Chinese Journal of Integrative Medicine

, Volume 21, Issue 12, pp 902–906 | Cite as

A randomized, double blinded, placebo-controlled clinical trial of silymarin in ulcerative colitis

  • Mansoor Rastegarpanah
  • Reza Malekzadeh
  • Homayoun Vahedi
  • Maryam Mohammadi
  • Elham Elahi
  • Meghedi Chaharmahali
  • Tahereh Safarnavadeh
  • Mohammad AbdollahiEmail author
Original Artical



To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients.


A randomized double blinded placebo-controlled clinical trial was conducted in 80 UC patients whose disease had been documented and were in remission state between September 2009 and October 2010. Patients were assigned to silymarin group (42 cases) and placebo group (38 cases) using a random number table. Either silymarin (140 mg) or placebo (lactose mono-hydrate, corn starch magnesium stearate) tablets were given once daily for 6 months along with their standard therapy. The efficacies were assessed by disease activity index (DAI), frequency difference of the disease flare-up, and paraclinical data.


Ten patients (4 in the silymarin group due to nausea and 6 in the placebo group due to disease flare-up and abdominal pain) discontinued the study. An improvement in hemoglobin level (11.8±1.6 g/dL vs. 13.4±1.2 g/dL,P<0.05) and erythrocyte sedimentation rate (23.7±11.5 mm/h vs.10.8±3.2 mm/h,P<0.05) was observed in the silymarin group but not in the placebo group. DAI significantly decreased in the silymarin group and reached from 11.3±3.5 to 10.7±2.8 (P<0.05). Thirty-five out of 38 patients in the silymarin group were in complete remission with no flare-up after 6 months as compared to 21 out of 32 patients in the placebo group (P=0.5000).


Silymarin as a natural supplement may be used in UC patients to maintain remission


