Background: Powered exoskeletons are designed to safely facilitate ambulation in patients with spinal cord injury (SCI). We conducted the first meta-analysis of the available published research on the clinical effectiveness and safety of powered exoskeletons in SCI patients. Methods: MEDLINE and EMBASE databases were searched for studies of powered exoskeleton-assisted walking in patients with SCI. Main outcomes were analyzed using fixed and random effects meta-analysis models. Results: A total of 14 studies (eight ReWalk™, three Ekso™, two Indego ® , and one unspecified exoskeleton) representing 111 patients were included in the analysis. Training programs were typically conducted three times per week, 60-120 minutes per session, for 1-24 weeks. Ten studies utilized flat indoor surfaces for training and four studies incorporated complex training, including walking outdoors, navigating obstacles, climbing and descending stairs, and performing activities of daily living. Following the exoskeleton training program, 76% of patients were able to ambulate with no physical assistance. The weighted mean distance for the 6-minute walk test was 98 m. The physiologic demand of powered exoskeleton-assisted walking was 3.3 metabolic equivalents and rating of perceived exertion was 10 on the Borg 6-20 scale, comparable to self-reported exertion of an able-bodied person walking at 3 miles per hour. Improvements in spasticity and bowel movement regularity were reported in 38% and 61% of patients, respectively. No serious adverse events occurred. The incidence of fall at any time during training was 4.4%, all occurring while tethered using a first-generation exoskeleton and none resulting in injury. The incidence of bone fracture during training was 3.4%. These risks have since been mitigated with newer generation exoskeletons and refinements to patient eligibility criteria. Conclusion: Powered exoskeletons allow patients with SCI to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits.
The proprietary probiotic blend used in this study was well tolerated and effective for reducing risk of AAD and, in particular, CDAD in hospitalized patients on antibiotics. A dose-ranging effect was shown with 100 billion c.f.u., yielding superior outcomes and fewer gastrointestinal events compared to 50 billion c.f.u. (ClinicalTrials.gov number NCT00958308).
We conducted a systematic review and meta-analysis of randomized saline-controlled trials to determine the safety and efficacy of US-approved intra-articular hyaluronic acid (IAHA) injections for symptomatic knee osteoarthritis. A total of 29 studies representing 4,866 unique subjects (IAHA: 2,673, saline: 2,193) were included. IAHA injection resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to pre-injection values, with standardized mean difference (SMD) values ranging from 1.07–1.37 (all P < 0.001). Compared to saline controls, SMDs with IAHA ranged from 0.38–0.43 for knee pain and 0.32–0.34 for knee function (all P < 0.001). There were no statistically significant differences between IAHA and saline controls for any safety outcome, including serious adverse events (SAEs) (P = 0.12), treatment-related SAEs (P = 1.0), study withdrawal (P = 1.0), and AE-related study withdrawal (P = 0.46). We conclude that intra-articular injection of US-approved HA products is safe and efficacious in patients with symptomatic knee osteoarthritis.
Objective. To assess the impact of Bifidobacterium lactis HN019 supplementation on whole gut transit time (WGTT) and frequency of functional gastrointestinal (GI) symptoms in adults. Material and methods. We randomized 100 subjects (mean age: 44 years; 64% female) with functional GI symptoms to consume a proprietary probiotic strain, B. lactis HN019 (Fonterra Research Centre, Palmerston North, New Zealand), at daily doses of 17.2 billion colony forming units (CFU) (high dose; n = 33), 1.8 billion CFU (low dose; n = 33), or placebo (n = 34) for 14 days. The primary endpoint of WGTT was assessed by X-ray on days 0 and 14 and was preceded by consumption of radiopaque markers once a day for 6 days. The secondary endpoint of functional GI symptom frequency was recorded with a subject-reported numeric (1–100) scale before and after supplementation. Results. Decreases in mean WGTT over the 14-day study period were statistically significant in the high dose group (49 ± 30 to 21 ± 32 h, p < 0.001) and the low dose group (60 ± 33 to 41 ± 39 h, p = 0.01), but not in the placebo group (43 ± 31 to 44 ± 33 h). Time to excretion of all ingested markers was significantly shorter in the treatment groups versus placebo. Of the nine functional GI symptoms investigated, eight significantly decreased in frequency in the high dose group and seven decreased with low dose, while two decreased in the placebo group. No adverse events were reported in any group. Conclusions. Daily B. lactis HN019 supplementation is well tolerated, decreases WGTT in a dose-dependent manner, and reduces the frequency of functional GI symptoms in adults.
Background-Endovenous recanalization of iliofemoral stenosis or occlusion with angioplasty and stent placement has been increasingly used to maintain long-term venous patency in patients with iliofemoral venous outflow obstruction. The purpose of this systematic review and meta-analysis was to determine safety and effectiveness of venous stent placement in patients with iliofemoral venous outflow obstruction. Methods and Results-We searched MEDLINE and EMBASE for studies evaluating safety or effectiveness of stent placement in patients with iliofemoral venous outflow obstruction. Data were extracted by disease pathogenesis: nonthrombotic, acute thrombotic, or chronic post-thrombotic. Main outcomes included technical success, periprocedural complications, symptom relief at final follow-up, and primary/secondary patency through 5 years. A total of 37 studies reporting 45 treatment effects (nonthrombotic, 8; acute thrombotic, 19; and chronic post-thrombotic, 18) from 2869 patients (nonthrombotic, 1122; acute thrombotic, 629; and chronic post-thrombotic, 1118) were included. Technical success rates were comparable among groups, ranging from 94% to 96%. Complication rates ranged from 0.3% to 1.1% among groups for major bleeding, from 0.2% to 0.9% for pulmonary embolism, from 0.1% to 0.7% for periprocedural mortality, and from 1.0% to 6.8% for early thrombosis. Patient symptom relief data were reported inconsistently. At 1 year, primary and secondary patency were 96% and 99% for nonthrombotic, 87% and 89% for acute thrombotic, and 79% and 94% for chronic post-thrombotic. Conclusions-Stent Methods Literature SearchThis study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses. 9 We searched MEDLINE and EMBASE for randomized or nonrandomized controlled studies and prospective or retrospective case series of stent placement for treatment of iliofemoral venous outflow obstruction by using a combination of relevant keywords. The details of the MEDLINE search strategy are listed in Table I in the Data Supplement. The syntax for EMBASE was similar, but adapted as necessary. In addition, manual searches were conducted using the Directory of Open Access Journals, Google Scholar, and the reference lists of included papers and relevant meta-analyses. No date restrictions were applied to the searches. The final search was conducted March 15, 2015. Study SelectionTwo researchers independently selected studies for inclusion in the review. Disagreements were resolved by consensus. Titles and abstracts were initially screened to exclude review articles, commentaries, letters, case reports, and obviously irrelevant studies. Full texts of the remaining articles were retrieved and reviewed. Main inclusion criteria included studies with (1) primary diagnosis of obstructive lesions of the common femoral vein, external iliac vein, and the common iliac vein, (2) stent placement in the common femoral vein, external iliac vein, common iliac vein, and the inferior vena cava, (3) outcomes reporte...
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