Home-Based Exercise Enhances Health-Related Quality of Life in Persons With Spinal Cord Injury: A Randomized Controlled Trial

Objective

To assess the influence of a home-based exercise intervention on indices of health-related quality of life (HRQOL) in persons with spinal cord injury (SCI).

Immediate Changes in Neck Pain Intensity and Widespread Pressure Pain Sensitivity in Patients With Bilateral Chronic Mechanical Neck Pain: A Randomized Controlled Trial of Thoracic Thrust Manipulation vs Non–Thrust Mobilization

Objective

The purpose of this study was to compare the effects of thoracic thrust manipulation vs thoracic non–thrust mobilization in patients with bilateral chronic mechanical neck pain on pressure pain sensitivity and neck pain intensity.

Methods

Fifty-two patients (58% were female) were randomly assigned to a thoracic spine thrust manipulation group or of thoracic non–thrust mobilization group. Pressure pain thresholds (PPTs) over C5-C6 zygapophyseal joint, second metacarpal, and tibialis anterior muscle and neck pain intensity (11-point Numerical Pain Rate Scale) were collected at baseline and 10 minutes after the intervention by an assessor blinded to group allocation. Mixed-model analyses of variance (ANOVAs) were used to examine the effects of the treatment on each outcome. The primary analysis was the group * time interaction.

Results

No significant interactions were found with the mixed-model ANOVAs for any PPT (C5-C6: P > .252; second metacarpal: P > .452; tibialis anterior: P > .273): both groups exhibited similar increases in PPT (all, P < .01), but within-group and between-group effect sizes were small (standardized mean score difference [SMD] < 0.22). The ANOVA found that patients receiving thoracic spine thrust manipulation experienced a greater decrease in neck pain (between-group mean difference: 1.4; 95% confidence interval, 0.8-2.1) than did those receiving thoracic spine non–thrust mobilization (P < .001). Within-group effect sizes were large for both groups (SMD > 2.1), and between-group effect size was also large (SMD = 1.3) in favor of the manipulative group.

Conclusions

The results of this randomized clinical trial suggest that thoracic thrust manipulation and non–thrust mobilization induce similar changes in widespread PPT in individuals with mechanical neck pain; however, the changes were clinically small. We also found that thoracic thrust manipulation was more effective than thoracic non–thrust mobilization for decreasing intensity of neck pain for patients with bilateral chronic mechanical neck pain.     

Efficacy of Urate–Lowering Therapy in Patients With Chronic Kidney Disease: A Network Meta-Analysis of Randomized Controlled Trials

PurposeThe goal of this study was to systematically review the efficacy and safety of urate-lowering therapy in patients with chronic kidney disease (CKD).MethodsPubMed, the Cochrane Central Registration of Controlled Trials, and EMBASE databases and several websites were electronically searched to collect randomized clinical trials on the efficacy of urate-lowering therapy in CKD from inception to December 31, 2020. The key primary end points were uric acid or estimated glomerular filtration rate (eGFR) levels; the safety end points were death, renal event, cardiovascular event, and gastrointestinal event. A Bayesian network meta-analysis was conducted with the use of ADDIS and R software.FindingsA total of 17 randomized clinical trials involving 2059 patients were included. The results of network meta-analysis showed that urate-lowering therapy could reduce urate levels in patients with CKD. Febuxostat was the most effective treatment in lowering urate levels according to the rank probability. Urate-lowering therapy has the tendency to delay the decline of eGFR, but the difference was not statistically significant. Ranking probability showed that benzbromarone, febuxostat, and allopurinol ranked higher than placebo in reducing the decline of eGFR. There were no statistically significant differences between groups in the incidence of all adverse effects.ImplicationsAll urate-lowering therapies could reduce the urate level in patients with CKD, but the benefit of such therapy in renal disease is still unclear. PROSPERO identifier: CRD42020222601.     

Online Resource to Promote Vocational Interests Among Job Seekers With Multiple Sclerosis: A Randomized Controlled Trial in Australia

Objective

To provide a preliminary evaluation of the effectiveness of an online resource for job seekers with multiple sclerosis (MS).

