A randomized comparison of paclitaxel-eluting stents versus bare-metal stents for treatment of unprotected left main coronary artery stenosis.

OBJECTIVES: To optimize percutaneous coronary intervention (PCI) strategy for unprotected left main (LM) disease, we performed a randomized study: intravascular ultrasound (IVUS)-guided bare-metal stent (BMS) or paclitaxel-eluting stent (PES) implantation after lesion pre-treatment with cutting balloon (CB) for unprotected LM lesions. BACKGROUND: Recent studies have shown promising results in terms of safety and feasibility for patients with LM disease who underwent PCI with stent implantation. However, comparison of BMS and PES for LM lesions has not yet been evaluated. METHODS: One hundred three patients were randomly assigned to receive BMS (n = 50) or PES (n = 53) implantation. All interventions were IVUS guided, and CB pre-treatment before stenting was performed in all patients. All patients were scheduled for 6-month follow-up. RESULTS: Baseline clinical characteristics were comparable in both cohorts. Stent implantation was successful in all lesions. Follow-up analysis showed binary restenosis in 11 (22%) BMS and in 3 (6%) PES patients (p = 0.021). By IVUS, percentage of neointimal volume obstruction at 6 months was reduced from 25.20 +/- 22.02% with BMS to 16.60 +/- 17.25% with PES (p = 0.02). At 6 months, the major adverse cardiac event-free survival rate was 70% in BMS and 87% in PES patients (p = 0.036). CONCLUSIONS: This study demonstrates that PCI of LM with IVUS guidance and CB pre-treatment is safe and effective. No serious procedure-related complications were observed, and clinical outcomes appeared to be good. Finally, the findings demonstrate that implantation of PES may be superior to BMS in the large-diameter LM vessel at 6 months, warranting the performance of a large-scale randomized trial.     

Clinical efficacy of OM-85 BV in COPD and chronic bronchitis: a systematic review

OM-85 BV is an immunomodulatory agent used for prevention of exacerbations in persons with chronic lung disease. We conducted a systematic review of OM-85 BV to evaluate its efficacy and safety. A systematic search for relevant articles was performed. Studies were included if they involved persons with chronic obstructive pulmonary disease or chronic bronchitis and were randomized to OM-85 BV or placebo. Investigators extracted data on study design, participant characteristics, and clinical outcomes. Thirteen trials involving 2066 individuals met inclusion criteria. Three trials enrolled an older, more homogenous population with chronic obstructive pulmonary disease. Utilizing quantitative pooled analysis in these studies, with one or more acute exacerbations as the endpoint, we found a non-statistically significant trend in favor of OM-85 BV [relative risk 0.83, 95% confidence interval 0.65-1.05]. Ten trials enrolled a heterogeneous population with chronic bronchitis. In these trials, exacerbation rates were less with OM-85 BV in 4 of 9 trials reporting this outcome. Varied results in the outcomes of hospitalization, symptom scores, and antibiotic or steroid use were found across studies. Withdrawals and adverse events were similar between OM-85 BV and placebo. While OM-85 BV is used to prevent exacerbations in persons with chronic lung disease, consistent evidence across multiple important outcomes does not exist to clearly demonstrate clinical benefit. Further randomized controlled trials enrolling large numbers of persons with well-defined COPD are necessary to confirm the effectiveness of this agent.     

Pygeum africanum for the treatment of patients with benign prostatic hyperplasia: a systematic review and quantitative meta-analysis

