-
The Cochrane Database of Systematic... 2004Erectile dysfunction (ED), the inability to achieve or maintain an erection sufficient for satisfactory sexual activity, is one of the most common sexual dysfunctions in... (Review)
Review
BACKGROUND
Erectile dysfunction (ED), the inability to achieve or maintain an erection sufficient for satisfactory sexual activity, is one of the most common sexual dysfunctions in men. ED may have a dramatic impact on the quality of life of many men and their partners.
OBJECTIVES
The aim of this systematic review was to evaluate and summarise the effectiveness and safety of PGE1 in the treatment of erectile dysfunction.
SEARCH STRATEGY
We searched the Cochrane MS Group Trials Register (June 2003), the Cochrane Central Register of Controlled Trials (issue 2, 2003), MEDLINE (January 1966 - June 2003), EMBASE (January 1988 - June 2003) and reference lists of articles. We also undertook handsearching and contacting trialists and pharmaceutical companies.
SELECTION CRITERIA
All unconfounded, double blind, randomised controlled trials comparing PGE1 and placebo treatment in participants with ED of different aetiology were considered. Primary outcomes were: (a) patient and partner satisfaction measured by means of a self-assessment; (b) quality of life and (c) safety assessment. Both parallel group and cross-over design trials were considered for inclusion.
DATA COLLECTION AND ANALYSIS
All the reviewers independently selected articles for inclusion, assessed the trials' quality and extracted the data. Study authors were contacted for additional information.
MAIN RESULTS
Four trials involving 1.873 people, heterogeneous with respect to aetiology of ED, were included. Study design was two cross-over and two parallel group trials. Only the latter provided adequate data for meta-analyses. PGE1 was effective during follow-up in the "at least one successful intercourse" outcome (Peto Odds Ratio, OR 7.22, 95% CI. 5.68-9.18) and "number of successful intercourse/number of PGE1 administrations" (Peto Odds Ratio, OR 6.46, 95% CI. 5.95-7.01). One cross-over study reported "at least one successful intercourse" in 63.6% of participants with at least one dose of PGE1 (P < 0.01 for each active dose versus placebo). In the other cross-over study, only one of three treatment groups conducted a self-evaluation (55.5%: "good" or "excellent" response). Adverse effects were most frequent in the treated groups and occurred more often and intensely as doses increased. Penile pain (Peto OR 7.39, 95% CI. 5.40-10.12) and minor urethral trauma (Peto OR 3.79, 95% CI. 1.88-7.65) were predominant.
REVIEWERS' CONCLUSIONS
PGE1 was beneficial for many participants with ED of different aetiology. Adverse effects were proportional to dosage, albeit never serious. The use of PGE1 in ED could have been better interpreted if its effectiveness were compared by aetiology and with different forms of administrations, a longer follow-up were considered and more emphasis given to patient/partner relationships and quality of life.
Topics: Alprostadil; Erectile Dysfunction; Humans; Male; Randomized Controlled Trials as Topic; Vasodilator Agents
PubMed: 15106162
DOI: 10.1002/14651858.CD001784.pub2 -
World Journal of Urology Jun 2019Data assessing the effectiveness of intracavernosal injections (ICIs) for the treatment of erectile dysfunction (ED) are limited. This study evaluates intracavernosal...
PURPOSE
Data assessing the effectiveness of intracavernosal injections (ICIs) for the treatment of erectile dysfunction (ED) are limited. This study evaluates intracavernosal injectable therapies for ED and reviews available guidelines that inform clinical practice.
METHODS
A systematic search using electronic databases (Medline, Pubmed) was performed for studies investigating injectable management strategies for ED published after 1990. Primary outcome measures were to comparatively evaluate clinical efficacy, continuation rates and adverse event profiles of each injectable agent as monotherapy or in combination. The secondary outcome measurement was to discuss available guidelines that inform clinical practice for injectable agents.
RESULTS
ICIs demonstrate clinical efficacy in 54-100% of patients, early discontinuation rates of ≤ 38% and adverse events in ≤ 26%. Discontinuation rates are typically greatest within 3-6 months of commencement. Anxiety related to the initial injection occurs in approximately 65% and anxiety levels can remain high for 4 months. Approval of intracavernosal injection agents is mainly limited to alprostadil with the recent addition of aviptadil/phentolamine combination therapy in a select few geographical regions. Although combination therapies are attractive alternative options, their formulations are variable and should be standardised before widespread acceptance is achieved.
