Group Mean Change Research Articles

Therapeutic effects of nebulized verapamil on chronic obstructive pulmonary disease: A randomized and double-blind clinical trial.

In this study, we assessed the clinical effect of inhaled verapamil on hospitalized COPD patients in a randomized and double-blind study. COPD patients randomly received 10mg of inhaled verapamil or 4 cc nebulized distilled water (DW) as placebo. Twenty patients enrolled in each group with no difference in baseline characteristics. Mean age was 64.95±8.9 and 66.9±10.74years in verapamil and control group; respectively, (P>0.05). The mean dyspnea score was 6.4±1.2 and 6.2±1.8 in the verapamil and control group, respectively and decreased to 4.9±1.3 and 5.7±1.8 after the intervention. The mean change in the verapamil group was significantly higher, (22.43%±10.6% vs 8.7%±12.1%), P=0.00. Unlike the control group, the FEV1 value in the verapamil group significantly increased and reached to 1.17±0.4L from 1.03±0.4. There was a significant decrease in airway resistance in both groups after intervention. However, neither total lung capacity and residual volume nor forced vital capacity changed significantly. Moreover, oxygen saturation in the verapamil group changed 4.8%±2.5% and this improvement in the control group was 1.8±1 (P=0.00). Smoker subjects, ones with PAP more than 35mmHg and obese patients benefit from verapamil. The beneficial impact of inhaled verapamil on the diminishing of dyspnea score along with its bronchodilatory effect would make this selective calcium blocker agent a therapeutic option in COPD.

Combined Exercise Effects on Lipid Profiles in Hypertensive Patients

Objective: The purpose of the study was to examine combined aerobic and resistance exercise training effect on lipid profiles in hypertensive patients. Method: A total of forty‑six hypertensive patients aged between 31 and 45 years were randomly assigned into two groups: control group (n=23) and exercise group (n=23). Total cholesterol (TC), high density lipoprotein cholesterol (HDL‑c), low density lipoprotein cholesterol (LDL‑c), and triglycerides (TGs) data were collected at baseline and after 16 weeks of the study period. Analyses of within group and between group comparisons were done using paired sample t‑test and independent sample t‑test, respectively. Results: Pre‑intervention data of TC, LDL‑c, TGs, and HDL‑c were homogeneous compared with groups (P>0.05). After completion of the study significant between group mean change difference was found in TC (‑7.2 mg/dl; P=0.0001), LDL‑c (‑10 mg/dl; P=0.0001), TGs (‑14.3 mg/dl; P=0.0001), and in HDL‑c (3.8 mg/ dl; P=0.001). In EG participants performed combined aerobic and resistance exercise training. Conclusions: Combined aerobic and resistance exercise training significantly reduced TC, LDL‑c, TGs and significantly increased HDL‑c levels in hypertensive patients. Public awareness promotion should be designed and implemented by concerned bodies for hypertensive patients to realize the importance of combined exercise trainings and thereby increases their adherence to exercise programs. Trial Registration: Clinicaltrials.gov Identifier: NCT03029767 on 20/01/2017.

The Effect of Total Motion Release on Functional Movement Screen Composite Scores: A Randomized Controlled Trial.

The Functional Movement Screen (FMS™) provides clinicians with objective criteria to assess movement patterns and overall movement quality. A relationship between low FMS™ composite scores and increased risk of injury has been reported, and researchers have begun to test the effect of interventions to improve FMS™ composite scores. Total Motion Release (TMR®), a novel active movement intervention, has been found to produce improvements in range of motion, as well as patient-reported pain and dysfunction. The effect of TMR® on movement patterns or movement quality is unknown. To assess the effect of a single treatment application of TMR® on FMS™ composite scores in participants with low baselines FMS™ composite scores. Single-blind randomized controlled study. Athletic training laboratory. Twenty-four participants (12 males and 12 females) with FMS™ composite scores of 13 or lower were randomly assigned to either a treatment group or control group. The FMS™ screening procedure was completed on all participants in a pretest and posttest design. In between FMS™ testing sessions, participants assigned to the treatment group completed the TMR® FAB 6-treatment protocol, whereas the control group participants did not receive an intervention. Following the treatment period (ie,20 min), participants again completed the FMS™. FMS™ composite scores. The improvement in FMS™ composite scores was significantly better (P ≤ .001, Cohen's d = 1.69) in the TMR® group (mean change = 3.7 [2.2]) compared with the control group (mean change = 0.7 [1.2]). A single application of the TMR® FAB 6 protocol produced immediate acute improvements in FMS™ composite scores in a young, physically active population compared with no intervention. Research evidence exists to suggest impaired or dysfunctional movement patterns or movement quality increases risk of injury. The FMS™ is commonly utilized to assess movement quality and risk of injury. This study provides initial evidence that the use of TMR® rapidly produces acute improvements in movement quality, as measured by the FMS™.

