Group Mean Change Research Articles

Two-Year Outcomes from a Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion vs. Non-Surgical Management for Sacroiliac Joint Dysfunction.

Sacroiliac joint (SIJ) dysfunction is an important and underappreciated cause of chronic low back pain. To prospectively and concurrently compare outcomes after surgical and non-surgical treatment for chronic SIJ dysfunction. One hundred and forty-eight subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (SIJF, n = 102) or non-surgical management (NSM, n = 46). SIJ pain (measured with a 100-point visual analog scale, VAS), disability (measured with Oswestry Disability Index, ODI) and quality of life scores were collected at baseline and at scheduled visits to 24 months. Crossover from non-surgical to surgical care was allowed after the 6-month study visit was complete. Improvements in continuous measures were compared using repeated measures analysis of variance. The proportions of subjects with clinical improvement (SIJ pain improvement ≥20 points, ODI ≥15 points) and substantial clinical benefit (SIJ pain improvement ≥25 points or SIJ pain rating ≤35, ODI ≥18.8 points) were compared. In the SIJF group, mean SIJ pain improved rapidly and was sustained (mean improvement of 55.4 points) at month 24. The 6-month mean change in the NSM group (12.2 points) was substantially smaller than that in the SIJF group (by 38.3 points, p<.0001 for superiority). By month 24, 83.1% and 82.0% received either clinical improvement or substantial clinical benefit in VAS SIJ pain score. Similarly, 68.2% and 65.9% had received clinical improvement or substantial clinical benefit in ODI score at month 24. In the NSM group, these proportions were <10% with non-surgical treatment only. Parallel changes were seen for EQ-5D and SF-36, with larger changes in the surgery group at 6 months compared to NSM. The rate of adverse events related to SIJF was low and only 3 subjects assigned to SIJF underwent revision surgery within the 24-month follow-up period. In this Level 1 multicenter prospective randomized controlled trial, minimally invasive SIJF with triangular titanium implants provided larger improvements in pain, disability and quality of life compared to NSM. Improvements after SIJF persisted to 24 months. This study was approved by a local or central IRB before any subjects were enrolled. All patients provided study-specific informed consent prior to participation.

Group-based exercise combined with dual-task training improves gait but not vascular health in active older adults without dementia

BackgroundGait abnormalities and vascular disease risk factors are associated with cognitive impairment in aging. ObjectiveTo determine the impact of group-based exercise and dual-task training on gait and vascular health, in active community-dwelling older adults without dementia. MethodsParticipants [n=44, mean (SD) age: 73.5 (7.2) years, 68% female] were randomized to either intervention (exercise+dual-task; EDT) or control (exercise only; EO). Each week, for 26 weeks, both groups accumulated 50 or 75min of aerobic exercise from group-based classes and 45min of beginner-level square stepping exercise (SSE). Participants accumulating only 50min of aerobic exercise were instructed to participate in an additional 25min each week outside of class. The EDT group also answered cognitively challenging questions while performing SSE (i.e., dual-task training). The effect of the interventions on gait and vascular health was compared between groups using linear mixed effects models. ResultsAt 26 weeks, the EDT group demonstrated increased dual-task (DT) gait velocity [difference between groups in mean change from baseline (95% CI): 0.29m/s (0.16–0.43), p<0.001], DT step length [5.72cm (2.19–9.24), p =0.002], and carotid intima-media thickness [0.10mm (0.003–0.20), p=0.04], as well as reduced DT stride time variability [8.31 coefficient of variation percentage points (−12.92 to −3.70), p<0.001], when compared to the EO group. ConclusionsGroup-based exercise combined with dual-task training can improve DT gait characteristics in active older adults without dementia.

