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Objectives: To compare antimicrobial and resource utilization with T2 Magnetic Resonance (T2MR) versus blood culture (BC) in patients with suspected bloodstream infection. Methods: We systematically searched MEDLINE, EMBASE, and CENTRAL for randomized trials or observational controlled studies of patients with suspected bloodstream infection receiving a diagnosis with T2MR or BC. Using an inverse variance meta-analysis model, we reported mortality using the risk ratio (RR) and the remaining outcomes as the mean difference (MD). Results: Fourteen studies were included in the meta-analysis. Time to detection (MD = −81 hours; p < 0.001) and time to species identification (MD = −77 hours; p < 0.001) were faster with T2MR. Patients testing positive on T2MR received targeted antimicrobial therapy faster (−42 hours; p < 0.001) and patients testing negative on T2MR were de-escalated from empirical therapy faster (−7 hours; p = 0.02) vs. BC. Length of intensive care unit stay (MD = −5.0 days; p = 0.03) and hospital stay (MD = −4.8 days; p = 0.03) were shorter with T2MR. Mortality rates were comparable between T2MR and BC (28.9% vs. 29.9%, RR = 1.02, p = 0.86). Conclusion: Utilization of T2MR for identification of bloodstream pathogens provides faster time to detection, faster transition to targeted microbial therapy, faster de-escalation of empirical therapy, shorter ICU and hospital stay, and with comparable mortality rate versus BC. [ABSTRACT FROM AUTHOR]

Background: The health benefits of regular aerobic exercise are well established, although there is limited high-quality evidence regarding its impact on erectile function. Aim: To determine the effect of aerobic exercise on erectile function in men and to identify factors that may influence this effect. Methods: This systematic review and meta-analysis included randomized controlled trials that evaluated the effects of aerobic exercise on erectile function via the Erectile Function domain of the International Index of Erectile Function (IIEF-EF). The mean difference in IIEF-EF scores between the aerobic exercise and nonexercising control groups was estimated by a random-effects meta-analysis. Meta-regression was used to evaluate the association of moderator variables on meta-analysis results. Outcomes: The IIEF-EF score is reported on a 6-30 scale, with higher values indicating better erectile function. Results: Among 11 randomized controlled trials included in the analysis, aerobic exercise resulted in statistically significant improvements in IIEF-EF scores as compared with controls, with a mean difference of 2.8 points (95% CI, 1.7-3.9; P < .001) and moderate heterogeneity among studies (I2 = 53%). The effect of aerobic exercise on erectile function was greater in men with lower baseline IIEF-EF scores, with improvements of 2.3, 3.3, and 4.9 points for mild, moderate, and severe erectile dysfunction, respectively (P = .02). The meta-analysis results were not influenced by publication bias or individual study effects. Clinical Implications: Health care providers should consider recommending regular aerobic exercise as a low-risk nonpharmacologic therapy for men experiencing erectile difficulties. Strengths and Limitations: The primary strength of this review was the generation of level 1 evidence on a topic of general interest regarding sexual health in men. However, the included studies evaluated diverse groups, which may complicate data interpretation for specific segments of the population. Conclusion: Regular aerobic exercise can improve the erectile function of men, particularly those with lower baseline IIEF-EF scores. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to determine whether in-hospital outcomes are different with anterior approach (AA) or posterior approach (PA) in primary total hip arthroplasty (THA). Methods: We performed a systematic review with random-effects meta-analysis of randomized controlled trials (RCTs) comparing AA with PA in primary THA. Hospital outcomes were reported as odds ratio (OR), weight mean difference, or standardized mean difference (SMD). Results: A total of seven RCTs with 609 patients were included. Outcomes favoring AA included 1.4 cm shorter incision (p=0.045), 0.5 days shorter hospital stay (p=0.01), 0.5 points less pain on a 0–10 scale (p=0.007), and less opioid use (SMD=-0.39 corresponding to 12 fewer morphine equivalents per day, p=0.01). The procedure time was 16 minutes longer with AA vs. PA (p=0.002). There were no statistical differences between AA and PA in operative blood loss (mean difference =19 mL, p=0.71), transfusions (9.7% vs. 16.2%, OR=0.45, p=0.39), or complications (5.5% vs. 4.1%, OR=1.42, p=0.62). Conclusion: While the AA to primary THA may take longer time compared with the PA, the incision is shorter, and patients report slightly less pain, require less opioid medication, and leave the hospital earlier. The clinical relevance of these differences during longer-term follow-up is uncertain. The choice of surgical approach in primary THA should also consider factors such as experience of the surgeon and preferences of the surgeon and patient. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to evaluate perioperative complications of lumbar discectomy with or without bone-anchored annular closure device (ACD) implant in patients at high risk of recurrent disc herniation. Methods: This was a post hoc analysis of a randomized controlled trial that compared outcomes of lumbar discectomy with or without additional placement of an ACD. Patients presented with imaging evidence of lumbar disc herniation and radicular pain that was unresponsive to conservative care. Randomization occurred intraoperatively following discectomy completion and confirmation of annular defect width ≥6 mm. Main outcomes included serious adverse events (SAEs) from any cause, device- or procedure-related SAEs, and reoperations at the index level. The perioperative period included all outcomes occurring between the day of surgery and 90 days following hospital discharge. Results: Analyses were performed on a modified intention-to-treat population consisting of 272 patients treated with ACD and 278 patients treated with lumbar discectomy only (controls). Mean patient age was 44 years, 59% were men, and mean body mass index was 26 kg/m2. Baseline patient characteristics and operative outcomes were comparable between groups. The risks of all-cause SAE (9.7% vs 16.3%, p=0.056), device- or procedure-related SAE (4.5% vs 10.2%, p=0.02), and index-level reoperation (1.9% vs 5.4%, p=0.03) were lower with ACD vs controls. In multivariable logistic regression, control group assignment and female gender were independently associated with higher risk of device- or procedure-related SAE and index-level reoperation, respectively. Conclusion: In patients undergoing lumbar discectomy to treat symptomatic intervertebral disc herniation, adjunctive placement of an ACD reduces the risk for perioperative complications occurring through 90 days following hospital discharge. [ABSTRACT FROM AUTHOR]

