We conducted a double-blind, placebo-controlled study to determine the efficacy of an herbal sexual supplement (vigRX) on premature ejaculation (PE).
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).
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.
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.
Ejaculation; Herbal medicine; Sexual dysfunction; Controlled trial
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.
Asia; comorbidity; erectile dysfunction; phosphodiesterase inhibitors; tadalafil
Men with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction.
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.
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.
Men ≥18 years old with ED.
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.
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.
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.
erectile dysfunction; impotence; self-esteem; confidence; quality of life; relationship; psychometrics
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.
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).
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.
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.
Sildenafil; Spinal cord injuries; Tetraplegia; Paraplegia; Erectile dysfunction; Impotence
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.
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.
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.
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.
ClinicalTrials.gov Identifier NCT00343200.
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.
Ashwagandha; International Index of Erectile Function; placebo; psychogenic erectile dysfunction
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.
Erectile dysfunction; hemodialysis; sildenafil citrate
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.
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.
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.
clinicaltrials.gov Identifier NCT00809471.
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
the efficacy and safety of sildenafil citrate (Viagra) in men with
erectile dysfunction and parkinsonism due either to Parkinson's
disease or multiple system atrophy.
patients with erectile disease were recruited, 12 with Parkinson's
disease and 12 with multiple system atrophy, into a randomised, double
blind, placebo controlled, crossover study of sildenafil citrate. The
starting dose was 50 mg active or placebo medication with the
opportunity for dose adjustment depending on efficacy and tolerability.
The international index of erectile function questionnaire (IIEF) was
used to assess treatment efficacy and a quality of life questionnaire
to assess the effect of treatment on sex life and whole life. Criteria
for entry included a definite neurological diagnosis and a standing
systolic blood pressure of 90-180 mm Hg and diastolic blood pressure
of 50-110 mm Hg, on treatment if necessary. Blood pressure was taken
at randomisation (visit 2) and crossover (visit 5) lying, sitting, and
standing, before and 1 hour after taking the study medication in hospital.
citrate was efficacious in men with parkinsonism with a significant
improvement, as demonstrated in questionnaire responses, in ability to
achieve and maintain an erection and improvement in quality of sex
life. In Parkinson's disease there was minimal change in blood
pressure between active and placebo medication. In multiple system
atrophy, six patients were studied before recruitment was stopped
because three men showed a severe drop in blood pressure 1 hour after
taking the active medication. Two were already known to have
orthostatic hypotension and were receiving treatment with ephedrine and
midodrine but the third had asymptomatic hypotension. However, the
blood pressures in all three had been within the inclusion criterion
for the study protocol. Despite a significant postural fall in blood
pressure after sildenafil, all patients with multiple system atrophy
reported a good erectile response and were reluctant to discontinue the medication.
citrate (50 mg) is efficacious in the treatment of erectile dysfunction
in parkinsonism due to Parkinson's disease or multiple system atrophy;
however, it may unmask or exacerbate hypotension in multiple system
atrophy. As Parkinson's disease may be diagnostically difficult to
distinguish from multiple system atrophy, especially in the early
stages, we recommend measurement of lying and standing blood pressure
before prescribing sildenafil to men with parkinsonism. Furthermore,
such patients should be made aware of seeking medical advice if they
develop symptoms on treatment suggestive of orthostatic hypotension.
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.
erectile dysfunction; Panax ginseng; tissue-cultured mountain ginseng extract
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.
Erectile dysfunction (ED) may be the most commonly observed adverse event (AE) associated with the combination of radiation therapy (RT) and androgen deprivation therapy (ADT). A significant number of men are trying phosphodiesterase type 5 inhibitors (PDE5s) such as sildenafil to treat ED, yet sildenafil studies to date shed little light on the response to ED after ADT.
The purpose of this trial was to evaluate sildenafil in the treatment of ED in prostate cancer patients previously treated with external beam RT and neoadjuvant and concurrent ADT.
