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Strength of the Evidence






Erectile dysfunction is a complex condition related to psychosocial and biological factors. It is difficult to reliably document and measure the degree of treatment success in patients diagnosed with this condition. Most of the validated and clinically relevant efficacy outcomes assessed in clinical trials of ED patients are subjective.

The strength of evidence regarding the utility of routine endocrinological blood tests found in this review was limited in terms of the both amount and quality of data. The studies were heterogeneous with respect to patient population characteristics, diagnostic methods, estimates of prevalence, and laboratory methods used (e.g. cut-off values, total, free, or bioavailable hormonal levels).

The placebo-controlled randomized trials that evaluated the efficacy and harms of PDE-5 inhibitors provided large amount of evidence and consistently indicated that patients who received PDE-5 inhibitors experienced greater improvements in erectile dysfunction compared with placebo-treated patients. The magnitude of benefit was clinically relevant and statistically significant. The methodological and reporting quality of the evidence provided by these trials was better than that for other studies (e.g. trials with active control arms or trials evaluating sublingual apomorphine, injections, topical, hormonal, or off-label therapies). Most of these trials enrolled ED patient populations with a broad spectrum of etiologies or comorbidities and assessed the same set of clinically relevant and validated outcome measures. Given the reported exclusion criteria for these trials, their results may not be readily applicable to ED patients with major chronic disorders (e.g. cancer, CVD, diabetes, psychiatric disorders, hepatic or renal diseases) or post-surgery patients, because the magnitude of clinical benefit conferred by PDE-5 inhibitors in such patients is relatively modest.384386 Furthermore, vardenafil trials may have been comprised of more responsive patients due to the fact that about half of these trials excluded patients refractory to prior sildenafil therapy, thereby limiting the applicability of the results to a broader population of ED patients. On average, trials that evaluated injected (e.g. intracavernosal, subcutaneous), intra-urethral, topical, or other treatments were of relatively lower methodological and reporting quality.

A common limitation of these trials was a failure to assess and/or report clinically relevant treatment efficacy outcomes used for the measurement of the degree of erectile dysfunction (e.g. mean scores for International Index of Erectile Function, Sexual Encounter Profile, Global Assessment Question regarding improved erection). The most commonly assessed efficacy outcomes in these trials were penile rigidity (using RigiScan) and the quality of erections achieved at home. The trials did not report information on the methods used for randomization, blinding, and allocation concealment. Many study results may have been biased in favor of active treatment, because the analyzed samples predominantly included responders and excluded many randomized participants from their efficacy analyses. There was substantial heterogeneity across the hormonal treatment trials with respect to the diversity of patient populations (variations in inclusion/exclusion criteria; not all patients had ED), treatment interventions (type of intervention, mode of administration, dose, dosing regimen, duration), and the assessed outcomes.

In general, the reporting of harms was less consistent and detailed than that of efficacy outcomes. For example, the occurrence of any or serious adverse events was not reported in many trials. The definition of a serious adverse event may have varied across the trials. Some trials reported only most frequently encountered or treatment-related adverse events, the ascertainment of which may be prone to subjective judgment. In some instances, it was not explicitly defined whether the number and percentage referred to the actual number of adverse events or to the number of patients with at least one adverse event. In open label trials, patients or investigators may have over- or under-reported the incidence of adverse events because of their knowledge of the assigned treatment. Moreover disease-specific complications in patients with comorbidities and/or disorders known to cause ED could have been overlooked. In many cases, the statistical test results for between-group differences in adverse events were not reported, thereby limiting the interpretability of the data.

The reviewed evidence indicated that there is a lack of long-term efficacy and harms data associated with treatments for ED. This is especially important in the case of oral PDE-5 inhibitors and associated harms, given their prevalent use by men in the Western world (e.g. 7 percent of American men aged 56–65 years in 2002).30 Overall, duration of followup for the majority of reviewed trials was not sufficient to permit the reliable assessment of long-term (> 6 months) treatment-related outcomes in patients with ED. The duration of followup for many of the PDE-5 inhibitor trials did not exceed 12 weeks. The long-term safety data obtained from retrospective observational studies is not as conclusive as that obtained from well-conducted long-term large randomized trials, which have fewer methodological limitations.

The reviewed evidence consisted of randomized trials using either parallel-arm or crossover design. Although crossover trials are efficient in terms of resources and study power, they require additional caution and careful interpretation of results. For example, one problem inherent in all crossover trials is a potential for a carryover effect, which could be minimized by employing an adequate washout period between alternative treatment periods.387 Although most of the authors reported the duration of washout periods (about 1–2 weeks), it is not clear what minimum length of time would be sufficient to avert or minimize carryover effects from the different types of treatment in patients with ED.

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Question 1: What is the Clinical Utility of Routine Blood Tests—Testosterone, Prolactin, Luteinizing Hormone, Follicle-stimulating Hormone—in Identifying and Affecting Therapeutic Outcomes for Treatable Causes of ED?

The current evidence does not clarify the role of routine hormonal blood tests in all men who present with ED, nor does it clarify whether testing should occur before initiation of a first-line PDE-5 inhibitor treatment versus a more selective approach guided by elevated clinical suspicion for endocrinopathies. The signs and symptoms indicative of hypogonadism may include decreased testes size, alteration in secondary sexual characteristics, decreased libido, changes in mood, a chronic fatigued state or reduced physical performance, as well as altered hematocrit, high- and low-density lipoproteins, or cholesterol.388 Also, it remains unclear whether testing for prolactin, LH, and FSH endocrinopathies is justified as a stand-alone diagnostic strategy if testosterone levels are within the normal limits.

In total, 21 unique studies were reviewed to summarize information needed for determining the clinical utility of routine testosterone, prolactin, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) testing in ED patients. Overall, the heterogeneous nature of the data precludes the reliable evaluation of the utility and limitations of endocrinological testing in the ED population.


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