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1.  Effects of Herbal vigRX on Premature Ejaculation: A randomized, double-blind study 
Objective
We conducted a double-blind, placebo-controlled study to determine the efficacy of an herbal sexual supplement (vigRX) on premature ejaculation (PE).
Method
A randomized double blind study was conducted on a fixed dose of herbal vigRX at Roozbeh Psychiatry Hospital, Tehran University of Medical Sciences. The sample consisted of 85 married patients diagnosed with primary PE according to Diagnostic and Statistical Manual of Mental Disorders. Each patient underwent diagnostic evaluation by one trained psychiatrist, using Structured Clinical Interview for DSM-IV-TR. Each patient was evaluated by researchers to exclude the organic sexual dysfunctions. The patients were randomly assigned in to two groups: group 1 consisting of 42 patients receiving placebo, and group 2 consisting of 43 patients receiving 540 mg herbal vigRX for a 4-week treatment course. The effects of the drug on the ejaculatory function in each group were assessed by the intravaginal ejaculation latency time (IELT), and the Chinese Index of Premature Ejaculation (CIPE) before and at the end of the treatment course. Statistical analysis was performed using SPSS software (15th version).
Results
The mean IELT increased 22.4 and 32.0 seconds in the placebo and the vigRX group respectively after the treatment course. The mean IELT differences between the two groups was not significant. The mean CIPE score increased 2.40 and 4.37 in the placebo and the vigRX group respectively. The mean CIPE score differences between the two groups was not significant.No side effect was reported by the subjects in neither groups during the treatment course.
Conclusion
Although the improvement in IELT and CIPE scores in the herbal vigRX group was more than the placebo group, this difference was not statistically significant. The increasing of IELT and CIPE score in the placebo group may be due to the placebo effects. Further studies with higher vigRX doses, greater sample size and longer treatment courses are warranted.
PMCID: PMC3430409  PMID: 22952482
Ejaculation; Herbal medicine; Sexual dysfunction; Controlled trial
2.  Do randomized clinical trials with inadequate blinding report enhanced placebo effects for intervention groups and nocebo effects for placebo groups? 
Systematic Reviews  2014;3:14.
Background
Studies suggest that expectations powerfully shape clinical outcomes. For subjective outcomes in adequately blinded trials, health improvements are substantial and largely explained by non-specific factors.
The objective of this study was to investigate if unblinding in randomized controlled trials (RCTs) is associated with enhanced placebo effects for intervention groups and nocebo effects for placebo groups. For these effects, a secondary objective was to explore potential moderating factors.
Methods
We included RCTs that investigated the efficacy of phosphodiesterase-5 (PDE-5) inhibitors for male erectile dysfunction by comparing one PDE-5 inhibitor to placebo. In addition, to be included studies must have reported scores for change from baseline, or baseline and final International Index of Erectile Functioning-Erectile Functioning domain score (IIEF-EF), and be published in either English, French, Dutch, or German.
We searched for both published and unpublished relevant trials using PUBMED, EMBASE, the Cochrane Central Register of Controlled Trials, a clinical trials register (clinicaltrials.gov) and the Food and Drug Administration clinical reviews through March 2012.
We evaluated the blinding status of trials with the Cochrane Risk of Bias Tool, using the domains of allocation sequence concealment, blinding of participants, healthcare providers and outcome assessors. Across these four domains, studies that scored low risk of bias were judged to be adequately blinded and studies that scored unclear or high risk of bias were judged to be inadequately blinded.
Results
We included 110 studies (205 journal publications and 2 unpublished sources) that involved 23,877 participants; 93 (85%), 51 (46%), 93 (85%) and 93 (85%) studies were assessed with an unclear risk of bias for allocation concealment, blinding of participant, blinding of caregiver and blinding of outcome assessor, respectively. None of the studies reported testing of blinding.
None of the 205 journal publications provided sufficient details to assess allocation concealment, blinding of participants, caregivers and outcome assessors. After contacting authors for additional information, we judged five studies to be adequately (n = 1,202) and 16 to be inadequately (n = 3,006) blinded. The IIEF-EF score for placebo groups in adequately blinded trials versus inadequately blinded trials was 1.92 points (95% CI, 0.64 to 3.20) versus 1.56 (95% CI, 0.93 to 2.20), respectively. The IIEF-EF score for intervention groups in adequately blinded trials versus inadequately blinded trials was 9.40 (95% CI, 6.96 to 11.83) versus 8.33 (95% CI, 7.29 to 9.37), respectively. In a secondary analysis, prior experience with the drug affected the scores; in placebo groups with participants naïve to the intervention the score was 2.89 (95% CI, 2.33 to 3.45) versus -0.11 (95% CI, -2.06 to 1.84) with participants having prior experience. In the intervention groups, these scores were 7.99 (95% CI, 6.85 to 9.14) versus 8.33 (95% CI, 7.51 to 9.16), respectively.
Unblinding lowered placebo scores (creating a nocebo effect) by 19% (0.33 points; 95% CI, -0.96 to 1.62). Unblinding lowered intervention scores by 11% (1.0; 95% CI, -1.35 to 3.47). The results provided no conclusive evidence for nocebo or enhanced placebo effects. Patients taking a PDE-5 inhibitor for the first time experience a larger placebo effect that accounts for 35% of the total effect.
Conclusions
Given the overall poor reporting of blinding in clinical trial reports and the small number of trials that could be rated as adequately or inadequately blinded, we could not draw any robust conclusions about the existence or absence of nocebo and enhanced placebo effects. A large placebo effect was found for patients taking PDE-5 inhibitors for the first time. It was not clear if previous exposure to the drug impacted trial blinding.
We found clear evidence that studies assessing a subjective continuous outcome fail to report on measures taken to secure double blinding. Although we observed a trend for the presence of a nocebo effect, there was insufficient evidence to quantify its impact on expectations. RCTs with patients with no prior experience with PDE-5 inhibitors reported larger placebo effects and possibly these studies were better blinded. Future research should further investigate the factors that contribute to blinding and their impact on health outcomes in randomized trials of subjectively assessed conditions. This research is part of a PhD project and has no external funding. The authors have no competing interests to declare.
doi:10.1186/2046-4053-3-14
PMCID: PMC3939643  PMID: 24555576
Placebo; Nocebo; Phosphodiesterase-5 inhibitor; Randomized controlled trial; Expectancy; Double blind; Bias; Treatment efficacy
3.  Lack of awareness of erectile dysfunction in many men with risk factors for erectile dysfunction 
BMC Urology  2010;10:18.