Efficacy of the Type 2 Diabetes Prevention Using LifeStyle Education Program RCT

Self-administered lifestyle interventions have been suggested as an alternative to face-to-face delivery modes, although their efficacy remains uncertain. The aim of this study was to evaluate the efficacy of the Type 2 diabetes mellitus Prevention Using LifeStyle Education (PULSE) Program, a self-administered and gender-tailored lifestyle intervention for men at high risk for developing Type 2 diabetes mellitus. A 6-month, assessor-blinded, parallel-group RCT was conducted at the University of Newcastle, Australia in 2012-2013. Men (aged 18-65 years, BMI 25-40 kg/m(2), high risk for developing Type 2 diabetes mellitus) were stratified by age (<50 and >50 years) and BMI category (25.0-29.9, 30.0-35.9, and 35.0-40 kg/m(2)) and individually randomized (1:1 ratio) to the intervention (n=53) or waitlist control groups (n=48). The intervention group received the PULSE Program, which contained print and video resources on weight loss (Self-Help, Exercise and Diet using Internet Technology [SHED-IT] Weight Loss Program), diet modification, and exercise for Type 2 diabetes mellitus prevention. The waitlist control group received no information until 6 months. Data were collected from September 2012 to September 2013 and analyzed in 2014-2015. Linear mixed models (intention-to-treat) were used to determine group X time interactions (differences between groups in changes over time) at 6 months for the primary outcome (weight), glycated hemoglobin, and several secondary outcomes (significance level, p<0.05). Differences between groups in mean changes from baseline to 6 months (group × time interaction) favored the intervention over control group for weight loss (-5.50 kg, 95% CI=-7.40 kg, -3.61 kg, p<0.001, Cohen's d=1.15), glycated hemoglobin (-0.2%, 95% CI=-0.3%, -0.1%, p=0.002, d=0.64), and BMI, waist circumference, body fat percentage, aerobic fitness, and lower body muscular fitness (all p<0.05). No group × time effects were observed for fasting plasma glucose, upper body muscular fitness, physical activity, or energy intake. The PULSE Program improved several Type 2 diabetes mellitus risk factors in men, including weight and glycated hemoglobin. These findings provide evidence for a self-administered and gender-tailored lifestyle intervention, which has potential for dissemination in community settings.

Intraocular Pressure Changes during Accommodation in Progressing Myopes, Stable Myopes and Emmetropes.

PurposeTo investigate the changes of intraocular pressure (IOP) induced by 3-diopter (3 D) accommodation in progressing myopes, stable myopes and emmetropes.DesignCross-sectional study.Participants318 subjects including 270 myopes and 48 emmetropes.Methods195 progressing myopes, 75 stable myopes and 48 emmetropes participated in this study. All subjects had their IOP measured using iCare rebound tonometer while accommodative stimuli of 0 D and 3 D were presented.Main Outcome MeasuresIOP values without accommodation and with 3 D accommodation were measured in all subjects. Baseline IOPs and IOP changes were compared within and between groups.ResultsThere was no significant difference in IOPs between progressing myopes, stable myopes and emmetropes when no accommodation was induced (17.47±3.46, 16.62±2.98 and 16.80±3.62 respectively, p>0.05). IOP experienced an insignificantly slight decrease after 3 D accommodation in three groups (mean change -0.19±2.16, -0.03±1.68 and -0.39±2.65 respectively, p>0.05). Subgroup analysis showed in progressing myopic group, IOP of children (<18 years old) declined with accommodation while IOP of adults (≥18 years) increased, and the difference was statistically significant (p = 0.008). However, after excluding the age factor, accommodation induced IOP changes of high progressing myopes (≤-6 D), low, moderate and non-myopes (>-6 D) was not significantly different after Bonferroni correction (p = 0.838).ConclusionsAlthough no difference was detected between the baseline IOPs and accommodation induced IOP changes in progressing myopes, stable myopes and emmetropes, this study found accommodation could cause transient IOP elevation in adult progressing myopes.

Levodopa as a possible treatment of visual loss in nonarteritic anterior ischemic optic neuropathy.

To determine the clinical effectiveness and potential neuroprotection of levodopa in improving visual acuity, visual field, and retinal nerve fiber layer (RNFL) thickness in eyes affected by NAION. Retrospective cohort study involving 59 eyes of 59 participants with NAION who were evaluated within 15days of NAION onset. Participants received 25mg carbidopa/100mg levodopa three times daily with meals for 12weeks (levodopa group) or were untreated (control group). Best-corrected visual acuity converted to logMAR, mean deviation (MD) threshold sensitivity on automated perimetry, and mean RNFL thickness on optical coherence tomography (OCT) were assessed. The primary outcome was the categorization of eyes into improved visual acuity (by 0.3 logMAR difference), worsened visual acuity (by 0.3 logMAR difference), or no change in visual acuity. The proportions in each category were compared between the levodopa and control groups. Among participants with 20/60 or worse initial visual acuity, levodopa-treated participants had significant improvement (P < 0.0001) in the mean change from initial to final logMAR visual acuity of -0.74 ± 0.56 (95% CI, -0.98 to -0.50), while the mean change for the control group at -0.37 ± 1.09 (95% confidence interval estimate, -1.00 to +0.26) was not significant (P = 0.23). A significant difference between groups was observed (P = 0.0086) such that 19/23 (83%) in the levodopa group improved and none got worse, as compared with 6/14 (43%) in the control group improving while four (29%) worsened. The change in visual field MD and RNFL thickness on OCT showed no significant difference at P = 0.23 and P = 0.75 respectively. No levodopa-treated participant had any adverse event from the levodopa. Treatment within 15days of onset of NAION with levodopa improved central visual acuity by an average of 6 lines on Snellen acuity chart. Levodopa may promote neuroprotection of the maculopapular retinal ganglion cell fibers in NAION.

Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study

Objective:To determine the impact of ranibizumab 0.5 mg on patient-reported visual function over 36 months in individuals with visual impairment from diabetic macular edema.Methods:RESTORE comprises a phase 3, randomized, multicenter, 12 month core study and a 24 month open-label extension study. Eyes assigned to ranibizumab in the core study received ranibizumab for 36 months; eyes assigned to laser monotherapy in the core study received ranibizumab during the extension. The primary outcome was least-squares mean change in National Eye Institute 25-item Visual Functioning Questionnaire (NEI VFQ-25) overall composite and subscale scores.Results:Of 303 core study participants, 240 (79%) entered the extension, comprising 83 (35%) participants initially assigned to ranibizumab, 83 (35%) assigned to ranibizumab plus laser combination therapy, and 74 (31%) assigned to laser monotherapy. Least-squares mean (standard error) change in NEI VFQ-25 composite score from baseline to month 12 (+5.9 [1.5]; +5.0 [1.5], for the ranibizumab and combination therapy groups, respectively) decreased by month 36 (+4.1 [1.7]; +4.0 [1.7], respectively, from baseline to month 36) following reduced injection frequency relative to the core study. At 36 months, the least-squares mean (standard error) change in the laser monotherapy group was similar to that in the ranibizumab groups (+4.1 [1.8]). Most subscale scores showed outcomes similar to that for the composite score. The greatest NEI VFQ-25 gains were consistently observed in participants for whom the study eye was the better-seeing eye.Limitations:Patients entering the extension were not randomized, and 21% of the core study participants did not enter the extension, which may have affected the results.Conclusions:Gains in patient-reported visual function at month 12 among eyes receiving ranibizumab in the core study decreased slightly by 36 months. Eyes originally receiving laser monotherapy for 12 months then ranibizumab for 24 months achieved similar gains by 36 months to eyes receiving ranibizumab for 36 months.Trial Registration:ClinicalTrials.gov: NCT00687804 and NCT00906464.

Beneficial effects of whey protein preloads on some cardiovascular diseases risk factors of overweight and obese men are stronger than soy protein preloads – A randomized clinical trial

BackgroundThe hypothesis that long term supplemental preloads of whey protein concentrate (WPC) and soy protein isolate (SPI) 30 min before the largest meal, will improve blood pressure (BP), fasting blood sugar (FBS) and lipid profile of overweight and obese men in their in free living condition was tested. MethodsForty - five men of 52, BMI = 25–40 kg/m2, after random allocation in WPC (n = 26) or SPI (n = 19) groups, drank 65 gr WPC or 60 gr SPI dissolved in 500 ml water 30 min before their ad libitum lunch for 12 weeks. Lipid profile and FBS were assessed before and after the study. Systolic and diastolic BP were measured before and after the study and every two weeks. ResultsAfter 12 weeks, mean changes between the groups were significant for SBP (p < 0.02), DBP (p = 0.001), apo A-I, apo B (p < 0.001), LDL (p = 0.015), HDL (p = 0.017). Within group mean changes of WPC were significant for reduction of DBP, FBS, apo B, VLDL, LDL, TG (p < 0.001), SBP, TC (p = 0.001), and for increase of apo A-I (p < 0.001) and HDL (p = 0.001) relative to baseline. In SPI group, mean changes were significant relative to baseline for decrease of SBP (p < 0.02), DBP (p = 0.001), apo B (p < 0.001), LDL (p = 0.015) and for increase of apo A-I (p < 0.001) and HDL (p = 0.017). ConclusionAccording to this study, WPC preloads at 30 min before ad libitum main meal, exert stronger beneficial effects than SPI preloads on BP, FBS and lipid profile of free living overweight and obese men after 12 weeks.Trial registration: Iranian Registry of Clinical Trials: IRCT201109062365N3.