P138 IMPACT OF NEOADJUVANT FLOT CHEMOTHERAPY ON CARDIORESPIRATORY RESERVE OF PATIENTS WITH OESOPHAGOGASTRIC ADENOCARCINOMA

Abstract Introduction Neoadjuvant chemotherapy is known to have a deleterious effect on the cardiorespiratory reserve of patients with oesophagogastric cancer[1,2]. A low anaerobic threshold is associated with increased morbidity after major surgery[3] The effect that FLOT (5FU, leucovorin, oxaliplatin, docetakel) chemotherapy has upon cardiopulmonary reserve has not been reported. This work aims to quantify this effect. Methods Cardiopulmonary exercise testing (CPET) was completed in 18 consecutive patients with oesophagogastric cancer who received FLOT chemotherapy. CPET pre-chemotherapy and 4-5weeks post-chemotherapy measured the ventilatory anaerobic threshold (AT) and peak oxygen uptake (Vo2p). Ventilatory equivalents for CO2 (Ve/VCO2) and total ventilation (Ve) were reported. The group mean change in these objective measurements of cardiopulmonary reserve was compared before and after FLOT. Results Between October 2018 and January 2019 eighteen patients (median age 58.1 years, 16/18 male) were tested before and after FLOT. In 14 patients (78%) a decline in AT and VO2p was demonstrated. A mean decrease in AT of 2.1 mlkg-1min-1 (14.9 Vs 12.8 mlkg-1min-1, p=0.02) and VO2p of 2.3 mlkg-1min-1 (20.6 vs 18.3 mlkg-1min-1, p=0.01) was seen after FLOT. Ve/VCO2 and Ve were unchanged. Conclusion Patients receiving FLOT chemotherapy demonstrate a clinically significant decrease in cardiorespiratory reserve. This appears to be similar to that observed in patients who have previously received neoadjuvant ECX (MAGIC regimen) [1,2,4]. Further investigation into the clinical impact of this observation is required.

Accelerated versus standard corneal cross linking in the treatment of ectasia post refractive surgery and penetrating keratoplasty: a medium term randomized trial.

To compare the clinical outcomes of the standard corneal cross linking (CXL) and the accelerated CXL in patients with progressive corneal ectasia post refractive surgery and penetrating keratoplasty. Totally 120 eyes of 83 patients scheduled to receive either standard CXL (3 mW/cm2 for a period of 30min) or accelerated CXL (18 mW/cm2 for a period of 5min). The main outcomes for comparison were the change in: maximum-K reading (K-max), manifest refractive spherical equivalent (SE), central corneal thickness (CCT), and the best corrected distance visual acuity (CDVA). One hundred and eleven eyes completed the study. The main outcome measurement was the K-max reading. Both group showed significant improvement in the value postoperatively at 6 and 12mo. The mean change in the standard group was 1.21±0.11 D and in the accelerated group was 0.90±0.05 D at the end of 12mo postoperatively, with no statistically significant difference between the 2 groups. Similarly, CDVA improved significantly from their preoperative value in the standard group by 2.98±0.11 letters, and in the accelerated group by 2.20±0.06 letters, with no statistically significant difference between the two groups. Both of the SE, and CCT showed no statistically significant difference at the end of follow up period in each group. Both standard CXL and accelerated CXL are safe and effective treatment in halting ectasia after corneal refractive surgery. The accelerated CXL results are comparable to the standard CXL with short time exposure of the cornea to ultraviolet irradiation, leading to reduced operation time, reduced operative ocular discomfort, and corneal haze.

Doravirine versus ritonavir-boosted darunavir in antiretroviral-naive adults with HIV-1 (DRIVE-FORWARD): 96-week results of a randomised, double-blind, non-inferiority, phase 3 trial

