A prospective study to evaluate the efficacy and adverse effects of alpha-blockers in the management of benign prostatic hyperplasia

Background: Benign prostatic hyperplasia (BPH) is the most common cause for the lower urinary tract symptoms in men. The conservative management of BPH comprises of alpha blockers, especially selective alpha 1 adrenergic blockers for symptomatic relief. Aims and Objectives: We aimed to evaluate the efficacy and adverse effects of alpha blockers in managing BPH. Materials and Methods: After getting approval from the Institutional Human Ethics Committee and consent from subjects, this prospective, randomized, and controlled trial was conducted. In this study, patients under inclusion criteria were divided into two groups. Group I received silodosin 8 mg once daily for 8 weeks. Group II received tamsulosin 0.4 mg once daily for 8 weeks. Primary outcome measure was reduction in international prostate symptom score (IPSS). Adverse events during study period were recorded. Results: A total of 90 patients were enrolled in this study. Ten patients were excluded and remaining 80 patients were divided as 40 in Group I (Silodosin) and 40 in Group II (Tamsulosin), patients were followed up for 8 weeks. As primary outcome, the IPSS at 8th week was significantly <0 week, that is, baseline in both the groups. The comparison of IPSS within Group I and Group II at 0 week and 8th week was significant (P < 0.05). The quality of life comparison within Group I and Group II at 0 week and 8th week was significant (P < 0.05). Both the drugs were well tolerated. Retrograde ejaculation and diarrhea were noted with silodosin (Group I), dizziness and orthostatic hypotension were noted with Tamsulosin (Group II). Conclusion: The obtained results showed that both silodosin and tamsulosin produced significant improvement in IPSS and quality of Life in BPH patients. In silodosin group, retrograde ejaculation and diarrhea were notable adverse effects and in tamsulosin group, dizziness and orthostatic hypotension were noted.

Comparative evaluation of cost-effectiveness of alpha blockers prescribed in patients with non-neurogenic lower urinary tract symptoms due to benign prostatic hyperplasia

Background: Lower urinary tract symptoms (LUTS) due to Benign Prostatic Hyperplasia (BPH) is a common problem among aging men. Several classes of drugs are efficacious and safe, but the first-line treatment is with alpha-1 adrenergic blockers. They provide symptomatic relief and have to be taken for a longer duration to sustain the effect. The preferred alpha-blockers among the stockpile should be efficacious, tolerable, and also cost-effective. Aim and Objective: This study focuses to compare the cost-effectiveness of various alpha blockers prescribed in patients with LUTS-BPH. Materials and Methods: An observational study of 78 patients who were newly diagnosed with LUTS-BPH from April 2014 to May 2015 was conducted. Patients were followed up at 4 weeks and at 12 weeks after the drugs had been prescribed. Efficacy assessment was done on basis of change in International Prostate Symptom Score (IPSS) score over 12 weeks. Average cost-effectiveness ratio of different alpha-blockers prescribed was evaluated and compared with Mann-Whitney U test in order to find the most cost-effective alpha-blocker in the study. Results: All patients were prescribed alpha-blockers either alone or in combination with other drugs. Tamsulosin was prescribed to n = 46, Silodosin to n = 16 and Alfuzosin to n = 16. The efficacy in terms of Mean change in IPSS after 12 weeks of study was 11.34 ± 5.23 for Tamsulosin, 11.70 ± 5.9 for Silodosin and 10.87 ± 4.77 for Alfuzosin and average cost-effectiveness ratio was 108.74, 183.07 and 127.50 for Tamsulosin, Silodosin, and Alfuzosin, respectively. Conclusion: Tamsulosin was the most cost-effective drug among the prescribed alpha-blockers. Since all the prescribed alpha-blockers had comparable efficacy so we concluded that the most cost-effective drug should be preferred for long-duration treatment.

Comparison Between Tamsulosin Vs Tamsulosin+Deflazacort In Expulsion Of Lower Ureteric Calculi

Background: Medical Expulsive Therapy (MET) has become an established part of the protocol for treatment of ureteric stones of 5–10 mm size in the lower 1/3rd of the ureter. α–1 adrenergic blockers with or without corticosteroid along with IV fluid therapyare in use to facilitate expulsion of stones. Aims & Objective: In this study comparison of α–1 adrenergic blocker Tamsulosin alone and in combination with corticosteroid deflazacort have been compared. Materials and Methods: Total of 50 symptomatic patients of lower ureteric stones, who presented in the OPD in MIMER Medical College Hospital were selected for our study. Patients were randomly divided in group 1 and group 2viz. Group 1 (Tamsulosin Group) & Group 2 (Tamsulosin + deflazacort Group). Results: It was found that with Tamsulosin + deflazacort offers better stone clearance rate with in shorter period. There was minimum discomfort to the patients during stone expulsion. Success rate was comparable in both groups up to 10 mm stone size. Conclusion: MET using Tamsulosin + Deflazacort has clear advantage over Tamsolusin alone therapy.

