Evaluation of efficacy, safety and antioxidant effect of Nigella sativa in patients with psoriasis: A randomized clinical trial

Abstract

Objective: Various drugs are used for treatment of psoriasis such as retinoids, hydroxyurea, methotrexate, and infliximab with variable benefits, but these drugs are associated with side effects. The aim of this study was to evaluate efficacy, safety of topical and oral doses of Nigella sativa (NS) in psoriatic patients. Methods: sixty patients with mild to moderate plaque and palmoplanter psoriasis were recruited for the study from January 2010 to March 2011. The patients were randomly divided into three groups: Twenty patients (group 1) were treated with (10% w/w) ointment of (NS), group 2 (20 patients) treated with crude powder of (NS), 500mg capsule t.d.s; group 3 (20 patients) were treated with the combination of ointment and capsule of (NS).PASI score was used for clinical evaluation of effect, and serum malondialdehyde (MDA) as an indicator of oxidative status. Results: (NS) ointment achieved complete cure of psoriatic lesions, excellent and good response in 65% of patients, with a relapse rate of 31% four weeks after cessation of treatment. Oral doses of (NS) produced good response in 50% of patients, with a relapse rate of 50% noticed four weeks after treatment cessation. The combination of (NS) ointment and oral doses achieved complete cure of lesions, excellent and good responses in 85% of patients, with a relapse rate of 18%. (NS) was well tolerated, no side effects were observed. Conclusion: (NS) has anti psoriatic effect with the best effect obtained with the combination of ointment and the oral dosage form of (NS). J Clin Exp Invest 2014; 5 (2): 186-193

Keywords

• Nigella sativa, Plague psoriasis, antioxidant, efficacy

Psöriazisli hastalarda çörek otunun etkinlik, güvenirlik ve antioksidan etkileri: Randomize bir klinik çalışma

Öz

Amaç: Psöriazis tedavisinde retinoidler, hidroksiüre, metotreksat ve infliksimab gibi pek çok ilaç farklı etkinlikleriyle kullanılmıştır. Ancak bu ilaçların yan etkileri vardır. Bu çalışmanın amacı, pöriatik hastalarda çörek otunun topikal ve oral dozlarının etkinlik ve güvenirliğini değerlendirmektir. Yöntemler: Hafif ve orta plaklı ve palmoplantar psöriazisli 60 hasta Ocak 2010 ile Mart 2011 arasında çalışmaya alındı. Hastalar rastgele üç gruba ayrıldı: 20 hasta (Grup 1) %10\'luk çörek otu merhemi ile, Grup 2\'deki 20 hasta çörek otunun 500 mg\'lık kuru tozunu içeren kapsüller ile günde 3 defa tedavi edildi. Grup 3\'teki 20 hasta ise hem çörek otu merhemi, hem de kapsülleri ile tedavi edildi. PASı skoru etkinliğin değerlendirilmesi ve serum malondialdehid düzeyi oksidatif durum belirteci olarak kullanıldı. Bulgular: Çörek otu merhemi ile psöriyatik lezyonlarda %65 oranında tam düzelme veya mükemmel ve iyi cevap alındı. Oral çörek otu hastaların %50\'sinde iyi cevap verdi, ancak tedavi kesilmesinden 4 hafta sonra %50 oranında rölaps gözlendi. Merhem ve oral çörek otu kombinasyonu ile vakaların %85\'inde mükemmel ve iyi cevap alındı ve kombinasyon tedavisi sonrası %18 rölaps oldu. Çörek otu iyi tolere edildi ve herhangi bir yan etki gözlenmedi. Sonuçlar: Çörek otu antipsöriatik etkilre sahiptir ve bu etkiler en iyi merhem ve oral formlarının kombine verilmesi ile elde edilir.

Anahtar Kelimeler

• Çörek otu, psöriazis plakları, antioksidan etki, etkinlik

References

1. Griffiths CE, Barker JN. Pathogenesis and clinical fea- tures of psoriasis. Lancet 2007; 370:263-271.
2. Hunter JAA, Saven JA and Dahi MV. Psoriasis in Clinical dermatology-3rd Ed; Blackwell science Ltd 2002;5:40-51.
3. Mommers JM, van Erp PEJ, van de Kerkhof PCM. Clobetasol under Hydrocolloid Occlusion in Psoriasis Results in a Complete Block of Proliferation and in a Rebound of Lesions following Discontinuation. Der- matology 1999;199:323-327.
4. British Association of Dermatologists. Guidelines for management of patients with psoriasis. Workshop of the Reısearch Unit of the Royal College of Physicians of London; Department of Dermatology, University of Glasgow. BMJ 1991;303:829-835.
5. Reich K, Nestle FO, Papp K, et al. Infliximab induc- tion and maintenance therapy for moderate to severe psoriasis: A phase III, multicentre , double -blind trial. Lancet 2005;366:1367-1374.
6. Ahmed JH, Abd SR, Al-Hamdi KI. Effectiveness of oral zinc sulfate, oral methotrexate and their combi- nation in the treatment of psoriasis. J ClinExp Invest 2010;1:134-149.
7. Kalus U, Pruss A, Bystron J, et al. Effect of Nigella sa- tiva (black seed) on subjective feeling in patients with allergic diseases. Phytother Res 2003;17:1209-1214.
8. Sharquie KE, Al-Nuaimy AA, JaburSS. Topical 10% Black Seed (Nigella sativa) Ointment: A new rem- edy for atopic dermatitis. JSSDDS 2006; available in: http://www.jssdds.org/index.php?option=com_medi&t ask=viewfulltext&rowid=31&Itemid=99999999

