A randomized, double-blind, placebo-controlled study of the efficacy and safety of bupropion for treating hypoactive sexual desire disorder in ovulating women.

OBJECTIVE: To compare the efficacy of sustained-release (SR) bupropion to placebo in treating hypoactive sexual desire disorder (HSDD) in ovulating women. PATIENTS AND METHODS: After a 1-week, placebo lead-in phase, 232 treatment-seeking women with regular menstrual cycles were randomly assigned to bupropion SR 150 mg/daily (116) or placebo (116) for 12 weeks under double-blind conditions. Efficacy was assessed with the Brief Index of Sexual Functioning for Women (BISF-W), the Personal Distress Scale (PDS), the global efficacy question (GEQ; 'Did the treatment you received during the 12-week improve meaningful your sexual desire?') and overall patient satisfaction question ('Are you satisfied with the efficacy of your treatment?'). RESULTS: The mean (sd) composite score on the BISF-W, increased from 15.8 (2.6) and 15.5 (2.2) at baseline to 33.9 (4.2) and 16.9 (2.6) in the bupropion and placebo groups, respectively (P= 0.001). The odds ratio (95% confidence interval) for response in the bupropion group relative to placebo was 3.2 (2.1-6.3). The thoughts/desire score more than doubled in patients treated with bupropion (P= 0.001). At the 12-week evaluation the reduction in the PDS scale was 29.4% in bupropion and 4.7% in the placebo group (P= 0.01). In response to the GEQ, of patients in the bupropion and placebo groups, 65.3%, and 4.3%, respectively, responded 'Definitely yes' (P= 0.001). Of patients in the bupropion and placebo groups, 71.8%, and 3.7%, respectively, were definitely satisfied with the efficacy of their treatment, (P= 0.001). After 12 weeks of treatment, 82 women (78.1%) in the bupropion and five (4.9%) in the placebo group were willing to continue therapy (P= 0.001). CONCLUSIONS: The results from this study indicate that bupropion SR is an effective and well-tolerated treatment for HSDD in ovulating women. Further controlled trials are warranted.

A double-blind placebo-controlled study of the efficacy and safety of pentoxifylline in early chronic Peyronie's disease.

OBJECTIVE: To analyse the safety and efficacy of pentoxifylline sustained-release (PTX-SR) treatment in patients with early chronic Peyronie's disease (PD). PATIENTS AND METHODS: In all, 228 patients with a mean (sd) age of 51 (9) years who had early chronic PD were randomized to receive 400 mg PTX-SR (Apo-Pentoxifylline, Apotex Inc., Toronto, Canada) twice daily (group 1, 114) or similar regimen of placebo (group 2, 114) for 6 months. A medical history was taken and the men had a complete physical examination. The following variables were assessed before and after therapy: penile curvature and penile artery spectral traces (end-diastolic velocity, EDV, peak systolic velocity, PSV, and resistivity index, RI, of the right and left cavernous arteries assessed with dynamic penile duplex ultrasonography), plaque characteristics (assessed by penile X-ray and penile ultrasonography), pain (assessed by visual analogue scale), erectile function (assessed by the International Index of Erectile Function, IIEF questionnaire), treatment satisfaction (assessed by Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire), and side-effects. Patient perception of penile curvature and plaque size, and mean weekly intercourse attempts were also assessed. RESULTS: Overall, 36.9% of patients who received PTX-SR reported a positive response, vs only 4.5% in the placebo group. Of patients in PTX-SR group, 12 (11%) had disease progression, vs 46 (42%) in placebo group (P = 0.01). Improvement in penile curvature (P = 0.01), and plaque volume (P = 0.001) was significantly greater in patients treated with PTX-SR than placebo. The increase in IIEF total score was significantly higher in the PTX-SR group (P = 0.02). Mean PSV changes after therapy compared to baseline were statistically significant between PTX-SR (right, +11.4%, left, +11.7%) and placebo-treated (+0.2% and -4.2%, respectively) patients (both P = 0.04). CONCLUSIONS: PTX-R was moderately effective in reducing penile curvature and plaque volume in patients with early chronic PD. Further studies with different treatment regimens are needed to better elucidate the beneficial effects of PTX-SR in PD.

Relationship of omega-3 and omega-6 fatty acids with semen characteristics, and anti-oxidant status of seminal plasma: a comparison between fertile and infertile men.

