 23: 1011-1017. Lupidi G, Camaioni E, Khalifé H, Avenali L, Damiani E, Tanfani F, Scirè A. 2012. Characterization of thymoquinone binding to human α₁-acid glycoprotein. J Pharm Sci, 101: 2564-2573. Mariod AA, Ibrahim RM, Ismail M, Ismail N. 2009. Antioxidant activity and phenolic content of phenolic rich fractions obtained from black cumin (Nigella sativa) seedcake. Food Chemistry, 116: 306-312. Mokhtari Z, Gibson DL, Hekmatdoost A. 2017. Nonalcoholic fatty liver disease, the gut microbiome, and diet. Adv Nutr, 8: 240-252. Moschen AR, Wieser V, Tilg H. 2012. Adiponectin: Key player in the adipose tissue-liver crosstalk. Curr Med Chem, 19: 5467-5473. Mummadi RR, Kasturi KS, Chennareddygari S, Sood GK. 2008. Effect of bariatric surgery on nonalcoholic fatty liver disease: systematic review and metaanalysis. Clin Gastroenterol Hepatol, 6: 1396-1402. Mohtashamian et al. AJP, Vol. 13, No. 1, Jan-Feb 2023 32 Muneera KE, Majeed A, Naveed AK. 2015. Comparative evaluation of Nigella sativa (Kalonji) and simvastatin for the treatment of hyperlipidemia and in the induction of hepatotoxicity. Pak J Pharm Sci, 28: 493-498. Pagano G, Pacini G, Musso G, Gambino R, Mecca F, Depetris N, Cassader M, David E, Cavallo-Perin P, Rizzetto M. 2002. Nonalcoholic steatohepatitis, insulin resistance, and metabolic syndrome: further evidence for an etiologic association. Hepatology, 35: 367-372. Promrat K, Kleiner DE, Niemeier HM, Jackvony E, Kearns M, Wands JR, Fava J L, Wing RR. 2010. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Hepatology, 51: 121-129. Rashidmayvan M, Mohammadshahi M, Seyedian SS, Haghighizadeh MH. 2019. The effect of Nigella sativa oil on serum levels of inflammatory markers, liver enzymes, lipid profile, insulin and fasting blood sugar in patients with non-alcoholic fatty liver. J Diabetes Metab Disord, 18: 453-459. Sahebkar A, Soranna D, Liu X, Thomopoulos C, Simental-Mendia LE, Derosa G, Maffioli P, Parati G. 2016. A systematic review and meta-analysis of randomized controlled trials investigating the effects of supplementation with Nigella sativa (black seed) on blood pressure. J Hypertens, 34: 2127-2135. Saleh HA, Abu-Rashed AH. 2007. Liver biopsy remains the gold standard for evaluation of chronic hepatitis and fibrosis. J Gastrointestin Liver Dis, 16: 425-426. Salehi B, Quispe C, Imran M, Ul-Haq I, Živković J, Abu-Reidah IM, Sen S, Taheri Y, Acharya K, Azadi H, Del Mar Contreras M, Segura-Carretero A, Mnayer D, Sethi G, Martorell M, Abdull Razis AF, Sunusi U, Kamal RM, Rasul Suleria HA, Sharifi-Rad J. 2021. Nigella plants - traditional uses, bioactive phytoconstituents, preclinical and clinical studies. Front Pharmacol, 12: 625386. Salem ML. 2005. Immunomodulatory and therapeutic properties of the Nigella sativa L. seed. Int Immunopharmacol, 5: 1749-1770. Salgado AL, Carvalho L, Oliveira AC, Santos VN, Vieira JG, Parise ER. 2010. Insulin resistance index (HOMA-IR) in the differentiation of patients with nonalcoholic fatty liver disease and healthy individuals. Arq Gastroenterol, 47: 165- 169. Samani NB, Jokar A, Soveid M, Heydari M, Mosavat SH. 2016. Efficacy of the hydroalcoholic extract of Tribulus terrestris on the serum glucose and lipid profile of women with diabetes mellitus: A double-blind randomized placebocontrolled clinical trial. J Evid Based Complementary Altern Med, 21: Np91-7. Sayed-Ahmed MM, Nagi MN. 2007. Thymoquinone supplementation prevents the development of gentamicin-induced acute renal toxicity in rats. Clin Exp Pharmacol Physiol, 34: 399-405. Sayiner M, Lam B, Golabi P, Younossi ZM. 2018. Advances and challenges in the management of advanced fibrosis in nonalcoholic steatohepatitis. Therap Adv Gastroenterol, 11: 1756284818811508. Sharifi N, Amani R. 2019. Vitamin D supplementation and non-alcoholic fatty liver disease: A critical and systematic review of clinical trials. Crit Rev Food Sci Nutr, 59: 693-703. Sharifi N, Amani R, Hajiani E, Cheraghian B. 2014. Does vitamin D improve liver enzymes, oxidative stress, and inflammatory biomarkers in adults with non-alcoholic fatty liver disease? A randomized clinical trial. Endocrine, 47: 70-80. Sheashea M, Xiao J, Farag MA. 2021. MUFA in metabolic syndrome and associated risk factors: is MUFA the opposite side of the PUFA coin? Food Funct, 12: 12221- 12234. Silva Figueiredo P, Inada AC, Ribeiro Fernandes M, Granja Arakaki D, Freitas KC, Avellaneda Guimaraes RC, Aragao do Nascimento V, Aiko Hiane P. 2018. An overview of novel dietary supplements and food ingredients in patients with metabolic syndrome and non-alcoholic fatty liver disease. Molecules, 23: 877. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Nigella Sativa supplementation and NAFLD AJP, Vol. 13, No. 1, Jan-Feb 2023 33 Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT. 2019. RoB 2: a revised tool for assessing risk of bias in randomised trials. Bmj, 366: l4898. Sui Y, Zhao H, Wong V, Brown N, Li X, Kwan A, Hui H, Ziea E, Chan J. 2012. A systematic review on use of Chinese medicine and acupuncture for treatment of obesity. Obes Rev, 13: 409-430. Tang G, Zhang L, Tao J, Wei Z. 2021. Effect of Nigella sativa in the treatment of nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials. Phytother Res, 35: 4183-4193. Yeh GY, Eisenberg DM, Kaptchuk TJ, Phillips RS. 2003. Systematic review of herbs and dietary supplements for glycemic control in diabetes. Diabetes care, 26: 1277-1294. Younossi ZM, Marchesini G, Pinto-Cortez H, Petta S. 2019. Epidemiology of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis: Implications for liver transplantation. Transplantation, 103: 22-27. | ||
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