Background
Men with erectile dysfunction often have concurrent medical conditions. Conversely, men with these conditions may also have underlying erectile dysfunction. The prevalence of unrecognized erectile dysfunction in men with comorbidities commonly associated with erectile dysfunction was determined in men invited to participate in a double-blind, randomized, placebo-controlled trial of sildenafil citrate.
Methods
Men ≥30 years old presenting with ≥1 erectile dysfunction risk factor (controlled hypertension, hypercholesterolemia, smoking, metabolic syndrome, stable coronary artery disease, diabetes, depression, lower urinary tract symptoms, obesity [body mass index ≥30 kg/m2] or waist circumference ≥40 inches), and not previously diagnosed with erectile dysfunction were evaluated. The screening question, "Do you have erectile dysfunction?," with responses of "no," "yes," and "unsure," and the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) were administered.
Results
Of 1084 men screened, 1053 answered the screening question and also had IIEF-EF scores. IIEF-EF scores indicating erectile dysfunction occurred in 71% (744/1053), of whom 54% (399/744) had moderate or severe erectile dysfunction. Of 139 answering "yes," 526 answering "unsure," and 388 answering "no," 96%, 90%, and 36%, respectively, had some degree of erectile dysfunction. The mean±SD (range) number of risk factors was 2.9 ± 1.7 (3-8) in the "yes" group, 3.2 ± 1.7 (3-9) in the "unsure" group, and 2.6 ± 1.5 (2-8) in the "no" group.
Conclusion
Although awareness of having erectile dysfunction was low, most men with risk factors had IIEF-EF scores indicating erectile dysfunction. Erectile dysfunction should be suspected and assessed in men with risk factors, regardless of their apparent level of awareness of erectile dysfunction.
Trial registration
ClinicalTrials.gov Identifier NCT00343200.
doi:10.1186/1471-2490-10-18
PMCID: PMC2991280  PMID: 21054874
4.  Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis 
Asian Journal of Andrology  2009;11(4):423-433.
We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population (with varying patient demographics, disease severity, and comorbid medical conditions) of Asian men with erectile dysfunction (ED). An integrated analysis of five double-blind, placebo-controlled trials (N = 1 046) was performed. Patients were randomly assigned to receive 10 mg tadalafil (N = 185), 20 mg tadalafil (N = 510), or placebo (N = 351). Efficacy assessments included the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary and Global Assessment Question (GAQ). Patients receiving 10 mg or 20 mg tadalafil showed significant improvement from baseline-to-end point on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) domain score in all clinical sub-populations analyzed, compared with patients receiving placebo (P < 0.001). The 10-mg and 20-mg tadalafil groups showed a mean success rate of 64.1% and 70.5% for sexual intercourse attempts (SEP3, successful intercourse), respectively, compared with 33.4% in the placebo group (P < 0.001), and 85.5% and 85.4% reported improved erections at end point GAQ, respectively, versus 43.5% in the placebo group (P < 0.001). Tadalafil was well tolerated across all groups studied. Headache and back pain were the most frequently reported adverse events. Overall, tadalafil was effective and well tolerated across a diverse clinical spectrum of Asian men with ED.
doi:10.1038/aja.2009.11
PMCID: PMC3735316  PMID: 19377488
Asia; comorbidity; erectile dysfunction; phosphodiesterase inhibitors; tadalafil
5.  Self-Esteem, Confidence, and Relationships in Men Treated with Sildenafil Citrate for Erectile Dysfunction 
Journal of General Internal Medicine  2006;21(10):1069-1074.
BACKGROUND
Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction.
OBJECTIVE
We evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire.
DESIGN
Pooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan.
PATIENTS
Men ≥18 years old with ED.
MEASUREMENTS
The impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes.
RESULTS
Compared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P<.0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P<.0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy.
CONCLUSIONS
In men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.
doi:10.1111/j.1525-1497.2006.00554.x
PMCID: PMC1831645  PMID: 16836626
erectile dysfunction; impotence; self-esteem; confidence; quality of life; relationship; psychometrics
6.  Efficacy of Ashwagandha (Withania somnifera Dunal. Linn.) in the management of psychogenic erectile dysfunction 
Ayu  2011;32(3):322-328.
Erectile dysfunction (ED) has been defined as the persistent inability to attain and maintain an erection sufficient to permit satisfactory sexual performance. By 2025, men with ED will be approximately 322 million, an increase of nearly 170 million men from 1995. The present study was aimed to evaluate the efficacy of Ashwagandha (Withania somnifera) in the management of psychogenic erectile dysfunction. In this study, a total of 95 patients with psychogenic erectile dysfunction satisfying the DSM IV TR diagnostic criteria were selected, out of them 86 patients completed the course of treatment. In Trial Group, Ashwagandha root powder and in Control group, Placebo (Wheat powder) were given for 60 days. Treatment selection and its allocation were done by following computerized randomization plan. Criterion of assessment was based on the scoring of International Index of Erectile Function (IIEF) Scale. Paired and Unpaired t test were used for statistical analysis. In Trial group (n=41), 12.6% and in Control group (n=45), 19.11% of improvement was observed with the significance of (P<0.001). There was no significant difference (P>0.05) found in between the two groups. Both Ashwagandha and Placebo provided no relief (<25% improvement on IIEF) in psychogenic erectile dysfunction.
doi:10.4103/0974-8520.93907
PMCID: PMC3326875  PMID: 22529644
Ashwagandha; International Index of Erectile Function; placebo; psychogenic erectile dysfunction
7.  Effects of tissue-cultured mountain ginseng (Panax ginseng CA Meyer) extract on male patients with erectile dysfunction 
Asian Journal of Andrology  2009;11(3):356-361.
