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International Braz J Urol : Official... 2012We aim to evaluate our experience and results with laparoscopic radical cystectomy and conduct a systematic review of studies reporting on 50 or more procedures. (Review)
Review
OBJECTIVE
We aim to evaluate our experience and results with laparoscopic radical cystectomy and conduct a systematic review of studies reporting on 50 or more procedures.
MATERIALS AND METHODS
Between February 2006 and March 2011, a prospective study in a single institute on patients with bladder cancer who underwent laparoscopic radical cystectomy was conducted. A search of the Cochrane Library, PubMed, Medline, and Scopus databases was conducted for studies reporting on 50 or more laparoscopic radical cystectomy procedures to compare with our results.
RESULTS
Sixty men and five women underwent laparoscopic radical cystectomy during the 5-year study period. Thirty-nine patients were submitted to ileal conduits, 24 to neobladders, and two patients to ureterocutaneostomies. The mean operative time was 294 ± 27 minutes, the mean blood loss was 249.69 ± 95.59 millilitres, the mean length of hospital stay was 9.42 ± 2 days, the mean morphine requirement was 3.69 ± 0.8 days. The overall complication rate was 44.6% (29/65). However, the majority of the patients with complications (90% (26/29)) had minor complications treated conservatively with no further surgical intervention needed. The literature search found seven studies, which reported on their institutions' laparoscopic radical cystectomy results of 50 or more patients. Generally, our results were similar to other reported studies of the same calibre.
CONCLUSION
Laparoscopic radical cystectomy is a safe and efficient modality of treatment of bladder cancer. However, it comes with a steep learning curve, once overcome, can provide an alternative to open radical cystectomy.
Topics: Aged; Blood Loss, Surgical; Cystectomy; Female; Humans; Laparoscopy; Lymph Node Excision; Male; Middle Aged; Operative Time; Prospective Studies; Treatment Outcome; Urinary Bladder Neoplasms
PubMed: 22765852
DOI: 10.1590/s1677-55382012000300006 -
AIDS Patient Care and STDs Aug 2012Women are often underrepresented in randomized clinical trials (RCT) of HIV-1 drugs. As a result, determining whether women have different virologic outcomes compared to... (Meta-Analysis)
Meta-Analysis
Women are often underrepresented in randomized clinical trials (RCT) of HIV-1 drugs. As a result, determining whether women have different virologic outcomes compared to men is not always possible because the gender-related analyses usually lack statistical power. To address this important public health concern, the Food and Drug Administration's (FDA) Division of Antiviral Products (DAVP) created a database including 20,328 HIV-positive subjects from 40 RCTs in 18 New Drug Applications (NDAs) submitted to the FDA between 2000 and 2008. These RCTs were conducted for at least 48 weeks in duration and were used to support approval of new molecular entity, new formulation, or major label change. To delineate potential gender differences in antiretroviral treatment (ART), we evaluated the percentage of subjects with HIV RNA less than 50 copies per milliliter at 48 weeks. Analyses of the database represent the most systematic review of gender-related ART efficacy data to date. Overall, the meta-analyses did not demonstrate statistically or clinically significant gender differences in virologic outcome at week 48. However, the corresponding subgroup analyses appear to show several statistically significant gender differences favoring males.
Topics: Anti-HIV Agents; Female; HIV Seropositivity; Health Status Disparities; Humans; Male; Randomized Controlled Trials as Topic; Sex Distribution; Sex Factors; Treatment Outcome; United States
PubMed: 22734949
DOI: 10.1089/apc.2011.0278 -
The Cochrane Database of Systematic... May 2012The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to... (Review)
Review
BACKGROUND
The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to treatment, issues of adherence and viral resistance are major challenges limiting its success. There is a need for an effective and safe first-line regimen, to cope with the ever-increasing incidence of non-adherence and primary resistance. A more recent first-line treatment regimen consists of Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg).
OBJECTIVES
To evaluate the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011.
SELECTION CRITERIA
Randomized controlled trials evaluating the effects of TDF + FTC + EFV compared with other HAART regimens.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed trial eligibility and risk of bias, and extracted data from the included study.