9. Hanafy MS, Hatem ME. Studies on the antimicrobial activity of Nigella sativa seed (black cumin). J Ethno- pharmacol 1991;34:275-278.
10. Haq A, Lobo PI, Al-Tufail M, et al. Immunomodula- tory effect of Nigella sativa proteins fractionated by ion exchanged chromatography. Int J Immunopharmacol 1992;21:283-295.
11. Haq A, Abdulatif M, Lobo PI, et al. Nigella sativa: ef- fect on human lymphocytes and polymorphonuclear leukocyte phagocytic activity. Immunopharmacology 1995;30:147-155.
12. Kanter M, Coskun O, Uysal H. The antioxidative and antihistaminic effect of Nigella sativa and its major constituent, thymoquinone on ethanol-induced gastric mucosal damage. Arch Toxicol 2006;80:217-224.
13. Chakravatry N. inhibition of histamine release from mast cells by nigellone. Ann Allergy 1993;70:237-242.
14. Shoieb AM, Elgayyar M, Dudrick PS, et al. In vitro in- hibition of growth and induction of apoptosis in cancer cell lines by thymoquinone. Int J Oncol 2003;22:107- 113.
15. Gurung RL, Lim SN, Khaw AK, et al. Thymoquinone Induces Telomere Shortening, DNA Damage and Apoptosis in Human Glioblastoma Cells. PLoSONE 2010;5:e12124.
16. Röhrig B, du Prel J, Wachtlin D, et al. Sample size calculation in clinical trials. Dtsch Arztebl Int 2010;107:552-556.
17. Dave’s M. The Psoriasis Area and severity Index: Inter- net 2003, available in http://www.Dave’sPsoriasisInfo. com.
18. Carlin CS, Feldman SR , Krueger JG, et al. A 50% reduction in the Psoriasis area and Severity Index (PASI) is a clinical significant end Point in the assess- ment of Psoriasis. J Am Acad Dermatol 2004;50:859- 866.
19. Bueg JA, Aust SD. Microsomal lipid peroxidation. Method Enzymol 1978;52:302-310.
20. Zaoui A, Cherrah Y, Mahassini N, et al. Acute and chronic toxicity of Nigella sativa fixed oil. Phytomedi- cine 2002;9:69-74.
21. Vahdati-Mashhadian N, Rakhshandeh H, OmidiA. An investigation on LD50 and subacute hepatic toxicity of Nigella sativa seed extracts in mice. Pharmazie 2005;60:544-547.
22. Zedlitz S, Kaufmann R, Boehncke WH. Allergic con- tact dermatitis from black cumin (Nigella sativa) oil- containing ointment. Contact Dermatitis 2002;46:188.
23. Gelot P, Bara-Passot C, Gimenez-Arnau E, et al. Bul- lous drug eruption with Nigella sativa oil. Ann Derma- tolVenereol. 2012;139:287-291.
24. Yi T, Cho SG, Yi Z, et al. Thymoquinone inhibits tumour angiogenesis and tumour growths through suppress- ing AKT and extracellular signal- regulated kinase sig- naling pathways. Mol Cancer Ther 2008;71:789-796.
25. Banerijee S, Padhye S, Azmi A, et al. Review on mo- lecular and therapeutic potential of thymoquinone in cancer. NutrCancer 2010;62:938-946.
26. Li F, Rajendran P, Sethi G. Thymoquinone inhibits proliferation, induces apoptosis and chemosensitizes human multiple myeloma cells through suppression of signal transducerand activator of transcription 3acti- vation pathway. Br J Pharmacol 2010;161:541-554.
27. Marsik P, KokoskaL, Landa P, et al. In vitro inhibitory effects of thymol and quinines of Nigella sativa seeds on cyclooxygenase-1- and -2- catalyzed prostaglan- din E2 biosynthesis. PlantaMed 2005;71:739-742.
28. Tekeoglu I, Dogan A, Demiralp L. Effects of thymoqui- none (volatile oil of black cumin) on rheumatoid arthri- tis in rate models. Phytother Res 2006;20:869-871.
29. Namazi MR. The beneficial and detrimental effects of linoleic acid on autoimmune disorders. Autoimmunity 2004;37:73-75.
30. HenselerT, Christophers E. Disease concomitance in psoriasis. J Am Acad Dermatol 1995;32:982-986.
31. Piskin S, Gurkok F, Ekuklu G, Senol M. Serum lipid levels in psoriasis. Yonsei Med J 2003;44:24-26.
32. Wakkee M, Thio HB, Prens EP, et al. Unfavorable cardiovascular risk profiles in un treated and treated psoriasis patients. Atherosclerosis 2007;190:1-9.
33. Dahri AH, Chandiol AM, Rahoo AA, Memon RA. Effect of Nigella sativa (Kalonji) on serum cholesterol of albi- no rats. J Ayub Med Coll Abbottabad. 2005;17:72-74.
34. Dwarampudi LP, Palaniswamy D, Nithyanantham M, Raghu PS. Antipsoriatic activity and cytotoxicity of ethanolic extract of Nigella sativa seeds. Pharmacogn Mag. 2012;8:268-272.