Background: Constipation is a common complaint in adults. Lactitol is an osmotic disaccharide laxative that increases fecal volume and stimulates peristalsis. In this paper, we present the first meta-analysis on the efficacy and tolerance of lactitol for adult constipation. Methods: We searched MEDLINE® and Embase, with no date or language restrictions, for studies of lactitol supplementation on adult constipation. A random-effects meta-analysis was performed on pre- to posttreatment changes in stool frequency and consistency with lactitol among all studies, as well as a comparison of efficacy and tolerance outcomes in randomized controlled trials (RCTs) of lactitol versus lactulose. Results: A total of eleven studies representing 663 distinct patients were included in the final analysis, including five single-arm studies, four RCTs comparing lactitol with lactulose, one RCT comparing lactitol with placebo, and one nonrandomized controlled trial comparing lactitol with stimulant laxatives. Weekly stool frequency was significantly increased with lactitol compared with baseline (standardized mean difference [SMD]: 1.56, P<0.001). Stool consistency also improved over the supplementation period with lactitol (SMD: 1.04, P<0.001). Approximately one-third of patients experienced an adverse event; however, symptoms were generally mild and rarely (5%) resulted in study withdrawal. In RCTs of lactitol versus lactulose, lactitol was slightly more effective than lactulose in increasing weekly stool frequency (SMD: 0.19, P=0.06). No statistically significant differences between lactitol and lactulose were identified in any other efficacy or tolerance outcome. Lactitol demonstrated favorable efficacy and tolerance in individual studies when compared to stimulant laxatives and placebo. Conclusion: Lactitol supplementation is well tolerated and improves symptoms of adult constipation. The efficacy and tolerance of lactitol and lactulose are similar, with a trend for more frequent stools with lactitol. Limited evidence suggests lactitol is superior to stimulant laxatives and placebo for relieving constipation symptoms. [ABSTRACT FROM AUTHOR]