In this randomized, double-blinded crossover trial, eligible patients received RT/ADT for intermediate risk prostate cancer and currently had ED as defined by the International Index of Erectile Function (IIEF). Patients were randomized to 12 weeks of sildenafil or placebo followed by 1 week of no treatment then 12 weeks of the alternative. Treatment differences were evaluated using a marginal model for binary crossover data.
Main Outcome Measures
The primary end point was improved erectile function, as measured by the IIEF.
The study accrued 115 patients and 61 (55%) completed all three IIEF assessments. Sildenafil effect was significant (P = 0.009) with a difference in probabilities of erectile response of 0.17 (95% confidence interval: 0.06, 0.29), and 0.21 (0.06, 0.38) for patients receiving ≤120 days of ADT. However, as few as 21% of patients had a treatment-specific response, only improving during sildenafil but not during the placebo phase.
This is the first controlled trial to suggest a positive sildenafil response for ED treatment in patients previously treated with RT/ADT, however, only a minority of patients responded to treatment. ADT duration may be associated with response and requires further study. The overall low response rate suggests the need for study of additional or preventative strategies for ED after RT/ADT for prostate cancer.
Erectile Dysfunction; Sildenafil; Prostate Cancer; Patient Reported Outcomes; Radiation Therapy; Phosphodiesterase Type 5 Inhibitors Following Prostate Cancer Treatment
The objective of this study was to assess the efficacy and safety of SX (combination of yohimbine and L-arginine) in the treatment of erectile dysfunction (ED).
This trial was a 4-week, double blind study of parallel groups of patients with mild to moderate ED. Forty married male patients with ED of mild-to-moderate severity were screened for the study entry;among them, those aged 25–50 who reported a minimum of a- 3-month history of ED were eligible to enroll in this study. The severity of ED was based on EF domain scores on the international index of erectile function (IIEF). The scores of 15–25 was considered as mild to moderate ED. Patients were randomized to receive one capsule of SX or placebo on demand in a 1:1 ratio using a computer-generated code.
The difference between the two groups was significant at week 4 (endpoint) (P=0.03). Four adverse events were observed over the study. The difference between the SX and placebo was not significant in the frequency of adverse events.
This study indicates that SX is safe and effective for the treatment of mild to moderate ED at least in the short-term.
Erectile Dysfunction; L-Arginine; Yohimbine
Testosterone deficiency seems to impair the clinical response to phophodiesterase-5 (PDE-5) inhibitors in patients with erectile dysfunction (ED). In hypogonadal men, testosterone repletion was associated with enhanced sexual function in patients who failed initial treatment with sildenafil or tadalafil. We conducted a systematic review of studies that evaluated combination therapy of testosterone and PDE-5 inhibitors in patients with ED and low, low-normal testosterone levels who failed monotherapy. The studies we examine are heterogeneous with several methodological drawbacks and that, overall, the addition of testosterone to PDE-5 inhibitors might benefit patients with ED associated with testosterone <300 ng/dL (10.4 nmol/L) who failed monotherapy. Further studies, with a randomized placebo-controlled and double blind design, are needed to describe the appropriate target patient group, testosterone cut-off and to define the optimal dose and duration of combination therapy.
Chronic nicotine treatment has deleterious effects on vascular functioning and catecholamine modulation, which may compromise erectile functioning. Evidence that long-term cigarette smoking is an independent risk factor for introducing impotence is robust. However, limited studies have focused on the acute effects of smoking on physiological sexual response, and none have investigated the deleterious effects of isolated nicotine on human sexual arousal. Consequently, pathophysiological underpinnings of tobacco-induced—and particularly, nicotine-induced—erectile dysfunction are not well understood.
To provide the first empirical examination of the acute effects of isolated nicotine on sexual arousal in nonsmoking men.
Twenty-eight sexually functional heterosexual men (mean age 21 years), each with less than 100 direct exposures to nicotine, participated in a double-blind, randomized, placebo-controlled, crossover trial. Participants received either Nicorette polacrilex gum (SmithKline Beecham Consumer Healthcare, Pittsburgh, PA, USA) (6 mg; approximately equivalent to smoking one high-yield cigarette) or placebo gum, matched for appearance, taste, and consistency, approximately 40 minutes prior to viewing an erotic film.