Korean ginseng and mountain ginseng (Panax ginseng CA Meyer) are important traditional herbal plants whose ginsenosides are generally accepted as serving to improve sexual functions, such as penile erection. We investigated the effects of tissue-cultured mountain ginseng extract (TMGE) on male patients with erectile dysfunction (ED). A double-blind, placebo-controlled study was conducted with 143 patients experiencing ED. Over the course of 8 weeks, one group took 1 000 mg of TMGE twice a day, and the other group took 1 000 mg of placebo twice a day. The effects of the TMGE and the placebo were analyzed using the Korean version of the International Index of Erectile Function (IIEF) questionnaire. A total of 86 patients completed 8 weeks of treatment. The scores on the five domains of the IIEF after medication were significantly higher than the baseline scores in the group treated with TMGE (P < 0.05), whereas no significant improvement was observed in the placebo group (P > 0.05). Erectile function and overall satisfaction scores after medication were significantly higher in the TMGE group than in the placebo group (P < 0.05). Erectile function of patients in the TMGE-treated group significantly improved, suggesting that TMGE could be utilized for improving erectile function in male patients.
doi:10.1038/aja.2008.32
PMCID: PMC3735289  PMID: 19234482
erectile dysfunction; Panax ginseng; tissue-cultured mountain ginseng extract
8.  Change in symptoms of erectile dysfunction in depressed men initiating buprenorphine therapy☆ 
Aims
The aim of this study is to describe the change in erectile dysfunction (ED) symptoms in the first 12 weeks of outpatient buprenorphine therapy.
Background
Erectile dysfunction is highly prevalent in men who use illicit opioids when compared with the general population. To date, no study has examined ED symptoms over time in men initiating buprenorphine therapy for opioid dependence.
Methods
A randomized, double blind, placebo-controlled trial was conducted to determine whether escitalopram treatment of depressive symptoms begun 1 week prior to buprenorphine induction would improve treatment retention. Male patients completed the International Index of Erectile Function scale at baseline prior to induction and monthly thereafter. A score of 25 or less on the erectile function domain (range 1–30) is considered indicative of erectile dysfunction.
Findings
A total of 111 male subjects enrolled: mean age 38.5 (± 9.7) years, 80.1% non-Hispanic Caucasian; 67.3% reported heroin as their opioid of choice. Mean IIEF at baseline was 20.4 (± 10.5). At baseline, 44.1% of the entire cohort had erectile dysfunction; among those who identified as sexually active at baseline, 26.1% had ED. Baseline erectile function was inversely and significantly correlated with age (r = −.27, p = .006), but was not associated significantly with race, heroin use, years of opioid use, smoking, or hazardous use of alcohol. Compared to baseline, mean erectile function was significantly improved (p = .001) at 3 months, and sexual desire (p = .002) improved significantly at both 2- and 3-month assessments.
Conclusion
Erectile dysfunction is highly prevalent in depressed males using illicit opioids. Men who remain in buprenorphine treatment for 3 months show improvement in erectile function and sexual desire.
doi:10.1016/j.jsat.2013.06.004
PMCID: PMC4020627  PMID: 23891461
Opioid dependence; Buprenorphine; Erectile dysfunction
9.  A Randomized, Double-Blind, Placebo-Controlled Crossover Study of Cappra® for the Treatment of Mild or Mild to Moderate Erectile Dysfunction in Thai Male 
Erectile dysfunction (ED) is one of the major health concerns affects the quality of life among Thai male. The treatment of ED by the first-line drugs is limited to a certain group of patients due to their side effects and costs. Alternative medicine can be beneficial for the treatment of ED. This is a randomized, double-blind, placebo-controlled, crossover study aimed to assess the efficacy and safety of Cappra®, a traditional herbal medicine which was used in Thailand for decades, for the treatment of mild and mild to moderate ED in Thai patients. A total of 63 patients with mild or mild to moderate ED were randomized to receive Cappra® or placebo for two weeks in the first period, followed by one week washout period. The patients were switched to the alternative treatment in the second period. The efficacy was assessed by the International Index of Erectile Function (IIEF) questionnaire and adverse events. Sixty one patients completed the study. There was an improvement of IIEF score for all domains in Cappra® group compared with placebo group. The mean change of IIEF score from baseline for erectile function domain of Cappra® was significantly higher than placebo (4.87 vs 3.44, p = 0.032). The most common adverse events were dizziness (13.3% Cappra®, 9.6% placebo), face numbness (1.6% Cappra®, 0% placebo), and tachycardia (1.6% Cappra®, 0% placebo). The results from this study demonstrated that Cappra® is effective and well-tolerated and can be used as alternative therapy for mild and mild to moderate ED.
PMCID: PMC3746578  PMID: 24146455
Erectile dysfunction; herbal medicine; International Index of Erectile Function; IIEF
10.  Randomized Clinical Trial on the Use of PHYSTA Freeze-Dried Water Extract of Eurycoma longifolia for the Improvement of Quality of Life and Sexual Well-Being in Men 
Eurycoma longifolia is reputed as an aphrodisiac and remedy for decreased male libido. A randomized, double-blind, placebo controlled, parallel group study was carried out to investigate the clinical evidence of E. longifolia in men. The 12-week study in 109 men between 30 and 55 years of age consisted of either treatment of 300 mg of water extract of E. longifolia (Physta) or placebo. Primary endpoints were the Quality of Life investigated by SF-36 questionnaire and Sexual Well-Being investigated by International Index of Erectile Function (IIEF) and Sexual Health Questionnaires (SHQ); Seminal Fluid Analysis (SFA), fat mass and safety profiles. Repeated measures ANOVA analysis was used to compare changes in the endpoints. The E. longifolia (EL) group significantly improved in the domain Physical Functioning of SF-36, from baseline to week 12 compared to placebo (P = 0.006) and in between group at week 12 (P = 0.028). The EL group showed higher scores in the overall Erectile Function domain in IIEF (P < 0.001), sexual libido (14% by week 12), SFA- with sperm motility at 44.4%, and semen volume at 18.2% at the end of treatment. Subjects with BMI ≥ 25 kg/m2 significantly improved in fat mass lost (P = 0.008). All safety parameters were comparable to placebo.
doi:10.1155/2012/429268
PMCID: PMC3518798  PMID: 23243445
11.  A double blind, randomised study of sildenafil citrate for erectile dysfunction in men with multiple sclerosis 
Objective: Identifying and effectively treating erectile dysfunction (ED) can result in an improvement of the quality of life (QoL) in men with multiple sclerosis (MS).
