Alireza Ghadian1, Mehran Rezaei2. 1. Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran. 2. Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran. mrezaei1986@gmail.com.
Abstract
PURPOSE: Inflammation and Cyclooxygenase-2 (COX-2) as a part of it are common in BPH specimens and may play a role in the pathogenesis of the disease through cytokines that promote cell growth or lead to smooth muscle contraction. The aim of this study is to analyze whether combination therapy with omega-3 fatty acids, which have anti-inflammatory and COX-2 inhibitory effects, and tamsulocin plus finasteride offers an advantage compared to tamsulocin plus finasteride therapy in patients with BPH. MATERIALS AND METHODS: This is a single-center blinded clinical trial. One hundred consecutive men between 50 and 70 years of age and no other comorbidities with LUTS and BPH were entered into the study and were randomized to receive omega-3 fatty acids 300 mg three times a day with meals plus tamsulocin 0.4 mg at bed time and finasteride 5 mg/day (study group) versus tamsulocin 0.4 mg at bed time and finasteride 5 mg/day (control group) for 6 months. The efficacy and safety of treatments were assessed at baseline and at month one, three and six. RESULTS: In our population, both treatments (groups study and control) produced statistically significant improvements in IPSS, Q max, Q ave and prostate volume from baseline during follow-up (p < 0.05). We found that study group showed higher improvement in IPSS (p = 0.007), Q max (p = 0.011) and Q ave (p = 0.004) at the 1 month interval. These higher improvements last at month three and six (p < 0.05). Prostate volume in the study group also showed more improvement at month six (p = 0.000). Adverse effects were the same in both groups during the study. CONCLUSION: It can be concluded that association of omega-3 fatty acids with tamsulocin and finasteride may produce better clinical results.
RCT Entities:
PURPOSE: Inflammation and Cyclooxygenase-2 (COX-2) as a part of it are common in BPH specimens and may play a role in the pathogenesis of the disease through cytokines that promote cell growth or lead to smooth muscle contraction. The aim of this study is to analyze whether combination therapy with omega-3 fatty acids, which have anti-inflammatory and COX-2 inhibitory effects, and tamsulocin plus finasteride offers an advantage compared to tamsulocin plus finasteride therapy in patients with BPH. MATERIALS AND METHODS: This is a single-center blinded clinical trial. One hundred consecutive men between 50 and 70 years of age and no other comorbidities with LUTS and BPH were entered into the study and were randomized to receive omega-3 fatty acids 300 mg three times a day with meals plus tamsulocin 0.4 mg at bed time and finasteride 5 mg/day (study group) versus tamsulocin 0.4 mg at bed time and finasteride 5 mg/day (control group) for 6 months. The efficacy and safety of treatments were assessed at baseline and at month one, three and six. RESULTS: In our population, both treatments (groups study and control) produced statistically significant improvements in IPSS, Q max, Q ave and prostate volume from baseline during follow-up (p < 0.05). We found that study group showed higher improvement in IPSS (p = 0.007), Q max (p = 0.011) and Q ave (p = 0.004) at the 1 month interval. These higher improvements last at month three and six (p < 0.05). Prostate volume in the study group also showed more improvement at month six (p = 0.000). Adverse effects were the same in both groups during the study. CONCLUSION: It can be concluded that association of omega-3 fatty acids with tamsulocin and finasteride may produce better clinical results.
Authors: S Zha; W R Gage; J Sauvageot; E A Saria; M J Putzi; C M Ewing; D A Faith; W G Nelson; A M De Marzo; W B Isaacs Journal: Cancer Res Date: 2001-12-15 Impact factor: 12.701