Main Outcome Measures
Physiological (circumferential change via penile plethysmography) and subjective (continuous self-report) sexual responses to erotic stimuli were examined, as well as changes in mood.
Nicotine significantly reduced erectile responses to the erotic films (P = 0.02), corresponding to a 23% reduction in physiological sexual arousal. This occurred in 16 of 20 men with valid physiological recordings. Nicotine had no significant effect on continuous subjective ratings of sexual arousal (P = 0.70) or on mood (all Ps > 0.05).
Isolated nicotine can significantly attenuate physiological sexual arousal in healthy nonsmoking men. These findings have implications for elucidating physiological mechanisms responsible for the effects of nicotine on sexual dysfunction, and for assisting public health policy in considering the deleterious effects of nicotine on sexual health.
Nicotine; Male Sexual Arousal; Penile Plethysmography
Penile erection is a hemodynamic process involving increased arterial inflow and restricted venous outflow, coordinated with corpus cavernosum and penile arterial smooth muscle relaxation. Any problem in this mechanism results in Erectile Dysfunction and its etiology is generally multifactorial. This study is aimed at determining the objective outcome of aerobic training in the management of Erectile Dysfunction of arterogenic origin using Meta analysis.
Relevant publications were searched up to November 2010 in the MEDLINE (PubMed) database. The citation lists of randomized controlled trials on the effect of aerobic training and Erectile Dysfunction management using the International Index of Erectile Function (IIEF) as treatment outcome measure. Studies on different operative techniques on the effects of aerobic training for men with Erectile Dysfunction due to arterogenic Erecile Dysfunction were selected. Data on participants' characteristics, study quality, population, intervention, treatment outcome were collected and analyzed.
There were 5 randomized controlled studies using the International Index of Erectile Function as measure of treatment outcome. A total of 385 subjects were involved in 5 studies; results indicated significant effect of aerobic training on Erecile Dysfunction (t=5.856, p= .000) at p< 0.05.
Subjects with arterogenic Erectile Dysfunction might benefit from aerobic training. More randomized controlled studies in this area are warranted
Erectile dysfunction; Impotence; Exercise; Index of erectile function
A randomised, double-blind, parallel, placebo-controlled, 12-week study was carried out to evaluate the efficacy and safety of 20-mg tadalafil taken ‘as needed’ in a population of men with erectile dysfunction (ED) from Egypt and Turkey. One hundred and thirty-two patients were randomised in this study. Tadalafil was superior to placebo on all three co-primary efficacy end points. The mean change from baseline for the erectile function domain of the International Index of Erectile Function was 9.3 ± 0.8 for the tadalafil group and 2.3 ± 1.6 for the placebo group. Tadalafil-treated patients reported a significantly greater improvement in the mean percentage of successful penetrations (tadalafil: 34.5 ± 4.1; placebo: −4.6 ± 8.1) and successful intercourse attempts (tadalafil: 52.2 ± 3.8; placebo: 16.8 ± 7.8) than placebo-treated patients as measured by the Sexual Encounter Profile. Tadalafil was generally well tolerated with 82% of adverse events being mild in severity. Tadalafil 20-mg taken ‘as needed’ significantly improved the erectile function in Egyptian and Turkish men with ED.
Tadalafil; erectile dysfunction; randomised controlled trial
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.
Hypogonadism in older men is a syndrome characterized by low serum testosterone levels and clinical symptoms often seen in hypogonadal men of younger age. These symptoms include decreased libido, erectile dysfunction, decreased vitality, decreased muscle mass, increased adiposity, depressed mood, osteopenia, and osteoporosis. Hypogonadism is a common disorder in aging men with a significant percentage of men over 60 years of age having serum testosterone levels below the lower limits of young male adults. There are a variety of testosterone formulations available for treatment of hypogonadism. Data from many small studies indicate that testosterone therapy offers several potential benefits to older hypogonadal men. A large multicenter NIH supported double blind, placebo controlled study is ongoing, and this study should greatly enhance the information available on efficacy and side effects of treatment. While safety data is available across many age groups, there are still unresolved concerns associated with testosterone therapy. We have reviewed the diagnostic methods as well as benefits and risks of testosterone replacement therapy for hypogonadism in aging men.