Methods: This randomised, double blind (DB), placebo controlled, flexible dose study with an open label extension (OLE) assessed efficacy, QoL, and safety of sildenafil citrate in men with MS and ED. Overall, 217 men received sildenafil (25–100 mg; n = 104) or placebo (n = 113) for 12 weeks. Efficacy was assessed by the International Index of Erectile Function (IIEF) questionnaire that includes questions on achieving (Q3) and maintaining (Q4) an erection as well as a global efficacy question (GEQ). QoL was also assessed.
Results: After 12 weeks, patients receiving sildenafil had higher mean scores for IIEF Q3 and Q4 compared with those receiving placebo (p<0.0001), and 89% (92/103) reported improved erections compared with 24% (27/112) of patients receiving placebo (p<0.0001). At the end of the OLE phase, 95% of men reported improved erections. Patients receiving placebo during the DB phase showed a nearly fourfold increase in improved erections (97% v 26%). Men receiving sildenafil also showed improvements in five of the eight general QoL questions compared with men receiving placebo (p<0.05). The total mean score for the QoL questionnaire improved by 43% for the sildenafil group versus 13% for the placebo group (p<0.0001). Treatment related AEs were predominantly mild in nature, and no patient discontinued due to an AE.
Conclusion: Sildenafil treatment for ED in men with MS was effective and well tolerated, and resulted in significant improvements in both general and disease specific QoL variables.
doi:10.1136/jnnp.2004.038695
PMCID: PMC1739638  PMID: 15834030
12.  A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Flexible-Dose, Two-Way Crossover Study to Evaluate the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction 
Background/Objective:
To show the efficacy, safety, and tolerability of sildenafil in men with erectile dysfunction (ED) associated with complete or incomplete spinal cord injury (SCI) and to assess its effects on quality of life (QoL) using the Life-Satisfaction Check List.
Methods:
This was a placebo-controlled, multicenter, randomized, double-blind, flexible-dose, 2-way crossover study with a 2-week washout period between each phase. Patients with ED attributable to SCI (Sexual Health Inventory—Male score ≤21) received 50 to 100 mg sildenafil (n = 24) or placebo (n = 26).
Results:
Compared with placebo, sildenafil produced higher levels of successful sexual stimulation, intercourse success, satisfaction with sexual life and sexual relationship, erectile function, overall sexual satisfaction, and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score, with no clinically relevant effects on vital signs. Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI, producing significant improvements, compared with placebo, in a number of measures only in patients with incomplete SCI. All patients who expressed a preference selected sildenafil over placebo, although the drug had no effect on patient QoL. Sildenafil was well tolerated, with a profile comparable to that of placebo.
Conclusions:
Compared with placebo, treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI, especially in those with incomplete injury, and was the agent of choice in those who expressed a preference.
PMCID: PMC2607124  PMID: 19086709
Sildenafil; Spinal cord injuries; Tetraplegia; Paraplegia; Erectile dysfunction; Impotence
13.  Erectile Dysfunction Severity as a Risk Marker for Cardiovascular Disease Hospitalisation and All-Cause Mortality: A Prospective Cohort Study 
PLoS Medicine  2013;10(1):e1001372.
In a prospective Australian population-based study linking questionnaire data from 2006–2009 with hospitalisation and death data to June 2010 for 95,038 men aged ≥45 years, Banks and colleagues found that more severe erectile dysfunction was associated with higher risk of cardiovascular disease.
Background
Erectile dysfunction is an emerging risk marker for future cardiovascular disease (CVD) events; however, evidence on dose response and specific CVD outcomes is limited. This study investigates the relationship between severity of erectile dysfunction and specific CVD outcomes.
Methods and Findings
We conducted a prospective population-based Australian study (the 45 and Up Study) linking questionnaire data from 2006–2009 with hospitalisation and death data to 30 June and 31 Dec 2010 respectively for 95,038 men aged ≥45 y. Cox proportional hazards models were used to examine the relationship of reported severity of erectile dysfunction to all-cause mortality and first CVD-related hospitalisation since baseline in men with and without previous CVD, adjusting for age, smoking, alcohol consumption, marital status, income, education, physical activity, body mass index, diabetes, and hypertension and/or hypercholesterolaemia treatment. There were 7,855 incident admissions for CVD and 2,304 deaths during follow-up (mean time from recruitment, 2.2 y for CVD admission and 2.8 y for mortality). Risks of CVD and death increased steadily with severity of erectile dysfunction. Among men without previous CVD, those with severe versus no erectile dysfunction had significantly increased risks of ischaemic heart disease (adjusted relative risk [RR] = 1.60, 95% CI 1.31–1.95), heart failure (8.00, 2.64–24.2), peripheral vascular disease (1.92, 1.12–3.29), “other” CVD (1.26, 1.05–1.51), all CVD combined (1.35, 1.19–1.53), and all-cause mortality (1.93, 1.52–2.44). For men with previous CVD, corresponding RRs (95% CI) were 1.70 (1.46–1.98), 4.40 (2.64–7.33), 2.46 (1.63–3.70), 1.40 (1.21–1.63), 1.64 (1.48–1.81), and 2.37 (1.87–3.01), respectively. Among men without previous CVD, RRs of more specific CVDs increased significantly with severe versus no erectile dysfunction, including acute myocardial infarction (1.66, 1.22–2.26), atrioventricular and left bundle branch block (6.62, 1.86–23.56), and (peripheral) atherosclerosis (2.47, 1.18–5.15), with no significant difference in risk for conditions such as primary hypertension (0.61, 0.16–2.35) and intracerebral haemorrhage (0.78, 0.20–2.97).
Conclusions
These findings give support for CVD risk assessment in men with erectile dysfunction who have not already undergone assessment. The utility of erectile dysfunction as a clinical risk prediction tool requires specific testing.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Erectile dysfunction is the medical term used when a man is unable to achieve or sustain an erection of his penis suitable for sexual intercourse. Although a sensitive topic that can cause much embarrassment and distress, erectile dysfunction is very common, with an estimated 40% of men over the age of 40 years experiencing frequent or occasional difficulties. The most common causes of erectile dysfunction are medications, chronic illnesses such as diabetes, and drinking too much alcohol. Stress and mental health problems can also cause or worsen erectile dysfunction. There is also increasing evidence that erectile dysfunction may actually be a symptom of cardiovascular disease—a leading cause of death worldwide—as erectile dysfunction could indicate a problem with blood vessels or poor blood flow commonly associated with cardiovascular disease.
Why Was This Study Done?