CONCLUSIONS
ICIs are associated with good clinical efficacy rates, high discontinuation rates and a moderate side-effect profile. They represent an important tool in the urological armamentarium for treating ED in patients that cannot tolerate or are refractory to oral therapies.
Topics: Alprostadil; Drug Combinations; Erectile Dysfunction; Humans; Injections, Intralesional; Male; Penis; Phentolamine; Vasoactive Intestinal Peptide; Vasodilator Agents
PubMed: 30895359
DOI: 10.1007/s00345-019-02727-5 -
The Cochrane Database of Systematic... Oct 2018Despite efforts to preserve the neurovascular bundles with nerve-sparing surgery, erectile dysfunction remains common following radical prostatectomy. Postoperative... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Despite efforts to preserve the neurovascular bundles with nerve-sparing surgery, erectile dysfunction remains common following radical prostatectomy. Postoperative penile rehabilitation seeks to restore erectile function but results have been conflicting.
OBJECTIVES
To evaluate the effects of penile rehabilitation strategies in restoring erectile function following radical prostatectomy for prostate cancer.
SEARCH METHODS
We performed a comprehensive search of multiple databases (CENTRAL, MEDLINE, Embase), the Cochrane Library, Web of Science, clinical trial registries (ClinicalTrials.gov, International Clinical Trials Registry Platform) and a grey literature repository (Grey Literature Report) from their inception through to 3 January 2018. We also searched the reference lists of other relevant publications and abstract proceedings. We applied no language restrictions.
SELECTION CRITERIA
We included randomised or quasi-randomised trials with a parallel or cross-over design.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. Two review authors independently screened the literature, extracted data, assessed risk of bias and rated quality of evidence according to GRADE on a per-outcome basis. Primary outcomes were self-reported potency, erectile function measured by validated questionnaires (with potency defined as an International Index of Erectile Function (IIEF-EF) score of 19 or greater and or an IIEF-5 of score of 17 or greater) and serious adverse events. For all quality of life assessments on a continuous scale, higher values indicated better quality of life.
MAIN RESULTS
We included eight randomised controlled trials with 1699 participants across three comparisons. This abstract focuses on the primary outcomes of this review only.Scheduled phosphodiesterase type 5 inhibitors (PDE5I) versus placebo or no treatmentScheduled PDE5I may have little or no effect on short-term (up to 12 months) self-reported potency (risk ratio (RR) 1.13, 95% confidence interval (CI) 0.91 to1.41; very low quality evidence), which corresponds to 47 more men with self-reported potency per 1000 (95% CI 33 fewer to 149 more) and short-term erectile function as assessed by a validated instrument (RR 1.11, 95% CI 0.80 to 1.55; very low quality evidence), which corresponds to 28 more men per 1000 (95% CI 50 fewer to 138 more), but we are very uncertain of both of these findings. Scheduled PDE5I may result in fewer serious adverse events compared to placebo (RR 0.32, 95% CI 0.11 to 0.94; low quality evidence), though this does not appear biologically plausible and may represent a chance finding. We are also very uncertain of this finding. We found no long-term (longer than 12 months) data for any of the three primary outcomes.Scheduled PDE5I versus on-demand PDE5I Daily PDE5I appears to result in little to no difference in both short-term and long-term (greater than 12 months) self-reported potency (short term: RR 0.97, 95% CI 0.62 to 1.53; long term: RR 1.00, 95% CI 0.60 to 1.67; both very low quality evidence); this corresponds to nine fewer men with self-reported short-term potency per 1000 (95% CI 119 fewer to 166 more) and zero fewer men with self-reported long-term potency per 1000 (95% CI 153 fewer to 257 more). We are very uncertain of these findings. Daily PDE5I appears to result in little to no difference in short-term and long-term erectile function (short term: RR 1.00, 95% CI 0.65 to 1.55; long term; RR 0.74, 95% CI 0.48 to 1.14; both very-low quality evidence), which corresponds to zero men with short-term erectile dysfunction per 1000 (95% CI 80 fewer to 125 more) and 119 fewer men with long-term erectile dysfunction per 1000 (95% CI 239 fewer to 64 more). We are very uncertain of these findings. Scheduled PDE5I may result in little or no effects on short-term adverse events (RR 0.69 95% CI 0.12 to 4.04; very low quality evidence), which corresponds to seven fewer men with short-term serious adverse events (95% CI 18 fewer to 64 more), but we are very uncertain of these findings. We found no long-term data for serious adverse events.Scheduled PDE5I versus scheduled intraurethral prostaglandin E1At short-term follow-up, daily PDE5I may result in little or no effect on self-reported potency (RR 1.10, 95% CI 0.79, to 1.52; very low quality evidence), which corresponds to 46 more men per 1000 (95% CI 97 fewer to 241 more). Daily PDE5I may result in a small improvement of erectile function (RR 1.64, 95% CI 0.84 to 3.20; very low quality evidence), which corresponds to 92 more men per 1000 (95% CI 23 fewer to 318 more) but we are very uncertain of both these findings. We found no long-term (longer than 12 months) data for any of the three primary outcomes.We found no evidence for any other comparisons and were unable to perform any of the preplanned subgroup analyses based on nerve-sparing approach, age or baseline erectile function.