Effects of modified sit-to-stand training on balance control in hemiplegic stroke patients: a randomized controlled trial

Objective: To explore the effectiveness of modified sit-to-stand training on balance function in hemiplegic stroke patients. Design: Randomized controlled trial. Setting: Rehabilitation medical centre. Participants: A total of 50 hemiplegic patients with stroke were randomly assigned to the control and experimental groups (n = 25 for each group). Interventions: Patients in the control group received the sit-to-stand training with symmetrical foot position, while patients in the experimental group were given the modified sit-to-stand training in which the paretic foot placed posterior. Subjects in both groups received 30 minutes of sit-to-stand training, five times a week, for four weeks. Main outcome measures: The time and weight-bearing distribution during sit-to-stand movement, the centre of pressure sway length during quiet standing, the centre of pressure sway areas during dynamic standing and Berg Balance Scale were assessed before and after completing the four-week sit-to-stand training. Results: Our data showed significant improvements in standing balance and the sit-to-stand movement for two groups in the post-training compared with the pre-training. After training, the rise time shortened more significantly in the experimental group (mean change, 0.90 ±0.25 seconds) than the control group (mean change, 0.42 ±0.18 seconds). Weight-bearing asymmetry showed significantly greater improvement in the experimental group (mean change, 0.17 ±0.10) than in the control group (mean change, 0.06 ±0.05). Centre of pressure sway length was significantly smaller in the experimental group (mean change, 27.85 ±10.58 cm) than in the control group (mean change, 21.95 ±8.19 cm). Centre of pressure sway areas was significantly larger in the experimental group (mean change, 84.24 ±26.48 cm2) than in the control group (mean change, 67.74 ±22.84 cm2) (P = 0.027). The Berg Balance Scale was significantly higher in the experiment group (mean change, 8.4 ±3.1) than the control group (mean change, 5.8±2.8). Conclusions: A modified sit-to-stand training improves the balance function in hemiplegic stroke patients.

Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension

BackgroundData on the effect of initial combination therapy with ambrisentan and tadalafil on long-term outcomes in patients with pulmonary arterial hypertension are scarce.MethodsIn this event-driven, double-blind study, we randomly assigned, in a 2:1:1 ratio, participants with World Health Organization functional class II or III symptoms of pulmonary arterial hypertension who had not previously received treatment to receive initial combination therapy with 10 mg of ambrisentan plus 40 mg of tadalafil (combination-therapy group), 10 mg of ambrisentan plus placebo (ambrisentan-monotherapy group), or 40 mg of tadalafil plus placebo (tadalafil-monotherapy group), all administered once daily. The primary end point in a time-to-event analysis was the first event of clinical failure, which was defined as the first occurrence of a composite of death, hospitalization for worsening pulmonary arterial hypertension, disease progression, or unsatisfactory long-term clinical response.ResultsThe primary analysis included 500 participants; 253 were assigned to the combination-therapy group, 126 to the ambrisentan-monotherapy group, and 121 to the tadalafil-monotherapy group. A primary end-point event occurred in 18%, 34%, and 28% of the participants in these groups, respectively, and in 31% of the pooled-monotherapy group (the two monotherapy groups combined). The hazard ratio for the primary end point in the combination-therapy group versus the pooled-monotherapy group was 0.50 (95% confidence interval [CI], 0.35 to 0.72; P<0.001). At week 24, the combination-therapy group had greater reductions from baseline in N-terminal pro–brain natriuretic peptide levels than did the pooled-monotherapy group (mean change, −67.2% vs. −50.4%; P<0.001), as well as a higher percentage of patients with a satisfactory clinical response (39% vs. 29%; odds ratio, 1.56 [95% CI, 1.05 to 2.32]; P=0.03) and a greater improvement in the 6-minute walk distance (median change from baseline, 48.98 m vs. 23.80 m; P<0.001). The adverse events that occurred more frequently in the combination-therapy group than in either monotherapy group included peripheral edema, headache, nasal congestion, and anemia.ConclusionsAmong participants with pulmonary arterial hypertension who had not received previous treatment, initial combination therapy with ambrisentan and tadalafil resulted in a significantly lower risk of clinical-failure events than the risk with ambrisentan or tadalafil monotherapy. (Funded by Gilead Sciences and GlaxoSmithKline; AMBITION ClinicalTrials.gov number, NCT01178073.)

Peripheral chemoreceptors determine the respiratory sensitivity of central chemoreceptors to CO2 : role of carotid body CO2.

