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Objectives: To investigate whether XueBiJing injection improves clinical outcomes in critically ill patients with severe community-acquired pneumonia.Design: Prospective, randomized, controlled study.Setting: Thirty-three hospitals in China.Patients: A total of 710 adults 18-75 years old with severe community-acquired pneumonia.Interventions: Participants in the XueBiJing group received XueBiJing, 100 mL, q12 hours, and the control group received a visually indistinguishable placebo.Measurements and Main Results: The primary outcome was 8-day improvement in the pneumonia severity index risk rating. Secondary outcomes were 28-day mortality rate, duration of mechanical ventilation and total duration of ICU stay. Improvement in the pneumonia severity index risk rating, from a previously defined endpoint, occurred in 203 (60.78%) participants receiving XueBiJing and in 158 (46.33%) participants receiving placebo (between-group difference [95% CI], 14.4% [6.9-21.8%]; p < 0.001). Fifty-three (15.87%) XueBiJing recipients and 84 (24.63%) placebo recipients (8.8% [2.4-15.2%]; p = 0.006) died within 28 days. XueBiJing administration also decreased the mechanical ventilation time and the total ICU stay duration. The median mechanical ventilation time was 11.0 versus 16.5 days for the XueBiJing and placebo groups, respectively (p = 0.012). The total duration of ICU stay was 12 days for XueBiJing recipients versus 16 days for placebo recipients (p = 0.004). A total of 256 patients experienced adverse events (119 [35.63%] vs 137 [40.18%] in the XueBiJing and placebo groups, respectively [p = 0.235]).Conclusions: In critically ill patients with severe community-acquired pneumonia, XueBiJing injection led to a statistically significant improvement in the primary endpoint of the pneumonia severity index as well a significant improvement in the secondary clinical outcomes of mortality, duration of mechanical ventilation and duration of ICU stay. [ABSTRACT FROM AUTHOR]

Objectives: Occurrence of delirium in the ICU is associated with a longer stay in the ICU. To examine whether the use of ramelteon, a melatonin agonist, can prevent delirium and shorten the duration of ICU stay of critically ill patients.Design: A single-center, triple-blinded, randomized placebo-controlled trial.Setting: ICU of an academic hospital.Patients: Eligible patients were ICU patients who could take medicines orally or through a nasogastric tube during the first 48 hours of admission.Interventions: The intervention group received ramelteon (8 mg/d), and the control group received placebo (1 g/d of lactose powder) at 20:00 hours every day until discharge from the ICU.Measurements and Main Results: A total of 88 subjects were randomized to the ramelteon group (45 subjects) or the placebo group (43 subjects). As the primary endpoint, there was a trend toward decrease in the duration of ICU stay (4.56 d) in the ramelteon group compared with the placebo group (5.86 d) (p = 0.082 and p = 0.028 before and after adjustments). As the secondary endpoints, statistically significant decreases in the occurrence rate (24.4% vs 46.5%; p = 0.044) and duration (0.78 vs 1.40 d; p = 0.048) of delirium were observed in the ramelteon group. The nonintubated patients of the ramelteon group showed statistically significantly fewer awakenings per night and a higher proportion of nights without awakenings.Conclusions: Ramelteon tended to decrease the duration of ICU stay as well as decreased the occurrence rate and duration of delirium statistically significantly. [ABSTRACT FROM AUTHOR]

Chronic low back pain (LBP) is a common condition, usually with the involvement of nociceptive and neuropathic pain components, high economic burden and impact on quality of life. Cebranopadol is a potent, first-in-class drug candidate with a novel mechanistic approach, combining nociceptin/orphanin FQ peptide and opioid peptide receptor agonism. We conducted the first phase II, randomized, double-blind, placebo- and active-controlled trial, evaluating the analgesic efficacy, safety, and tolerability of cebranopadol in patients with moderate-to-severe chronic LBP with and without neuropathic pain component. Patients were treated for 14 weeks with cebranopadol 200, 400, or 600 μg once daily, tapentadol 200 mg twice daily, or placebo. The primary efficacy endpoints were the change from baseline pain to the weekly average 24-hour pain during the entire 12 weeks and during week 12 of the maintenance phase. Cebranopadol demonstrated analgesic efficacy, with statistically significant and clinically relevant improvements over placebo for all doses as did tapentadol. The responder analysis (≥30% or ≥50% pain reduction) confirmed these results. Cebranopadol and tapentadol displayed beneficial effects on sleep and functionality. Cebranopadol treatment was safe, with higher doses leading to higher treatment discontinuations because of treatment-emergent adverse events occurring mostly during titration. Those patients reaching the target doses had an acceptable tolerability profile. The incidence rate of most frequently reported treatment-emergent adverse events during maintenance phase was ≤10%. Although further optimizing the titration scheme to the optimal dose for individual patients is essential, cebranopadol is a new drug candidate with a novel mechanistic approach for potential chronic LBP treatment. [ABSTRACT FROM AUTHOR]