Clinical Efficacy and Tolerability of Ezetimibe in Combination With Atorvastatin in Japanese Patients With Hypercholesterolemia—Ezetimibe Phase IV Randomized Controlled Trial in Patients With Hypercholesterolemia

ObjectiveThe purpose of this study was to compare the efficacy and tolerability of combination therapy of ezetimibe and atorvastatin in patients with high LDL cholesterol that had not reached the lipid management target value with 10 mg atorvastatin monotherapy, against increasing the dose to 20 mg atorvastatin or switching to 2.5 mg rosuvastatin.Design, setting, and participantsThis was an open-label, randomized, multicenter, 3-parallel-group comparison trial at 23 community hospitals and clinics in Japan (enrollment period March 2009 to May 2010) in 125 patients with high LDL cholesterol.InterventionsA total of 125 Japanese patients with high LDL cholesterol level were randomized to 1 of the following 3 treatment groups: the ezetimibe (10 mg/d) and atorvastatin (10 mg/d) group, the atorvastatin (20 mg/d) group, or the rosuvastatin (2.5 mg/d) group for 12 weeks after treatment with 10 mg atorvastatin alone for 4 weeks.Main outcome measurePercent change in LDL cholesterol level from baseline (4 weeks after treatment with 10 mg atorvastatin alone) until study completion.ResultsThe percent change in LDL cholesterol level from baseline until study completion was statistically greater for the combination of 10 mg ezetimibe + 10 mg atorvastatin compared with increasing atorvastatin to 20 mg (?25.8% vs ?15.1%; P < 0.0001). A similar result was observed for ezetimibe + atorvastatin compared with switching to 2.5 mgt rosuvastatin (?25.8% vs 0.8%; P < 0.0001). The proportion of patients who reached the target LDL cholesterol value with the combination of ezetimibe + atorvastatin was significantly higher than increasing atorvastatin and switching to rosuvastatin (78.7%, 41.3%, and 3.1%, respectively). Although 5 serious adverse experiences bearing no relation to the study medications were reported, there were no adverse reactions.ConclusionsThe combination of 10 mg ezetimibe +10 mg atorvastatin was more effective than increasing atorvastatin to 20 mg or switching to 2.5 mg rosuvastatin in patients with hypercholesterolemia whose LDL cholesterol levels had not reached the recommended target value with 10 mg atorvastatin monotherapy for 4 weeks. Ezetimibe coadministration with atorvastatin was well tolerated. ClinicalTrials.gov identifier: NCT00871351.     

Treatment Effect in Earlier Trials of Patients With Chronic Medical Conditions: A Meta-Epidemiologic Study

Objective

To determine whether the early trials in chronic medical conditions demonstrate an effect size that is larger than that in subsequent trials.

Functional Electrical Stimulation—A New Therapeutic Approach to Enhance Exercise Intensity in Chronic Obstructive Pulmonary Disease Patients: A Randomized,Controlled Crossover Trial

Objective

To evaluate the effect of quadriceps functional electrical stimulation (FES)-cycling on exertional oxygen uptake ($\dot{\text{V}}$o₂) compared with placebo FES-cycling in patients with chronic obstructive pulmonary disease (COPD).

Determination of the Effectiveness of Informing With the Guidance of an Education Booklet in Patients Undergoing Colonoscopy—A Randomized Controlled Trial

PurposeThe aim of this study was to determine the effect of precolonoscopy information with the guidance of an education booklet on anxiety and bowel preparation adequacy in patients undergoing colonoscopy.DesignA randomized controlled study.MethodsThe education group was informed face to face by the researcher with the guidance of the colonoscopy education booklet and provided the education booklet. The control group received usual care.FindingsThe mean state and trait anxiety scores of the patients in the education group were found to be significantly lower than the control group. In the education group, the bowel preparation adequacy was determined to be higher compared with the control group.ConclusionsInforming patients with the guidance of the education booklet before the colonoscopy decreased patients' state and trait anxiety levels and increased their bowel preparation adequacy.     

Controlled-Release Oxycodone vs. Placebo in the Treatment of Chronic Breathlessness—A Multisite Randomized Placebo Controlled Trial

ContextChronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated.ObjectivesDoes oxycodone reduce chronic breathlessness compared with placebo?MethodsA multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less doses/day) was available for both arms as required by one ethics committee overseeing the trial. Recruitment occurred from 2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology, and palliative care services across Australia. Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0–100 mm visual analogue scale) comparing arms Days 5–7. Secondary end points were average and worst breathlessness, quality of life, function, and harms.ResultsOf 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P < 0.001).ConclusionThere was no signal of benefit from oxycodone over placebo. Future research should focus on investigating the existence of an opioid class effect on the reduction of chronic breathlessness.     

A Fixed Nitrous Oxide and Oxygen Mixture for Analgesia in Children With Leukemia With Lumbar Puncture–induced Pain: A Randomized,Double-blind Controlled Trial