Doravirine is a novel, non-nucleoside reverse transcriptase inhibitor that has shown non-inferior efficacy to ritonavir-boosted darunavir, with a superior lipid profile, in adults with HIV who were treatment naive at week 48 in the phase 3 DRIVE-FORWARD trial. Here we present the 96-week data for the study. This randomised, controlled, double-blind, multicentre, non-inferiority, phase 3 study was undertaken at 125 clinical centres in 15 countries. Eligible participants were adults (aged ≥18 years) infected with HIV-1 who were naive to antiretroviral therapy, with a plasma HIV-1 RNA concentration of 1000 copies per mL or higher at screening, and no known resistance to any of the study drugs. Participants were randomly assigned (1:1) using an interactive voice and web response system, stratified by baseline HIV-1 RNA concentration and background nucleoside reverse transcriptase inhibitor therapy, to doravirine (100 mg per day) or ritonavir-boosted darunavir (100 mg ritonavir and 800 mg darunavir per day), both with investigator-selected nucleoside reverse transcriptase inhibitors: emtricitabine and tenofovir disoproxil fumarate or abacavir and lamivudine. Participants and investigators were masked to treatment assignment until week 96. The primary efficacy endpoint was the proportion of participants who had a plasma HIV-1 RNA concentration of less than 50 copies per mL at week 48, which has been reported previously. Here we report the key secondary efficacy endpoint of the proportion of participants who achieved this concentration by week 96, assessed in all participants who received at least one dose of any study drug, regardless of whether it was their randomly assigned treatment. We used a US Food and Drug Administration snapshot approach and a margin of 10 percentage points to define the non-inferiority of doravirine to ritonavir-boosted darunavir at 96 weeks. Key safety endpoints were change in fasting serum lipid concentrations, the incidence of adverse events, and time to discontinuation due to an adverse event, assessed in all participants who received at least one dose of any study medication. This study is registered with ClinicalTrials.gov, NCT02275780, and is closed to accrual. Between Dec 1, 2014, and Oct 20, 2015, 1027 individuals were screened, of whom 769 participants were randomly assigned to doravirine (n=385) or ritonavir-boosted darunavir (n=384), and 383 in both groups were given at least one dose of their allocated treatment. Most participants were male (645 [84%] of 766) and white (560 [73%]), with a mean age of 35·2 years (SD 10·6). 292 participants in the doravirine group and 273 in the darunavir group completed 96 weeks of treatment. At week 96, a higher proportion of the doravirine group (277 [73%] of 383) achieved an HIV-1 RNA concentration of less than 50 copies per mL than did of the darunavir group (248 [66%] of 383; difference 7·1%, 95% CI 0·5-13·7). Responses were similar regardless of baseline characteristics. Treatment-emergent resistance to any study drug occurred in two (1%) of 383 participants in the doravirine group and one (<1%) of 383 in the ritonavir-boosted darunavir group. Significant differences were seen between treatment groups in mean changes from baseline in LDL cholesterol (-14·6 mg/dL, 95% CI -18·2 to -11·0) and non-HDL cholesterol (-18·4 mg/dL, -22·5 to -14·3). Frequencies of adverse events were similar between groups. No significant treatment difference (log-rank nominal p=0·063) through week 96 was observed in time to discontinuation due to an adverse event. The most common adverse events (week 0-96) were diarrhoea (65 [17%] in the doravirine group vs 91 [24%] in the ritonavir-boosted darunavir group), nausea (45 [12%] vs 52 [14%]), headache (57 [15%] vs 46 [12%]), and upper respiratory tract infection (51 [13%] vs 30 [8%]). Two participants, one in each group, died during treatment; neither death was considered to be related to study medication. These results through 96 weeks support the efficacy and safety results reported previously for doravirine at 48 weeks, supporting the use of doravirine for the long-term treatment of adults with previously untreated HIV-1 infection. Merck.

689 Early Improvement After Intravenous Ustekinumab Induction in Patients With Ulcerative Colitis: Results From the UNIFI Induction Trial

INTRODUCTION: The UNIFI induction study evaluated the efficacy and safety of ustekinumab (UST) in patients with moderately to severely active ulcerative colitis (UC) after a single intravenous infusion. In this analysis, we evaluated the rapidity of the onset of the treatment effect. METHODS: Eligible patients were randomly assigned to placebo (PBO) or UST 130 mg or ∼6 mg/kg. Patients recorded stool frequency and categorized rectal bleeding daily for the 7 days before each visit. Partial Mayo scores were calculated at baseline and Week 2 using the average of the stool frequency and rectal bleeding scores from the most recent consecutive 3-day period before the visit and the physician's global assessment score recorded at the visit. C-reactive protein (CRP) and fecal biomarkers were measured at baseline and Day 14. RESULTS: At baseline, the mean 3-day average daily stool frequency was 7.0 in the PBO group, 6.9 in the UST 130-mg group, and 7.0 in the UST ∼6-mg/kg group. Patients receiving UST showed greater reductions in the daily number of stools compared with PBO as soon as the first assessment time point at Day 7. Mean changes from baseline in daily stool frequency were -0.7 for PBO, -1.0 for UST 130-mg (P = 0.098), and -1.2 for UST ∼6-mg/kg group (P = 0.018) by Day 7, respectively, and -0.9, -1.6 (P &lt; 0.001), and -1.9 (P &lt; 0.001) by Day 13, respectively (Figure 1). Rectal bleeding scores at baseline and Week 2 are summarized in Figure 2. Patients receiving UST showed significantly greater improvement from baseline to Day 14 in partial Mayo score and CRP (Table, P &lt; 0.001 for all comparisons of UST vs PBO). Differences between the UST and PBO treatment groups in mean changes from baseline to Day 14 in fecal calprotectin did not reach significance (PBO -33.96 mg/kg, UST 130 mg 79.12 mg/kg [P = 0.875], UST ∼6 mg/kg -412.68 mg/kg [P = 0.152]). However, patients receiving UST showed significantly greater improvement in fecal calprotectin at Week 4 (mean changes from baseline: PBO -226.78 mg/kg, UST 130 mg -881.22 mg/kg [P = 0.013], UST ∼6 mg/kg -802.75 mg/kg [P &lt; 0.001]). Similar results were observed for fecal lactoferrin. CONCLUSION: The effect of UST began rapidly after induction, with symptomatic improvement and reduction of systemic inflammation seen as early as the first assessments at Days 7 and 14, respectively.