We asked if the type of carotid body (CB) chemoreceptor stimulus influenced the ventilatory gain of the central chemoreceptors to CO2 . The effect of CB normoxic hypocapnia, normocapnia and hypercapnia (carotid body PCO2 ≈ 22, 41 and 68 mmHg, respectively) on the ventilatory CO2 sensitivity of central chemoreceptors was studied in seven awake dogs with vascularly-isolated and extracorporeally-perfused CBs. Chemosensitivity with one CB was similar to that in intact dogs. In four CB-denervated dogs, absence of hyper-/hypoventilatory responses to CB perfusion with PCO2 of 19-75 mmHg confirmed separation of the perfused CB circulation from the brain. The group mean central CO2 response slopes were increased 303% for minute ventilation (V̇I)(P ≤ 0.01) and 251% for mean inspiratory flow rate (VT /TI ) (P ≤ 0.05) when the CB was hypercapnic vs. hypocapnic; central CO2 response slopes for tidal volume (VT ), breathing frequency (fb ) and rate of rise of the diaphragm EMG increased in 6 of 7 animals but the group mean changes did not reach statistical significance. Group mean central CO2 response slopes were also increased 237% for V̇I(P ≤ 0.01) and 249% for VT /TI (P ≤ 0.05) when the CB was normocapnic vs. hypocapnic, but no significant differences in any of the central ventilatory response indices were found between CB normocapnia and hypercapnia. These hyperadditive effects of CB hyper-/hypocapnia agree with previous findings using CB hyper-/hypoxia.We propose that hyperaddition is the dominant form of chemoreceptor interaction in quiet wakefulness when the chemosensory control system is intact, response gains physiological, and carotid body chemoreceptors are driven by a wide range of O2 and/or CO2 .

Pioglitazone in early Parkinson's disease: a phase 2, multicentre, double-blind, randomised trial

A systematic assessment of potential disease-modifying compounds for Parkinson's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease. We assessed the effect of pioglitazone on the progression of Parkinson's disease in a multicentre, double-blind, placebo-controlled, futility clinical trial. Participants with the diagnosis of early Parkinson's disease on a stable regimen of 1 mg/day rasagiline or 10 mg/day selegiline were randomly assigned (1:1:1) to 15 mg/day pioglitazone, 45 mg/day pioglitazone, or placebo. Investigators were masked to the treatment assignment. Only the statistical centre and the central pharmacy knew the treatment name associated with the randomisation number. The primary outcome was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS) score between the baseline and 44 weeks, analysed by intention to treat. The primary null hypothesis for each dose group was that the mean change in UPDRS was 3 points less than the mean change in the placebo group. The alternative hypothesis (of futility) was that pioglitazone is not meaningfully different from placebo. We rejected the null if there was significant evidence of futility at the one-sided alpha level of 0·10. The study is registered at ClinicalTrials.gov, number NCT01280123. 210 patients from 35 sites in the USA were enrolled between May 10, 2011, and July 31, 2013. The primary analysis included 72 patients in the 15 mg group, 67 in the 45 mg group, and 71 in the placebo group. The mean total UPDRS change at 44 weeks was 4·42 (95% CI 2·55-6·28) for 15 mg pioglitazone, 5·13 (95% CI 3·17-7·08) for 45 mg pioglitazone, and 6·25 (95% CI 4·35-8·15) for placebo (higher change scores are worse). The mean difference between the 15 mg and placebo groups was -1·83 (80% CI -3·56 to -0·10) and the null hypothesis could not be rejected (p=0·19). The mean difference between the 45 mg and placebo groups was -1·12 (80% CI -2·93 to 0·69) and the null hypothesis was rejected in favour of futility (p=0·09). Planned sensitivity analyses of the primary outcome, using last value carried forward (LVCF) to handle missing data and using the completers' only sample, suggested that the 15 mg dose is also futile (p=0·09 for LVCF, p=0·09 for completers) but failed to reject the null hypothesis for the 45 mg dose (p=0·12 for LVCF, p=0·19 for completers). Six serious adverse events occurred in the 15 mg group, nine in the 45 mg group, and three in the placebo group; none were thought to be definitely or probably related to the study interventions. These findings suggest that pioglitazone at the doses studied here is unlikely to modify progression in early Parkinson's disease. Further study of pioglitazone in a larger trial in patients with Parkinson's disease is not recommended. National Institute of Neurological Disorders and Stroke.

Cognitive Behavioral Therapy for Management of Dyspnea: A Pilot Study.

In patients with COPD, psychological interventions usually target generalized anxiety and depression rather than the sensation of breathlessness. The objectives of this pilot study were to develop and implement a cognitive behavioral therapy (CBT) program specific to the perceptual experience of breathlessness, identify practical issues in the study protocol, and estimate beneficial effects of combining the CBT program with comprehensive pulmonary rehabilitation. The CBT program for the sensation of breathlessness (Breathing: Recognize sensations, Explore thoughts and beliefs, Validate thoughts as useful or harmful, Evolve and change behavior [BREVE]) was developed as a sequential series of 8 modules enabling it to be embedded within an 8-week comprehensive pulmonary rehabilitation program. When appropriate, outcomes from the pilot group (comprehensive pulmonary rehabilitation program + BREVE) were compared with those from a retrospective control group (comprehensive pulmonary rehabilitation program only). Outcomes included feedback provided by pilot study subjects, sensation of breathlessness (volunteered and endorsed descriptors of breathlessness), 6-min walk distance (6MWD), and St George Respiratory Questionnaire (SGRQ) total score. Within-group analyses were undertaken for descriptors of breathlessness (the McNemar test), whereas between-group analyses (repeated-measures analysis of variance, effect-size comparison) were conducted for the 6MWD and SGRQ total score. Pilot (n = 11) and control (n = 58) groups were not significantly different at baseline. Feedback indicated that the program structure and content were positively received. No significant changes were evident for the sensation of breathlessness or the SGRQ score (< 4 points). The 6MWD improved significantly in both groups, with the pilot group demonstrating greater gains compared with the control group (mean change of 57 m and effect size of 0.73 vs mean change of 27 m and effect size of 0.23; between groups, P = .03, effect size of 0.69). The CBT program for the perceptual experience of breathlessness was feasible and well accepted by subjects, although the protocol raised a number of methodological limitations warranting modification. A larger randomized controlled trial is needed to determine the effectiveness and longer-term outcomes.