MAIN RESULTS
Only one study involving 517 antiretroviral-naive HIV infected adults was included in this review. Participants were randomly assigned to receive either a regimen of TDF (300 mg), FTC (200mg), and EFV (600mg ) once daily; or a regimen of fixed-dose zidovudine (AZT) (300 mg) and lamivudine (3TC) (150 mg) twice daily plus EFV (600mg) once daily. Significantly more patients in the TDF-FTC group reached and maintained HIV RNA levels of less than 50 copies per milliliter compared to the AZT- 3TC group (RR 1.13; 95% CI 1.02 to 1.25). Also, more participants in the TDF-FTC group had greater increase from baseline CD4 cell counts compared to the AZT-3TC group (190 vs. 158 cells per mm(3)). More patients in the AZT-3TC group than in the TDF-FTC group had adverse events resulting in discontinuation of the study drugs (9% vs. 4%, respectively; P = 0.02). There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
AUTHORS' CONCLUSIONS
Only one trial has shown beneficial effects and safety of TDF+ FTC + EFV as first-line treatment for patients with HIV. The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed.
Topics: Adenine; Deoxycytidine; Drug Combinations; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Organophosphonates; Oxazines; Reverse Transcriptase Inhibitors
PubMed: 22592718
DOI: 10.1002/14651858.CD007276.pub3 -
The Cochrane Database of Systematic... Feb 2012The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to... (Review)
Review
BACKGROUND
The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to treatment, issues of adherence and viral resistance are major challenges limiting its success. There is a need for an effective and safe first-line regimen, to cope with the ever-increasing incidence of non-adherence and primary resistance. A more recent first-line treatment regimen consists of Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg).
OBJECTIVES
To evaluate the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011.
SELECTION CRITERIA
Randomized controlled trials evaluating the effects of TDF + FTC + EFV compared with other HAART regimens.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed trial eligibility and risk of bias, and extracted data from the included study.
MAIN RESULTS
Only one study involving 517 antiretroviral-naive HIV infected adults was included in this review. Participants were randomly assigned to receive either a regimen of TDF (300 mg), FTC (200mg), and EFV (600mg ) once daily; or a regimen of fixed-dose zidovudine (AZT) (300 mg) and lamivudine (3TC) (150 mg) twice daily plus EFV (600mg) once daily. Significantly more patients in the TDF-FTC group reached and maintained HIV RNA levels of less than 50 copies per milliliter compared to the AZT- 3TC group (RR 1.13; 95% CI 1.02 to 1.25). Also, more participants in the TDF-FTC group had greater increase from baseline CD4 cell counts compared to the AZT-3TC group (190 vs. 158 cells per mm(3)). More patients in the AZT-3TC group than in the TDF-FTC group had adverse events resulting in discontinuation of the study drugs (9% vs. 4%, respectively; P = 0.02). There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
AUTHORS' CONCLUSIONS
Only one trial has shown beneficial effects and safety of TDF+ FTC + EFV as first-line treatment for patients with HIV. The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed.
Topics: Adenine; Deoxycytidine; Drug Combinations; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; HIV Infections; Humans; Organophosphonates; Oxazines; Reverse Transcriptase Inhibitors
PubMed: 22336829
DOI: 10.1002/14651858.CD007276.pub2 -
The Cochrane Database of Systematic... Nov 2011Prostate cancer is a common cause of death in developed countries, yet the benefits of screening for prostate cancer still remain controversial. A prostate-specific... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Prostate cancer is a common cause of death in developed countries, yet the benefits of screening for prostate cancer still remain controversial. A prostate-specific antigen (PSA) test result greater than 4 ng/mL (nanograms/millilitre) has commonly been used as the cut-off level for seeking further tests to diagnose the presence (or absence) of prostate cancer. An increase in PSA levels may not necessarily be associated with an increased risk of prostate cancer, as PSA levels may also be increased in men with benign prostatic hyperplasia and prostatitis. Despite the uncertainty of the net benefit of early detection and treatment, safe and effective methods to prevent prostate cancer are of value. Consumers, seeking greater involvement in their healthcare, are increasingly turning to lifestyle modification and complementary and alternative medicines (CAMs) to maintain their health and prevent disease. Lycopene is a member of the carotenoid family, which is found abundantly in tomatoes, tomato-based products, strawberries, and watermelon. It has been hypothesised that lycopene is a strong antioxidant, which may lower the risk of cancer (including prostate cancer) in people who have diets rich in lycopene.