A comparative study of efficacy of tadalafil and alfuzosin regimens in patients of benign prostate hyperplasia

Background: Aim of the study was to compare efficacy of Tadalafil and Alfuzosin regimens in patients of Benign Prostate Hyperplasia.Methods: It was a comparative, prospective, observational, non-invasive, parallel and randomised study conducted at the Outpatient Department of Urology, Rajindra Hospital, Patiala. 60 patients diagnosed with Benign Prostate Hyperplasia along with Lower Urinary Tract Symptoms, out which, 30 patients, consuming Tadalafil and 30 patients consuming Alfuzosin were considered. History regarding the concerned disease and the compliance of treatment was taken. Symptom scores were assessed with the help of International Prostate Symptom Score, Quality of Lifestyle Score and Erectile Dysfunction Score. Physical examination consisting of Focused Neurological Examination along with Digital Rectal Examination were conducted. Parameters like Renal Function Test, Urine analysis, Ultrasound of Prostate and uroflowmetry were also considered.Results: The mean age selected for study was 64 years for Tadalafil and Alfuzosin group. The mean level of IPS Score, Qol Score and ED Score at the first day of inclusion of patients were 23.96±4.49, 4±0.78, and 25.33±4.02 respectively for Tadalafil group and regarding Alfuzosin group they were 25.23±4.84, 3.56±0.81, and 26.1±4.04 respectively. Follow ups were conducted at 15 days, 1 month and 3 months for both the groups which were found to be statistically significant after 3 months and Alfuzosin showed a favourable result.Conclusions: Alfuzosin 10mg given at daily dose was found to have higher efficacy than Tadalafil (5mg).

Is Tamsulosin 0.2 mg Effective and Safe as a First-Line Treatment Compared with Other Alpha Blockers?: A Meta-Analysis and a Moderator Focused Study

PURPOSE: Tamsulosin 0.2 mg is used widely in Asian people, but the low dose has been studied less than tamsulosin 0.4 mg or other alpha blockers of standard dose. This study investigated the efficacy and safety of tamsulosin 0.2 mg by a meta-analysis and meta-regression. MATERIALS AND METHODS: We conducted a meta-analysis of efficacy of tamsulosin 0.2 mg using International Prostate Symptom Score (IPSS), maximal urinary flow rate (Qmax), post-voided residual volume (PVR), and quality of life (QoL). Safety was analyzed using adverse events. Relevant studies were searched using MEDLINE, EMBASE, and Cochrane library from January 1980 to June 2013. RESULTS: Ten studies were included with a total sample size of 1418 subjects [722 tamsulosin 0.2 mg group and 696 other alpha-blockers (terazosin, doxazosin, naftopidil, silodosin) group]. Study duration ranged from 4 to 24 weeks. The pooled overall standardized mean differences (SMD) in the mean change of IPSS from baseline for the tamsulosin group versus the control group was 0.02 [95% confidence interval (CI); -0.20, 0.25]. The pooled overall SMD in the mean change of QoL from baseline for the tamsulosin group versus the control group was 0.16 (95% CI; -0.16, 0.48). The regression analysis with the continuous variables (number of patients, study duration) revealed no significance in all outcomes as IPSS, QoL, and Qmax. CONCLUSION: This study clarifies that tamsulosin 0.2 mg has similar efficacy and fewer adverse events compared with other alpha-blockers as an initial treatment strategy for men with lower urinary tract symptoms.