A prospective, double-blind, randomized controlled trial of the angiotensin-converting enzyme inhibitor Ramipril In Aortic Stenosis (RIAS trial).

AimsAngiotensin-converting enzyme (ACE) inhibitors improve left ventricular (LV) remodelling and outcome in heart failure and hypertensive heart disease. They may be similarly beneficial in patients with aortic stenosis (AS), but historical safety concerns have limited their use, and no prospective clinical trials exist.Methods and resultsWe conducted a prospective, randomized, double-blind, placebo-controlled trial in 100 patients with moderate or severe asymptomatic AS to examine the physiological effects of ramipril, particularly LV mass (LVM) regression. Subjects were randomized to ramipril 10 mg daily (n = 50) or placebo (n = 50) for 1 year, and underwent cardiac magnetic resonance, echocardiography, and exercise testing at 0, 6, and 12 months, with follow-up data available in 77 patients. There was a modest but progressive reduction in LVM (the primary end point) in the ramipril group vs. the placebo group (mean change −3.9 vs. +4.5 g, respectively, P = 0.0057). There were also trends towards improvements in myocardial physiology: the ramipril group showed preserved tissue Doppler systolic velocity compared with placebo (+0.0 vs. −0.5 cm/s, P = 0.04), and a slower rate of progression of the AS (valve area 0.0 cm2 in the ramipril group vs. −0.2 cm2 in the placebo arm, P = 0.067). There were no significant differences in major adverse cardiac events.ConclusionACE inhibition leads to a modest, but progressive reduction in LVM in asymptomatic patients with moderate–severe AS compared with placebo, with trends towards improvements in myocardial physiology and slower progression of valvular stenosis. A larger clinical outcome trial to confirm these findings and explore their clinical relevance is required.

Sports-Related Concussion in Helmeted vs. Unhelmeted Athletes: Who Fares Worse?

In the management of sports-related concussion, little is known about the effect of wearing or not wearing a helmet (i. e., helmet status) on the acute outcomes of concussed athletes. We endeavored to assess acute neurocognitive and symptom changes after SRC in helmeted vs. unhelmeted athletes. In a retrospective study, 1 025 athletes from 2 regional databases sustained a SRC. Athletes were matched by age, gender, number of prior concussions, and days to post-concussion test, yielding a final cohort of 138 athletes. For each group of 69, differences in post-concussion neurocognitive and symptom scores were compared using group mean differences as well as reliable change index (RCI) scores set at the 80% confidence interval. With gender, prior concussions, and days to post-concussion test similar in each group, using group mean change scores and RCI methodology, we found no significant differences between the helmeted and unhelmeted groups in 4 neurocognitive tests and one total symptom score. In a cohort of carefully matched athletes from 2 regional concussion centers, helmet status was unrelated to neurocognitive scores and total symptoms in athletes after suffering a SRC. These findings suggest that acute outcomes in helmeted vs. unhelmeted sports are quite similar.

Changes in emotional distress, short term memory, and sustained attention following 6 and 12 sessions of progressive muscle relaxation training in 10–11 years old primary school children

Purpose: This study compared the effects of 6 and 12 sessions of relaxation training on emotional distress, short-term memory, and sustained attention in primary school children. Methods: Participants (N = 132) aged 10 and 11 years old participated in this study. All participants and their parents provided written informed consent. Participants completed the measurement instruments before and after the completion of relaxation training. Results: Nearly half (49%) of all respondents reported moderate to extremely severe stress, and 80 and 61% reported moderate to extremely severe anxiety and depression, respectively. The results of a one-way analysis of variance revealed a significant difference among the groups in mean changes in short-term memory. A greater memory increase was observed in the 12-session than in the six-session and no-training group. Conclusion: It can be conceived that 12-session of training should be considered when prescribing relaxation regimens as a nonspecific clinical treatment (i.e. for healthy students).

