Mansoor Rastegarpanah1,2,3, Reza Malekzadeh1, Homayoun Vahedi1, Maryam Mohammadi4, Elham Elahi1, Meghedi Chaharmahali1, Tahereh Safarnavadeh1, Mohammad Abdollahi5,6. 1. Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran, Iran. 2. Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. 3. Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran. 4. Pharmaceutical Branch, Islamic Azad University, Tehran, Iran. 5. Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. Mohammad@tums.ac.ir. 6. Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran. Mohammad@tums.ac.ir.
Abstract
OBJECTIVE: To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients. METHODS: 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. RESULTS: 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). CONCLUSION:Silymarin as a natural supplement may be used in UC patients to maintain remission.
RCT Entities:
OBJECTIVE: To evaluate the clinical efficacy of silymarin in ulcerative colitis (UC) patients. METHODS: 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. RESULTS: 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). CONCLUSION:Silymarin as a natural supplement may be used in UC patients to maintain remission.
Authors: Golshid Jahanshahi; Vian Motavasel; Ali Rezaie; Ali A Hashtroudi; Naser E Daryani; Mohammad Abdollahi Journal: Dig Dis Sci Date: 2004 Nov-Dec Impact factor: 3.487
Authors: Katarzyna Dziąbowska-Grabias; Małgorzata Sztanke; Przemysław Zając; Michał Celejewski; Katarzyna Kurek; Stanisław Szkutnicki; Patryk Korga; Włodzimierz Bulikowski; Krzysztof Sztanke Journal: Antioxidants (Basel) Date: 2021-03-09