The skin tissue is adversely affected by TNF-alpha blockers in patients with chronic inflammatory arthritis: a 5-year prospective analysis

OBJECTIVE: We evaluated the incidence of and the main risk factors associated with cutaneous adverse events in patients with chronic inflammatory arthritis following anti-TNF-α therapy. METHODS: A total of 257 patients with active arthritis who were taking TNF-α blockers, including 158 patients with rheumatoid arthritis, 87 with ankylosing spondylitis and 12 with psoriatic arthritis, were enrolled in a 5-year prospective analysis. Patients with overlapping or other rheumatic diseases were excluded. Anthropometric, socioeconomic, demographic and clinical data were evaluated, including the Disease Activity Score-28, Bath Ankylosing Spondylitis Disease Activity Index and Psoriasis Area Severity Index. Skin conditions were evaluated by two dermatology experts, and in doubtful cases, skin lesion biopsies were performed. Associations between adverse cutaneous events and clinical, demographic and epidemiological variables were determined using the chi-square test, and logistic regression analyses were performed to identify risk factors. The significance level was set at p<0.05. RESULTS: After 60 months of follow-up, 71 adverse events (73.85/1000 patient-years) were observed, of which allergic and immune-mediated phenomena were the most frequent events, followed by infectious conditions involving bacterial (47.1%), parasitic (23.5%), fungal (20.6%) and viral (8.8%) agents. CONCLUSION: The skin is significantly affected by adverse reactions resulting from the use of TNF-α blockers, and the main risk factors for cutaneous events were advanced age, female sex, a diagnosis of rheumatoid arthritis, disease activity and the use of infliximab. .

The effect of alpha-blocker treatment on bladder hypoxia inducible factor-1 alpha regulation during lower urinary tract obstruction

AIMS: To determine whether á1-blocker treatment, in chronic bladder outlet obstruction (BOO), influences bladder tissue ischemia. Materials and methods: This prospective study included 60 patients with BOO, of which 40 were under á1-blocker medication and 20 without treatment. Patients underwent transurethral resection of the prostate (TURP) or suprapubic prostatectomy (SPP). Ten patients with non-muscle invasive bladder cancer underwent transurethral resection of the bladder tumor and served as the control group. Tissue specimens were immunohistochemically stained for hypoxia inducible factor-1á (HIF-1á). Results: Bladder tissue from obstructed subjects showed high immunoreactivity to HIF-1á. The specimens from the control group, showed no or weak, mainly cytoplasmic immunoreactivity to HIF-1á. Patients under á -blocker treatment did not differ in the number of HIF-1á positive cells compared to subjects with no treatment (median number 86.8 [20-150] and 88.6 [0-175], respectively) (p > 0.05). The lowest bladder pressure at which HIF-1á was up regulated, was detected at detrusor pressure Qmax (PdetQmax) = 60 cm H2O. Conclusions: Treatment with á-blockers in obstructed patients considered as non-responders, does not result in HIF-1á down regulation, thus bladder continues to be under chronic stress.

Comparison of the Efficacy of Antibiotic Monotherapy and Antibiotic Plus Alpha-blocker Combination Therapy for Patients with Inflammatory Chronic Prostatitis/Chronic Pelvic Pain Syndrome / 대한비뇨기과학회지

PURPOSE: The objectives of this study was to compare the efficacy of antibiotic monotherapy with antibiotic plus alpha-blocker combination therapy for the treatment of inflammatory chronic pelvic pain syndrome (CPPS) patients. MATERIALS AND METHODS: Between October 2005 and May 2006, 69 patients who were diagnosed as CPPS(National Institutes of Health; NIH-catagory IIIa), were included in this study. The patients were randomly placed into two groups: group I was treated with gatifloxacin alone(35 patients), and group II was treated with gatifloxacin and doxazosin(34 patients) for 6 weeks. For all the patients, the urinalysis, expressed prostatic massage, the National Institute of Health-Chronic Prostatitis Symptom Index(NIH-CPSI) and a distal rectal examination(DRE) were performed at the initial visit. The NIH-CPSI was compared both before and after the treatment. RESULTS: On the initial diagnosis, the mean CPSI of the group I patients was 24.0+/-6.3, and that for the group II patients was 24.7+/-6.9. After the treatment, that of the group I was 16.6+/-5.4, and that of group II was 13.4+/-5.3. After 6 weeks of treatment, the changes in the total CPSI scores had significantly improved in group II compared with group I(p<0.05). A statistically significant improvement occurred in the pain score, the voiding symptom score and the quality of life in the group II compared with group I(p<0.05) CONCLUSIONS: This study suggests that combination therapy of antibiotic plus alpha-blocker would be more effective than antibiotic monotheraphy for treating patients with inflammatory chronic prostatitis/chronic pelvic pain syndrome.