BACKGROUND & AIMS: Fatty acid (FA) composition of the spermatozoa may be an important determinant of fertility. The aim was to evaluate polyunsaturated fatty acid (PUFA) composition of the blood plasma and spermatozoa in infertile men with idiopathic oligoasthenoteratozoospermia (OAT). METHODS: Eighty-two infertile men with idiopathic OAT and seventy-eight fertile men defined according to semen concentration and proven fertility were enrolled in the study. The semen parameters were assessed according to World Health Organization criteria; three omega-3 fatty acids--alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and two omega-6 fatty acids--linoleic acid (LA) and arachidonic acid (AA) concentrations were measured in blood plasma and spermatozoa; and the seminal plasma enzymatic antioxidant levels of catalase, and superoxide dismutase (SOD) were also assessed. RESULTS: Proven fertile men had higher blood and spermatozoa levels of omega-3 FAs compared with the infertile patients. The ratio of serum omega-6/omega-3 fatty acids was significantly higher in infertile (14.8+/-4.3) patients compared to fertile controls (6.3+/-2.2) (P=0.001). Additionally, levels of AA were higher and the omega-3 index (EPA+DHA) was lower in infertile subjects than in fertile controls (all P values<0.05). Infertile men had higher mean AA:DHA ratio and AA:EPA (6.4+/-2.9 and 12.0+/-4.9, respectively) than fertile men (3.3+/-1.8 and 6.7+/-2.6, respectively) (both P=0.001). A strong negative correlation was found between the AA:DHA and AA:EPA ratios and total sperm count (r=-0.62, P=0.001 and r=-0.64, P=0.001, respectively), sperm motility (r=-0.63, P=0.001 and r=-0.61, P=0.001, respectively), and sperm morphology (r=-0.61, P=0.001, and r=-0.59, P=0.002, respectively). CONCLUSIONS: Infertile men had lower concentrations of omega-3 FAs in spermatozoa than fertile men. These results suggest that research should be performed to assess the potential benefits of omega-3 FA supplementation as a therapeutic approach in infertile men with idiopathic OAT.

Opium consumption and risk of bladder cancer: A case-control analysis.

OBJECTIVE: We evaluated the relationship between opium consumption and bladder cancer (BC) in a case-control study of an Iranian population. MATERIALS AND METHODS: In a hospital-based case-control study of 179 patients with BC and 179 cancer-free controls frequency-matched by age, sex, and smoking status, we investigated the relationship between opium consumption and BC. A comprehensive epidemiologic interview was conducted on all participants to collect personal information, such as demographics and smoking status. RESULTS: Overall, we found significant age, sex, cigarette smoking adjusted association between BC risk and opium consumption, [odds ratio (OR) = 4.60; 95% confidence interval (CI) = 3.53-6.28]. The elevated risk was more evident in older individuals (OR = 5.42; 95% CI, 4.12-7.28) than younger individuals (OR = 3.65; 95% CI, 2.76-4.76) (P = 0.01). Heavy smokers with the opium consumption exhibited a 6-fold elevated risk for BC (OR = 6.16; 95% CI, 3.34-8.32) (P = 0.0001). When stratified according to different grades of BC, a 3.4-fold increased risk was associated with the opium consumption in grade III with an OR of 3.44 (95% CI, 2.82-8.28) (P = 0.001). A similar but slightly higher risk was also seen in case of grade IV tumors (OR = 3.86; 95% CI, 2.14-10.16) (P = 0.001). Invasive bladder tumors were more common among the opiates users (OR = 2.6; 95% CI, 1.44-5.42) (P = 0.01). Cumulative risk of BC in women with opium consumption (OR = 4.10 95% CI, 3.54-5.88) (P = 0.001) was slightly less than in men (OR = 5.10 95% CI, 3.54-5.88) (P = 0.0001). Based on Pearson correlations, the risk of BC significantly correlated with opium dependence duration (r = 0.74, P = 0.001), type of opiate used (r = 0.65, P = 0.001), and simultaneous cigarette smoking (r = 0.74, P = 0.0001). CONCLUSION: The results indicated that there is about 5-fold increase in risk of developing this cancer in the presence of opium consumption. Further research is needed to investigate the functional implications of the opium consumption in BC.

Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.