Objective: The aims of this work were to evaluate the effects of home-based telesupervising rehabilitation on physical function for stroke survivors with hemiplegia and to determine if the rehabilitation therapy can relieve the burden on caregivers. Design: This study is a randomized, controlled, assessor-blinded trial. Stroke survivors were randomly assigned to either home-based telesupervising rehabilitation group or conventional rehabilitation group to receive physical exercise and electromyography-triggered neuro-muscular stimulation. Modified Barthel Index, Berg Balance Scale, modified Rankin Scale, Caregiver Strain Index, root mean square of extensor carpi radialis longus and tibialis anterior muscle were measured at 3 time points: baseline, postintervention (12 weeks), and 12-week follow-up (24 weeks). Results: Both the home-based telerehabilitation and conventional rehabilitation groups demonstrated significant effects within groups over the 3 time points in increasing Modified Barthel Index, Berg Balance Scale, and root mean square value of extensor carpi radialis longus and tibialis anterior, as well as decreasing Caregiver Strain Index (P < 0.001), but none of the between-group differences was significant. For modified Rankin Scale, the percentage of participants of grades 0 and 1 in 2 groups increased over time without significant difference between the groups. Conclusions: Home-based telesupervising rehabilitation is most likely as effective as the conventional outpatient rehabilitation for improving functional recovery in stroke survivors and could ease the burden of caregivers as conventional rehabilitation. [ABSTRACT FROM AUTHOR]

Ketamine is often added to opioids in patient-controlled analgesia devices. We tested whether in surgical patients, ketamine added to an opioid patient-controlled analgesia decreased pain intensity by ⩾25%, cumulative opioid consumption by⩾30%, the risk of postoperative nausea and vomiting by⩾30%, the risk of respiratory adverse effects by⩾50%, and increased the risk of hallucination not more than 2-fold. In addition, we searched for evidence of dose-responsiveness. Nineteen randomized trials (1349 adults, 104 children) testing different ketamine regimens added to various opioids were identified through searches in databases and bibliographies (to 04.2016). In 9 trials (595 patients), pain intensity at rest at 24 hours was decreased by 32% with ketamine (weighted mean difference 21.1 cm on the 0-10 cm visual analog scale [98%CI, 21.8 to 20.39], P < 0.001). In 7 trials (495 patients), cumulative 24 hours morphine consumption was decreased by 28% with ketamine (weighted mean difference 212.9 mg [222.4 to 23.35], P = 0.002). In 7 trials (435 patients), the incidence of postoperative nausea and vomiting was decreased by 44% with ketamine (risk ratio 0.56 [0.40 to 0.78], P<0.001). There was no evidence of a difference in the incidence of respiratory adverse events (9 trials, 871 patients; risk ratio 0.31 [0.06 to 1.51], P = 0.08) or hallucination (7 trials, 690 patients; odds ratio 1.16 [0.47 to 2.79], P = 0.70). Trial sequential analyses confirmed the significant benefit of ketamine on pain intensity, cumulative morphine consumption, and postoperative nausea and vomiting and its inability to double the risk of hallucination. The available data did not allow us to make a conclusion on respiratory adverse events or to establish dose-responsiveness. [ABSTRACT FROM AUTHOR]