Efficacy of Combination Therapy for Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Study / 대한비뇨기과학회지

PURPOSE: The National Institute of Health (NIH) category III chronic nonbacterial prostatitis/chronic pelvic pain syndromes (CPPS) are commonly seen disorders; however, there has been no consensus on how to manage these patients. The purpose of this trial was to compare the efficacy of antibiotic monotherapy and antibiotic plus alpha-blocker combination therapy for the treatment of CPPS patients. MATERIALS AND METHODS: The study was comprised of 54 patients who were randomly placed into two groups: group I was treated with levofloxacin alone (28 patients), and group II was treated with levofloxacin and alfuzosin (26 patients). The levofloxacin, or the levofloxacin and alfuzosin were given to the respective groups for 8 weeks. The NIH Chronic Prostatitis Symptom Index (NIH-CPSI) was evaluated both before and after the treatment. RESULTS: Before the treatment, the mean CPSI of the group I patients was 23.1+/-8.1, and after the treatment, it was 15.6+/-5.6. For the group II, the mean CPSI before the treatment was 23.9+/-8.3, and after the treatment, it was 11.0+/-4.5. The difference between the pre-and post-treatment CPSI scores of group II was significantly larger than that of group I (p=0.001). The mean differences of the CPSI from the initial scores to the final scores in both groups were followed: 2.2 in group I and 4.3 in group II for the pain domain, 1.5 in group I and 2.8 in group II for the urinary domain, and 3.8 in group I and 5.7 in group II for the quality of life domain. CONCLUSIONS: Combination therapy of levofloxacin with alfuzosin appeared more effective for treating patients with chronic prostatitis/chronic pelvic pain syndrome than just administering antibiotic alone.

Efficacy of Tamsulosin 0.2 mg/day in Female Patients with Lower Urinary Tract Symptoms

PURPOSE: The study of lower urinary tact symptoms(LUTS) in women is rare except urinary incontinence, and there were even no diagnostic or therapeutic guidelines for female bladder outlet obstruction. The objective of this study was to determine the efficacy of tamsulosin 0.2 mg/day single therapy for the female patients with LUTS. MATERIALS AND METHODS: A total 71 patients were evaluable. Tamsulosin 0.2 mg/day was administered orally in a nonblind design for 8 weeks. The efficacy parameters were International Prostate Symptom Score(IPSS), quality of life(QOL) score, frequency in daytime and night, maximal flow rate(Qmax), post-void residual urine volume(PVR), and changes in blood pressure and pulse rates. Changes in parameters between baseline and 8 weeks were assessed using Student's paired t-test. RESULTS: Statistically significant changes in the total, obstructive and irritative IPSS, QOL score, daytime and night time frequency, Qmax and PVR were observed at week 8. Adverse events included dizziness in 2 patients and increased nocturia in 1 patient. There were no withdrawals resulting from adverse events. There were significant differences in systolic blood pressure, but did not cause significant hypotension events. CONCLUSION: Treatment with tamsulosin 0.2 mg/day in female patients with LUTS was effective and well tolerated in improving LUTS and QOL.

The Characteristics of Voiding Difficulty in Women and the Effect of Tamsulosin / 대한비뇨기과학회지

PURPOSE: The aim of this study was to define the characteristics of female voiding difficulty, and evaluate the effects of the alpha-blocker, tamsulosin, on the symptoms in those patients. MATERIAL AND METHODS: 148 patients, who complained of voiding difficulty between March 2002 and September 2004, were retrospectively evaluated. 32 patients with anatomical and neuropathic causes were excluded, with the remaining 116 assigned to 4 groups from their urodynamic evaluations: group I, bladder outlet obstruction (BOO) only; group II, BOO plus an overactive bladder (OAB); group III, detrusor underactivity (DU) only; and group IV, DU plus an OAB. After 2 weeks of observation, tamsulosin, 0.2mg/d, was prescribed in all groups, with the patients re-evaluated after 3 months. RESULTS: 58 (50%), 23 (19.8%), 20 (17.3%) and 15 (12.9%) of the 116 study subjects were placed into groups I, II, III and IV, respectively. In group I, 45 (77.5%) had symptomatic improvement after taking tamsulosin for 3 months, and in group II improvement was observed in 73.9% (17/23) of patients. In groups III and IV; however, improvements were seen in only 25 (5/20) and 13.3% (2/15) of cases, respectively. Dizziness, postural hypotension and urinary incontinence occurred in some patients, but these disappeared after the medication was discontinued. CONCLUSIONS: 81 patients (69.8%) had a bladder outlet obstruction, without detrusor underactivity, and 62 (76.5%) of these exhibited a voiding improvement after taking tamsulosin for three months. However, in patients with detrusor underactivity, the response rate was very low (20%).