PURPOSE: We evaluated the safety and efficacy of intranasal bremelanotide in men with erectile dysfunction who did not respond to sildenafil. MATERIALS AND METHODS: A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo (group 2, 170). Patients were asked to use at least 16 doses/attempts at home. They underwent preliminary assessment, including medical and sexual history, and self-administered International Index of Erectile Function. The efficacy of 2 treatments was assessed every 4 attempts during treatment and at the end of study, using responses to International Index of Erectile Function, and evaluation of mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. RESULTS: Positive clinical results were seen in 51 (33.5%) patients in the bremelanotide group compared with 13 (8.5%) patients in the placebo group (p = 0.03). Patients in the bremelanotide group reported significantly greater intercourse satisfaction than those in placebo group (p = 0.03). More drug related adverse effects occurred in the bremelanotide group (p = 0.01). CONCLUSIONS: Bremelanotide can be an alternative treatment for erectile dysfunction with a potentially broad patient base. Further studies with different dosages and treatment regimens are necessary to draw final conclusions on the efficacy of this drug in erectile dysfunction.

Comparison of vitamin E and propionyl-L-carnitine, separately or in combination, in patients with early chronic Peyronie's disease: a double-blind, placebo controlled, randomized study.

PURPOSE: We compared the efficacy and safety of oral vitamin E and propionyl-L-carnitine, separately or in combination, for the treatment of Peyronie's disease. MATERIALS AND METHODS: A total of 236 men (mean age 43.4 years) with Peyronie's disease were randomly assigned to 4 groups. Group 1 (58 men) received 300 mg vitamin E orally twice daily. Group 2 (59) received 1 gm propionyl-L-carnitine orally twice daily, and group 3 (60) received 300 mg vitamin E and 1 gm propionyl-L-carnitine orally twice daily. Group 4 (control group, 59 men) received a similar regimen of placebo during the 6-month treatment period. The efficacy of the 4 treatments was assessed using responses to the International Index of Erectile Function, visual analog scale for pain evaluation, mean intercourse satisfaction domain, mean weekly coitus episodes, penile curvature, plaque size and adverse drug effects. RESULTS: Pain decreased in 60.4%, 63%, 62.3% and 59.2% of the patients treated with vitamin E, propionyl-L-carnitine, vitamin E plus propionyl-L-carnitine and placebo, respectively (p = 0.1). After therapy a reduction in penile curvature was observed by 18.9%, 20.4%, 22.6% and 18.4% of the patients in groups 1, 2, 3 and 4, respectively (p = 0.09), and a decrease in plaque size was noted in 11.3%, 12.9%, 13.2% and 11.1%, respectively (p = 0.1). CONCLUSIONS: This study did not show significant improvement in pain, curvature or plaque size in patients with PD treated with vitamin E, propionyl-L-carnitine, or vitamin E plus propionyl-L-carnitine compared with those treated with placebo.

Population-based screening for prostate cancer by measuring total serum prostate-specific antigen in Iran.

OBJECTIVE: To report the results from an Iranian large population-based randomized study of screening using prostate-specific antigen (PSA) to detect prostate cancer. MATERIALS AND METHODS: A total of 3758 Iranian men older than 40 years were mass checked by PSA-based screening. Men with an abnormal digital rectal examination (DRE) and serum total PSA level of greater than 4 ng/mL, underwent transrectal ultrasonography (TRUS)-guided extended prostate biopsy. RESULTS: The PSA value (mean +/- standard deviation, SD) in all men without prostate cancer was 1.6 +/- 1.1 ng/mL and in those with cancer 18 +/- 44.8 ng/mL (P = 0.001). PSA values increased with age. In those aged 40-49, 50-59, 60-69 and > or = 70 years, the mean +/- SD PSA values were 1.3 +/- 0.7, 1.4 +/- 0.8, 1.8 +/- 1 and 2.2 +/- 1.6 ng/mL, respectively. Among the screened men, 323 (8.6%) had a serum PSA concentration greater than 4 ng/mL. Of patients who underwent prostate biopsy (230, 71.2%), 129 (positive predictive value, 56.1%) had prostate cancer. Additionally, nine cancers were detected among 16 patients with PSA of less than 4 ng/mL who had a doubtful DRE finding. The overall cancer detection rate was 3.6%; 1.4% at 40-49, 1.6% at 50-59, 4.2% at 60-69 and 12.9% at >/=70 years. Conventional systematic sextant biopsies, which accounted for six of the 10 cores in our biopsy scheme, detected 98 (71%) of the cancers. CONCLUSIONS: The Iranian male population develops prostate cancer quite commonly if their serum PSA levels are greater than 4.0 ng/mL. In this study, 65.9% of the detected cancers were clinically significant. The conventional systematic sextant technique may be inappropriate for detection of all prostate cancers. The results need to be confirmed in other randomized trials.