Impact of daily yoga-based exercise on pain, catastrophizing, and sleep amongst individuals with fibromyalgia.

BackgroundFibromyalgia (FM) is a chronic widespread pain disorder characterized by negative affect, sleep disturbance, and fatigue. This uncontrolled pilot study investigated the efficacy of daily yoga-based exercise to improve FM symptoms and explored baseline phenotypic characteristics associated with the greatest benefit.MethodsFM patients (n=46, with 36 completers) reported psychosocial functioning and a range of FM symptoms using validated instruments before and after participation in Satyananda yoga, which included weekly in-person pain-tailored group classes for 6 weeks and daily home yoga video practice.ResultsChanges in FM symptoms from pre- to post-yoga were variable amongst participants. Group means for pain decreased, as reported by average daily diary and Brief Pain Inventory, with greater home practice minutes associated with a greater decrease in pain. Average daily ratings of sleep and fatigue improved. Pain catastrophizing was decreased overall, with greater change correlated to a decrease in FM symptoms. We did not observe any group mean changes in actigraphy sleep efficiency, Patient-Reported Outcomes Measurement Information System-anxiety and the Revised Fibromyalgia Impact Questionnaire. Multilevel Modeling analysis revealed a significant interaction between anxiety and catastrophizing for end-study sleep efficiency, fatigue, and pain, such that patients with higher baseline catastrophizing and lower baseline anxiety reported less pain and fatigue, and higher sleep efficiency after the sixth week of yoga practice.ConclusionThis pilot study suggests that yoga may reduce pain and catastrophizing, as well as improve sleep, but these changes were modest across study participants. Greater uptake of home yoga practice as well as a phenotype of higher baseline catastrophizing combined with lower baseline anxiety were associated with greater impact. Future randomized, controlled trials comparing different types of yoga or exercise will allow determination of the most effective treatments for FM and allow closer targeting to the patients who will benefit most from them.

Inhaled GM-CSF for Pulmonary Alveolar Proteinosis

BackgroundPulmonary alveolar proteinosis is a disease characterized by abnormal accumulation of surfactant in the alveoli. Most cases are autoimmune and are associated with an autoantibody against granulocyte–macrophage colony-stimulating factor (GM-CSF) that prevents clearing of pulmonary surfactant by alveolar macrophages. An open-label, phase 2 study showed some therapeutic efficacy of inhaled recombinant human GM-CSF in patients with severe pulmonary alveolar proteinosis; however, the efficacy in patients with mild-to-moderate disease remains unclear.MethodsWe conducted a double-blind, placebo-controlled trial of daily inhaled recombinant human GM-CSF (sargramostim), at a dose of 125 μg twice daily for 7 days, every other week for 24 weeks, or placebo in 64 patients with autoimmune pulmonary alveolar proteinosis who had a partial pressure of arterial oxygen (Pao2) while breathing ambient air of less than 70 mm Hg (or <75 mm Hg in symptomatic patients). Patients with severe pulmonary alveolar proteinosis (Pao2 <50 mm Hg) were excluded to avoid possible exacerbation of the disease in patients who were assigned to receive placebo. The primary end point was the change in the alveolar–arterial oxygen gradient between baseline and week 25.ResultsThe change in the mean (±SD) alveolar–arterial oxygen gradient was significantly better in the GM-CSF group (33 patients) than in the placebo group (30 patients) (mean change from baseline, −4.50±9.03 mm Hg vs. 0.17±10.50 mm Hg; P=0.02). The change between baseline and week 25 in the density of the lung field on computed tomography was also better in the GM-CSF group (between-group difference, −36.08 Hounsfield units; 95% confidence interval, −61.58 to −6.99, calculated with the use of the Mann–Whitney U test and the Hodges–Lehmann estimate of confidence intervals for pseudo-medians). Serious adverse events developed in 6 patients in the GM-CSF group and in 3 patients in the placebo group.ConclusionsIn this randomized, controlled trial, inhaled recombinant human GM-CSF was associated with a modest salutary effect on the laboratory outcome of arterial oxygen tension, and no clinical benefits were noted. (Funded by the Japan Agency for Medical Research and Development and the Ministry of Health, Labor, and Welfare of Japan; PAGE ClinicalTrials.gov number, NCT02835742; Japan Medical Association Center for Clinical Trials number, JMA-IIA00205.)

Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial.