OBJECTIVES
To determine whether lycopene reduces the incidence of prostate cancer and prostate cancer-specific mortality. Secondary objectives include changes in PSA levels, prostate symptoms and the nature of adverse events associated with lycopene use.
SEARCH METHODS
Electronic searches were conducted across MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL) databases. No language or other limitations were imposed.
SELECTION CRITERIA
Randomised controlled trials (RCTs) that investigated the use of lycopene for the prevention of prostate cancer were eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS
A search of electronic databases, performed in August 2011, identified 64 citations. All articles were selected for full-text review. From these citations, three studies were identified as meeting the inclusion criteria. Handsearching did not provide any additional studies.
MAIN RESULTS
Three RCTs, with a total of 154 participants were included in this review. None of the studies reported data on prostate cancer mortality. All of the included studies differed with respect to design, participants included and allocation of lycopene. This clinical heterogeneity limits the value on the pooled estimated of the meta-analyses. The methodological quality of two of the three included studies was assessed as posing a 'high' risk of bias. Meta-analysis indicated no statistical difference in PSA levels between men randomised to receive lycopene and the comparison group (MD (mean difference) -0.34, 95% CI (confidence interval) -2.01, 1.32). Only one study reported incidence of prostate cancer (10% in the lycopene group versus 30% in control group). The level of lycopene was also not statistically different in men randomised to receive lycopene and the comparison group (MD 0.39 µg/mL (micrograms/millilitre), 95% CI -0.19, 0.98). No other meta-analyses were possible since other outcomes assessed only had one study contributing data.
AUTHORS' CONCLUSIONS
Given that only three RCTs were included in this systematic review, and the high risk of bias in two of the three studies, there is insufficient evidence to either support, or refute, the use of lycopene for the prevention of prostate cancer. Similarly, there is no robust evidence from RCTs to identify the impact of lycopene consumption upon the incidence of prostate cancer, prostate symptoms, PSA levels or adverse events.
Topics: Anticarcinogenic Agents; Carotenoids; Humans; Lycopene; Male; Prostate-Specific Antigen; Prostatic Neoplasms; Randomized Controlled Trials as Topic
PubMed: 22071840
DOI: 10.1002/14651858.CD008007.pub2 -
The Cochrane Database of Systematic... May 2011Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple (CW) operation or a pylorus-preserving pancreaticoduodenectomy (PPW). It is unclear which of the procedures is more favourable in terms of survival, mortality, complications and quality of life.
OBJECTIVES
The objective of this systematic review is to compare the effectiveness of each operation.
SEARCH STRATEGY
We conducted searches on 28 March 2006 and 11 January 2011 to identify all randomised controlled trials (RCTs), applying no language restrictions. We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), CDSR and DARE from The Cochrane Library (2010, Issue 4), MEDLINE (1966 to January 2011), and EMBASE (1980 to January 2011). Abstracts from Digestive Disease Week and U nited European Gastroenterology Week (1995 to 2010). No additional studies were indentified upon updating the systematic review in 2011.
SELECTION CRITERIA
We considered RCTs comparing the CW with PPW to be eligible if they included patients with periampullary or pancreatic carcinoma.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data from the included studies. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (OR), pooled continuous outcomes using mean differences (MD) and used hazard ratios (HR) for meta-analysis of survival. Two authors independently evaluated the methodological quality and risk of bias of the included studies according to Cochrane standards.
MAIN RESULTS
We included six randomised controlled trials with a total of 465 patients. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. In-hospital mortality (OR 0.49; 95% confidence interval (CI) 0.17 to 1.40; P = 0.18), overall survival (HR 0.84; 95% CI 0.61 to 1.16; P = 0.29) and morbidity showed no significant differences. However, we noted that operating time (MD -68.26 minutes; 95% CI -105.70 to -30.83; P = 0.0004) and intra-operative blood loss (MD -0.76 millilitres; 95% CI -0.96 to -0.56; P < 0.00001) were significantly reduced in the PPW group. All significant results have low quality of evidence based on GRADE criteria.