Neuropathic pain and spasticity after spinal cord injury (SCI) represent significant problems. Palmitoylethanolamide (PEA), a fatty acid amide that is produced in many cells in the body, is thought to potentiate the action of endocannabinoids and to reduce pain and inflammation. This randomized, double-blind, placebo-controlled, parallel multicenter study was performed to investigate the effect of ultramicronized PEA (PEA-um) as add-on therapy on neuropathic pain in individuals with SCI. A pain diary was completed and questionnaires were completed before and after the 12-week treatment with either placebo or PEA-um. The primary outcome measure was the change in mean neuropathic pain intensity from the 1-week baseline period to the last week of treatment measured on a numeric rating scale ranging from 0 to 10. The primary efficacy analysis was the intention to treat (baseline observation carried forward). Secondary outcomes included a per protocol analysis and effects on spasticity, evoked pain, sleep problems, anxiety, depression, and global impression of change. We randomized 73 individuals with neuropathic pain due to SCI, of which 5 had a major protocol violation, and thus 68 were included in the primary analysis. There was no difference in mean pain intensity between PEA-um and placebo treatment (P = 0.46, mean reductions in pain scores 0.4 (-0.1 to 0.9) vs 0.7 (0.2-1.2); difference of means 0.3 (-0.4 to 0.9)). There was also no effect of PEA-um as add-on therapy on spasticity, insomnia, or psychological functioning. PEA was not associated with more adverse effects than placebo. [ABSTRACT FROM AUTHOR]

Objective: To examine a school-based high-intensity neuromuscular training (NMT) program in reducing sport injury risk and improving fitness in youth. Participants: Students (ages 11-15) (n = 725) in physical education (PE) classes were randomized by school to intervention or control groups. Intervention: A 12-week high-intensity NMT program (including aerobic, strength, balance, and agility components) was designed to reduce sport injury risk and improve measures of fitness. The control program was a standard of practice warm-up (including running and stretching). Results: A Poisson regression model using an intent-to-treat analysis demonstrated a reduced risk of sport injury: incidence rate ratio (IRR)all injury = 0.30 (95% CI, 0.19-0.49), IRRlower extremity injury = 0.31 (95% CI, 0.19-0.51), IRRankle sprain injury = 0.27 (95% CI, 0.15-0.50), and IRRknee sprain injury = 0.36 (95% CI, 0.13-0.98). A change in waist circumference: 20.99 centimeters (95% CI, 21.84 to 20.14) and an increase in indirect measures of aerobic fitness: 1.28 mL⋅kg-1 ⋅min-1 (95% CI, 0.66-1.90) in the intervention school compared with the control school also occurred. Conclusions: A NMT program in junior high school PE class was efficacious in reducing sport-related injury and improving measures of adiposity and fitness in the intervention group. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy and safety of scheduled low-dose haloperidol versus placebo for the prevention of delirium (Intensive Care Delirium Screening Checklist ≥ 4) administered to critically ill adults with subsyndromal delirium (Intensive Care Delirium Screening Checklist = 1-3).Design: Randomized, double-blind, placebo-controlled trial.Setting: Three 10-bed ICUs (two medical and one surgical) at an academic medical center in the United States.Patients: Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery, or requiring deep sedation.Interventions: Patients were randomly assigned to receive IV haloperidol 1 mg or placebo every 6 hours until delirium occurred (Intensive Care Delirium Screening Checklist ≥ 4 with psychiatric confirmation), 10 days of therapy had elapsed, or ICU discharge.Measurements and Main Results: Baseline characteristics were similar between the haloperidol (n = 34) and placebo (n = 34) groups. A similar number of patients given haloperidol (12/34 [35%]) and placebo (8/34 [23%]) developed delirium (p = 0.29). Haloperidol use reduced the hours per study day spent agitated (Sedation Agitation Scale ≥ 5) (p = 0.008), but it did not influence the proportion of 12-hour ICU shifts patients spent alive without coma (Sedation Agitation Scale ≤ 2) or delirium (p = 0.36), the time to first delirium occurrence (p = 0.22), nor delirium duration (p = 0.26). Days of mechanical ventilation (p = 0.80), ICU mortality (p = 0.55), and ICU patient disposition (p = 0.22) were similar in the two groups. The proportion of patients who developed corrected QT-interval prolongation (p = 0.16), extrapyramidal symptoms (p = 0.31), excessive sedation (p = 0.31), or new-onset hypotension (p = 1.0) that resulted in study drug discontinuation was comparable between the two groups.Conclusions: Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium. [ABSTRACT FROM AUTHOR]