AUTHORS' CONCLUSIONS
Based on mostly very-low and some low-quality evidence, penile rehabilitation strategies consisting of scheduled PDE5I use following radical prostatectomy may not promote self-reported potency and erectile function any more than on demand use.
Topics: Alprostadil; Drug Administration Schedule; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Postoperative Complications; Prostatectomy; Prostatic Neoplasms; Quality of Life; Surveys and Questionnaires; Urological Agents; Withholding Treatment
PubMed: 30352488
DOI: 10.1002/14651858.CD012414.pub2 -
Renal Failure Dec 2024To evaluate the efficacy, effectiveness and safety of fermented mycelium (FOSM) products for preventing contrast-associated acute kidney injury (CA-AKI).
BACKGROUND
To evaluate the efficacy, effectiveness and safety of fermented mycelium (FOSM) products for preventing contrast-associated acute kidney injury (CA-AKI).
METHODS
Randomized controlled trials were searched from four Chinese and four English electronic databases and three clinical trial registries up to July 2023. Methodological quality was assessed by using the Cochrane risk-of-bias tool 2.0. Risk difference (RD) or risk ratio (RR) and mean difference (MD) were calculated along with the 95% confidence intervals (CIs).
RESULTS
Fourteen trials testing three types of FOSM products (Bailing, Zhiling, and Jinshuibao capsules) involving 1271 participants injected contrast agents were included. For the risk of bias, all trials were rated as some concerns. Compared with routine preventive procedure (RPP) (saline hydration and alprostadil), FOSM products plus RPP showed beneficial effects in reducing the incidence of CA-AKI (14.62% and 5.35%, respectively; RD -0.06, 95% CI -0.09 to -0.03). Subgroup analysis showed that Bailing/Jinshuibao plus RPP demonstrated lower incidence of CA-AKI compared to RPP. However, there was no statistically significant difference between Zhiling with RPP and RPP in the incidence of CA-AKI. Additionally, only when FOSM products were taken before injection of the contrast, it was superior to RPP in reducing the incidence of CA-AKI. There was no statistical difference in adverse events between these two groups.
CONCLUSIONS
Low certainty evidence suggests that preventive oral use of FOSM products as an adjuvant agent was safe and might decrease the incidence of CA-AKI. However, high-quality placebo-controlled trials are needed to confirm its benefit.
Topics: Humans; Acute Kidney Injury; Adjuvants, Pharmaceutic; Cordyceps; Randomized Controlled Trials as Topic; Biological Products
PubMed: 38189088
DOI: 10.1080/0886022X.2023.2300302 -
Minerva Urologica E Nefrologica = the... Oct 2020We aimed to summarize evidences about the efficacy of available treatments for erectile disfunction after robotic assisted radical prostatectomy (RARP).
INTRODUCTION
We aimed to summarize evidences about the efficacy of available treatments for erectile disfunction after robotic assisted radical prostatectomy (RARP).