PURPOSE: To conduct a systematic review and quantitative meta-analysis of the therapeutic efficacy and tolerability of Pygeum africanum in men with symptomatic benign prostatic hyperplasia. METHODS: Studies were identified through the search of Medline (1966 to 2000), Embase, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. Randomized trials were included if participants had symptomatic benign prostatic hyperplasia, the intervention was a preparation of P. africanum alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacologic therapies for benign prostatic hyperplasia, and treatment duration was at least 30 days. Two investigators independently extracted key data on design features, subject characteristics, and therapy allocation.RESULTS: A total of 18 randomized controlled trials involving 1,562 men met the inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Only 1 of the studies reported a method of treatment allocation concealment, although 17 were double-blinded. The mean study duration was 64 days (range 30 to 122). Compared with placebo in 6 studies, P. africanum provided a moderately large improvement in the combined outcome of urologic symptoms and flow measures as assessed by an effect size defined by the difference of the mean change for each outcome divided by the pooled standard deviation for each outcome (-0.8 SD [95% confidence interval (CI): -1.4 to -0.3]). Summary estimates of individual outcomes were also improved by P. africanum. Men were more than twice as likely to report an improvement in overall symptoms (risk ratio = 2.1, 95% CI: 1.40 to 3.1). Nocturia was reduced by 19% and residual urine volume by 24%; peak urine flow was increased by 23%. Adverse effects due to P. africanum were mild and similar to placebo. The overall dropout rate was 12% and was similar for P. africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus placebo and P = 0.5 versus other controls).CONCLUSIONS: The literature on P. africanum for the treatment of benign prostatic hyperplasia is limited by the short duration of studies and the variability in study design, the use of phytotherapeutic preparations, and the types of reported outcomes. However, the evidence suggests that P. africanum modestly, but significantly, improves urologic symptoms and flow measures. Further research is needed using standardized preparations of P. africanum to determine its long-term effectiveness and ability to prevent complications associated with benign prostatic hyperplasia.     

Effectiveness of Family and Caregiver Interventions on Patient Outcomes in Adults with Cancer: A Systematic Review

BACKGROUND

Family and caregiver interventions typically aim to develop family members’ coping and caregiving skills and to reduce caregiver burden. We conducted a systematic review of published randomized controlled trials (RCTs) evaluating whether family-involved interventions improve patient outcomes among adults with cancer.

METHODS

RCTs enrolling patients with cancer were identified by searching MEDLINE, PsycInfo and other sources through December 2012. Studies were limited to subjects over 18 years of age, published in English language, and conducted in the United States. Patient outcomes included global quality of life; physical, general psychological and social functioning; depression/anxiety; symptom control and management; health care utilization; and relationship adjustment.

RESULTS

We identified 27 unique trials, of which 18 compared a family intervention to usual care or wait list (i.e., usual care with promise of intervention at completion of study period) and 13 compared one family intervention to another individual or family intervention (active control). Compared to usual care, overall strength of evidence for family interventions was low. The available data indicated that overall, family-involved interventions did not consistently improve outcomes of interest. Similarly, with low or insufficient evidence, family-involved interventions were not superior to active controls at improving cancer patient outcomes.

DISCUSSION

Overall, there was low or insufficient evidence that family and caregiver interventions were superior to usual or active care. Variability in study populations and interventions made pooling of data problematic and generalizing findings from any single study difficult. Most of the included trials were of poor or fair quality.     

Interventions to Improve Veterans’ Access to Care: A Systematic Review of the Literature

Objectives

To conduct a systematic review to address the following key questions: (1) what interventions have been successful in improving access for veterans with reduced health care access? (2) Have interventions that have improved health care access led to improvements in process and clinical outcomes?

Data Sources

OVID MEDLINE, CINAHL, PsychINFO.

Study Eligibility Criteria, Participants, and Interventions

English language articles published in peer-reviewed journals from 1990 to June 2010. All interventions designed to improve access to health care for US veterans that reported the impact of the intervention on perceived (e.g., satisfaction with access) or objective (e.g., travel time, wait time) access were included.

Appraisal and Synthesis Methods

Investigators abstracted data on study design, study quality, intervention, and impact of the intervention on access, process outcomes, and clinical outcomes.

Results

Nineteen articles (16 unique studies) met the inclusion criteria. While there were a small number of studies in support of any one intervention, all showed a positive impact on either perceived or objective measures of access. Implementation of Community Based Outpatient Clinics (n?=?5 articles), use of Telemedicine (n?=?5 articles), and Primary Care Mental Health Integration (n?=?6 articles) improved access. All 16 unique studies reported process outcomes, most often satisfaction with care and utilization. Four studies reported clinical outcomes; three found no differences.

Limitations

Included studies were largely of poor to fair methodological quality.

Conclusions and Implications of Key Findings

Interventions can improve access to health care for veterans. Increased access was consistently linked to increased primary care utilization. There was a lack of data regarding the link between access and clinical outcomes; however, the limited data suggest that increased access may not improve clinical outcomes. Future research should focus on the quality and appropriateness of care and clinical outcomes.