AUTHORS' CONCLUSIONS
There is no evidence of relevant differences in mortality, morbidity and survival between the two operations. Given obvious clinical and methodological heterogeneity, future research must be undertaken to perform high-quality randomised controlled trials of complex surgical interventions on the basis of well-defined outcome parameters.
Topics: Ampulla of Vater; Common Bile Duct Neoplasms; Gastric Emptying; Humans; Pancreatic Fistula; Pancreatic Neoplasms; Pancreaticoduodenectomy; Pylorus; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 21563148
DOI: 10.1002/14651858.CD006053.pub4 -
The Cochrane Database of Systematic... Apr 2011Upper tract transitional cell carcinomas (TCC) are uncommon and aggressive tumours. There are a number of surgical approaches to manage this condition including open... (Review)
Review
BACKGROUND
Upper tract transitional cell carcinomas (TCC) are uncommon and aggressive tumours. There are a number of surgical approaches to manage this condition including open radical nephroureterectomy and laparoscopic procedures.
OBJECTIVES
To determine the best surgical management option for upper tract transitional cell carcinoma.
SEARCH STRATEGY
A sensitive search strategy was developed to identify relevant studies for inclusion in this review. The following databases were searched for randomised trials evaluating surgical approaches to the management of upper tract TCC: Medline EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, British Nursing Index, AMED, LILACS, Web of Science®, Scopus, Biosis, TRIP, Biomed Central, Dissertation Abstracts, and ISI Proceedings.
SELECTION CRITERIA
The following criteria that were considered for this review.Types of studies - All randomised or quasi-randomised controlled trials comparing the various surgical methods and approaches for the management of localised upper tract transitional cell carcinoma. Types of participants - All adult patients with localised transitional cell carcinoma. Localised disease was defined as limited to the kidney or ureter with no gross regional lymph nodal enlargement on imaging. Types of interventions - Any surgical method or approach for managing localised upper tract transitional cell carcinoma. Types of outcome measures - Overall and cancer-specific survival were primary outcomes. Surgery-related morbidity. Quality of life and health economics outcomes were secondary outcomes.
DATA COLLECTION AND ANALYSIS
Two review authors examined the search results independently to identify trials for inclusion.
MAIN RESULTS
We identified one randomised controlled trial that met our inclusion criteria. The trial showed that the laparoscopic approach had superior peri-operative outcomes compared to open approach. Laparoscopic was superior and statistically significant for blood loss (104 mL (millilitres) versus 430 mL, P < 0.001) and mean time to discharge (2.3 days versus 3.7, P < 0.001). Oncological outcomes (bladder tumour-free survival, metastasis-free survival, cancer-specific survival curves), at a median follow up of 44 months and in organ-confined disease, were comparable for both groups.
AUTHORS' CONCLUSIONS
There is no high quality evidence available from adequately controlled trials to determine the best surgical management of upper tract transitional cell carcinoma. However, one small randomised trial and observational data suggests that laparoscopic approach is associated with less blood loss and early recovery from surgery with similar cancer outcomes when compared to open approach.
Topics: Adult; Carcinoma, Transitional Cell; Humans; Kidney Neoplasms; Laparoscopy; Nephrectomy; Randomized Controlled Trials as Topic; Ureter; Ureteral Neoplasms
PubMed: 21491399
DOI: 10.1002/14651858.CD007349.pub2 -
The Cochrane Database of Systematic... Feb 2011Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple... (Review)
Review
WITHDRAWN: Pancreaticoduodenectomy (classic Whipple) versus pylorus-preserving pancreaticoduodenectomy (pp Whipple) for surgical treatment of periampullary and pancreatic carcinoma.
BACKGROUND
Pancreatic cancer is the fourth leading cause of cancer death for men and the fifth for women. The standard treatment for resectable tumours is either a classic Whipple operation or a pylorus-preserving pancreaticoduodenectomy. It is unclear which of the procedures is more favourable in terms of survival, mortality, complications and quality of life.