silymarin ulcerative colitis randomized controlled trial 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    Rezaie A, Parker RD, Abdollahi M. Oxidative stress and pathogenesis of inflammatory bowel disease: an epiphenomenon or the cause? Dig Dis Sci 2007;52:2015–2021.CrossRefPubMedGoogle Scholar
  2. 2.
    Hosseini-Tabatabaei A, Abdollahi M. Potassium channel openers and improvement of toxic stress: do they have role in the management of inflammatory bowel disease? Inflamm Allergy Drug Targets 2008:7:129–135.CrossRefPubMedGoogle Scholar
  3. 3.
    Rahimi R, Nikfar S, Rezaie A, Abdollahi M. A meta-analysis of antibiotic therapy for active ulcerative colitis. Dig Dis Sci 2007;52:2920–2925.CrossRefPubMedGoogle Scholar
  4. 4.
    Rahimi R, Nikfar S, Rezaie A, Abdollahi M. A meta-analysis of broad spectrum antibiotic therapy in patients with active Crohn's disease. Clin Ther 2006;28:1983–1988.CrossRefPubMedGoogle Scholar
  5. 5.
    Elahi B, Nikfar S, Derakhshani S, Vafaie M, Abdollahi M. Benefit of antibiotic therapy on pouchitis after ileal pouch anal anastomosis: a systematic review and meta-analysis of clinical trials. Cent Eur J Med 2009;4:164–170.Google Scholar
  6. 6.
    Nikfar S, Mirfazaelian H, Abdollahi M. Efficacy and tolerability of immunoregulators and antibiotics in fistulizing Crohn's disease: a systematic review and meta-analysis of placebocontrolled trials. Curr Pharm Des 2010;16:3684–3698.CrossRefPubMedGoogle Scholar
  7. 7.
    Nikfar S, Rahimi R, Rezaie A, Abdollahi M. A metaanalysis of the efficacy of sulfasalazine in comparison with 5-aminosalicylates in the induction of improvement and maintenance of remission in patients with ulcerative colitis. Dig Dis Sci 2009;54:1157–1170.CrossRefPubMedGoogle Scholar
  8. 8.
    Rahimi R, Nikfar S, Rezaie A, Abdollahi M. Comparison of mesalazine and balsalazide in induction and maintenance of remission in patients with ulcerative colitis: a metaanalysis. Dig Dis Sci 2009;54:712–721.CrossRefPubMedGoogle Scholar
  9. 9.
    Rahimi R, Nikfar S, Abdollahi M. Meta-analysis technique confirms the effectiveness of anti-TNF-α in the management of active ulcerative colitis when administered in combination with corticosteroids. Med Sci Monit 2007;13(7):P13–P18.Google Scholar
  10. 10.
    Rahimi R, Nikfar S, Abdollahi M. Do anti-tumor necrosis factors induce response and remission in patients with acute refractory Crohn's disease? A systematic metaanalysis of controlled clinical trials. Biomed Pharmacother 2007;61:75–80.CrossRefPubMedGoogle Scholar
  11. 11.
    Rahimi R, Nikfar S, Rahimi F, Elahi B, Derakhshani S, Vafaie M, et al. A meta-analysis on the efficacy of probiotics for maintenance of remission and prevention of clinical and endoscopic relapse in Crohn's disease. Dig Dis Sci 2008;53:2524–2531.CrossRefPubMedGoogle Scholar
  12. 12.
    Elahi B, Nikfar S, Derakhshani S, Vafaie M, Abdollahi M. On the benefit of probiotics in the management of pouchitis in patients underwent ileal pouch anal anastomosis: a meta-analysis of controlled clinical trials. Dig Dis Sci 2007;53:1278–1284.CrossRefPubMedGoogle Scholar
  13. 13.
    Rahimi R, Nikfar S, Rezaie A, Abdollahi M. A meta-analysis of the benefit of probiotics in maintaining remission of human ulcerative colitis: evidence for prevention of disease relapse and maintenance of remission. Arch Med Sci 2008;4:185–190.Google Scholar
  14. 14.
    Nikfar S, Darvish-Damavandi M, Abdollahi M. A review and meta-analysis of the efficacy of antibiotics and probiotics in management of pouchitis. Int J Pharmacol 2010;6:826–835.CrossRefGoogle Scholar
  15. 15.
    Nikfar S, Ehteshami-Afshar S, Rahimi R, Abdollahi M. Systematic review and meta-analysis of the efficacy and tolerability of nicotine preparations in active ulcerative colitis. Clin Ther 2010;32:2304–2315.CrossRefPubMedGoogle Scholar
  16. 16.
    Salari P, Abdollahi M. Current opinion in the pharmaceutical management of irritable and inflammatory bowel diseases: role of ATP. Rec Pat Endoc Metab Immun Drug Disc 2009;3:69–75.CrossRefGoogle Scholar
  17. 17.
    Salari-Sharif P, Abdollahi M. Phosphodiesterase 4 inhibitors in inflammatory bowel disease: a comprehensive review. Curr Pharm Des 2010;16:3661–3667.CrossRefPubMedGoogle Scholar
  18. 18.
    Rahimi R, Nikfar S, Rezaie A, Abdollahi M. Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a metaanalysis. Rep Toxicol 2008;25:271–275.CrossRefGoogle Scholar
  19. 19.
    Rahimi R, Mozaffari S, Abdollahi M. On the use of herbal medicines in management of inflammatory bowel diseases: a systematic review of animal and human studies. Dig Dis Sci 2009;54:471–480.CrossRefPubMedGoogle Scholar
  20. 20.
    Rahimi R, Shams-Ardekani MR, Abdollahi M. A review of the efficacy of traditional Iranian medicine for inflammatory bowel disease. World J Gastroenterol 2010;16:4504–4514.PubMedCentralCrossRefPubMedGoogle Scholar
  21. 21.
    Esmaily H, Hosseini-Tabatabaei A, Rahimian R, Khorasani R, Baeeri M, Barazesh-Morgani A, et al. On the benefits of silymarin in murine colitis by improving balance of destructive cytokines and reduction of toxic stress in the bowel cells. Cent Eur J Biol 2009;4:204–213.Google Scholar