Background: The purpose of this paper was to assess the feasibility of Micro-Mobile Compression® (MMC) on lactate clearance following exhaustive exercise and on subsequent exercise performance. Methods: Elite male cyclists were randomized to MMC (n = 8) or passive recovery (control, n = 8). MMC is incorporated into a sandal that intermittently compresses the venous plexus during non-weight bearing to augment venous return. On day 1, subjects performed a graded exercise test on a cycle ergometer followed by 60 minutes of seated recovery, with or without MMC. Blood lactate concentration ([La-]) was measured during exercise and recovery. Subjects returned home for 3 more hours of seated recovery, with or without MMC. On days 2 and 3, subjects exercised to exhaustion in a fixed-load cycle ergometer test at 85% peak power and then repeated the day 1 post-exercise recovery procedures. Lactate clearance data after the time to exhaustion tests on days 2 and 3 were averaged to adjust for interday variation. Results: On the day after MMC or control recovery, mean time to exhaustion was 15% longer (mean difference, 2.1 minutes) in the MMC group (P = 0.30). The standardized mean difference of MMC for time to exhaustion was 0.55, defined as a moderate treatment effect. Following the graded exercise test, area under the 60-minute lactate curve was nonsignificantly lower with MMC (3.2 ± 0.4 millimolar [mM]) versus control (3.5 ± 0.4 mM, P = 0.10) and times from end of exercise to 4mM and 2mM were 2.1 minutes (P = 0.58) and 7.2 minutes (P = 0.12) shorter, although neither achieved statistical significance. Following time to exhaustion testing, the area under the 60-minute lactate curve was lower with MMC (3.2 ± 0.2 mM) versus control (3.5 ± 0.2 mM, P = 0.02) and times from end of exercise to 4mM and 2mM were 4.4 minutes (P = 0.02) and 7.6 minutes (P < 0.01) faster. The standardized mean difference of MMC on most lactate clearance parameters was >0.8, defined as a large treatment effect. Conclusion: MMC yields large treatment effects on lactate clearance following high-intensity exercise and moderate treatment effects on subsequent exercise performance in elite male cyclists. [ABSTRACT FROM AUTHOR]

A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational interspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP). One hundred sixty-six patients with moderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n = 80) or X-STOP (n = 86) interspinous spacer. Study subjects were followed through 6 months posttreatment. Zurich Claudication Questionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P < 0.001). Similar changes were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P < 0.001). Mean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits. The proportion of subjects that achieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP. Axial pain decreased from 55 ± 27mm at pretreatment to 22 ± 26mm at 6 months in the Superion group (P < 0.001) and from 54 ± 29mm to 32 ± 31mm with X-STOP (P < 0.001). Extremity pain decreased from 61 ± 26mm at pretreatment to 18 ± 27mm at 6 months in the Superion group (P < 0.001) and from 64 ± 26mm to 22 ± 30mm with X-STOP (P < 0.001). Back function improved from 38 ± 13% to 21 ± 19% with Superion (P < 0.001) and from 40 ± 13% to 25 ± 16% with X-STOP (P < 0.001). Preliminary results suggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients with moderate LSS who are unresponsive to conservative care. [ABSTRACT FROM AUTHOR]

Abstract: The use of blinding strengthens the credibility of randomized controlled trials (RCTs) by minimizing bias. However, there is confusion surrounding the definition of blinding as well as the terms single, double, and triple blind. It has been suggested that these terms should be discontinued due to their broad misinterpretation. We recommend that, instead of abandoning the use of these terms, explicit definitions of blinding should be adopted. We address herein the concept of blinding, propose standard definitions for the consistent use of these terms, and detail when different types of blinding should be utilized. Standardizing the definition of blinding and utilizing proper blinding methods will improve the quality and clarity of reporting in RCTs. [Copyright &y& Elsevier]

We compared the safety and effectiveness of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) to open TLIF (O-TLIF) for lumbar degenerative disease. We systematically searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for randomized trials of MI-TLIF versus O-TLIF. The perioperative outcomes included the procedure time, fluoroscopy time, blood loss, complications, and hospital stay. The midterm outcomes included pseudarthrosis, the Oswestry Disability Index, and pain severity—all reported at 1-year minimum follow-up. A total of 7 randomized trials including 496 patients (246 MI-TLIF; 250 O-TLIF) were included in our review. No statistically significant group differences in procedure time (mean difference [MD], −4 minutes; P = 0.70) were found. However, the fluoroscopy time was significantly longer with MI-TLIF (MD, 48 seconds; P < 0.001). MI-TLIF resulted in less perioperative blood loss (MD, −200 mL; P < 0.001) and shorter hospitalization (MD, −2.2 days; P < 0.001) compared with O-TLIF. The risk of perioperative complications was comparable between the 2 groups (risk ratio, 1.03; P = 0.94). No group differences were found in the incidence of pseudarthrosis at the 1-year minimum follow-up (risk ratio, 0.84; P = 0.67). Pain severity at midterm follow-up was comparable between the 2 groups (MD, −1; P = 0.59), and the ODI was slightly lower in the MI-TLIF group (MD, −3; P = 0.01). Relative to O-TLIF, MI-TLIF was associated with less blood loss, a shorter hospital stay, and slightly less disability, at the expense of longer fluoroscopy times. [ABSTRACT FROM AUTHOR]