Although previous studies have suggested that erectile dysfunction can serve as a marker for cardiovascular disease in men not previously diagnosed with the condition, few studies to date have investigated whether erectile dysfunction could also indicate worsening disease in men already diagnosed with cardiovascular disease. In addition, previous studies have typically been small and have not graded the severity of erectile dysfunction or investigated the specific types of cardiovascular disease associated with erectile dysfunction. In this large study conducted in Australia, the researchers investigated the relationship of the severity of erectile dysfunction with a range of cardiovascular disease outcomes among men with and without a previous diagnosis of cardiovascular disease.
What Did the Researchers Do and Find?
The researchers used information from the established 45 and Up Study, a large cohort study that includes 123,775 men aged 45 and over, selected at random from the general population of New South Wales, a large region of Australia. A total of 95,038 men were included in this analysis. The male participants completed a postal questionnaire that included a question on erectile functioning, which allowed the researchers to define erectile dysfunction as none, mild, moderate, or severe. Using information captured in the New South Wales Admitted Patient Data Collection—a complete record of all public and private hospital admissions, including the reasons for admission and the clinical diagnosis—and the government death register, the researchers were able to determine health outcomes of all study participants. They then used a statistical model to estimate hospital admissions for cardiovascular disease events for different levels of erectile dysfunction.
The researchers found that the rates of severe erectile dysfunction among study participants were 2.2% for men aged 45–54 years, 6.8% for men aged 55–64 years, 20.2% for men aged 65–74 years, 50.0% for men aged 75–84 years, and 75.4% for men aged 85 years and over. During the study period, the researchers recorded 7,855 hospital admissions related to cardiovascular disease and 2,304 deaths. The researchers found that among men without previous cardiovascular disease, those with severe erectile dysfunction were more likely to develop ischemic heart disease (risk 1.60), heart failure (risk 8.00), peripheral vascular disease (risk 1.92), and other causes of cardiovascular disease (risk 1.26) than men without erectile dysfunction. The risks of heart attacks and heart conduction problems were also increased (1.66 and 6.62, respectively). Furthermore, the combined risk of all cardiovascular disease outcomes was 1.35, and the overall risk of death was also higher (risk 1.93) in these men. The researchers found that these increased risks were similar in men with erectile dysfunction who had previously been diagnosed with cardiovascular disease.
What Do These Findings Mean?
These findings suggest that compared to men without erectile dysfunction, there is an increasing risk of ischemic heart disease, peripheral vascular disease, and death from all causes in those with increasing degrees of severity of erectile dysfunction. The authors emphasize that erectile dysfunction is a risk marker for cardiovascular disease, not a risk factor that causes cardiovascular disease. These findings add to previous studies and highlight the need to consider erectile dysfunction in relation to the risk of different types of cardiovascular disease, including heart failure and heart conduction disorders. However, the study's reliance on the answer to a single self-assessed question on erectile functioning limits the findings. Nevertheless, these findings provide useful information for clinicians: men with erectile dysfunction are at higher risk of cardiovascular disease, and the worse the erectile dysfunction, the higher the risk of cardiovascular disease. Men with erectile dysfunction, even at mild or moderate levels, should be screened and treated for cardiovascular disease accordingly.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001372.
Wikipedia defines erectile dysfunction (note that Wikipedia is a free online encyclopedia that anyone can edit)
MedlinePlus also has some useful patient information on erectile dysfunction
The Mayo Clinic has patient-friendly information on the causes of, and treatments for, erectile dysfunction, and also includes information on the link with cardiovascular disease
The National Heart Foundation of Australia provides information for health professionals, patients, and the general public about how to prevent and manage cardiovascular disease, including assessment and management of cardiovascular disease risk
doi:10.1371/journal.pmed.1001372
PMCID: PMC3558249  PMID: 23382654
14.  THE STAMP TEST DELIVERS THE MESSAGE ON ERECTILE DYSFUNCTION FOLLOWING HIGH DOSE IMRT FOR PROSTATE CANCER 
Urology  2012;80(2):337-342.
Objectives
To evaluate erectile function following high dose radiotherapy for prostate cancer using the international index of erectile function (IIEF), expanded prostate cancer index composite (EPIC), and stamp test.
Methods
Men with favorable and intermediate risk prostate cancer were assigned to receive prostate intensity modulated radiotherapy (IMRT) vs. an erectile tissue-sparing IMRT technique on a phase III randomized prospective study. The stamp test, IIEF, and EPIC questionnaires were completed at baseline, 6 months, one year, and two years after IMRT. Sexual Health Inventory for Men (SHIM) scores were abstracted from IIEF questionnaires. A partner questionnaire, designated IIEF-P, modeled after the IIEF but from the perspective of the partner, was collected.
Results
Ninety four men enrolled on the trial who completed at least one questionnaire or one stamp test were analyzed. The median age of the patient population was 62.5 years. The median RT dose was 76 Gy (range: 74–80 Gy). At 6-months and one year after high-dose IMRT, a positive stamp result significantly correlated with median EPIC sexual summary, sexual function (EF), and bother subscale scores. Additionally, 6-months after IMRT the stamp test correlated with median IIEF, IIEF EF domain, and SHIM scores. Robust concordance for the IIEF and SHIM results was appreciated between responding patients: partner pairs.
Conclusions
Nocturnal tumescence indicated by a positive stamp test correlates well with established quality of life questionnaires after IMRT. The stamp test should strongly be considered as an objective measure of erectile function in future studies of ED in prostate cancer patients.
doi:10.1016/j.urology.2012.04.048
PMCID: PMC3461589  PMID: 22749428
prostate cancer; intensity modulated radiotherapy; erectile dysfunction
15.  Correlation between Serum Total Testosterone and the AMS and IIEF Questionnaires in Patients with Erectile Dysfunction with Testosterone Deficiency Syndrome 
Korean Journal of Urology  2011;52(6):416-420.
Purpose
This study was conducted to investigate the relationship between serum total testosterone levels and scores on the Aging Male's Symptom (AMS) scale and the International Index of Erectile Function (IIEF) in men with erectile dysfunction with testosterone deficiency syndrome (TDS).
Materials and Methods
From January 2005 to July 2008, 134 patients who complained of sexual dysfunction such as erectile dysfunction or decreased libido as the main symptoms of TDS with serum total testosterone levels less than 3.5 ng/ml were evaluated by independent t-test and linear regression analysis, respectively. Patients with treated hypogonadism within 6 months, with a history of taking a PDE5 inhibitor or an antidepressant for a depressive disorder, or who had metabolic syndrome were excluded from this study.