EVIDENCE ACQUISITION
A systematic literature review searching on PubMed (Medline), Scopus, and Web of Science databases was performed in December 2019. PRISMA guidelines were followed. Population consisted of patients with erectile disfunction after RARP (P), conservative and surgical intervention were considered of interest (I). No comparator was considered mandatory (C). Outcomes of interest were the recovery of erectile function after conservative treatments and sexual function after surgical treatments (O).
EVIDENCE SYNTHESIS
Eleven studies were included. Seven studies focused on the use of phosphodiesterase-5 inhibitors (PDE5i) alone (five studies) or associated with other treatments (two studies). All the studies confirmed the efficacy of PDE5i, while the most promising association is with vacuum pump erectile devices. Two studies investigated topical treatments, namely low intensity extracorporeal shock wave therapy and alprostadil. Low intensity extracorporeal shock wave therapy may be a promising option in patients in whom nerve-sparing surgery was performed. The use of alprostadil could be an effective alternative to intracorporeal injection in those who underwent non-nerve-sparing surgery. One study focused and confirmed the efficacy of penile implants. Furthermore, one study reported the efficacy of a multi-modal treatment with preoperative medication, showing the benefits of a multimodal approach.
CONCLUSIONS
Penile rehabilitation with PDE5i is effective after nerve sparing RARP. The association of PDE5i with vacuum devices could led to a faster recovery. A multimodal approach with preoperative specific care seems to be effective to fasten erectile function recovery.
Topics: Erectile Dysfunction; Humans; Male; Penile Prosthesis; Phosphodiesterase 5 Inhibitors; Postoperative Complications; Prostatectomy; Prostatic Neoplasms; Robotic Surgical Procedures
PubMed: 32748616
DOI: 10.23736/S0393-2249.20.03780-7 -
Arquivos de Gastroenterologia 2020Lubiprostone is a type 2 chloride channel activator that has been shown to be efficacious and safe in the treatment for chronic constipation. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Lubiprostone is a type 2 chloride channel activator that has been shown to be efficacious and safe in the treatment for chronic constipation.
OBJECTIVE
To systematically review randomized clinical trials (RCTs) assessing efficacy of lubiprostone for patients with chronic idiopathic constipation (CIC), irritable bowel syndrome with predominant constipation (IBS-C) and opioid-induced constipation (OIC).
METHODS
Searches were conducted in PubMed, LILACS, Cochrane Collaboration Database, and Centre for Reviews and Dissemination. Lubiprostone RCTs reporting outcomes of spontaneous bowel movements (SBM) and abdominal pain or discomfort were deemed eligible. Meta-analysis was performed calculating risk ratios and 95% confidence intervals, using the Mantel-Haenszel method and random effects model.
RESULTS
Searches yielded 109 records representing 93 non-duplicate publications, and 11 RCTs (978 CIC, 1,366 IBS-C, 1,300 OIC, total = 3,644) met inclusion criteria. Qualitative synthesis showed that for CIC patients, lubiprostone is superior to placebo in terms of SBM outcomes. Meta-analysis for CIC was feasible for full responder and SBM within 24h rates, indicating superiority of lubiprostone over placebo. For IBS-C, lubiprostone was significantly superior for all SBM outcomes in follow-ups ranging from 1 week-3 months. In terms of abdominal pain, lubiprostone provided significantly better symptoms relief, particularly after 1 month of treatment. For OIC, lubiprostone was more effective than placebo for both SBM and discomfort measures.
CONCLUSION
Our findings demonstrated that lubiprostone is superior to placebo in terms of SBM frequency for CIC, IBS-C and OIC. In terms of abdominal symptoms, the most pronounced effect was seen for abdominal pain in IBS-C patients.
Topics: Analgesics, Opioid; Constipation; Defecation; Humans; Irritable Bowel Syndrome; Lubiprostone; Treatment Outcome
PubMed: 33331483
DOI: 10.1590/S0004-2803.202000000-83 -
Sexual Medicine Reviews Jul 2019On-demand phosphodiesterase type 5 inhibitor (PDE5i) monotherapy is a first-line treatment for erectile dysfunction (ED), but 30%-40% of patients exhibit little or no...
INTRODUCTION
On-demand phosphodiesterase type 5 inhibitor (PDE5i) monotherapy is a first-line treatment for erectile dysfunction (ED), but 30%-40% of patients exhibit little or no response. The success rate of alprostadil therapy is high in these patients, but this treatment requires painful intracavernosal injection.