ContextLeukemia is the most common cancer in the childhood population. Lumbar puncture (LP) plays central role in the diagnosis and treatment process, but options for analgesia are limited.ObjectivesThe present study aims to evaluate the efficacy of a fixed N₂O/O₂ mixture to reduce pain in children with leukemia during LP as compared with placebo.MethodsA double-blind, placebo-controlled, and randomized clinical trial involving children who needed LP for diagnosis or treatment was conducted in the pediatrics department of the General Hospital of Ningxia Medical University. Eligible patients were randomly assigned to inhale either a fixed N₂O/O₂ mixture or O₂. The primary endpoint was the maximal pain level felt by the patient during the procedure measured using a numerical rating scale (0–10).ResultsOne-hundred fourteen consecutive patients were enrolled in this study and randomized. Pain scores during the procedure showed a significant decrease in N₂O/O₂ mixture–treated patients to 1.05 ± 1.40 versus 8.00 ± 2.13 in controls (P < 0.01). No serious adverse effects were attributed to N₂O/O₂ mixture inhalation. Analysis of the satisfaction of patients receiving N₂O/O₂ mixture indicated that medical staff were satisfied with this treatment.ConclusionsThis study demonstrated that self-administered fixed N₂O/O₂ is efficient to reduce pain related to LP in children with leukemia.     

Effects of Whole Body Vibration on Tibia Strength and Structure of Competitive Adolescent Swimmers: A Randomized Controlled Trial

Background

Swimming has no effect on bone mass or structure. Therefore, adolescent swimmers present similar bone strength values when compared to normo-active controls, and lower values when compared to weight-bearing athletes. It thus seems necessary to try to improve bone structure and strength of adolescent swimmers through a weight-bearing intervention in order to reduce the risk of suffering osteoporosis later in life.

Haptoglobin Genotype and Vitamin E Versus Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis in China: A Multicenter,Randomized, Placebo-Controlled Trial Design

Introduction

Vitamin E is one of the most promising agents for nonalcoholic steatohepatitis (NASH) treatment, and its drug responsiveness may be closely associated with haptoglobin (Hp) genotype. However, its efficacy and safety remain unknown in China. This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH.

Methods

VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in nondiabetic adults with NASH versus treatment with placebo in China. Liver biopsies are read by a pathological evaluation committee independently according to the NASH Clinical Research Network (CRN) scoring system. The NAFLD activity score (NAS) represents the sum of scores for steatosis, lobular inflammation, and hepatocyte ballooning. The definition of histologic improvement requires all three of the following criteria to be met: (a) either improvement in NAS by at least 2 points or post-treatment NAS score no higher than 3, (b) at least 1-point improvement in the score for ballooning, and (c) no worsening of fibrosis stages. We plan to recruit 120 biopsy-proven NASH patients from13 centers in China. Participants will be randomly assigned to groups treated with either with vitamin E (100 mg, tid) or placebo for 96 weeks then followed by 24 weeks of post-treatment observation. Biochemical parameters, cytokines, anthropometric parameters, CAP and TE values, Hp genotype, and several questionnaires will be collected as per the schedule. This protocol was approved by the Ethics Committee of Hangzhou Normal University Affiliated Hospital to ensure patients safety, and R&G Pharmastudies Co., Ltd. was established for monitoring the accumulated interim data to review efficacy and quality of data collection and overall study management.

Results

As a preliminary study, a mobile phone application (app) for lifestyle modification and database recording (http://laiyivens.365hy.com) was exploited for every participant. The percentage of NAFLD patients with Hp 2-2 allele is much higher than that of Western patients (65.71% vs 36%, respectively), which suggests that the Chinese benefit more from vitamin E treatment.

Conclusion

VENS is the first randomized controlled trial (RCT) to evaluate the efficacy of Vitamin E in treating nondiabetic NASH patients in China.

Trial Registration

This study registered at https://clinicaltrials.gov (registration number: NCT02962297).

Funding

Zhejiang Medicine Co., Ltd.

     

Does the Use of a Handheld Fan Improve Chronic Dyspnea? A Randomized,Controlled, Crossover Trial

ContextDyspnea is a disabling distressing symptom that is common in advanced disease affecting millions of people worldwide. Current palliative strategies are partially effective in managing this symptom; facial cooling has been shown to reduce the sensation of breathlessness when induced in volunteers but has not been formally investigated in dyspnea associated with disease.ObjectiveThe objective of this study was to investigate whether a handheld fan reduces the sensation of breathlessness in such patients, enhancing palliative approaches.MethodsThe effectiveness of a handheld fan (blowing air across the nose and mouth) in reducing the sensation of breathlessness was assessed in patients with advanced disease. Fifty participants were randomized to use a handheld fan for five minutes directed to their face or leg first and then crossed over to the other treatment. The primary outcome measure was a decrease of greater than 1 cm in breathlessness recorded on a 10 cm visual analog scale (VAS).ResultsThere was a significant difference in the VAS scores between the two treatments, with a reduction in breathlessness when the fan was directed to the face (P = 0.003).ConclusionThis study supports the hypothesis that a handheld fan directed to the face reduces the sensation of breathlessness. The fan was acceptable to participants: it is inexpensive, portable, enhances self-efficacy, and available internationally. It should be recommended as part of a palliative management strategy for reducing breathlessness associated with advanced disease.