OBJECTIVES
Several publications have highlighted advantages and disadvantages of the two techniques and the current basis of evidence remains unclear. The objective of this systematic review is to compare the effectiveness of each operation.
SEARCH STRATEGY
We conducted a search on 28/03/2006 to identify all RCTs, applying no language restriction.We searched the following electronic databases: CENTRAL, CDSR and DARE from The Cochrane Library (2006, issue 2), MEDLINE (1966 to 2006) and EMBASE (1980 to 2006). We handsearched abstracts from 1995 to 2006 from the American Digestive Disease Week (DDW), published in Gastroenterology, and the United European Gastroenterology Week (UEGW), published in Gut.
SELECTION CRITERIA
We considered randomised controlled trials comparing the classic Whipple operation with pylorus-preserving pancreaticoduodenectomy to be eligible if they included patients with periampullary or pancreatic carcinoma.
DATA COLLECTION AND ANALYSIS
Two authors independently extracted data from the included studies. We used a random-effects model for pooling data. We compared binary outcomes using odds ratios (OR), pooled continuous outcomes using weighted mean differences (WMD), and used hazard ratios (HR) for meta-analysis of survival. Two authors independently evaluated the methodological quality of included studies according to quality standards and by using a questionnaire.
MAIN RESULTS
We retrieved 1235 abstracts and checked these for eligibility, including seven randomised controlled trials. Our critical appraisal revealed vast heterogeneity with respect to methodological quality and outcome parameters. Our comparisons of in-hospital mortality (OR 0.49; 95% confidence interval (CI) 0.17 to 1.40; P = 0.18), overall survival (HR 0.84; 95% CI 0.61 to 1.16; P = 0.29) and morbidity showed no significant differences. However, we noted that operating time (WMD -68.26 minutes; 95% CI -105.70 to -30.83; P = 0.0004) and intra-operative blood loss (WMD -0.76 millilitres; 95% CI -0.96 to -0.56; P < 0.00001) were significantly reduced in the pylorus-preserving pancreaticoduodenectomy group.
AUTHORS' CONCLUSIONS
There is no evidence of relevant differences in mortality, morbidity and survival between the two operations. Given obvious clinical and methodological heterogeneity, future research must be undertaken to perform high-quality randomised controlled trials of complex surgical interventions on the basis of well-defined outcome parameters.
Topics: Ampulla of Vater; Common Bile Duct Neoplasms; Gastric Emptying; Humans; Pancreatic Neoplasms; Pancreaticoduodenectomy; Quality of Life; Randomized Controlled Trials as Topic
PubMed: 21328281
DOI: 10.1002/14651858.CD006053.pub3 -
Iranian Journal of Kidney Diseases Jul 2010The efficacy and safety of pegylated and standard interferon (IFN) have been scrutinized in meta-analyses; however, factors associated with hepatitis C viral response in... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The efficacy and safety of pegylated and standard interferon (IFN) have been scrutinized in meta-analyses; however, factors associated with hepatitis C viral response in patients on hemodialysis are not well investigated.
MATERIALS AND METHODS
We evaluated factors that could be associated with sustained virological response (SVR) to pegylated or standard IFN monotherapy in patients on hemodialysis with chronic hepatitis C virus (HCV) infection, by performing a systematic review of the literature with a meta-analysis of clinical trials. We used both Mantel-Haenszel and DerSimonian and Laird random effects models, with heterogeneity and sensitivity analyses.
RESULTS
Twenty-one studies on IFN-alfa2a or IFN-alfa2b (491 patients) and 12 on pegylated-IFN-alfa2a or PEG-IFN-alfa2b (279 patients) were evaluated. The pooled SVR for standard and pegylated IFN monotherapy in random effects model was 39.1% (95% confidence interval [CI], 32.1 to 46.1) and 39.3% (95% CI, 26.5 to 52.1), respectively. Pooled dropout rates were 22.6% (95% CI, 10.4 to 34.8) and 29.7% (95% CI, 21.7 to 37.7), respectively. Female gender, HCV-RNA copies per milliliter, HCV genotype, alanine transaminase pattern, duration of infection, liver fibrosis stage, and treatment duration were not associated with SVR. Only an age less than 40 years was significantly associated with SVR in both models (odds ratio, 2.17; 95% CI, 1.03 to 4.50).