Background: We assessed the effect of automated treatment adherence support delivered via mobile phone short message system (SMS) text messages on blood pressure.Methods and Results: In this pragmatic, single-blind, 3-arm, randomized trial (SMS-Text Adherence Support [StAR]) undertaken in South Africa, patients treated for high blood pressure were randomly allocated in a 1:1:1 ratio to information only, interactive SMS text messaging, or usual care. The primary outcome was change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. All trial staff were masked to treatment allocation. Analyses were intention to treat. Between June 26, 2012, and November 23, 2012, 1372 participants were randomized to receive information-only SMS text messages (n=457), interactive SMS text messages (n=458), or usual care (n=457). Primary outcome data were available for 1256 participants (92%). At 12 months, the mean adjusted change in systolic blood pressure compared with usual care was -2.2 mm Hg (95% confidence interval, -4.4 to -0.04) with information-only SMS and -1.6 mm Hg (95% confidence interval, -3.7 to 0.6) with interactive SMS. Odds ratios for the proportion of participants with a blood pressure <140/90 mm Hg were 1.42 (95% confidence interval, 1.03-1.95) for information-only messaging and 1.41 (95% confidence interval, 1.02-1.95) for interactive messaging compared with usual care.Conclusions: In this randomized trial of an automated adherence support program delivered by SMS text message in a general outpatient population of adults with high blood pressure, we found a small reduction in systolic blood pressure control compared with usual care at 12 months. There was no evidence that an interactive intervention increased this effect.Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02019823. South African National Clinical Trials Register, number SANCTR DOH-27-1212-386; Pan Africa Trial Register, number PACTR201411000724141. [ABSTRACT FROM AUTHOR]

Over the last decade, the apparent increase in placebo responses in randomized controlled trials (RCTs) of neuropathic pain have complicated and potentially limited development and availability of new effective pain medication. Placebo analgesia and nocebo hyperalgesia effects are well described in nociceptive and idiopathic pain conditions, but less is known about the magnitude and mechanisms of placebo and nocebo effects in neuropathic pain. In neuropathic pain, placebo treatments have primarily been used as control conditions for active agents under investigation in RCTs and these placebo responses are typically not controlled for the natural history of pain and other confounding factors. Recently, mechanistic studies that control for the natural history of pain have investigated placebo and nocebo effects in neuropathic pain in their own right. Large placebo analgesia but no nocebo hyperalgesic effects have been found, and the underlying mechanisms are beginning to be elucidated. Here we review placebo and nocebo effects and the underlying mechanisms in neuropathic pain and compare them with those of nociceptive and idiopathic pain. This allows for a novel discussion on how knowledge of psychological, neurobiological, and genetic factors underlying well-controlled placebo effects may help improve the information that can be obtained from and potentially restore the utility of RCTs. [ABSTRACT FROM AUTHOR]

Internet-delivered interventions are emerging as a strategy to address barriers to care for individuals with chronic pain. This is the first large multicenter randomized controlled trial of Internet-delivered cognitive-behavioral therapy (CBT) for pediatric chronic pain. Participants included were 273 adolescents (205 females and 68 males), aged 11 to 17 years with mixed chronic pain conditions and their parents, who were randomly assigned in a parallel-group design to Internet-delivered CBT (n = 138) or Internet-delivered Education (n = 135). Assessments were completed before treatment, immediately after treatment, and at 6-month follow-up. All data collection and procedures took place online. The primary analysis used linear growth models. Results demonstrated significantly greater reduction on the primary outcome of activity limitations from baseline to 6-month follow-up for Internet CBT compared with Internet education (b = -1.13, P = 0.03). On secondary outcomes, significant beneficial effects of Internet CBT were found on sleep quality (b = 0.14, P = 0.04), on reducing parent miscarried helping (b = -2.66, P = 0.007) and protective behaviors (b = -0.19, P = 0.001), and on treatment satisfaction (P values < 0.05). On exploratory outcomes, benefits of Internet CBT were found for parent-perceived impact (ie, reductions in depression, anxiety, self-blame about their adolescent's pain, and improvement in parent behavioral responses to pain). In conclusion, our Internet-delivered CBT intervention produced a number of beneficial effects on adolescent and parent outcomes, and could ultimately lead to wide dissemination of evidence-based psychological pain treatment for youth and their families. [ABSTRACT FROM AUTHOR]

