KEY POINTS A recent review finds no solid evidence for the numerous claims made by the health supplement Pycnogenol. The fifteen trials - performed in the USA, Europe, China and Iran - involved 791 participants. The new review's authors could draw no solid conclusions regarding benefits that many studies purported to find. Both scientists called for bigger, better studies of Pycnogenol® before consumers can trust in its efficacy and safety.
Please note: CFAH reserves the right to moderate all comments posted to the Health Behavior News Service.
For questions regarding CFAH operations prior to January 1, 2015 contact Dorothy Jeffress, former CFAH Executive Director. He asked another Pfizer chemist, Willard Welch, to synthesize some previously unexplored tametraline derivatives. Welch then prepared stereoisomers of this compound, which were tested in vivo by animal behavioral scientist Albert Weissman. Mechanisms of ischemia-induced cavernosal smooth muscle relaxation impairment in a rabbit model of vasculogenic erectile dysfunction. Cardiovascular effects of the 3 phosphodiesterase-5 inhibitors approved for the treatment of erectile dysfunction. Phosphodiesterase type 5 inhibition does not reverse endothelial dysfunction in patients with coronary heart disease.
Cerivastatin, a hydroxymethylglutaryl coenzyme a reductase inhibitor, improves endothelial function in elderly diabetic patients within 3 days. Effect of pravastatin on endothelial function in patients with coronary artery disease (cholesterol-independent effect of pravastatin).
The effect of statin therapy on testosterone levels in subjects consulting for erectile dysfunction. The effect of statins on testosterone in men and women, a systematic review and meta-analysis of randomized controlled trials. The effects of quinapril and atorvastatin on the responsiveness to sildenafil in men with erectile dysfunction.
Atorvastatin improves the response to sildenafil in hypercholesterolemic men with erectile dysfunction not initially responsive to sildenafil. Atorvastatin improves erectile dysfunction in patients initially irresponsive to Sildenafil by the activation of endothelial nitric oxide synthase. Can atorvastatin improve the response to sildenafil in men with erectile dysfunction not initially responsive to sildenafil? The effect of simvastatin in penile erection: a randomized, double-blind, placebo-controlled clinical trial (Simvastatin treatment for erectile dysfunction-STED TRIAL). Can simvastatin improve erectile function and health-related quality of life in men aged≥40 years with erectile dysfunction? The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Minimal clinically important differences in the erectile function domain of the International Index of Erectile Function scale. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Erectile response to type 5 phosphodiesterase inhibitor could be preserved with the addition of simvastatin to conventional insulin treatment in rat model of diabetes.
Is hyperlipidemia or its treatment associated with erectile dysfunction?: results from the Boston Area Community Health (BACH) survey. Of the 15 randomized controlled trials of Pycnogenol, the manufacturer sponsored 11, making them likely to be biased. It contains the antioxidant proanthocyanidin, which is present in fruits, red wine and chocolate. The disorders studied included asthma, attention deficit hyperactivity disorder, chronic venous insufficiency, diabetes, erectile dysfunction, hypertension and osteoarthritis. The 15 trials exhibited poor quality, with small sample sizes (11 to 156 participants) and often inadequate blinding. When reproducing any material, including interview excerpts, attribution to the Health Behavior News Service, part of the Center for Advancing Health, is required.

These reviews bring together research on the effects of health care and are considered the gold standard for determining the relative effectiveness of different interventions.
All users agree not to claim, infer, or imply GW endorsement of the user’s activities. For information on obtaining a commercial use license, please contact the George Washington University Office of Technology Transfer. Mikhailidis Current Opinion in Cardiology. Key results were sometimes missing for relevant outcomes and some trials provided results only for the treatment group taking Pycnogenol®, but not for controls. The trials also examined diverse outcomes, making combining the results difficult or impossible.
While the information provided in this news story is from the latest peer-reviewed research, it is not intended to provide medical advice or treatment recommendations.
Supported by the Jessie Gruman Memorial Fund, resources will remain online until January 2020.
Arch Gen Psychiatry -- Early Coadministration of Clonazepam With Sertraline for Panic Disorder, July 2001, Goddard et al. It is now widely accepted that ED can be a consequence of a generalized vascular disorder caused by endothelial dysfunction.
Frei,Ishak Mansi The Journal of Sexual Medicine. Yashar Tashakkor Canadian Journal of Cardiology. Endothelial dysfunction is considered to be the main factor resulting in PDE5Is treatment failure [8] because PDE5Is are unlikely to reverse endothelial dysfunction with reduced NO bioavailability.
It suppresses the conversion of 3-hydroxy-methylglutaryl-CoA to mevalonate, which is the rate-limiting step in de novo synthesis of cholesterol.
In addition, it was reported that statin therapy was associated with reduced levels of testosterone and even symptoms of hypogonadism.
We tried to contact all corresponding authors when data were found to be missing.Identification of articles and data extractionsAfter the studies were reviewed, it was noted that none of the previously performed meta-analyses of RCTs reported statins as a treatment for ED.
With 629 articles identified, seven studies were retrieved that were RCTs [17],[18],[19],[20],[21],[22],[23] [Figure 1]). The International Index of Erectile Function (IIEF) is a validated and widely used multidimensional, self-report instrument for the evaluation of male sexual function.
Two specific segments of the full IIEF are used to measure erectile function, namely an abridged five-item version (IIEF-5; questions 2, 4, 5, 7 and 15) [Table 1] and the ED domain (questions 1-5 and 15). Included studies compared treatment with statins against a control (placebo or no treatment). Our primary outcome measures were IIEF-5 scores and secondary outcomes were lipid parameters, including total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides (TGs). The quality of included studies were assessed by the Cochrane Risk-of-Bias Tool, attributing one point to each item (total score range: 0-8).
Review Manager 5.2 software (The Cochrane Collaboration, Oxford, UK) statistical package was used to generate statistical values. Mean differences (MDs) were calculated for continuous variables and a random effects model was applied because of the limited number of studies. Statistical heterogeneity was expressed as the I2 index as described by Higgins and colleagues. The primary findings of five studies was an improvement of erectile function after statins administration, [17],[18],[19],[20],[21] whereas, the other two studies had no significant difference between the statins and the control groups. One study included two phases of trials, with an additional intake of vardenafil for 4 weeks after the initial 6 months of daily simvastatin or placebo. Atorvastatin was investigated in three trials, [17],[18],[19] and simvastatin was investigated in two trials. Four meta-analyses of lipid parameters regarding total cholesterol, HDL cholesterol, LDL cholesterol and TGs were performed. We tried to explain the heterogeneity by performing subgroup analyses involving trial duration, types of statins, additional PDE5Is regimens and responsiveness to PDE5Is. However, the I2 test in these analyses remained to be over 50%, indicating that the heterogeneity could not be explicitly explained by these confounding factors.Other trialsTwo studies were not included in the quantitative analysis described above. One was a double-blind, placebo-controlled trial, [21] and the other was a single-blind, no treatment controlled trial.