  22. 22.
    Miroliaee AE, Esmaily H, Vaziri-Bami A, Baeeri M, Shahverdi AR, Abdollahi M. Amelioration of experimental colitis by a novel nanoselenium-silymarin mixture. Toxicol Mech Methods 2011;21:200–208.CrossRefPubMedGoogle Scholar
  23. 23.
    Esmaily H, Vaziri-Bami A, Miroliaee AE, Baeeri M, Abdollahi M. The correlation between NF-κB inhibition and disease activity by coadministration of silibinin and ursodeoxycholic acid in experimental colitis. Fundam Clin Pharmacol 2011;25:723–733.CrossRefPubMedGoogle Scholar
  24. 24.
    Rezaie A, Ghorbani F, Eshghtork A, Zamani MJ, Dehghan G, Taghavi B, et al. Alterations in salivary antioxidants, nitric oxide, and transforming growth factor-β1 in relation to disease activity in Crohn's disease patients. Ann N Y Acad Sci 2006;1091:110–122.CrossRefPubMedGoogle Scholar
  25. 25.
    Rezaie A, Khalaj S, Shabihkhani M, Nikfar S, Zamani MJ, Mohammadirad A, et al. Study on the correlations among disease activity index and salivary transforming growth factor-β1 and nitric oxide in ulcerative colitis patients. Ann N Y Acad Sci 2007;1095:305–314.CrossRefPubMedGoogle Scholar
  26. 26.
    Jahanshahi G, Motavasel V, Rezaie A, Hashtroudi AA, Daryani NE, Abdollahi M. Alterations in antioxidant power and levels of epidermal growth factor and nitric oxide in saliva of patients with inflammatory bowel diseases. Dig Dis Sci 2004;49:1752–1757.CrossRefPubMedGoogle Scholar
  27. 27.
    Hasani-Ranjbar S, Larijani B, Abdollahi M. A systematic review of the potential herbal sources of future drugs effective in oxidant-related diseases. Inflamm Allergy Drug Targets 2009;8:2–10.CrossRefPubMedGoogle Scholar
  28. 28.
    Nakhai LA, Mohammadirad A, Yasa N, Minaie B, Nikfar N, Ghazanfari G, et al. Benefits of Zataria multiflora boiss in experimental model of mouse inflammatory bowel disease. Evid Base Complement Altern Med 2007;4:43–50.CrossRefGoogle Scholar
  29. 29.
    Ghafari H, Yasa N, Mohammadirad A, Dehghan G, Zamani MJ, Nikfar S, et al. Protection by Ziziphora clinopoides of acetic acid-induced toxic bowel inflammation through reduction of cellular lipid peroxidation and myeloperoxidase activity. Hum Exp Toxicol 2006;25:325–332.CrossRefPubMedGoogle Scholar
  30. 30.
    Amini-Shirazi N, Hoseini A, Ranjbar A, Mohammadirad A, Khoshakhlagh P, Yasa N, et al. Inhibition of tumor necrosis factor and nitrosative/oxidative stresses by Ziziphora clinopoides (Kahlioti), a molecular mechanism of protection against dextran sodium sulfate-induced colitis in mice. Toxicol Mech Methods 2009;19:183–189.CrossRefPubMedGoogle Scholar
  31. 31.
    Ghazanfari G, Minaie B, Yasa N, Ashtaral-Nakhai L, Mohammadirad A, Nikfar S, et al. Biochemical and histopathological evidences for beneficial effects of Satureja khuzestanica jamzad essential oil on the mouse model of inflammatory bowel diseases. Toxicol Mech Methods 2006;16:365–372.CrossRefPubMedGoogle Scholar
  32. 32.
    Rastegarpanah M, Omidzohour N, Vahedi H, Malekzadeh R, Hashemian F, et al. Management of human ulcerative colitis by SaturexIM: a randomized controlled trial. Int J Pharmacol 2011;7:415–418.CrossRefGoogle Scholar
  33. 33.
    Abdolghaffari AH, Baghaei A, Moayer F, Esmaily H, Baeeri M, Monsef-Esfahani HR, et al. On the benefit of Teucrium in murine colitis through improvement of toxic inflammatory mediators. Hum Exp Toxicol 2010;29:287–295.CrossRefPubMedGoogle Scholar
  34. 34.
    Baghaei A, Esmaily H, Abdolghaffari AH, Baeeri M, Gharibdoost F, Abdollahi M. Efficacy of Setarud (IMOD®), a novel drug with potent anti-toxic stress potential in rat inflammatory bowel disease and comparison with dexamethasone and infliximab. Indian J Biochem Biophys 2010;47:219–226.PubMedGoogle Scholar
  35. 35.
    Ebrahimi F, Esmaily H, Baeeri M, Mohammadirad A, Fallah S, Abdollahi M. Molecular evidences on the benefit of N-acetylcysteine in experimental colitis. Cent Eur J Biol 2008;3:135–142.Google Scholar
  36. 36.
    Khoshakhlagh P, Bahrololoumi-Shapourabadi M, Mohammadirad A, Ashtaral-Nakhai L, Minaie B, Abdollahi M. Beneficial effect of phosphodiesterase-5 inhibitor in experimental inflammatory bowel disease: molecular evidence for involvement of oxidative stress. Toxicol Mech Methods 2007;17:281–288.CrossRefPubMedGoogle Scholar

Copyright information

© Chinese Association of the Integration of Traditional and Western Medicine and Springer-Verlag Berlin Heidelberg 2015

Authors and Affiliations

  • Mansoor Rastegarpanah
    • 1
    • 2
    • 3
  • Reza Malekzadeh
    • 1
  • Homayoun Vahedi
    • 1
  • Maryam Mohammadi
    • 4
  • Elham Elahi
    • 1
  • Meghedi Chaharmahali
    • 1
  • Tahereh Safarnavadeh
    • 1
  • Mohammad Abdollahi
    • 2
    • 3
    Email author
  1. 1.Digestive Disease Research CenterTehran University of Medical SciencesTehranIran
  2. 2.Faculty of PharmacyTehran University of Medical SciencesTehranIran
  3. 3.Pharmaceutical Sciences Research CenterTehran University of Medical SciencesTehranIran
  4. 4.Pharmaceutical BranchIslamic Azad UniversityTehranIran

Personalised recommendations