Opioid analgesics are commonly used for the treatment of chronic low back pain (CLBP); however, abuse potential is a major concern. This study used a randomized, double-blind, placebo-controlled, enriched-enrollment randomized-withdrawal study design to evaluate the safety, tolerability, and analgesic efficacy of an abuse-deterrent formulation of extended-release oxycodone, Xtampza ER, in opioid-naive and opioid-experienced adults with moderate-to-severe CLBP. Patients entered an open-label titration phase (N = 740); those who were successfully titrated on Xtampza ER (≥40 to ≤160 mg oxycodone hydrochloride equivalent per day) were randomized to active drug (N = 193) or placebo (N = 196) for 12 weeks. Primary efficacy results showed a statistically significant difference in average pain intensity from randomization baseline to treatment week 12 between the Xtampza ER and placebo groups (mean [±SE], -1.56 [0.267]; P < 0.0001). All sensitivity analyses results supported the primary result of the study. Secondary efficacy outcomes indicated that Xtampza ER vs placebo had more patients with improvement in patient global impression of change (26.4% vs 14.3%; P < 0.0001), longer time-to-exit from the study (58 vs 35 days; P = 0.0102), and a greater proportion of patients with ≥30% (49.2% vs 33.2%; P = 0.0013) and ≥50% (38.3% vs 24.5%; P = 0.0032) improvement in pain intensity. There was less rescue medication (acetaminophen) use in the Xtampza ER treatment group than in the placebo group. Xtampza ER had an adverse event profile consistent with other opioids and was well tolerated; no new safety concerns were identified. In conclusion, Xtampza ER resulted in clinically and statistically significant efficacy in patients with CLBP. [ABSTRACT FROM AUTHOR]

The article focuses on cardiovascular disease (CVD) treatment by repurposing metformin, which is considered the cornerstone of diabetic drug management in patients with type 2 diabetes mellitus. Critical topics being discussed include treating patients who have (CVD) with diabetes comorbidity as well as metformin’s cellular mechanism.

Ferreira M, Marques EE, Duarte JA, Santos PC: Physical therapy with drug treatment in bell palsy: a focused review. Am J Phys Med Rehabil 2015;94:331 -3 4 0 . The physical therapy (PT) associated with standard drug treatment (SDT) in Bell palsy has never been investigated. Randomized controlled trials or quasirandomized controlled trials have compared facial PT (except treatments such as acupuncture and osteopathic) combined with SDT against a control group with SDT alone. Participants included those older than 15 yrs with a clinical diagnosis of Bell palsy, and the primary outcome measure was motor function recovery by the House-Brackmann scale. The methodologic quality of each study was also independently assessed by two reviewers using the PEDro scale. Four studies met the inclusion criteria. Three trials indicate that PT in association with SDT supports higher motor function recovery than SDT alone between 1 5 days and 1 yr of follow-up. On the other hand, one trial showed that electrical stimulation added to conventional PT with SDT did not influence treatment outcomes. The present review suggests that the current practice of Bell palsy treatment by PT associated with SDT seems to have a positive effect on grade and time recovery compared with SDT alone. Flowever, there is very little quality evidence from randomized controlled trials, and such evidence is insufficient to decide whether combined treatment is beneficial in the management of Bell palsy. [ABSTRACT FROM AUTHOR]

This double-blind, placebo-controlled, 3-period cross-over, 4-treatment option, incomplete block study (ClinicalTrials.gov number NCT01485185 ), with an adaptive design for sample size re-estimation, was designed to evaluate gabapentin plus donepezil in an established experimental model of electrical hyperalgesia. Thirty healthy male subjects aged 18–55 years were randomized to receive gabapentin 900 mg or gabapentin 900 mg + donepezil 5 mg for 2 of the 3 treatment periods, with 50% of subjects randomized to receive placebo (negative control) and 50% to gabapentin 1800 mg (positive control) for the remaining period. Each treatment period was 14 days. Gabapentin or corresponding placebo was administered on Day 13 and the morning of Day 14. Donepezil or corresponding placebo was administered nocturnally from Day 1–13 and the morning of Day 14. Co-primary endpoints were the area of pinprick hyperalgesia (260 mN von Frey filament) and allodynia (stroking by cotton bud) evoked by electrical hyperalgesia on Day 14. Gabapentin 1800 mg (n = 14) significantly reduced the area of allodynia vs placebo (n = 14; −12.83 cm 2 ; 95% confidence interval [CI] −23.14 to −2.53; P = 0.015) with supportive results for hyperalgesia (−14.04 cm 2 ; 95% CI −28.49–0.41; P = 0.057), validating the electrical hyperalgesia model. Gabapentin + donepezil (n = 30) significantly reduced the area of hyperalgesia vs gabapentin 900 mg (n = 30; −11.73 cm 2 ; 95% CI −21.04 to −2.42; P = 0.014), with supportive results for allodynia (−6.62 cm 2 ; 95% CI −13.29–0.04; P = 0.052). The adverse event profile for gabapentin + donepezil was similar to the same dose of gabapentin. Data are supportive of further clinical investigation of a gabapentin-and-donepezil combination in patients with an inadequate response to gabapentin. [ABSTRACT FROM AUTHOR]