Effect of Omega-3 fatty acids on blood pressure and serum lipids in continuous ambulatory peritoneal dialysis patients.

Objective:Hypertension and hyperlipidemia are two major risk factors for cardiovascular disease in continuous ambulatory peritoneal dialysis (CAPD) patients. This study was designed to investigate the effect of omega-3 fatty acids on blood pressure (BP) and serum lipids in CAPD patients.Methods:This study was a randomized double-blind clinical trial in which 90 CAPD patients were randomly assigned to either the omega-3 or the placebo group. Patients in omega-3 group received 3 g/day omega-3 for 8 weeks, whereas patients in the control group received placebo. At baseline and at the end of 8 weeks, the patients’ BP was controlled, and serum biochemistry was measured.Findings:Mean systolic BP decreased (–22.2 ± 14.2 mmHg) in the omega-3 group at the end of the study while in the placebo group increased (+0.5 ± 30.2 mmHg) (P < 0.0001). Mean diastolic BP of the omega-3 group decreased more (–11.95 ± 11.9 mmHg) comparing with the placebo group (–1.1 ± 17.3 mmHg) (P = 0.001). There were no significant differences between the two groups in mean changes in serum triglyceride, and total, high-density lipoprotein, and low-density lipoprotein cholesterol.Conclusion:The results of this study indicate that omega-3 reduced BP significantly but had no effect on lipid profile in our CAPD patients.

Etifoxine versus alprazolam for the treatment of adjustment disorder with anxiety: a randomized controlled trial.

BackgroundAdjustment disorder with anxiety (ADWA) is a highly prevalent condition, particularly in primary care practice. There are relatively few systematic treatment trials in the area of ADWA, and there are few data on predictors of treatment response. Etifoxine is a promising agent insofar as it is not associated with dependence, but in primary care settings benzodiazepines continue to be frequently prescribed for psychiatric symptoms. A randomized controlled trial of etifoxine versus alprazolam for ADWA was undertaken, focusing on efficacy and safety measures, and including an investigation of predictors of clinical response.MethodsThis was a comparative, multicenter, double-blind, randomized trial in two parallel groups of outpatients with ADWA. One group was treated with 150 mg/day for etifoxine, and the other with 1.5 mg/day for alprazolam for 28 days. Patients were followed for 4 weeks of treatment, and for an additional week after treatment discontinuation. The primary outcome measure was the Hamilton Anxiety Rating Scale (HAM-A), while secondary outcome measures included the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Change Scale (CGI-C), and the Self-Report for the Assessment of Adjustment Disorders. Non-inferiority analysis was used to assess the primary outcome measure, and a multivariate logistic regression was employed to investigate predictors of response.ResultsTwo hundred and two adult outpatients with ADWA were enrolled at 17 primary care sites. One hundred and seventy seven patients completed the study (n = 87 in the etifoxine group; n = 90 in the alprazolam group). Etifoxine and alprazolam were accompanied by decreases in the HAM-A at day 28, with a difference between treatment groups in HAM-A score of 1.78 [90% CI; 0.23, 3.33] in favor of alprazolam. However, after medication discontinuation, HAM-A scores continued to improve in the etifoxine group, but increased in the alprazolam group; the difference between groups in mean change between day 28 and day 35 was significant (p = 0.019). Secondary outcome measures showed similar results for etifoxine and alprazolam at day 35. More treatment-related adverse events were reported in patients treated with alprazolam, particularly central nervous system-related AEs, and especially after medication discontinuation. No significant predictors of treatment response were found.ConclusionThis randomized controlled trial provides support for the efficacy and safety of etifoxine in the management of adjustment disorder with anxiety, particularly when treatment discontinuation data are also assessed. Etifoxine has the important clinical advantage of having anxiolytic effects, which are not being associated with dependence. Pharmacotherapy was equally efficacious in patients with more severe anxiety symptoms at baseline. Additional work using longer-term follow-up and collecting data on cost-efficiency of management options would further advance the field of ADWA.FundingSponsorship and article processing charges for this study were provided by Biocodex, Gentilly, France.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0176-6) contains supplementary material, which is available to authorized users.