CONCLUSIONS
Additional benefit of monotherapy with pegylated IFN in patients on hemodialysis with HCV infection in terms of viral response and adverse events is still unclear. According the current literature, younger age was the only determinant of SVR.
Topics: Antiviral Agents; Hepatitis C, Chronic; Humans; Interferon alpha-2; Interferon-alpha; Polyethylene Glycols; Recombinant Proteins; Renal Dialysis
PubMed: 20622305
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2009Benign prostatic hyperplasia (BPH) is a common condition in aging men causing lower urinary tract symptoms (LUTS). Treatment aims are to relieve symptoms and prevent... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Benign prostatic hyperplasia (BPH) is a common condition in aging men causing lower urinary tract symptoms (LUTS). Treatment aims are to relieve symptoms and prevent disease progression. Of the different alpha-1 adrenergic receptors (ARs) in the prostate, alpha-1a receptors are known to be central to prostatic smooth-muscle contraction. Recent studies have shown that patients with BPH may also have a predominance of alpha-1d receptors.
OBJECTIVES
To evaluate the efficacy and adverse effects of naftopidil, a selective alpha-1d oral alpha-blocking agent for the treatment of LUTS associated with BPH.
SEARCH STRATEGY
Systematic review of trials published January 1950 to January 2009. Sources included MEDLINE and bibliographies of retrieved articles and review articles.
SELECTION CRITERIA
Eligible trials included: men diagnosed with symptomatic BPH; compared Naftopidil to placebo, control, or combination therapy; evaluated clinically relevant outcomes between randomized groups; had at least 4-weeks follow up; and were published in English language.
DATA COLLECTION AND ANALYSIS
Participant demographics and comorbidities, enrollment criteria, outcomes, adverse events, numbers and reasons for dropouts were extracted onto standardized extraction forms by one reviewer. The mean change and per cent improvement from baseline in AUA (American Urological Association Symptom Score) and IPSS (International Prostate Symptom Score) scores and other efficacy outcomes for treatment and control groups were calculated. If feasible, the efficacy outcomes and adverse events data were pooled.
MAIN RESULTS
Eight trials were eligible (N = 744 participants). All trials were conducted in Japan. Study duration ranged from 4 to 17 weeks. The mean age of participants was 68 years; pretreatment mean IPSS = 17.8 and mean peak urine flow (Qmax) = 9.5 mL/s (milliliters/second). No trials compared naftopidil to placebo. In 5 trials (N = 419), naftopidil in doses of 25 to 75 mg/d (milligrams/day) showed a mean IPSS improvement similar to low-dose tamsulosin (0.2 mg/d) (8.4 versus 8.9 points). Compared to a phytotherapy preparation (eviprostat), naftopidil significantly improved total IPSS (-5.9 versus 0.4; P < 0.0002). In one trial, the addition of anticholinergic drugs (oxybutynin or propiverine hydrochloride) to naftopidil did not offer any significant improvement for IPSS or Qmax in comparison to treatment with naftopidil alone. Although IPSS did not significantly differ between high- (75 mg/d) and low-dose (25mg/d) naftopidil, high dose significantly improved Qmax compared to low dose (1.2 mL/s versus 0.2 mL/s). Adverse events reported were few, mild and similar to those seen with 0.2 mg/d tamsulosin.
AUTHORS' CONCLUSIONS
There are no data from placebo controlled trials regarding the efficacy of naftopidil in men with symptomatic BPH. Limited information suggests that treatment with naftopidil provides short-term improvement in urinary symptom-scale scores (total IPSS/AUA), QoL (quality of life) score, and urinary symptoms from baseline comparable to low-dose tamsulosin. Adverse effects due to naftopidil were few and usually mild.
Topics: Adrenergic alpha-Antagonists; Humans; Male; Naphthalenes; Piperazines; Prostatic Hyperplasia; Prostatism; Randomized Controlled Trials as Topic; Sulfonamides; Tamsulosin
PubMed: 19821408
DOI: 10.1002/14651858.CD007360.pub2