AIM
To systematically review the efficacy and safety of second-line oral pharmacologic combination therapies of ED when PDE5i monotherapy fails.
METHODS
PubMed and Embase were searched to identify reports providing quantitative data on the treatment of ED in patients failing PDE5i monotherapy.
MAIN OUTCOME MEASURES
The measures of erectile function were the International Index of Erectile Function (IIEF) and the Erectile Function Domain (EFD).
RESULTS
Chronic treatment with the PDE5i tadalafil alone or in combination with sildenafil on demand showed similar IIEF-5 score improvements. None of the 3 randomized controlled trials (RCTs) in patients who had failed PDE5i monotherapy found a superior effect on IIEF scores from the combination of androgen plus PDE5i compared with PDE5i monotherapy. Combination therapy with androgen supplementation and PDE5i appears safe. In 1 RCT, combination therapy with PDE5i and an α-adrenoceptor antagonist was not superior to PDE5i monotherapy. Six other studies, each with a different combination of PDE5i and another drug (eg, metformin, folic acid, 5-alpha-reductase inhibitors), were identified, but further research is required to investigate their efficacy in treating ED.
CONCLUSION
For ED, chronic treatment with low-dose PDE5i can be attempted when standard on-demand regimens fail. Combination therapy with androgen supplementation and a PDE5i appears to be safe. The combination of an α-adrenoceptor antagonist and PDE5i shows no advantageous effect on ED compared with PDE5i monotherapy. The efficacy of combining PDE5i with metformin, folic acid, or 5-alpha-reductase inhibitors is uncertain and requires further research. There is an unmet need for oral treatment of ED in nonresponders to PDE5i treatment. Munk NE, Knudsen JS, Comerma-Steffensen S, et al. Systematic Review of Oral Combination Therapy for Erectile Dysfunction When Phosphodiesterase Type 5 Inhibitor Monotherapy Fails. Sex Med Rev 2019;7:430-441.
Topics: Administration, Oral; Alprostadil; Drug Therapy, Combination; Erectile Dysfunction; Humans; Male; Penile Erection; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate; Tadalafil; Treatment Failure; Treatment Outcome; Vasodilator Agents
PubMed: 30711478
DOI: 10.1016/j.sxmr.2018.11.007 -
Medicine Feb 2020Adequate bowel preparation is essential to the quality of colonoscopy. We performed a meta-analysis to determine the efficacy and safety of the addition of lubiprostone... (Meta-Analysis)
Meta-Analysis
AIM
Adequate bowel preparation is essential to the quality of colonoscopy. We performed a meta-analysis to determine the efficacy and safety of the addition of lubiprostone to the bowel preparation process prior to colonoscopy.
METHODS
Online databases, namely, PubMed, MEDLINE and Cochrane Library, were searched for randomized controlled trials that assessed the additive effect of lubiprostone on the quality of colon preparation in patients undergoing colonoscopy. Each included study was evaluated by the Jadad score to assess the quality of the study. The primary outcome was bowel preparation efficacy, defined as the proportion of patients with an excellent or poor preparation. The secondary outcomes included the length of the colonoscopy, polyp detection, and any adverse effects.
RESULTS
In total, 5 articles published between 2008 and 2016 fulfilled the selection criteria. The addition of lubiprostone to the bowel cleansing process significantly increased the proportion of patients with an excellent preparation (risk ratio [RR] = 1.68, 95% confidence interval (CI): 1.40-2.02, P < .00001) but did not decrease the procedural time or increase the polyp detection rate (mean difference = -0.52, 95% CI: -3.74-2.69, P = .75; RR = 1.16, 95% CI: 0.96-1.42, P = .13, respectively). There was no significant difference in the proportion of patients with any adverse events.
CONCLUSION
The addition of lubiprostone to the bowel preparation regimen prior to colonoscopy is effective and safe.
Topics: Cathartics; Colonoscopy; Drug Therapy, Combination; Humans; Lubiprostone; Operative Time; Polyethylene Glycols; Randomized Controlled Trials as Topic
PubMed: 32080109
DOI: 10.1097/MD.0000000000019208