The other study demonstrated that atorvastatin alone improved erectile function with approximately a seven-point increase in ED domain scores compared with not using any medication. The effect of statin treatment is more obvious in patients with elevated LDL cholesterol levels. Although patients treated with atorvastatin reached normal serum lipid levels at the end of the trial, all patients with elevated LDL cholesterol in the statins group had normal nocturnal penile tumescence test results, while only 34% of ED patients with normal LDL levels treated with atorvastatin had normal nocturnal penile tumescence test results.
The seven RCTs in our systematic review, which were published between 2006 and 2013, studied two statins, atorvastatin and simvastatin.
In our meta-analysis, we identified five placebo-controlled RCTs that evaluated these two statins for the treatment of patients with ED.
The pooled results across all five trials demonstrated a significant increase in IIEF-5 scores by 3.27 points and an overall improvement of lipid profiles in patients treated with statins compared with placebo controls. The minimal clinically important difference in the erectile function domain is accepted to be a four-point improvement in the IIEF-5 score.
Sildenafil was only administered continuously in patients whose IIEF-5 scores were still under 21 after sildenafil therapy. A previous study showed that treatment with atorvastatin increased plasma NO concentrations, [32] which was consistent with the outcomes in the most recent trial in our review. Through the effects of statins, the cyclic guanosine monophosphate levels improved, and smooth muscle relaxation was restored through increased arterial blood flow, leading to improved erectile function. Furthermore, we found that the efficacy of statins for the treatment of ED was associated with modulated lipid levels.
Accordingly, larger, well-designed, RCTs should investigate the correlation between dyslipidemia correction and erectile function.Although statins exert potential beneficial effects on ED through the aforementioned mechanisms, they have also been reported to have a negative influence on erectile function.
In a prospective observational study, 93 male patients starting on lipid-lowering therapy were recruited from the cardiology and lipid clinics and 82 completed the IIEF-5 questionnaire. Before statin administration, the median IIEF-5 score was 21 and 57% had erectile function impairment.
After statin administration, the median IIEF-5 score decreased significantly to 6.5 and 22% of these patients suffered new onset of ED. Before statin therapy, no correlation was observed between IIEF-5 score and any individual cardiovascular risk factor.
After 6 months of statin administration, lower IIEF scores correlated significantly with age, diabetes and weakly with cigarette smoking. However, a recent meta-analysis of RCTs assessed the effects of lifestyle interventions and pharmacotherapy for cardiovascular risk factors, including statins, on the severity of ED. It demonstrated that cardiovascular disease-related interventions and pharmacotherapy were associated with significant improvement in erectile function. Treatment for these cardiovascular risk factors could improve erectile function in patients with ED.Previous systematic reviews containing case reports, review articles and information from clinical trials suggested that statins may cause ED.
They found that both total and free testosterone levels were significantly lower in patients taking statins compared with those not using lipid-lowering drugs. The use of statins also correlated with a reduced testicular volume and a higher prevalence of hypogonadism-related symptoms and signs, as assessed by higher ANDROTEST scores. Based on these outcomes, they concluded that statin therapy might induce an overt primary hypogonadism and may be considered as a risk factor for ED.
This negative effect of statins on testosterone levels were attributed to the suppression of presqualenic steroid synthesis within the testis by inhibiting mevalonate formation, thus interfering with testosterone production. Therefore, it is necessary to evaluate the effect of statins on hormone metabolism in more RCTs with high-quality and large sample sizes.
Although our study revealed positive consequences of these lipid-lowering drugs on erectile function, especially for patients with no response to PDE5Is, the study was limited in the number of RCTs included and high heterogeneity existed in the meta-analysis.
Hence, additional large, well-designed RCTs with high-quality are needed to explore the general effects of statins for the treatment of ED. TW and CXC extracted the data from each article and SYB drew the tables and figures of the review.

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