The primary purpose of this study was to histologically determine if there is a significant difference in new bone formation, residual graft material, and connective tissue/other when ridge preservation is accomplished using a bovine versus a porcine xenograft. Forty-four patients needing a single rooted tooth extraction and ridge preservation in preparation for dental implant placement were recruited in the study. After minimally traumatic tooth extraction, alveolar ridge dimensions were measured using a custom-fabricated acrylic stent. Patients were then randomized 1:1 to receive ridge preservation using either bovine or porcine xenograft material. A trimmed dense polytetrafluoroethylene (d-PTFE) membrane was overlaid on the graft material, the mucoperiosteal flaps were replaced, and the surgical site was sutured. After 18 to 20weeks of wound healing, sites were surgically re-entered, ridge dimensions were again measured using the previously fabricated acrylic stents and a bone core sample of the grafted site was harvested for histomorphometric analysis. Thirty eight of the 44 enrolled patients completed the study, 17 from the bovine group and 21 from the porcine group. Histologically, there were no statistically significant differences between the groups for mean percentage of vital bone formation (bovine=36.21%, porcine=31.27%, P=0.49), residual graft material (bovine=20.47%, porcine=19.52%, P=0.82) and connective tissue/other (bovine=43.32%, porcine=49.21%, P=0.19). For secondary outcomes, there were no significant differences between the groups for mean change in buccal ridge height, lingual ridge height, and ridge width. However, a higher number of patients in the porcine group had additional grafting at the time of implant placement, either because of thin buccal plate or failure of implant stability. The findings suggest that ridge preservation with porcine xenograft results in comparable histomorphometric outcomes and dimensional stability with bovine xenograft.

The Dry Eye Assessment and Management (DREAM) extension study – A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease

PurposeTo determine effects of continued or discontinued use of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among patients assigned to ω3 supplements in the first year of the DREAM study. MethodsPatients who were initially assigned to ω3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to ω3 active supplements or placebos (refined olive oil) for 12 more months. The primary outcome was change in the Ocular Surface Disease Index (OSDI) score. Secondary outcomes included change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events. ResultsAmong 22 patients assigned to ω3 and 21 to placebo supplements, the mean change in OSDI score between month 12 and 24 was similar between treatment groups (mean difference in change −0.6 points, 95% confidence interval [CI], (−10.7, 9.5), p = 0.91). There were no significant differences between groups in mean change in conjunctival staining (difference in mean change −0.5 points; 95% CI (−1.2, 0.3)), corneal staining (−0.3 points; 95% CI (−1.2, 0.3)), tear break-up time (−0.8 s; 95% CI (−2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI (−2.0, 3.2)). Rates of adverse events were similar in both groups. ConclusionAmong patients who received ω3 supplements for 12 months in the primary trial, those discontinuing use of ω3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of ω3.ClinicalTrials.gov number NCT02128763.

An investigation into the effects of kinesiotaping for posture correction on kyphosis angle, pain, and balance in patients with postmenopausal osteoporosis-associated thoracic kyphosis.

The present study aims to investigate whether kinesiotaping for posture correction in patients with osteoporosis-related increased kyphosis provides additional benefits to routine osteoporosis and balance exercises in reducing dorsal kyphosis angle, pain, and balance. A single-center, parallel-group randomized controlled trial with unblinded assessments at baseline, week 3, and week 6 and additional measures 30min immediately after taping in intervention group only. Forty-two female osteoporotic patients with hyperkyphosis were enrolled and randomized into 2 groups. The intervention group received an exercise program plus 3 sessions of kinesiotaping over the upper back; the control group received only an exercise program. The primary outcome measure was dorsal kyphosis angle, measured using a digital inclinometer. Secondary outcome measures were pain assessed on a visual analog scale (VAS 0-10cm) and balance assessed with the Berg Balance Scale and SportKAT device. The study was conducted on 22 patients with an average age of 64 ± 7.08 in the control group and 20 patients with an average age of 63.1 ± 8.8 in the treatment group. There was not a significant difference when dorsal kyphosis angle of the two groups was compared in terms of the change between the baseline and week 6. The mean change in the control group was 0.86 ± 2 while it was 0.70 ± 1.75 in the intervention group. No significant difference was detected between the groups in terms of balance measurements. Significant differences were seen in favor of the intervention group when the VAS pain scores of the two groups were compared in terms of the change between the baseline and week 3 (p < 0.001) and the baseline and week 6 (p < 0.001), while no such difference was identified when the changes between weeks 3 and 6 were compared between the two groups. A significant effect on dorsal kyphosis angle and balance was also shown in the treatment group 30min after taping. Application of kinesiotaping may have short-term positive effects on pain, but is unlikely to have significant effects on kyphosis angle or balance for women with osteoporosis. Positive changes seen in kyphosis angle and balance 30min after taping are short-lived.