Study Design. Economic evaluation conducted alongside a randomized controlled trial with 1-year follow-up. Objective. To examine the cost-effectiveness of initiating rehabilitation 6 weeks after surgery as opposed to 12 weeks after surgery. Summary of Background Data. In a previously reported randomized controlled trial, we assessed the impact of timing of rehabilitation after a lumbar spinal fusion and found that a fast-track strategy led to poorer functional ability. Before making recommendations, it seems relevant to address the societal perspective including return to work, quality of life, and costs. Methods. A cost-effectiveness analysis and a cost-utility analysis were conducted. Eighty-two patients undergoing instrumented lumbar spinal fusion due to degenerative disc disease or spondylo[isthesis (grade I or II) were randomized to an identical protocol of 4 sessions of group-based rehabilitation and were instructed in home exercises focusing on active stability training. Outcome parameters included functional disability (Oswestry Disability Index) and quality-adjusted life years. Health care and productivity costs were estimated from national registries and reported in euros. Costs and effects were transformed into net benefit. Bootstrapping was used to estimate 95% confidence intervals (95% CI). Results. The fast-track strategy tended to be costlier by 6869 (95% CI, -4640 to 18,378) while at the same time leading to significantly poorer outcomes of functional disability by -9 points (95% CI, -18 to -3) and a tendency for a reduced gain in quality-adjusted life years by -0.04 (95% CI, -0.13 to 0.01). The overall probability for the fast-track strategy being cost-effective does not reach 10% at conventional thresholds for cost-effectiveness. Conclusion. Initiating rehabilitation at 6 weeks as opposed to 12 weeks after surgery is on average more costly and less effective. The uncertainty of this result did not seem to be sensitive to methodological issues, and clinical managements who have already adapted fast-track rehabilitation strategies have reason to reconsider their choice. [ABSTRACT FROM AUTHOR]

The article presents a study which compares the antiswelling and analgesis impact of different ice pack therapy durations in patients with soft tissue injuries. The study uses pretest and posttests, convenient sampling, and randomized block assignment to assess skin temperature, swelling and pain in ice treated areas. Results show that the duration of ice pack therapy can lower skin temperature and reduce partial swelling and pain.

The article presents a randomized controlled trial (RCT) on the use of ProDisc-C and anterior cervical disectomy and fusion (ACDF) as surgical treatment for single-level cervical symptomatic degenerative disc disease. It notes that implant-related complications were lower in ProDisc-C patients than ACDF patients. It also shows that ProDisc-C continues to be a safe and effective treatment for this disease and adds that reoperation rates after this treatment is lower compared with ACDF.

The article presents a randomized controlled study which examines the cost effectiveness of balloon kyphoplasty (BKP) against standard medical treatment in Swedish patients with vertebral compression fracture (VCF) due to osteoporosis. Findings reveal that the controlled trial failed to show whether BKP was cost effective than standard treatment. It concludes that further study should be considered.

Background--We sought to determine the safety and efficacy of Cutting Balloon therapy (CB) compared with conventional high-pressure balloon therapy (HPB) for the treatment of pulmonary artery stenosis. Methods and Results--This prospective, randomized, multicenter, investigational device exemption trial compared CB with HPB. Patient eligibility was determined at the precatheterization assessment: vessel eligibility was determined at catheterization. In all vessels, low-pressure balloon dilation to 8 atm was performed, and if it was not successful, the vessel was randomized to CB or HPB. The primary efficacy outcome was percent change in minimum lumen diameter. A core laboratory performed all vessel measurements and angiographic assessment of vessel damage. The primary safety outcome was any serious adverse event attributable to vessel dilation as assessed by the Data and Safety Monitoring Board. Seventy-three patients from 8 institutions were enrolled between 2004 and 2008. In these patients, 72 vessels responded to low-pressure balloon dilation. Of the 173 vessels that met eligibility criteria, 107 were randomized to CB and 66 to HPB. In randomized vessels, CB therapy was associated with greater percent increase in lumen diameter (85% versus 52%; P=0.004). After crossover was introduced, 26 of 47 vessels treated with HPB underwent CB therapy and experienced an additional 48% increase in lumen diameter; the final diameter after CB was 99% greater than the initial diameter. There were no serious adverse events related to treatment in a study vessel. Conclusion--CB therapy for pulmonary artery stenosis not responsive to low-pressure balloon is more effective than HPB therapy and has an equivalent safety profile. [ABSTRACT FROM AUTHOR]

