Oral Pentoxifylline in the Treatment of Venous Leg Ulcers: a Meta-Analysis

Compression bandaging improves rates of healing in people with venous ulceration. Some ulcers appear resistant to compression therapy and may benefit from adjunctive therapy. Pentoxifylline is known to improve circulation, but individual trials have failed to conclusively demonstrate its effectiveness in venous ulceration. The objective of this meta-analysis was to assess the effectiveness of pentoxifylline as an adjunct to compression bandaging in the treatment of venous leg ulcers. The CENTRAL registers of the Cochrane Peripheral Vascular Diseases and Wounds Groups were searched - each register is routinely updated by extensive searches of electronic databases, handsearching of relevant journals and conference proceedings, and contact with product companies and experts in the field. The drug's manufacturer was contacted and the references of review articles and all obtained trials were scrutinised for further citations. Randomised controlled trials published in any language comparing pentoxifylline and compression with placebo in adult participants with venous ulceration were included. Trials must have reported a meaningful objective outcome (rates of healing, proportions healed, time to healing). Details from eligible trials (independently selected by two reviewers) were extracted and summarised by one reviewer. A second reviewer independently verified extracted data. Eleven clinical trials were identified. Five trials compared pentoxifylline with placebo (compression standard therapy). Six trials were excluded. Pentoxifylline and compression was more effective than placebo and compression (RR 1.30, 95% C1 1.10-1.54) and was robust to sensitivity analyses. The greater number of adverse effects (46 reports) occurred in the pentoxifylline group, although this was not significant (RR 1.12, 95% C1 0.77-1.62); 34 percent of adverse effects were gastro-intestinal. Seven of 21 reported withdrawals were for adverse effects. In conclusion, pentoxifylline appears an effective adjunct to compression bandaging in the treatment of venous ulcers. The absence of cost-effectiveness data suggests it not be employed as a routine adjunct, but it could be considered as for those patients not responding to compression therapy alone. The majority of adverse effects are likely to be tolerated by patients

Couch potatoes to jumping beans: A pilot study of the effect of active video games on physical activity in children

The primary objective of this pilot study was to evaluate the effect of active video games on children's physical activity levels

The effect of active video games by ethnicity, sex and fitness: Subgroup analysis from a randomised controlled trial

Background: The prevention and treatment of childhood obesity is a key public health challenge. However, certain groups within populations have markedly different risk profiles for obesity and related health behaviours. Well-designed subgroup analysis can identify potential differential effects of obesity interventions, which may be important for reducing health inequalities. The study aim was to evaluate the consistency of the effects of active video games across important subgroups in a randomised controlled trial (RCT).Findings: A two-arm, parallel RCT was conducted in overweight or obese children (n = 322; aged 10-14 years) to determine the effect of active video games on body composition. Statistically significant overall treatment effects favouring the intervention group were found for body mass index, body mass index z-score and percentage body fat at 24 weeks. For these outcomes, pre-specified subgroup analyses were conducted among important baseline demographic (ethnicity, sex) and prognostic (cardiovascular fitness) groups. No statistically significant interaction effects were found between the treatment and subgroup terms in the main regression model (p = 0.36 to 0.93), indicating a consistent treatment effect across these groups.Conclusions: Preliminary evidence suggests an active video games intervention had a consistent positive effect on body composition among important subgroups. This may support the use of these games as a pragmatic public health intervention to displace sedentary behaviour with physical activity in young people. © 2014 Foley et al.; licensee BioMed Central Ltd

Active video games: the mediating effect of aerobic fitness on body composition

BACKGROUND: Increased understanding of why and how physical activity impacts on health outcomes is needed to increase the effectiveness of physical activity interventions. A recent randomized controlled trial of an active video game (PlayStation EyeToy&trade;) intervention showed a statistically significant treatment effect on the primary outcome, change from baseline in body mass index (BMI), which favored the intervention group at 24 weeks. In this short paper we evaluate the mediating effects of the secondary outcomes. OBJECTIVE: To identify mediators of the effect of an active video games intervention on body composition. METHODS: Data from a two-arm parallel randomized controlled trial of an active video game intervention (n&thinsp;=&thinsp;322) were analyzed. The primary outcome was change from baseline in BMI. A priori secondary outcomes were considered as potential mediators of the intervention on BMI, including aerobic fitness (VO2Max), time spent in moderate-to-vigorous physical activity (MVPA), and food snacking at 24 weeks. RESULTS: Only aerobic fitness at 24 weeks met the conditions for mediation, and was a significant mediator of BMI. CONCLUSION: Playing active video games can have a positive effect on body composition in overweight or obese children and this effect is most likely mediated through improved aerobic fitness. Future trials should examine other potential mediators related to this type of intervention.<br /

Honey as a topical treatment for wounds (Review)

