The effectiveness of Nigella sativa, methotrexate and their combination in the treatment of moderate to severe psoriasis

Yıl 2014, , 521 - 528, 01.12.2014

Jawad Hassan Ahmed Sheima Nadim Kadhim Khalil İsmael Al-hamdi

https://doi.org/10.5799/ahinjs.01.2014.04.0450

Cited By: 3

Öz

Objective: Methotrexate (MTX) is a commonly prescribed drug for patients with psoriasis. Nigella sativa (NS) has been shown beneficial in vitiligo and in eczema. Recently, NS has shown activity in modifying psoriatic lesions. The aim of this study was to evaluate the effect of the combination (NS+MTX) on psoriasis and to compare that with NS or MTX monotherapy. Methods: Sixty patients with moderate to severe plaque, palmoplantar and guttate psoriasis were enrolled for 12 weeks study. The patients were divided into 3 groups; 20 patients in each. Group 1 was treated with NS ointment (20% w/w) 2 times daily + 500 mg NS capsule 3 times daily. Group 2 received MTX tablets 15 mg weekly and group 3 received MTX + NS (topical + oral). Results: Marked response was achieved in 60%, 80%, and 90% of patients on NS, MTX, and (NS + MTX) respectively. The respective relapse rate was 33.3%, 56.3%, and 27.8%. Serum malondialdehyde (sMDA), a parameter of oxidative stress was decreased from 4.39 ± 0.81 to 2.31 ± 0.72 µmol/L with NS treatment while a small increase in sMDA was observed with MTX. NS + MTX treatment reduced sMDA from 4.39 ± 0.67 to 3.49 ± 0.65 µmol/L after 12 weeks treatment. All treatments did not change liver enzymes or complete blood count. NS was well tolerated and showed ability in ameliorating gastric upset of MTX. Conclusion: NS augments antipsoriatic effect of MTX. Topical and oral use of NS is effective and safe in moderate to severe psoriasis. J Clin Exp Invest 2014; 5 (4): 521-528

Anahtar Kelimeler

Psoriasis, methotrexate, Nigella sativa

Orta ve ağır psoriazis tedavisinde Nigella sativa, metotreksat ve ikisinin kombinasyonlarının etkinliği

Öz

Amaç: Metotreksat (MTX) psöriazisli hastalarda sıklıkla kullanılan bir ilaçtır. Nigella sativa (NS - çörek otu)\'nun vitiligo ve egzemada yaralı olduğu gösterilmiştir. Yakın zamanda NS\'nin psöriatik lezyonları modifiye etmede etkin olduğu gösterildi. Bu çalışmanın amacı psöriazisde MTX+NS kombinasyonunun etkisini değerlendirmek ve bu etkinin NS ve MTX\'in tek başına olan etkinliği ile karşılaştırmaktır. Yöntemler: Orta-ağır plak, palmoplantar ve guttat psöriazisli 60 hasta 12 haftalık çalışmaya alındı. Hastalar her grupta 20\'şer hasta olacak şekilde 3 gruba ayrıldı. Grup 1\'e günde 2 kez uygulanan NS merhemi (%20\'lik)\'ne ilaveten günde 3 kez 500 mg NS kapsülleri verildi. Grup 2 haftada bir 15 mg MTX tableti aldı ve Grup 3\'e MTX+NS (Topikal ve oral) verildi. Bulgular: NS, MTX ve NS+MTX gruplarında sırasıyla %60, %80 ve %90 cevap alındı. NS tedavisi ile oksidatif stres belirteci olan serum malondialdehid (sMDA) 4,39 ± 0,81 µmol/L\'den 2,31 ± 0,72 µmol/L\'ye düştü, ancak MTX ile sMDA\'da hafif artış gözlendi. 12 haftalık MTX ve NS+MTX tedavilerini takiben sMDA 4.39 ± 0.67 µmol/L\'den 3.49 ± 0.65 µmol/L\'ye indi. Tedavilerin tümünde karaciğer enzimleri ve tam kan sayımlarında bir değişiklik gözlenmedi. NS iyi tolere edildi ve MTX\'in yaptığı mide rahatsızlığını iyileştirici etkisi gözlendi. Sonuç: NS, MTX\'in anti-psöriatik etkisini kuvvetlendirdi. Topikal ve oral NS kullanımı orta ve ağır psöriazisde etkin ve güvenlidir.