Human gut microbiome changes during a 10 week Randomised Control Trial for micronutrient supplementation in children with attention deficit hyperactivity disorder

It has been widely hypothesized that both diet and the microbiome play a role in the regulation of attention-deficit/hyperactivity disorder (ADHD) behaviour. However, there has been very limited scientific investigation into the potential biological connection. We performed a 10-week pilot study investigating the effects of a broad spectrum micronutrient administration on faecal microbiome content, using 16S rRNA gene sequencing. The study consisted of 17 children (seven in the placebo and ten in the treatment group) between the ages of seven and 12 years, who were diagnosed with ADHD. We found that micronutrient treatment did not drive large-scale changes in composition or structure of the microbiome. However, observed OTUs significantly increased in the treatment group, and showed no mean change in the placebo group. The differential abundance and relative frequency of Actinobacteria significantly decreased post- micronutrient treatment, and this was largely attributed to species from the genus Bifidobacterium. This was compensated by an increase in the relative frequency of species from the genus Collinsella. Further research is required to establish the role that Bifidobacterium contribute towards neuropsychiatric disorders; however, these findings suggest that micronutrient administration could be used as a safe, therapeutic method to modulate Bifidobacterium abundance, which could have potential implications for modulating and regulating ADHD behaviour. Our pilot study provides an initial observation into this area of research, and highlights an interesting avenue for further investigation in a larger cohort. Furthermore, these novel results provide a basis for future research on the biological connection between ADHD, diet and the microbiome.

Improving the Signal-To-Noise Ratio When Monitoring Countermovement Jump Performance.

Kennedy, RA and Drake, D. Improving the signal-to-noise ratio when monitoring countermovement jump performance. J Strength Cond Res 35(1): 85-90, 2021-Countermovement jump (CMJ) performance has been routinely used to monitor neuromuscular status. However, the protocol used to establish the criterion score is not well documented. The purpose of this study was to examine how the protocol used would influence of the sensitivity of CMJ variables in rugby union players. Fifteen male (age: 19.7 ± 0.5 years) rugby union players performed 8 CMJs on 2 occasions, separated by 7 days. The between-session coefficient of variation (CV) was calculated using 2 techniques for treating multiple trials, the average, and the trial with the best jump height (JH), and then compared with the smallest worthwhile change (SWC). The signal-to-noise ratio was measured as the group mean change in a variable divided by the CV. Using the average value across multiple trials is superior to the best trial method, based on lower CVs for all variables. Only the average performance across 6 or more trials was classified as ideal (CV < 0.5 × SWC) for peak velocity (PV). In addition, the signal-to-noise ratio for peak concentric power (PCP), PV, and JH were classified as good, irrespective of the treatment method. Although increasing the number of trials can reduce the random error, it may be pragmatic to simply take the average from 2 to 3 trials, facilitating a CV < SWC for PV, PCP, and JH. Due to its simplicity, JH may be considered the principal variable to monitor neuromuscular fatigue.

Comparison of eye-rubbing effect in keratoconic eyes and healthy eyes using Scheimpflug analysis and a dynamic bidirectional applanation device

To compare the effect of eye rubbing on Scheimpflug imaging parameters and corneal biomechanics in eyes with keratoconus and healthy eyes. Oftalmosalud Instituto de Ojos, Lima, Peru. Prospective cohort study. The study included healthy and keratoconus patients who attended the institution between January 2017 and July 2017. Eye rubbing was performed for 1minute followed by a 5-second break, followed by further rubbing for 1minute. Baseline tests were performed before rubbing; post-rubbing tests were performed immediately after (0minutes), and then again at 7minutes and 14minutes. Parameters related to anterior and posterior curvature and elevation, pachymetry, and corneal biomechanics obtained from tomography with a rotating Scheimpflug camera (Pentacam HR) and a dynamic bidirectional applanation device (Ocular Response Analyzer) were measured and compared between healthy and keratoconic eyes. The study included 30 healthy eyes and 31 keratoconic eyes. In the healthy group, the immediate mean changes in steeper anterior keratometry, posterior astigmatism, anterior chamber volume (ACV), flattest posterior keratometry, and Goldmann-correlated intraocular pressure (IOPg) after eye rubbing were 0.07 diopters (D)±0.15 (SD), -0.01±0.08 D, 0.03±7.06mm3, -0.001±0.04mm, and -1.21±1.99mm Hg, respectively, whereas the mean changes in the keratoconus group were -0.03±0.32 D, 0.14±0.50 D, -5.09±8.45mm3, 0.03±0.06mm, and -1.61±1.41mm Hg, respectively. There were statistically significant differences between the preoperative and postoperative eye-rubbing values of posterior astigmatism, ACV, and IOPg in the keratoconus group (P=.03, P=.0003, and P=.001, respectively) but not in the healthy group (P=.65, P=.85, and P=.23, respectively). Unlike the healthy eyes group, the keratoconus group experienced significant changes in ACV, IOP, and corneal posterior astigmatism after eye rubbing.