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.
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.
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.
Erectile dysfunction; Questionnaires; Testosterone
Quantitative research into sexual function and dysfunction in men who have sex with men (MSM) has been sparse due in large part to a lack of validated, quantitative instruments for the assessment of sexuality in this population.
To assess prevalence and associations of erectile problems and premature ejaculation in MSM.
MSM were invited to complete an online survey of sexual function. Ethnodemographic, sexuality, and health related factors were assessed.
Main Outcome Measure
Participants completed a version of the International Index of Erectile Function modified for use in MSM (IIEF-MSM) and the Premature Ejaculation Diagnostic Tool. Total score on the erectile function domain of the IIEF-EF (IIEF-MSM-EF) was used to stratify erectile dysfunction (ED) severity (25–30=no ED, 16–24 mild or mild moderate ED, 11–15 moderate ED, and ≤ 10 severe ED). PEDT scores were used to stratify risk of premature ejaculation (PE, diagnosed as PEDT score ≥9).
Nearly 80% of the study cohort of 2,640 men resided in North America. The prevalence of ED was higher in older men whereas the prevalence of PE was relatively constant across age groups. Multivariate logistic regression revealed that increasing age, HIV seropositivity, prior use of erectogenic therapy, lower urinary tract symptoms (LUTS), and lack of a stable sexual partner were associated with greater odds of ED. A separate multivariate analysis revealed that younger age, LUTS, and lower number of lifetime sexual partners were associated with greater odds of PE.
Risk factors for sexual problems in MSM are similar to what has been observed in quantitative studies of non-MSM males. Urinary symptoms are associated with poorer sexual function in MSM.
Elevated blood glucose is a major component in metabolic syndrome and pre-diabetes, sometimes leading to type 2 diabetes mellitus (DM II). Additionally, it may lead to adipose deposits when left elevated for long periods. The epidemiology of DM II clearly shows that uncontrolled blood glucose levels leads to many adverse conditions including heart disease, retinal damage, renal failure, erectile dysfunction, and other significant medical conditions. Here we conducted a single-center, prospective, randomized, double-blinded, placebo-controlled, parallel-group- clinical trial of a nutraceutical supplement vs. placebo to measure its glucose lowering effect in generally healthy adults before and after a simple sugars meal. Subjects reported to the test clinic on multiple days to receive placebo or treatment, a simple sugars meal, as well as pre-and postprandial blood glucose measurement (modified oral glucose tolerance test). Each subject served as his or her own control and thirty-one subjects completed the trial with at least one oral glucose tolerance test (OGTT) with the nutraceutical supplement and placebo. Statistical analysis revealed the nutraceutical supplement significantly lowered postprandial glucose levels by 36% and 59% at 45 and 60 minutes, respectively (***P<.001). The study was limited by its composition of primarily overweight females. Future studies will be required over longer periods in more heterogeneous and larger groups to determine the long-term effect of this supplement on blood glucose levels in terms of prophylaxis or treatment for DM II.