Results
The AMS scale and its 3 subdomain scores were not significantly correlated with the total testosterone level. By contrast, the total IIEF score and the score of each IIEF domain except sexual desire showed a weakly significantly positive correlation with serum total testosterone.
Conclusions
In TDS patients with erectile dysfunction, there was a low relationship between serum total testosterone levels and the AMS scale and a weakly positive correlation between total testosterone levels and all IIEF domains except sexual desire. There was a low relationship between the AMS scale, the sexual desire domain score of the IIEF, and total testosterone. We should understand these limitations when evaluating patients with erectile dysfunction with TDS. New scales should be developed for the evaluation of erectile dysfunction in these patients.
doi:10.4111/kju.2011.52.6.416
PMCID: PMC3123819  PMID: 21750754
Erectile dysfunction; Questionnaires; Testosterone
16.  Medical management of erectile dysfunction in aging males: Is it too late to treat? 
Asian Journal of Andrology  2013;16(1):153-156.
Erectile dysfunction (ED) is a common disorder among aging males. However, most aging males refuse to seek medical help and believe that ED is an irreversible event in the aging process. The purpose of this study was to describe the current medical management of ED in aging males and to examine whether it is too late to treat this disorder in these elderly men. From 2007 to 2008, 4507 patients diagnosed with ED were gathered from 46 centers in China; 4241 completed the study, 3837 of whom were treated with sildenafil. The 3837 patients were divided into five groups based on age (group A: 20–30 years; group B: 31–40 years; group C: 41–50 years; group D: 51–60 years; and group E: >60 years). After comparing pre- and posttreatment International Index of Erectile Function-Erectile Function domain (IIEF-EF) questionnaires, Erection Hardness Scale (EHS), and IIEF Q13 (“How satisfied have you been with your overall sex life?”), we discovered that the aging males had worse erectile function, erection hardness, and sexual satisfaction than the younger males (P < 0.001). After treatment, the improvement rates in the IIEF-EF, EHS, and IIEF Q13 scores were 107.0%, 83.1%, and 116.5%, respectively. The magnitude of these changes demonstrated significant differences among groups (P < 0.001). Accordingly, aging males are likely to benefit more from medical treatment. We propose that aging males should be informed that age is not a limiting factor for medical ED management, and it is never too late to treat.
doi:10.4103/1008-682X.122580
PMCID: PMC3901875  PMID: 24369150
aging males; erectile dysfunction; international index of erectile dysfunction (IIEF); sildenafil; sex
17.  Assessment of Erectile and Ejaculatory Function after Penile Prosthesis Implantation 
Korean Journal of Urology  2010;51(3):202-207.
Purpose
We investigated erectile and ejaculatory function after penile prosthesis implantation.
Materials and Methods
A total of 121 patients were enrolled in the surgery group (SG) and 120 patients in the nonsurgery group (NSG). All subjects were evaluated by use of the following questionnaires: the erection function and intercourse satisfaction domains of the International Index of Erectile Function (IIEF) and the ejaculation domain of the Male Sexual Health Questionnaire (MSHQ-EjD). Comparisons were made between the SG and the NSG, by prosthesis types, and of postoperative periods and complication rates for each prosthesis type.
Results
Differences in the erection function and intercourse satisfaction domains of the International Index of Erectile Function (IIEF-EF and IIEF-IS) between before and after treatment were significantly higher in the SG group than in the NSG group (p=0.02, 0.03, respectively). When comparing prosthesis types, differences in the erection confidence and intercourse satisfaction items between before and after surgery were significantly higher in the SG group (p=0.03, 0.04, respectively). In the comparison of each prosthesis type by postoperative period, differences in the IIEF-EF and IIEF-IS between before and after surgery were not statistically significant but the MSHQ-EjD domain after surgery was significantly lower in cases of >5 years (p=0.02, 0.03, respectively).
Conclusions
Subjective symptoms such as erectile confidence and erectile function were improved more in the SG group than in the NSG group, especially in the inflatable group. It appeared that there was no significant difference in improvement in ejaculatory function depending on the treatment method, but that ejaculatory function decreased as time passed.
doi:10.4111/kju.2010.51.3.202
PMCID: PMC2855449  PMID: 20414398
Questionnaires; Penile prosthesis; Penile erection; Ejaculation
18.  Patient-Reported Validated Functional Outcome After Extraperitoneal Robotic-Assisted Nerve-Sparing Radical Prostatectomy 
Background and Objectives:
Erectile function after prostate surgery is an important criterion for patients when they are choosing a treatment modality for prostate cancer. Improved visualization, dexterity, and precision afforded by the da Vinci robot allow a precise dissection of the neurovascular bundles. We objectively assessed erectile function after robot-assisted extraperitoneal prostatectomy by using the SHIM (IIEF-5) validated questionnaire.
Methods:
Between July 2003 and September 2004, 150 consecutive men underwent da Vinci robot-assisted extraperitoneal radical prostatectomy for clinically localized prostate cancer. The IIEF-5 questionnaire was used to assess postoperative potency in 67 patients who were at least 6 months postsurgery. Erectile function was classified as impotent <11), moderate dysfunction (11 to 15), mild dysfunction (16 to 21), and potent (22 to 25). All patients used oral pharmacological assistance postprocedure.
Results:
Sixty-seven patients were available to complete the IIEF-5 questionnaire 6 months to 1 year postprostatectomy. Twelve patients were excluded from the study who abstained from all sexual activity after surgery for emotional or social reasons. Of the 55 patients evaluated, 22 (40%) were impotent, 3 (5.5%) had moderate erectile dysfunction (ED), 12 (21.8%) had mild ED, and 18 (32.7%) were fully potent. The table compares IIEF-5 scores with nerve-sparing status. Of patients who had bilateral nerve sparing, 28/45 (62.2%) had mild or no ED within 6 to 12 months postsurgery, and all expressed satisfaction with their current sexual function or rate of improvement after robotic prostatectomy.
Conclusion:
Robot-assisted extraperitoneal prostatectomy provides comparable outcomes to those of open surgery with regards to erectile function. Assessment of the ultimate maximal erectile function will require continued analysis, as this is likely to further improve beyond 6 to 12 months.