Anahtar Kelimeler

Psöriazis, metotreksat, Nigella sativa

Kaynakça

• James W D, Berger TG, Elston DM. Seborrheic Derma- titis, Psoriasis, Recalcitran Palmoplantar Eruptions, Pustular Dermatitis and Erythroderma. In Andrew̕s the clinical dermatology of the skin disease. 11th ed. Saunders Elsevier 2011; 188-202.
• Kurd SK, Gelfand JM. The prevalence of previously di- agnosed and undiagnosed psoriasis in US adults: re- sults from NHANES 2003-2004. J Am Acad Dermatol 2009;60:218-224.
• Tristani-Firouzi P, Krueger GG. Efficacy and safety of treatment modalities for psoriasis. Cutis 1998; 61: 11- 21.
• Fowler JF, Duh MS, Rovba L, et al. The impact of pso- riasis on health care costs and patient work loss. J Am Acad Dermatol 2008;59:772-780.
• Ghorbanibirgani A, Khalili A, Rokhafrooz D. Comparing Nigella sativa Oil and Fish Oil in Treatment of Vitiligo. Iran Red Crescent Med J 2014;16:1-5.
• Yousefi M, Barikbin B, Kamalinejad M, et al. Compari- son of therapeutic effect of topical Nigella with Beta- methasone and Eucerin in hand eczema. J Eur Acad Dermatol Venereol 2013;27:1498-1504
• Ahmed JH, Ibraheem AY, Al-Hamdi KI. Evaluation of efficacy, safety and antioxidant effect of Nigella sativa in patients with psoriasis: A randomized clinical trial. J Clin Exp Invest 2014;5:186-193
• Burits M, Bucar F. Antioxidant activity of Nigella sativa essential oil. Phytother Res 2000;14: 23-328.
• Hassan AS, Ahmed JH, Al-Haroon SS. A study of the ef- fect of Nigella sativa (Black seeds) in isoniazid (INH)- induced hepatotoxicity in rabbits. Indian J Pharmacol 2012;44:678-682.
• Röhrig B, du Prel J, Wachtlin D, et al. Sample size calculation in clinical trials. Dtsch Arztebl Int 2010;107:552-556.
• Ozel MZ, Kaymaz H. Superheated water extrac- tion, steam distillation and Soxhlet extraction of es- sential oils of Origanum onites. Anal Bioanal Chem 2004;379:1127-1133.
• Dave’s M.(2003).The Psoriasis Area and severity In- dex: Internet http://www.Dave’sPsoriasisInfo.com
• Carlin CS, Feldman SR , Krueger JG, et al. A 50% re- duction in the Psoriasis area and Severity Index (PASI 50) is a clinical significant endpoint in the assessment of Psoriasis. J Am Acad Dermatol 2004;50:859- 866.
• Bueg JA, Aust SD. Microsomal lipid peroxidation. Method Enzymol 1978;52:302-310.
• Janagond, AB , Kanwar AJ, Handa S. Efficacy and safety of systemic methotrexate vs. acitretin in psoria- sis patients with significant palmoplantar involvement: a prospective, randomized study. J Eur Acad Derma- tol Venereol 2013;27:384-389.
• Abel-Salam BK. Immunomodulatory effects of black seeds and garlic on alloxan-induced Diabetes in al- bino rat. Allergol Immunopathol (Madr) 2012;40:336- 340.
• Yi T, Cho SG, Yi Z, et al. Thymoquinone inhibits tumor angiogenesis and tumor growth through suppressing AKT and extracellular signal-regulated kinase signal- ing pathways. Mol Cancer Ther 2008;7:1789-1796.
• Peng L, Liu A, Shen Y, et al. Antitumor and anti-an- giogenesis effects of thymoquinone on osteosarcoma through the NF-κB pathway. Oncol Rep 2013;29:571- 578.
• Li F, Rajendran P, Sethi G. Thymoquinone inhibits proliferation, induces apoptosis and chemosensitizes human multiple myeloma cells through suppression of signal transducer and activator of transcription 3 ac- tivation pathway. Br J Pharmacol 2010;161:541-554.
• Tripathi YB, Chaturvedi AP, Pandey N. Effect of Nige- lla sativa seeds extracts on iNOS through antioxidant potential only: crude/total extract as molecular thera- py drug. Indian J Exp Biol 2012;50:413-418.
• Woo CC, Kumar AP, Sethi G, Tan KH. Thymoquinone: potential cure for inflammatory disorders and cancer. Biochem Pharmacol 2012;83:443-451.
• Hannan A, Saleem S, Chaudhary S, Antibacterial ac- tivity of Nigella sativa against clinical isolates of meth- icillin resistant Staphylococcus aureus. J Ayub Med Coll Abbottabad 2008;20:2-74.
• 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.
• Ahmed JH, Abd SR, Al-hamdi KI. Effectiveness of oral zinc sulfate, oral methotrexate and their combi- nation in the treatment of psoriasis. J Clin Exp Invest 2010;1:134-149.
• Woźniak A, Drewa G, Krzyzyńska-Maliniowska E, et al. Oxidant-antioxidant balance in patients with pso- riasis. Med Sci Monit 2007;13:30-33.
• Ramadan R, Tawdy A, Abdel Hay R, The antioxidant role of paraoxonase 1 and vitamin E in three autoim- mune diseases. Skin Pharmacol Physiol 2013;26:2-7.
• Ayromlou H, Hajipour B, Hossenian MM, et al. Oxi- dative effect of methotrexate administration in spinal cord of rabbits. J Pak Med Assoc 2011;61:1096-1099.
• Oktem F, Yilmaz HR, Ozguner F, et al. Methotrexate- induced renal oxidative stress in rats: the role of a novel antioxidant caffeic acid phenethyl ester. Toxicol Ind Health 2006;22:241-247.
• Puig L. Methotrexate: New Therapeutic Approaches. Actas Dermosifiliogr 2014;105:583-589
• Mansour MA, Ginawi OT, El-Hadiyah T, et al. Effects of volatile oil constituents of Nigella sativa on carbon tetrachloride-induced hepatotoxicity in mice: evidence for antioxidant effects of thymoquinone. Res Commun Mol Pathol Pharmacol 2001;110:239-251.
• Nosbaum A, Ben Said B, Halpern SJ, et al. Systemic allergic contact dermatitis to black cumin essential oil expressing as generalized erythema multiforme. Eur J Dermatol 2011;21:447-448.
• 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.