for confounders (clinical, exercise, and nuclear scintigraphic variables), LBBB was an independent predictor of mortality (hazard ratio [HR] 1.5; 95% CI, 1.0–2.0).2 One study specifically evaluated bundle branch block as a risk factor in noncardiac, nonemergent surgery. This retrospective cohort study investigated patients with LBBB (n=119) or right bundle branch block (RBBB; n=336) undergoing preoperative evaluation for noncardiac surgery. Mean age was 67 years (range 40–93), 64% had hypertension, 18% CHF, 18% a history of CAD, and 22% angina. No cardiovascular complications were observed in the patients with a bundle branch block intraoperatively. Postoperatively, no patients with a bundle branch block experienced myocardial infarction, pulmonary edema, or ventricular dysrhythmias. One patient with LBBB developed atrial fibrillation postoperatively. Four patients (0.9%) with bundle branch blocks (1 with RBBB, 3 with LBBB) died postoperatively compared with 2 (0.4%) in the control cohort. All 3 of the LBBB deaths were due to sepsis (2 after prolonged postoperative hospitalization) and all had known heart disease. Hence, LBBB may be associated with increased noncardiac postoperative complications; however, a larger cohort study is needed to validate this finding.3 The ACC/AHA 2007 Perioperative Executive Summary considers the presence of a LBBB a “minor clinical predictor.” In the absence of clinically active cardiac conditions, such individuals may proceed to low-risk surgery. In patients undergoing other than low-risk surgery, further workup is not required if their functional capacity is greater than 4 metabolic equivalent tests (METs). Patients with poor (<4 METs) or unknown functional capacity undergoing other than low-risk surgery require a clinical risk factor assessment to determine if further evaluation is warranted.4 Robert Gauer, MD Womack FMR Clinic Fort Bragg, NC 1.Imanishi R, Seto S, Ichimaru S, Nakashima E, Yano K, Akahoshi M. Prognostic significance of incident complete left bundle branch block observed over a 40-year period. Am J Cardiol. 2006; 98(5):644–648. [LOE 2b] 2.Hesse B, Diaz LA, Snader CE, Blackstone EH, Lauer MS. Completed bundle branch block as an independent predictor of all-cause mortality: report of 7,073 patients referred for nuclear exercise testing. Am J Med. 2001; 110(4):253–259. [LOE 2b] 3.Dorman T, Breslow MJ, Pronovost PJ, Rock P, Rosenfeld BA. Bundle-branch block as a risk factor in noncardiac surgery. Arch Intern Med. 2000; 160(8):1149–1152. [LOE 2b] 4.Fleisher LA, Beckman JA, Brown KA, et al. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2007; 116(17):1971–1996. [LOE 5] 8 Evidence-Based Practice / July 2009 What treatments are effective for chronic prostatitis? Evidence-Based Answer No treatments for chronic prostatitis/chronic pelvic pain syndrome have been proven effective. Ciprofloxacin, tamsulosin, corticosteroids, and rofecoxib have all failed to show benefit. (SOR B, based on a single study for each agent.) Chronic prostatitis/chronic pelvic pain syndrome is a common disorder that is defined clinically by inflammation of the prostate and discomfort or pain in the perineal or pelvis region, and lower urinary tract symptoms with or without bacteriuria. In 2001, a double-blind, double-dummy trial compared the effectiveness of ciprofloxacin, tamsulosin, a combination of both drugs, and placebo in patients with chronic prostatitis/chronic pelvic pain syndrome. This trial evaluated 196 men with a score of at least 15 on the National Institute of Health Chronic Prostatitis Symptom Index (the NIH-CPSI, with a maximum of 43 points) and a mean of 6.2 years of symptoms. They were randomized to 1 of 4 groups: 49 were given ciprofloxacin 500 mg twice daily, 49 were given tamsulosin 0.4 mg once daily, 49 were given combination of both drugs, and 49 were given placebo. The NIH-CPSI was readministered at the end of 6 weeks of treatment. Despite a slight decrease in the NIH-CPSI total score in all treatment groups, no statistically significant outcomes were noted.1 In 2002, a randomized controlled trial (RCT) evaluated the effectiveness of a short course of oral prednisone therapy for chronic prostatitis/chronic pelvic pain syndrome. The trial enrolled 21 men with the condition for at least 6 months, for whom antibiotic therapy had failed. They were randomized to oral prednisone (20 mg daily for 1 week, 15 mg daily for 1 week, 10 mg daily for 1 week, and 5 mg daily for 1 week) or an equivalent placebo. No difference was noted between the groups in outcomes measured by the McGill Pain Questionnaire, the Hospital Anxiety and Depression Scale, General Health Questionnaire-30, and the NIH-CPSI score. A significant limitation in this study was the small number of patients and failure to use intent-to-treat