Ankle-Foot Continuous Passive Motion Device for Mobilization of Acute Stroke Patients

Purpose: To develop a continuous passive motion (CPM) device for the passive motion of the paretic ankle-foot and investigate the effect of continuous passive motion of bedridden, hemiparetic acute stroke patients. Methods: 49 patients with stroke were investigated. Results in stroke patients (device group) were compared with those of 15 control subjects (manual group) also with stroke but not treated by device. The period of the treatment was 7 days; the duration was 30 minutes per day by CPM device in the device group. The efficacy of the device was evaluated by scales used in the clinical routine (6th item of National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), modified Rankin Scale (mRS)). Ankle’s passive range of motion (PROM) and flexible equinovalgus deformitiy were measured every day with a goniometer. Results: 6th item of NIHSS score improved by -0.76 (SD = 0.56) points in the device group (p < 0.001) compared to the baseline values; the mean change in the manual group was -0.33 (SD = 0.62) points (p = 0.055). The mean of MAS decreased significantly by -0.53 (SD = 1.12) point in the device group (p < 0.001). The ankle’s mean plantar flexion PROM increased by 3.41 (SD = 5.19) degrees in the device group (p < 0.001). Significant improvement of the mean dorsiflexion in the PROM of the ankle was also detected (p = 0.019). The equinovalgus improved significantly by -5.12 (SD = 8.02) degrees (p < 0.001) in the device group. The scores of the mRS also improved significantly in the device group (p < 0.001). Conclusion: In the early phase of rehabilitation, ankle-foot continuous passive motion device treatment combined with manual therapy improved the ankle’s PROM better than manual therapy alone; in addition, device treatment decreased the foot’s equinovalgus, improved the 6th item NIHSS score, and decreased the severity of spasticity.

Fat and fibre behaviour questionnaire: Reliability, relative validity and responsiveness to change in Australian adults with type 2 diabetes and/or hypertension

AbstractAimThe aim of this study was to assess the test–retest reliability, relative validity and responsiveness to change of a 20‐item fat and fibre behaviour questionnaire (FFBQ) compared with a semi‐quantitative food frequency questionnaire (FFQ).MethodsFour hundred thirty‐four primary care patients with type 2 diabetes and/or hypertension were randomised to lifestyle intervention or usual care. Data (FFBQ and FFQ) were collected at baseline and 4 months follow‐up. A subset of usual care participants (n = 27) completed the FFBQ 2 weeks after baseline. FFQ‐measured nutrients included total and saturated fat (percentage of energy; energy‐adjusted grams) and fibre (crude grams; energy‐adjusted grams). The FFBQ was scored as a total, fat and fibre index. Test–retest reliability was assessed by intra‐class correlations (ICCs); relative validity by Pearson's correlations between the FFBQ and FFQ; and responsiveness (mean change in intervention group divided by SD of usual care group change).ResultsTest–retest ICCs (95% CI) were 0.87 (0.62, 0.95) for total index, 0.87 (0.69, 0.95) for fat index and 0.89 (0.69, 0.95) for fibre index. Pearson's correlations for fat index ranged from −0.50 to −0.54, and for fibre index from 0.42 to 0.56. Total index had correlations of 0.5–0.6 (or −0.5 to −0.6) with all FFQ‐measured nutrients except crude fibre. The fat index showed similar responsiveness compared with FFQ‐measured fat intake while the fibre index was significantly more responsive than FFQ‐measured fibre.ConclusionsThe FFBQ may provide a suitable alternative or adjunct to FFQs for use in intervention trials in adults with chronic diseases, because of its ability to detect changes in dietary behaviours.

Effects of ginger on serum glucose, advanced glycation end products, and inflammation in peritoneal dialysis patients

ObjectiveThe aim of this study was to investigate the effects of ginger supplementation on serum glucose, advanced glycation end products, oxidative stress, and systemic and vascular inflammatory markers in patients on peritoneal dialysis (PD). MethodsIn this randomized, double-blind, placebo-controlled trial, 36 patients on PD were randomly assigned to either the ginger or the placebo group. The patients in the ginger group received 1000 mg/d ginger for 10 wk, whereas the placebo group received corresponding placebos. At baseline and the end of week 10, serum concentrations of glucose, carboxymethyl lysine, pentosidine, malondialdehyde (MDA), high-sensitivity C-reactive protein (hs-CRP), soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), and sE-selectin were measured after a 12- to 14-h fast. ResultsSerum fasting glucose decreased significantly up to 20% in the ginger group at the end of week 10 compared with baseline (P < 0.05), and the reduction was significant in comparison with the placebo group (P < 0.05). There were no significant differences between the two groups in mean changes of serum carboxymethyl lysine, pentosidine, MDA, hs-CRP, sICAM-1, sVCAM-1, and sE-selectin. ConclusionThis study indicated that daily administration of 1000 mg ginger reduces serum fasting glucose, which is a risk factor for hyperinsulinemia, dyslipidemia, peritoneal membrane fibrosis, and cardiovascular disease, in patients on PD.