PMCID: PMC3015850  PMID: 18237507
Robotics; Prostatectomy; Sexual dysfunction; Postoperative complications
19.  A green and black tea extract benefits urological health in men with lower urinary tract symptoms 
Objectives:
The objective of this study was to examine the effects of a green and black tea extract blend [AssuriTEA Men’s Health (AMH)] in men with lower urinary tract symptoms (LUTS).
Methods:
In this randomized, double-blind, placebo-controlled study, 46 men aged 30–70 with an American Urologic Association symptom score (AUAss) of at least 8 and up to 24 were randomized to 500 mg AMH, 1000 mg AMH, or placebo daily for 12 weeks. Measurements were taken at baseline (BL), week 6 and week 12 for AUAss, simple uroflowmetry, postvoid residual volume (PVR), C-reactive protein (CRP), Short-Form 36 Health Survey (SF-36), and International Index of Erectile Function (IIEF).
Results:
A total of 40 subjects completed the study. AUAss decreased 34.5% from BL to week 12 in the 1000 mg AMH group (p = 0.008). At week 12, CRP increased in the 500 mg AMH (p = 0.003) and placebo (p = 0.012) groups from their BL levels but not in the 1000 mg group. Average urine flow (Qmean) increased in the 500 mg (p = 0.033) and 1000 mg AMH (p = 0.002) groups versus placebo. PVR decreased in the 1000 mg AMH group (p = 0.034) from BL at week 6. Treatment group effects were observed for the physical functioning and sexual desire domains of the SF-36 and IIEF (p = 0.051 and p = 0.005 respectively). AMH was well tolerated.
Conclusions:
Oral administration of AMH improved LUTS and quality of life in as little as 6 weeks.
doi:10.1177/1756287214526924
PMCID: PMC4003843  PMID: 24883106
green tea; black tea; lower urinary tract symptoms; Men’s Health; clinical trial
20.  Randomised controlled trial of pelvic floor muscle exercises and manometric biofeedback for erectile dysfunction 
Background: The pelvic floor muscles are active in normal erectile function. Therefore, it was hypothesised that weak pelvic floor muscles could be a cause of erectile dysfunction.
Aims: To compare the efficacy of pelvic floor muscle exercises and manometric biofeedback with lifestyle changes for men with erectile dysfunction.
Design of study: Randomised controlled trial.
Setting: The Somerset Nuffield Hospital, Taunton, United Kingdom.
Method: Fifty-five men with erectile dysfunction (median age 59.2 years; range 22–78 years) were enrolled from a local urology clinic. Of these, 28 participants were randomised to an intervention group and engaged in pelvic floor exercises, as well as receiving biofeedback and suggestions for lifestyle changes. Twenty-seven controls were solely advised on lifestyle changes. Baseline, 3- and 6-month assessments were: erectile function domain of International Index of Erectile Function (IIEF), Partner's International Index of Erectile Function (PIIEF), Erectile Dysfunction-Effect on Quality of Life (ED-EQoL), anal manometry, digital anal measurements, and clinical assessment by an assessor blind to treatment allocation. After 3 months, the control group were transferred to the active arm.
Results: At 3 months, compared with controls, men in the intervention group showed significant mean increases in the erectile function domain of the IIEF (6.74 points, P = 0.004); anal pressure (44.16 cmH2O, P<0.001); and digital anal grades (1.5 grades, P<0.001). All showed further improvement in these outcomes at 6 months. Similar benefits were seen in men of the control arm after transfer to active treatment. A total of 22 (40.0%) participants attained normal function, 19 (34.5%) participants had improved erectile function, and 14 (25.5%) participants failed to improve.
Conclusion: Pelvic floor muscle exercises and biofeedback are an effective treatment for men with erectile dysfunction.
PMCID: PMC1324914  PMID: 15527607
pelvic floor exercises; biofeedback; erectile dysfunction
21.  Avanafil for the Treatment of Erectile Dysfunction: A Multicenter, Randomized, Double-Blind Study in Men With Diabetes Mellitus 
Mayo Clinic Proceedings  2012;87(9):843-852.
Objective
To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus.
Patients and Methods
This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score.
Results
Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion.
Conclusion
Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors.
Trial Registration
clinicaltrials.gov Identifier NCT00809471.
doi:10.1016/j.mayocp.2012.06.016
PMCID: PMC3498142  PMID: 22857780
AE, adverse event; BP, blood pressure; ED, erectile dysfunction; IIEF-EF, International Index of Erectile Function erectile function; LS, least square; PDE, phosphodiesterase; SEP, Sexual Encounter Profile
22.  Sildenafil citrate can improve erectile dysfunction among chronic hemodialysis patients 
Indian Journal of Nephrology  2010;20(3):142-145.
Erectile dysfunction (ED) is common among patients with end-stage renal disease (ESRD), who undergo hemodialysis (HD). The aim of this study was to evaluate the safety and effectiveness of sildenafil in male HD patients with ED. Twenty-seven HD patients were recruited for this prospective, randomized, double-blind, placebo-controlled, clinical trial study of sildenafil during a period of 1 week. Efficacy was assessed by using the International Index of Erectile Function (IIEF) before and 1 week after treatment. Baseline demographic and clinical features were similar in both the groups. There was a weak correlation between ED and duration of undergoing dialysis (P = 0.073). There was significant relationship between sildenafil usage and improvement in erectile function (P < 0.0001). Placebo improved significantly the erectile function (P = 0.016), perhaps by psychological way. However, sildenafil had a more significant effect than placebo in increasing IIEF score among HD patients (P = 0.00 compared to 0.016). Sildenafil is effective and safe for treating ED among HD patients.
doi:10.4103/0971-4065.70845
PMCID: PMC2966980  PMID: 21072154
Erectile dysfunction; hemodialysis; sildenafil citrate
23.  Patient-Reported Validated Functional Outcome After Extraperitoneal Robotic-Assisted Nerve-Sparing Radical Prostatectomy 
Background and Objectives:
Erectile function after prostate surgery is an important criterion for patients when they are choosing a treatment modality for prostate cancer. Improved visualization, dexterity, and precision afforded by the da Vinci robot allow a precise dissection of the neurovascular bundles. We objectively assessed erectile function after robot-assisted extraperitoneal prostatectomy by using the SHIM (IIEF-5) validated questionnaire.