analysis.2 A 2003 multicenter RCT evaluated the effects of rofecoxib therapy for 161 patients with chronic prostatitis: 53 were given rofecoxib 25 mg PO, 49 were given rofecoxib 50 mg PO, and 59 were given a placebo PO. NIH-CPSI pain scores were used to evaluate the patients at baseline and after 6 weeks of treatment. The NIH-CPSI total scores were lowered by –4.18, –4.92, and –6.22 points in the placebo, rofecoxib 25-mg, and rofecoxib 50-mg groups, respectively, compared with baseline. None of these changes was statistically significant.3 Bryant Huy Nguyen, MD Barbara Jo McGarry, MD Beatrix Roemheld-Hamm, MD, PhD UMDNJ-RWJMS FMR New Brunswick, NJ 1.Alexander RB, Propert KJ, Schaeffer AJ, et al, for the Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004; 141(8):581– 589. [LOE 1b] 2.Bates SM, Hill VA, Anderson JB, et al. A prospective, randomized, double-blind trial to evaluate the role of a short reducing course of oral corticosteroid therapy in the treatment of chronic prostatitis/chronic pelvic pain syndrome. BJU Int. 2007; 99(2):355–359. [LOE 1b–] 3.Nickel JC, Pontari M, Moon T, et al, for the Rofecoxib Prostatitis Investigator Team. A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis. J Urol. 2003; 169(4):1401– 1405. [LOE 1b] How can we best manage chronic pain for patients taking long-term narcotic analgesics? Evidence-Based Answer Tramadol has proven efficacy up to 6 months and less abuse potential than hydrocodone over 1 year. (SOR B, based on randomized controlled trials [RCTs].) Transdermal fentanyl and sustained-release morphine have been proven effective for longer-term use, although constipation is more common with morphine. (SOR A, based on consistent RCTs.) Tricyclic and tetracyclic antidepressants appear to be moderately effective for reduction of chronic back pain. (SOR B, based on a systematic review with heterogeneity.) The long-term management of chronic noncancer pain is challenging as no consistent, high-quality data are available to guide therapeutic decisions. Tramadol, an analgesic that is not a controlled substance but binds weakly to opioid receptors and inhibits the reuptake of serotonin and norepinephrine, has the most evidence supporting its use for noncancer pain. However, studies are primarily short-term and sponsored by the manufacturer. A Cochrane review pooled data from 3 RCTs (N=914) lasting 7 to 12 weeks that compared tramadol with placebo among patients with chronic low back pain.1 Tramadol was more effective than placebo for pain relief (standardized mean difference [SMD] 0.71; 95% CI, 0.39–1.02) and for improving function (SMD 0.17; 95% CI, 0.04–0.30). In a separate RCT with 11,352 chronic pain patients, a series of structured interviews was performed over a 12-month period to calculate an “abuse index” for each patient randomized to tramadol, nonsteroidal antiinflammatory drugs (NSAIDs), or hydrocodone.2 The percentage of patients who scored positive for abuse at least once during the 12-month period was 2.5% for NSAIDs, 2.7% for tramadol, and 4.9% for hydrocodone. The percentages of patients scoring positive for abuse more than once (indicating persistent abuse) were 0.5% for NSAIDs, 0.7% for tramadol, and 1.2% for hydrocodone. Tramadol had similar rates of abuse as NSAIDS, but significantly less abuse than hydrocodone (P<.01). The only evidence supporting long-term use of tramadol was a 6-month open extension trial of 117 patients with diabetic neuropathy that followed a 6-week RCT and demonstrated continued pain relief.3 According to a recent evidence-based guideline, the opioids with the best evidence for efficacy with therapy 6 months or longer are sustained-release morphine and transdermal fentanyl.4 This guideline referenced 5 studies with a total of 688 patients that demonstrated persistent improvement of pain scores and quality of life with sustained-release morphine in chronic noncancer pain. For transdermal fentanyl, 3 studies with a total of 1,399 patients demonstrated persistent improvement of pain scores and quality of life. All of the long-term studies were open-label and used variable outcome measures, making it difficult to quantify the pooled results. One open RCT over 13 months compared sustained-release morphine and transdermal fentanyl in the treatment of chronic low back pain.5 This study found similar improvement in pain relief and quality of life with the 2 treatments, but significantly less constipation with fentanyl. At the study endpoint, 31% of the transdermal fentanyl patients and 48% of the sustained-release morphine patients reported constipation (P<.001). Baseline levels constipation were similar for both groups at 23% and 26%, respectively. continued Evidence-Based Practice / Vol. 12, No. 7 9
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