Objective: We assessed the effectiveness of vaginal probiotic capsules for recurrent bacterial vaginosis (BV) prevention. Study Design: One hundred twenty healthy Chinese women with a history of recurrent BV were assigned randomly to daily vaginal prophylaxis with 1 capsule (Probaclac Vaginal; Nicar Laboratories, Inc, Blainville, Quebec, Canada) that contained 8 billion colony-forming units of Lactobacillus rhamnosus, L acidophilus, and Streptococcus thermophilus (n = 58 women) or 1 placebo capsule (n = 62 women) for 7 days on, 7 days off, and 7 days on. Results: Probiotic prophylaxis resulted in lower recurrence rates for BV (15.8% [9/57 women] vs 45.0% [27/60 women]; P < .001) and Gardnerella vaginalis incidence through 2 months (3.5% [2/57 women] vs 18.3% [11/60 women]; P = .02). Between the 2- and 11-month follow-up period, women who received probiotics reported a lower incidence of BV and G vaginalis. Aside from vaginal discharge and malodor, no adverse events were reported in either study group. Conclusion: Short-term probiotic prophylaxis is well tolerated and reduces BV recurrence and G vaginalis risk through 11 months after treatment. [Copyright &y& Elsevier]

Study Design: Post hoc analysis of a randomized controlled trial.Objective: To characterize the morphology and clinical relevance of vertebral endplate changes (VEPC) following limited lumbar discectomy with or without implantation of a bone-anchored annular closure device (ACD).Summary Of Background Data: Implantation of an ACD following limited lumbar discectomy has shown promise in reducing the risk of recurrent herniation in patients with large annular defects. However, the interaction between the ACD and the lumbar endplate over time is not well understood.Methods: Patients undergoing limited lumbar discectomy with large postsurgical annular defects were randomized intraoperatively to receive additional ACD implantation or limited lumbar discectomy only (Controls). VEPC morphology, area, and volume were assessed with low-dose computed tomography preoperatively and at 1 and 2 years follow-up.Results: Of 554 randomized patients, the as-treated population consisted of 550 patients (267 ACD, 283 Controls). VEPC were preoperatively identified in 18% of patients in the ACD group and in 15% of Controls. At 2 years, VEPC frequency increased to 85% with ACD and 33% in Controls. Device- or procedure-related serious adverse event (8% vs. 17%, P = 0.001) and secondary surgical intervention (5% vs. 13%, P < 0.001) favored the ACD group over Controls. In the ACD group, clinical outcomes were comparable in patients with and without VEPC at 2 years follow-up. In the Control group, patients with VEPC at 2 years had higher risk of symptomatic reherniation versus patients without VEPC (35% vs. 19%, P < 0.01) CONCLUSION.: In patients with large annular defects following limited lumbar discectomy, additional implantation with a bone-anchored ACD reduces risk of postoperative complications despite a greater frequency of VEPC. VEPC were associated with higher risk of symptomatic reherniation in patients treated with limited lumbar discectomy, but not in those who received additional ACD implantation.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Study Design: A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.Objective: The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy.Summary Of Background Data: Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR.Methods: Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational TDR device (activL, n = 218) or FDA-approved control TDR devices (ProDisc-L or Charité, n = 106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls.Results: The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P < 0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P = 0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P < 0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P = 0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P = 0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%).Conclusion: The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years.Level Of Evidence: 2. [ABSTRACT FROM AUTHOR]

Abstract: Strong evidence supports the ability of dietary fibers to improve satiety. However, large variations in the physical and chemical characteristics of dietary fiber modulate the physiologic responses. We hypothesized that a nonviscous soluble dietary fiber may influence satiety. This randomized, double-blind, placebo-controlled clinical study in 100 overweight healthy adults in China investigated the effect of different dosages of dietary supplementation with a dextrin, NUTRIOSE (ROQUETTE frères, Lestrem, France), on short-term satiety over time. Subjects were randomized by body mass index and energy intake and then assigned to receive either placebo or 8, 14, 18, or 24 g/d of NUTRIOSE mixed with orange juice (n = 20 volunteers per group). On days −2, 0, 2, 5, 7, 14, and 21, short-term satiety was evaluated with a visual analog scale, and hunger feeling status was assessed with Likert scale. NUTRIOSE exhibits a progressive and significant impact on short-term satiety, which is time and dosage correlated. Some statistical differences appear for the group 8 g/d from day 5, and from day 0 for the groups 14, 18, and 24 g/d. The hunger feeling status decreases significantly from day 5 to the end of the evaluation for the group 24 g and from day 7 for the groups 14 and 18 g. By day 5, the group 24 g showed significantly longer time to hunger between meals compared with placebo. These results suggest that dietary supplementation with a soluble fiber can decrease hunger feeling and increase short-term satiety over time when added to a beverage from 8 to 24 g/d with time- and dose-responses relationship. [Copyright &y& Elsevier]