Glucose tolerance test; nutraceutical supplement; diet; hyperglycemia; diabetes mellitus II; insulin resistance
Erectile dysfunction (ED) is a highly prevalent disease associated with aging as well as with several risk factors including hypertension, heart disease, obesity, dyslipidemia, diabetes, hypogonadism, drugs-related, and pelvic surgery. Many of these factors are components of the metabolic syndrome, a multiplex risk factor for cardiovascular disease (CVD). ED shares common risk factors with CVD. Endothelial dysfunction seems to be the early underlying pathophysiology across both conditions. The efficacy, tolerability and cardiovascular safety of sildenafil has been evaluated in numerous large, randomized, double-blind, placebo-controlled clinical studies in the broad population of men with ED including men with several co-morbid conditions. Sildenafil is effective in several specific patient populations including the difficult-to-treat subpopulations such as diabetes mellitus and after radical prostatectomy. It is associated with rapid onset of action – within 14 minutes for some men – and an extended duration of action for up to 12 hours. Sildenafil improves quality of life and satisfaction for treated men and is well tolerated with a favorable safety profile. New data suggest that sildenafil has beneficial effects in several chronic conditions. It has been approved for the treatment of idiopathic pulmonary hypertension. Numerous articles have suggested that it improves endothelial function and a possible role on premature ejaculation or treatment of lower urinary tract symptoms has been suggested.
erectile dysfunction; phosphodiesterase inhibitors; safety; treatment outcome
Vardenafil has been shown to be efficacious in patients with erectile dysfunction (ED). We evaluated first-dose and repeat-dose response to vardenafil 20 mg.
This randomized, placebo-controlled study consisted of a 4-week, treatment-free run-in phase; a 1-week, open-label challenge phase; and a 12-week, double-blind treatment phase. Primary efficacy was assessed in terms of reliability of insertion based on dose as measured by the Sexual Encounter Profile question 2 (SEP2). We assessed safety by evaluating adverse events (AEs).
Baseline patient characteristics in the 2 treatment groups were similar. The most common comorbidities were hypertension (41%), dyslipidemia (28%) and diabetes mellitus (24%). Of the 573 patients receiving the 20-mg vardenafil challenge dose, 464 (81%) achieved first-time successful penetration (SEP2), and 401 (70%) reported successful erection maintenance (SEP3). Patients receiving vardenafil 20 mg had statistically (p < 0.001) and clinically superior SEP2 rates (85%) through weeks 0–12, compared with patients receiving placebo (45%). The increase in reliability of insertion was seen within the first 4 weeks of treatment. Vardenafil therapy was statistically (p < 0.001) and clinically superior to placebo for all secondary efficacy end points as well. Most AEs associated with vardenafil were mild to moderate, with headache, flushing and nasal congestion most frequently reported.
Vardenafil 20 mg had a high first-dose success rate for both SEP2 (81%) and SEP3 (70%); this was maintained through to the study end point (85% for SEP2 and 78% for SEP3). These findings were achieved in men with frequently associated comorbidities including hypertension, dyslipidemia and diabetes.
Decreased sexual function is a major concern of men with spinal cord injuries (SCIs). Treatment of erectile dysfunction (ED) through oral pharmacotherapies has been proven to be an effective way to address and treat this concern.
To find an efficacious and satisfactory treatment ED secondary to SCI through the compilation of studies that utilized the International Index of Erectile Function (IIEF) when testing phosphodiesterase V inhibitors (PDE5i).
Ten articles, which used the IIEF to study satisfaction and/or efficacy of PDE5is sildenafil, tadalafil, and vardenafil in the treatment of ED were reviewed and analyzed. Through the use of a self-made grading scale the value of each article was determined for this research.
Sildenafil, tadalafil, and vardenafil all have been proven to be effective in treating ED in men with SCI. While sildenafil is the most thoroughly studied ED treatment for patients with SCI, tadalafil has a longer time duration effectiveness, which allows for more spontaneity in the sexual experience. Minimal adverse effects have been noted in patients with SCI using these medications; headache, flushing, and mild hypotension are the most common. In articles that study satisfaction, patients show great improvement over baseline with the use of these medications.
Although there is a need for further research on the safety in long-term use of tadalafil and vardenafil, comparative studies done on all three medications show no statistically significant difference in effectiveness or satisfaction. New medications and treatment options, such as avanafil, are being studied in hope of continued improvement of sexual function in men with SCI.
Spinal cord injuries; Erectile dysfunction; Phosphodiesterase V inhibitors; Sildenafil; Tadalafil; Vardenafil