The article presents a study that investigated if fish oil could reduce pulmonary and systemic inflammation in patients with acute lung injury. The study involved mechanically ventilated patients with acute lung injury in which 41 participants received fish oil and 49 received placebo. Results revealed that fish oil had no significant effect on patients with acute lung injury and that the outcome of the experiment did not encourage a further clinical study on the material.

The article discusses a retrospective cohort study on out-of-hospital pediatric cardiac arrest at 15 Pediatric Emergency Care Applied Research Network clinical sites. The goal of the study is to determine the effectiveness of therapeutic hypothermia after pediatric cardiac arrest. It found that more than three doses of epinephrine were related to poor outcome.

The article presents a study that compares dialysis catheter function according to catheter site. It shows that baseline demography and dialysis prescriptions were similar between the site arms. It found that jugular site did not significantly outperform femoral site placement in terms of catheter dysfunction and dialysis performance among critically ill adults requiring acute renal replacement therapy.

The article presents a study which investigates the effectivity and safety of quetiapine intervention in patients with delirium. Adult patients with delirium in three hospitals such as Tufts Medical Center, Maine Medical Center, and Mainsonneuve-Rosemont Hospital were randomized to receive quetiapine intervention. Results show that patients who have used quetiapine were discharged from the hospital and received a short period of haloperidol theraphy.

The article presents a study which evaluates the effects of botulinum toxin type A on nocturnal bruxism. The study is conducted on 12 subjects diagnosed with nocturnal bruxism who underwent double-blind, randomnized clinical trial, wherein six subjects are injected with botulinum toxin while six are injected with saline. Results show that events of nocturnal bruxism decrease using botulinum toxin type A injection.

The article presents a study on HPV-16 E6E7 ISCOMATRIX vaccine as treatment for anal intra-epithelial neoplasia caused by human papilloma virus (HPV). It aims to measure safety, tolerability and immunogenicity of the vaccine based on the dosage and schedule administering of the vaccine. It concludes that the vaccine is safe and tolerable and induces strong antibody responses and moderate interferon-#x03B3; levels.

The article focuses on pediatric cardiac arrest (CA) with return of circulation (ROC) from in-hospital (IH) and out-of-hospital (OH) setting. The study aims to determine the difference in IH and OH pediatric cardiac arrest that is significant for the clinical trial of therapeutic hypothermia (TH). The study found out that mortality is greater in the OH event due to neurologic indications. It is suggested that future researchers for the efficacy of TH should consider independent clinical trials.

The article reports on the review of clinical trial design issues related to control groups. The patients included in the studies have lethal conditions. The majority of intensive care patients suffer from syndromes which cannot be precisely assessed. the treatment consists of interacting therapies.

The article reports that the highest level of evidence on the usefulness of therapy is obtained from double-blind clinical trials. Traditional statistics have been used predominantly but a Bayesian approach offer more flexibility by leveraging more information from clinical trials. Innovative designs can limit the number of patients included in a trial and decrease the chance of maintaining a patient on an unfavorable treatment.

Abstract: Since pain-related fear may contribute to the development and maintenance of chronic low back pain (CLBP), an exposure in vivo treatment (EXP) was developed for CLBP patients. We examined the effectiveness as well as specific mediating mechanisms of EXP versus operant graded activity (GA) directly and 6 months post-treatment in a multi-centre randomized controlled trial. In total, 85 patients suffering from disabling non-specific CLBP reporting at least moderate pain-related fear were randomly allocated to EXP or GA. It was demonstrated that EXP, despite excelling in diminishing pain catastrophizing and perceived harmfulness of activities, was equally effective as GA in improving functional disability and main complaints, although the group difference almost reached statistical significance favouring EXP. Both treatment conditions did not differ in pain intensity and daily activity levels either. Nor was EXP superior to GA in the subgroup of highly fearful patients. Irrespective of treatment, approximately half the patients reported clinically relevant improvements in main complaints and functional disability, although for the latter outcome the group difference was almost significant favouring EXP. Furthermore, the effect of EXP relative to GA on functional disability and main complaints was mediated by decreases in catastrophizing and perceived harmfulness of activities. In sum, this study demonstrates that up to 6 months after treatment EXP is an effective treatment, but not more effective than GA, in moderately to highly fearful CLBP patients, although its superiority in altering pain catastrophizing and perceived harmfulness of activities is clearly established. Possible explanations for these findings are discussed. [Copyright &y& Elsevier]