Methods:
Between July 2003 and September 2004, 150 consecutive men underwent da Vinci robot-assisted extraperitoneal radical prostatectomy for clinically localized prostate cancer. The IIEF-5 questionnaire was used to assess postoperative potency in 67 patients who were at least 6 months postsurgery. Erectile function was classified as impotent (<11), moderate dysfunction (11 to 15), mild dysfunction (16 to 21), and potent (22 to 25). All patients used oral pharmacological assistance postprocedure.
Results:
Sixty-seven patients were available to complete the IIEF-5 questionnaire 6 months to 1 year postprostatectomy. Twelve patients were excluded from the study who abstained from all sexual activity after surgery for emotional or social reasons. Of the 55 patients evaluated, 22 (40%) were impotent, 3 (5.5%) had moderate ED, 12 (21.8%) had mild ED, and 18 (32.7%) were fully potent. The table compares IIEF-5 scores with nerve-sparing status. Of patients who had bilateral nerve sparing, 28/45 (62.2%) had mild or no ED within 6 to 12 months postsurgery, and all expressed satisfaction with their current sexual function or rate of improvement after robotic prostatectomy.
Conclusion:
Robot-assisted extraperitoneal prostatectomy provides comparable outcomes to those of open surgery with regards to erectile function. Assessment of the ultimate maximal erectile function will require continued analysis, as this is likely to further improve beyond 6 to 12 months.
PMCID: PMC3015835  PMID: 17931513
Robotics; Prostatectomy; Sexual dysfunction; Postoperative complications
24.  Sexual asthenia: Tradamixina versus Tadalafil 5 mg daily 
BMC Surgery  2012;12(Suppl 1):S23.
Background
Reduced libido is widely considered the most prominent symptomatic reflection of low testosterone (T) levels in men. Testosterone deficiency (TD) afflicts approximately 30% of men aged 40-79 years. This study seeks to evaluate the effect of a new natural compound “tradamixina “in order to improve male sexual function in elderly men, particularly libido and possible erectile dysfunction, versus administration of tadalafil 5 mg daily.
Methods
Seventy patients (67.3± 3.7 years) with stable marital relations and affected by reduced libido, with or without erectile dysfunction were recruited. They were randomly separated in 2 groups A-B of 35. Group A was administered twice a day a new compound “Tradamixina” (150 mg of Alga Ecklonia Bicyclis, 396 mg of Tribulus Terrestris and 144 mg of D-Glucosamine and N-Acetyl-D-Glucosamine) for two months, while Group B was administered tadalafil 5 mg daily, for two months. At visit and after 60 days of treatment patients were evaluated by means of detailed medical and sexual history, clinical examination, laboratory investigations (Total and Free T), instrumental examination (NPTR- nocturnal penile tumescence and rigidity test- with Rigiscan). Patients completed a self-administered IIEF questionnaire (The international index of erectile function) and SQoLM questionnaire (Sexual quality of life Questionnarie-Male). The results pre and post treatment were compared by Student t test (p<0.005).
Results
After 2 months of treatment in group A serum TT levels (230±18 ng/dl vs 671±14 ng/dl ) and FT levels(56± 2.4 pg/ml vs 120± 3.9pg/ml) increased, while in group B serum TT levels (245±12 ng/dl vs 247±15 ng/dl ) and FT levels(53± 0.3 pg/ml vs 55± 0.5pg/ml) increased not statistically significant. The patient’s numbers with negative NPTR improved after treatment in group A and B (15 vs 18 and 13 vs 25 respectively). The IIEF total score in group A increased after treatment with tradamixina (15±1.5 vs 29.77±1.2); the IIEF total score in group B increased slightly (12±1.3 vs 23.40±1.2). The SQoLM total score improved in both groups (A:16±2,3 vs 33±4,1 and B: 16±3,4 vs 31±2,1).
Conclusion
The treatment twice a day with “Tradamixina” for 2 months improved libido in elderly men without side effects of Tadalafil.
doi:10.1186/1471-2482-12-S1-S23
PMCID: PMC3499213  PMID: 23173697
Testosterone deficiency; libido; erectile dysfunction
25.  Systematic Review and Meta-Analysis of the Use of Phosphodiesterase Type 5 Inhibitors for Treatment of Erectile Dysfunction following Bilateral Nerve-Sparing Radical Prostatectomy 
PLoS ONE  2014;9(3):e91327.
Prostate cancer is relatively common cancer occurring in males. Radical prostatectomy (RP) is the most effective treatment for a localized tumor but erectile dysfunction (ED) is common complication, even when bilateral nerve-sparing RP (BNSRP) is performed. Clinical trials have shown varied effectiveness of phosphodiesterase type-5 inhibitors (PDE5-Is) for treatment of post-BNSRP ED, but there remains controversy over the application of this treatment and no formal systematic review and meta-analysis for the use of PDE5-Is for this condition has been conducted. This review was to systematically assess the efficacy and safety of oral PDE5-Is for post-BNSRP ED. A database search was conducted to identify randomized controlled trials (RCTs). The comparative efficacy of treatments was analyzed by fixed or random effect modeling. Erectile function was measured using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) question-2, 3 and the Global Assessment Question (GAQ). The rate and incidence of adverse events (AEs) were determined. The quality of included studies was appraised using the Cochrane Collaboration bias appraisal tool. Eight RCTs were included in the analyses. PDE5-Is were effective for treating post-BNSRP ED compared to placebo when erectile function was determined using the IIEF score [mean difference (MD) 5.63, 95% confidence interval (CI) (4.26–6.99)], SEP-2 [relative risk (RR) 1.63, 95% CI (1.18–2.25) ], SEP-3 [RR 2.00, 95% CI (1.27–3.15) ] and GAQ [RR 3.35, 95% CI (2.68–4.67) ]. The subgroup analysis could find a trend that longer treatment duration, higher dosage, on-demand dosing, sildenafil and mild ED are associated with more responsiveness to PDE5-Is. PDE5-Is were overall well tolerated with headache being the most commonly reported AE. Our data provides compelling evidence for the use of PDE5-Is as a primary treatment for post-BNSRP ED. However, further studies are required to optomize usage parameters (such as dosage and duration of treatment).
doi:10.1371/journal.pone.0091327
PMCID: PMC3949994  PMID: 24618671

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