BackgroundHoney is a viscous, supersaturated sugar solution derived from nectar gathered and modified by the honeybee, Apis mellifera. Honey has been used since ancient times as a remedy in wound care. Evidence from animal studies and some trials has suggested that honey may accelerate wound healing.ObjectivesThe objective of this review was to assess the effects of honey compared with alternative wound dressings and topical treatments on the of healing of acute (e.g. burns, lacerations) and/or chronic (e.g. venous ulcers) wounds.Search methodsFor this update of the review we searched the Cochrane Wounds Group Specialised Register (searched 15 October 2014); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 9); Ovid MEDLINE (1946 to October Week 1 2014); Ovid MEDLINE (In-Process & Other Non-Indexed Citations 13 October 2014); Ovid EMBASE (1974 to 13 October 2014); and EBSCO CINAHL (1982 to 15 October 2014).Selection criteriaRandomised and quasi-randomised trials that evaluated honey as a treatment for any sort of acute or chronic wound were sought. There was no restriction in terms of source, date of publication or language. Wound healing was the primary endpoint.Data collection and analysisData from eligible trials were extracted and summarised by one review author, using a data extraction sheet, and independently verified by a second review author. All data have been subsequently checked by two more authors.Main resultsWe identified 26 eligible trials (total of 3011 participants). Three trials evaluated the effects of honey in minor acute wounds, 11 trials evaluated honey in burns, 10 trials recruited people with different chronic wounds including two in people with venous leg ulcers, two trials in people with diabetic foot ulcers and single trials in infected post-operative wounds, pressure injuries, cutaneous Leishmaniasis and Fournier's gangrene. Two trials recruited a mixed population of people with acute and chronic wounds. The quality of the evidence varied between different comparisons and outcomes. We mainly downgraded the quality of evidence for risk of bias, imprecision and, in a few cases, inconsistency.There is high quality evidence (2 trials, n= 992) that honey dressings heal partial thickness burns more quickly than conventional dressings (WMD -4.68 days, 95% CI -5.09 to -4.28) but it is unclear if there is a difference in rates of adverse events (very low quality evidence) or infection (low quality evidence).There is very low quality evidence (4 trials, n= 332) that burns treated with honey heal more quickly than those treated with silver sulfadiazine (SSD) (WMD-5.12 days, 95% CI -9.51 to -0.73) and high quality evidence from 6 trials (n= 462) that there is no difference in overall risk of healing within 6 weeks for honey compared with SSD (RR 1.00, 95% CI 0.98 to 1.02) but a reduction in the overall risk of adverse events with honey relative to SSD.There is low quality evidence (1 trial, n= 50) that early excision and grafting heals partial and full thickness burns more quickly than honey followed by grafting as necessary (WMD 13.6 days, 95% CI 9.82 to 17.38). There is low quality evidence (2 trials, different comparators, n= 140) that honey heals amixed population of acute and chronic wounds more quickly than SSD or sugar dressings.Honey healed infected post-operative wounds more quickly than antiseptic washes followed by gauze and was associated with fewer adverse events (1 trial, n= 50, moderate quality evidence, RR of healing 1.69, 95% CI 1.10 to 2.61); healed pressure ulcers more quickly than saline soaks (1 trial, n= 40, very low quality evidence, RR 1.41, 95% CI 1.05 to 1.90), and healed Fournier's gangrene more quickly than Eusol soaks (1 trial, n= 30, very low quality evidence, WMD -8.00 days, 95% CI -6.08 to -9.92 days).The effects of honey relative to comparators are unclear for: venous leg ulcers (2 trials, n= 476, low quality evidence); minor acute wounds (3 trials, n= 213, very low quality evidence); diabetic foot ulcers (2 trials, n= 93, low quality evidence); Leishmaniasis (1 trial, n= 100, low quality evidence); mixed chronic wounds (2 trials, n= 150, low quality evidence).Authors' conclusionsIt is difficult to draw overall conclusions regarding the effects of honey as a topical treatment for wounds due to the heterogeneous nature of the patient populations and comparators studied and the mostly low quality of the evidence. The quality of the evidence was mainly downgraded for risk of bias and imprecision. Honey appears to heal partial thickness burns more quickly than conventional treatment (which included polyurethane film, paraffin gauze, soframycin-impregnated gauze, sterile linen and leaving the burns exposed) and infected post-operative wounds more quickly than antiseptics and gauze. Beyond these comparisons any evidence for differences in the effects of honey and comparators is of low or very low quality and does not form a robust basis for decision making

Rugby Fans in Training New Zealand (RUFIT-NZ): a pilot randomized controlled trial of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand

Background Healthy lifestyle programs that are designed specifically to appeal to and support men to improve lifestyle behaviors and lose weight are needed. The Rugby Fans in Training-New Zealand (RUFIT-NZ) program is delivered by professional rugby clubs and inspired by the successful Football Fans In Training program (FFIT), a gender sensitized weight loss program for obese middle-aged men delivered by professional football clubs in Scotland. RUFIT-NZ required development and evaluation for feasibility. Methods To develop the intervention we reviewed content from the FFIT program and evidence-based physical activity, dietary and weight management guidelines, and undertook a series of focus groups and key informant interviews. We then evaluated the feasibility of the intervention in a two-arm, parallel, pilot randomized controlled trial in New Zealand. Ninety-six participants were randomized to either the 12-week RUFIT-NZ intervention (N = 49) or a control group (N = 47). The intervention was delivered through professional rugby clubs and involved physical activity training and classroom sessions on healthy lifestyle behaviors. Pilot trial outcomes included body weight, heart rate, blood pressure, cardiorespiratory fitness, and lifestyle behaviors. Feasibility was assessed by recruitment and retention rates, and acceptability of the intervention. Results At 12 weeks the mean difference in body weight was 2.5 kg (95% CI -0.4 to 5.4), which favored the intervention. Statistically significant differences in favor of the intervention group were also observed for waist circumference, resting heart rate, diastolic blood pressure, cardiorespiratory fitness, and the proportion of participants that were adherent to 3 or more healthy lifestyle behaviors. The intervention was considered feasible to test in a full trial given the good recruitment and retention rates, and positive feedback from participants. Conclusions A pilot study of a healthy lifestyle intervention delivered via professional rugby clubs in New Zealand demonstrated positive effects on weight and physiological outcomes, as well as adherence to lifestyle behaviors. Feasibility issues in terms of recruitment, retention, and participant acceptability were assessed and findings will be used to inform the design of a definitive trial. Trial registration The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry ACTRN12616000137493, 05/12/2016

Prescribed exercise regimen versus usual care and hypochlorous acid wound solution versus placebo for treating venous leg ulcers: study protocol for a randomised controlled trial (Factorial4VLU)

IntroductionCompression is the mainstay of treatment for venous leg ulcers (VLUs) and there are few effective adjuvant treatments. There is only observational evidence supporting the use of hypochlorous acid (HOCl) as a topical wound solution on VLU and some limited randomised evidence for the effect of a prescribed regimen of exercise.Methods and analysisThe Factorial4VLU trial is a pragmatic, blinded, factorial randomised controlled trial, with 380 participants receiving either a prescribed exercise regimen compared with usual care and either active HOCl wound solution or placebo wound solution at each dressing change for up to 24 weeks. All participants will receive compression therapy. The primary outcome is the proportion of participants with healed VLU at 12 weeks after randomisation as adjudicated by blinded review of ulcer photographs. Secondary outcomes are proportion healed at 24 weeks, time to healing, estimated change in ulcer area, change in 2-Minute Walk Test, change in health-related quality of life, incidence of infection and incidence of all-cause adverse events. If either of the interventions shows a statistically significant positive difference on healing outcomes, cost-effectiveness will be modelled using a health service perspective.Ethics and disseminationThe Factorial4VLU trial received ethical approval from the Northern B Health and Disability Ethics Committee. We plan to publish the results within 1 year of trial completion and will include the results on the trial registration page.Trial registration numbersAustralia and New Zealand Clinical Trials Register (http://www.anzctr.org.au) (ACTRN12620000116921); Universal Trial Number (WHO) (U1111-1236-2997).</jats:sec

Effects of active video games on body composition: a randomized controlled trial

BACKGROUND: Sedentary activities such as video gaming are independently associated with obesity. Active video games, in which players physically interact with images on screen, may help increase physical activity and improve body composition. OBJECTIVE: The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight, body composition, physical activity, and physical fitness. DESIGN: We conducted a 2-arm, parallel, randomized controlled trial in Auckland, New Zealand. A total of 322 overweight and obese children aged 10-14 y, who were current users of sedentary video games, were randomly assigned at a 1:1 ratio to receive either an active video game upgrade package (intervention, n = 160) or to have no change (control group, n = 162). The primary outcome was the change from baseline in body mass index (BMI; in kg/m(2)). Secondary outcomes were changes in percentage body fat, physical activity, cardiorespiratory fitness, video game play, and food snacking. RESULTS: At 24 wk, the treatment effect on BMI (-0.24; 95% CI: -0.44, -0.05; P = 0.02) favored the intervention group. The change (&plusmn;SE) in BMI from baseline increased in the control group (0.34 &plusmn; 0.08) but remained the same in the intervention group (0.09 &plusmn; 0.08). There was also evidence of a reduction in body fat in the intervention group (-0.83%; 95% CI: -1.54%, -0.12%; P = 0.02). The change in daily time spent playing active video games at 24 wk increased (10.03 min; 95% CI: 6.26, 13.81 min; P &lt; 0.0001) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games (-9.39 min; 95% CI: -19.38, 0.59 min; P = 0.06). CONCLUSION: An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children