The article discusses a randomized controlled study of percutaneous radiofrequency neurotomy which was conducted in 40 patients with chronic back pain. The active treatment group showed significant improvement in quality of life variables. The results indicate that radiofrequency facet denervation is not a placebo and could be used in patients with chronic back pain.

The article presents medical research into the effects of a cognitive behavior therapy on HIV-positive persons' compliance with antiretroviral therapy (ART). This is a randomized controlled multisite clinical trial. The cognitive behavior therapy sessions dealt with stress, adjustment, health behavior, and safety behavior. Results indicate that the positive effect of the cognitive behavior therapy on ART compliance may be short-lived.

The article focuses on the assessment of the effectiveness of antiretroviral adherence interventions using marginal structural models (MSM). Randomized controlled trials of interventions to improve adherence to antiretroviral medications are not always effective so MSM is needed. MSM is a statistical methodology that replicates the findings of randomized controlled trials using observational data.

The article presents a clinical trial on the effect of enhanced services on virologic outcomes in a directly administered antiretroviral therapy trial for HIV-infected drug users. Even though directly administered antiretroviral therapy (DAART) is helpful in HIV treatment, there are still unknown elements in the DAART program. The results showed that on-site medical and case management services should be integrated into DAART interventions.

Abstract: The aim of this study was to compare the effect of a physical therapy regimen including active exercises with the current standard treatment on reduction of pain 6 weeks and 6 months after whiplash injury caused by motor vehicle collision. Two hundred patients were enrolled in a prospective randomized controlled trial. In the standard group, treatment consisted of immobilization with a soft collar over 7 days. In the physical therapy group, patients were scheduled for 10 physical therapy appointments including active exercises within 14 days after enrollment. Pain intensity was rated by all patients daily during the first week, the sixth week, and 6 months after recruitment, using a numeric rating scale (0–10). Data analyses were performed by comparing the mean (over 1 week) pain scores between the two different treatment groups. Ninety-seven patients were randomly assigned to the standard treatment group and 103 to the physical therapy group. During the first week, there was no significant difference in mean pain intensity between the standard treatment group (4.76±2.15) and the physical therapy group (4.36±2.14). However, after 6 weeks, mean pain intensity was significantly (p =0.002) lower in the physical therapy group (1.49±2.26 versus 2.7±2.78). Similarly, after 6 months, significantly (p <0.001) less pain was reported in the physical therapy group (1.17±2.13) than the standard treatment group (2.33±2.56). We conclude that a physical therapy regimen which includes active exercises is superior in reducing pain 6 weeks and 6 months after whiplash injury compared to the current standard treatment with a soft collar. [Copyright &y& Elsevier]

Patient, provider, and clinical investigator expectations concerning treatments are believed to play important roles in patient response. This study examined the association of patient and research nurse/physician pretreatment expectations of pain relief with actual pain relief, the accuracy of patient and research nurse guesses about patient medication assignment, and changes in research nurse and patient pain relief expectations over the course of a randomized double-blind trial of amitriptyline versus an active placebo for patients with chronic pain and spinal cord injuries (SCI). Patient expectations of pain relief with amitriptyline were associated significantly with actual pain decrease for patients in the amitriptyline, but not placebo, condition. Research nurse/physician expectations did not predict patient pain relief. Both patients and the research nurse were able to guess patient medication assignment at a rate significantly greater than chance. The research nurse''s, but not the patients’, expectations of pain relief with amitriptyline decreased significantly over the course of the study. These findings have implications for future randomized controlled trials. Fully double-blind conditions are very difficult to achieve, and it is informative to assess patient and research clinician expectations and guesses regarding medication assignment. [Copyright &y& Elsevier]