Effectiveness of School-Based Education Programs on Health Risk Behaviors in Adolescents: South-East of Iran

Background: Improving and providing community health is one of the main pillars of community development. Objectives: The present study aimed at investigating the effect of school-based interventions on health-risk behaviors among adolescents in the South-East of Iran. Methods: This interventional quasi-experimental study recruited a total of 420 adolescent females in the 10th grade of public schools, selected by the census in Zahedan, Iran. The study tool was a questionnaire of high-risk health behaviors with a Content Validity Ratio (CVR) of 0.80, a Content Validity Index (CVI) of 0.88, and reliability (α) of 0.70. After the pre-test, multidimensional interventions (individual education, group education, individual counseling, modern education, and parents’ educational packages) were provided for the intervention group from October 2015 to June 2016. After a three-month interval, the post-test was conducted during October 2016. Results: The mean score changes in interventional and control group were -0.7 (2.3) and 0.1 (2.7) for high-risk behaviors; 0.8 (5.5) and -0.4 (5.2) for healthy nutritional behaviors, and physical activity behaviors with 1.4 (4.5) and 0.3 (5.1). Also, there was a positive significant relationship between score changes of high-risk behaviors (P < 0.001), healthy nutritional behaviors, and physical activity (P < 0.05) of students with study group (interventional and control) in univariate linear regression, yet in the multivariate linear model, only high-risk behaviors remained (P < 0.001). Furthermore, after the intervention, three simultaneous behaviors decreased among the students in the intervention group by 8.4% compared to 1.6% in the control group. The individual consultations among adolescents, who smoked cigarettes or hookahs, drank alcohol, abused drugs or had unprotected sex resulted in high-risk behaviors. Conclusions: To sum up, school-based interventions can improve health behaviors if they target multiple environmental and behavioral dimensions with a complementary strategy in the target society. Therefore, it is recommended for interventions to be designed and tailored to the needs of students and employed continuously to maintain the effect of education.

Effect of Creatine Supplementation on the Airways of Youth Elite Soccer Players.

ABSTRACTIntroductionOwing to its well-established ergogenic potential, creatine is a highly popular food supplement in sports. As an oral supplement, creatine is considered safe and ethical. However, no data exist on the safety of creatine on lung function in athletes. The aim of this project was to evaluate the effects of a standard course of creatine on the airways of youth elite athletes.MethodsNineteen elite soccer players, 16–21 yr old, completed a stratified, randomized, double-blind, placebo-controlled, parallel-group trial. The creatine group (n = 9) ingested 0.3 g·kg−1⋅d−1 of creatine monohydrate (CM) for 1 wk (loading phase) and 5 g·d−1 for 7 wk (maintenance phase), and the placebo group (n = 10) received the same dosages of maltodextrin. Airway inflammation (assessed by exhaled nitric oxide, FENO) and airway responsiveness (to dry air hyperpnoea) were measured pre- and postsupplementation.ResultsMild, unfavorable changes in FENO were noticed by trend over the supplementation period in the CM group only (P = 0.056 for interaction, η2 = 0.199), with a mean group change of 9 ± 13 ppb in the CM group versus −5 ± 16 ppb in the placebo group (P = 0.056, d = 0.695). Further, the maximum fall in forced expiratory volume in 1 s after dry air hyperpnoea was larger by trend postsupplementation in the CM group compared with the placebo group: 9.7% ± 7.5% vs 4.4% ± 1.4%, respectively (P = 0.070, d = 0.975). These adverse effects were more pronounced when atopic players only (n = 15) were considered.ConclusionOn the basis of the observed trends and medium to large effect sizes, we cannot exclude that creatine supplementation has an adverse effect on the airways of elite athletes, particularly in those with allergic sensitization. Further safety profiling of the ergogenic food supplement is warranted.

Endothelial Dysfunction in Patients With Erectile Dysfunction: A Double-Blind, Randomized-Control Trial Using Tadalafil.

ObjectiveTo assess whether tadalafil improves endothelial dysfunction(EnD) in a placebo-controlled randomized-control trial.MethodsErectile dysfunction and EnD were assessed by the International Index of Erectile Function (IIEF-5) and flow-mediated dilation (FMD) of the brachial artery respectively, at baseline and 4 weeks by blinded observer. Patients with FMD of < 15% were randomized in 1:1 ratio to receive either placebo or tadalafil. Both placebo and tadalafil in similar-appearing capsules but coded separately, were dispensed by a blinded co-investigator. Compliance and drug-related events were recorded. The randomization codes were then decoded and appropriate statistical tests applied.Results89 patients were randomized and 82 completed the study. Both groups were comparable. Posttreatment, there were significant improvements in IIEF-5 score (pre- vs posttreatment; tadalafil: 11.432 vs 15.937, P < .001 and placebo 11.232 vs 14.935, P < .00) and FMD% pre- vs posttreatment; tadalafil: 11.222 vs 13.827, P < .001 and placebo: 11.617 vs 14.027, P < .001). Intergroup comparison did not show any significant difference in IIEF scores (mean change in tadalafil vs placebo group: 3.719 vs 4.433, P = .223) and FMD% (mean change tadalafil vs placebo group: 2.426 and 2.829, P = .528). The adverse events were significantly more in the tadalafil group (tadalafil vs placebo 14 adverse reactions [ADR] vs 5 ADR, P < .001).ConclusionThe response of low-dose tadalafil on IIEF and FMD is largely similar to placebo; however, the utility of FMD% in young patients and placebo effect needs to be studied further.Pattanaik S, Kaundal P, Mavuduru RS, et al. Endothelial Dysfunction in Patients With Erectile Dysfunction: A Double-Blind, Randomized-Control Trial Using Tadalafil. Sex Med 2019;7:41–47.

The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial.

The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics. Forty episodic and 39 chronic migraine patients who completed this randomized double-blind controlled trial received two capsules of multispecies probiotic or placebo. The migraine severity was assessed by visual analog scale (VAS). The number of abortive drugs consumed, migraine days, frequency and duration of attacks were recorded on paper-based headache diaries. Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels were measured at baseline and the end of the intervention. After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change: -2.64 vs. 0.06; respectively, p < 0.001). A significant reduction was also evident in the migraine severity (mean decrease: -2.14 in the probiotic group and 0.11 in the placebo group; p < 0.001). Episodic migraineurs who received the probiotic also showed significant reduction in abortive drug usage per week (mean change: -0.72; p < 0.001) compare to baseline, while there was no significant changes within the placebo group. In chronic migraine patients, after an 8-week intervention, the mean frequency of migraine attacks significantly reduced in the probiotic compared to the placebo group (mean change: -9.67 vs. -0.22; p ≤ 0.001). In contrast to the placebo, probiotic supplementation significantly decreased the severity (mean changes: -2.69; p ≤ 0.001), duration (mean changes: -0.59; p ≤ 0.034) of attacks and the number of abortive drugs taken per day (mean changes: -1.02; p < 0.001), in chronic migraine patients. We failed to detect any significant differences in the serum levels of inflammatory markers at the end of the study either in chronic or in episodic migraineurs. The results of this study showed that the 14-strain probiotic mixture could be an effective and beneficial supplement to improve migraine headache in both chronic and episodic migraineurs. Further research is required to confirm our observations.

Efficacy and Safety of Long Acting HIV Fusion Inhibitor Albuvirtide in Antiretroviral-Experienced Adults with HIV-1: Interim 48 Week Results from the Randomized, Controlled, Phase 3 Trial, Non-Inferiority TALENT Study

Background: Albuvirtide is a once-weekly injectable HIV-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs. Methods: We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on WHO-recommended first-line treatment for > 6 months with a plasma viral load > 1000 copies per mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies per mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%. Findings: At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies per mL (difference: 14.4%, 95% CI: -3.0 to 31.9), meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated (94.9% vs. 74.4%, difference: 20.5%, 95% CI: 5.7 to 35.2, p=0.01). The frequency of grade 3-4 adverse events was similar in the two groups (14.0% vs. 11.1%); the most common adverse events were diarrhea (8.6% vs. 14.1% for the ABT and NRTI groups, respectively), upper respiratory tract infections (4.3% vs. 6.1%), and grade 3-4 increases in triglyceride concentration (6.5% vs. 4.0%). Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received TDF than in those of the ABT group (mean change in eGFR: -11.47 vs. -1.22 mL/min/1.73m2, p=0.02). Interpretation: The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis suggests that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure. Clinical Trial Number: This study is registered with ClinicalTrials.gov, number NCT02369965 and with the Chinese Clinical Trial Registry, number ChiCTR-TRC-14004276. Funding Statement: This work was supported by the Frontier Biotechnologies Inc., Ministry of Science and Technology of China (Grant No. 2013ZX09101001, 2017ZX09201007), the Beijing Municipal of Science and Technology Major Project (D141100000314005, D141100000314002, D161100000416003), the National Natural Science Foundation of China (81772165, 81571973), and Beijing Key Laboratory for HIV/AIDS Research (BZ0089). No funding bodies had any role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Declaration of Interests: The authors of this manuscript have read the journal's policy and have the following competing interests: CY, RL, JH, and DX have received salary support from Frontier Biotechnologies Inc. All authors had full access to all study data and analyses, and approved the final report. All other authors have declared that no competing interests exist. Ethics Approval Statement: The institutional ethics committee at each site reviewed and approved the protocol and the written informed consent form which was provided according to the declaration of Helsinki. Each patient gave written informed consent before undergoing study procedures. The methods were carried out in accordance with approved guidelines and regulations.