Meta-analytic approaches to determine gender differences for delayed healing in venous leg ulcers

2016 ◽  
Vol 31 (10) ◽  
pp. 744-752 ◽  
Author(s):  
Xiao-Lei Tang ◽  
Hong-Lin Chen ◽  
Fang-Fang Zhao
Keyword(s):  
Gender Difference ◽  
Odds Ratio ◽  
Healing Rate ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Leg Ulcers ◽  
Odds Ratios ◽  
Venous Leg Ulcers ◽  
Delayed Healing ◽  
Meta Regression Analysis

Objective The aim of this analysis was to perform a meta-analysis evaluating gender difference of delayed healing risk in patients with venous leg ulcers. Methods We searched the PubMed and Web of Knowledge from their inception to 4 July 2015. The meta-analysis of pooled odds ratio and 95% confidence interval for venous leg ulcers healing risk were calculated. Results Twelve studies with 4453 patients were included in the meta-analysis. The pooled odds ratio for healing rate stratified by gender was 1.055 (95% CI 0.955–1.165; Z = 1.05, p = 0.292) by fix-effects model. The Begg's test (z = 2.67, p = 0.007), the Egger's test (t = 4.00, p = 0.003), and asymmetric funnel plot suggested there was significant publication bias. Subgroup analysis showed the pooled odds ratios were 1.048 (95% CI 0.945–1.162; Z = 0.88, p = 0.376) in prospective studies and 1.439 (95% CI 0.757–2.736; Z = 1.11, p = 0.266) in retrospective studies. Sensitivity analyses by only pooled adjusted odds ratios showed the pooled odds ratio was 1.049 (95% CI 0.946–1.163; Z = 0.91, p = 0.365), which indicated the results of meta-analysis were robust. Meta-regression analysis showed the healing rate odds ratio stratified by gender was not related with healing rate (t = 0.73, p = 0.484). Conclusion Our meta-analysis indicates that no gender difference existed for delayed healing in venous leg ulcers. Our results may be also useful in developing a risk score for failure of venous leg ulcers to heal.

scholarly journals Efficacy and Safety of Pentoxifylline for Venous Leg Ulcers: An Updated Meta-Analysis

2021 ◽  
pp. 153473462110507
Author(s):  
Shi-Yi Sun ◽  
Yan Li ◽  
Yun-Yi Gao ◽  
Xing-Wu Ran
Keyword(s):  
Clinical Trials ◽  
Healing Rate ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Leg Ulcers ◽  
Efficacy And Safety ◽  
Ulcer Size ◽  
Venous Leg Ulcers ◽  
Ulcer Healing Rate ◽  
Complete Wound Healing

The venous leg ulcers are debilitating, painful, and often unresponsive to advanced dressing treatments, so drugs used locally and systematically are essential adjuvant therapy—pentoxifylline (PTX) whose anti-inflammatory effects may offer a promising avenue to treat venous leg ulcers. However, the current results are controversial. To further evaluate the efficacy and safety of PTX, we performed an updated meta-analysis of randomized placebo-controlled trials of PTX in the treatment of venous leg ulcers. We systematically searched multiple electronic databases PubMed, Web of Science, Embase, the Cochrane Library, the Cochrane Central Register of Controlled Trials, China Science and Technology Journal Database, WanFang Data, China National Knowledge Infrastructure, and the Chinese Biomedical Literature Database to identify eligible studies. Randomized clinical trials of pentoxifylline versus placebo treatment in patients with venous leg ulcers were considered for inclusion. The primary outcomes included ulcer healing rate and the incidence of adverse events after treatment. The secondary outcomes were the ulcer significant improvement (the ulcer size shrank by more than 60% after treatment) rate, mean duration of complete wound healing and changes in mean ulcer size. A meta-analysis and qualitative analysis were conducted to estimate endpoints. A total of 13 randomized clinical trials, including 921 individuals, were finally included. Compared with placebo, pentoxifylline significantly improved the ulcer healing rate (RR = 1.59, 95%CI 1.22 to 2.07, P < .001) and significant improvement rate (RR = 2.36, 95%CI 1.31 to 4.24, P = .004) while increased the incidence of gastrointestinal disturbances (RR = 2.29, 95%CI 1.04 to 5.03, P = .04) at the same time. Moreover, pentoxifylline also shortened mean duration of complete wound healing ( P = .007) and shrank ulcer size ( P = .02). Currently available evidence suggests that pentoxifylline could help venous leg ulcers heal more quickly and effectively. However, the evidence is insufficient to prove the results due to moderate-certainty evidence. Large-scale, well-designed randomized clinical trials are warranted.

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

2021 ◽  
Author(s):  
◽  
Andrew B Jull
Keyword(s):  
Adverse Effects ◽  
Meta Analysis ◽  
Vascular Diseases ◽  
Compression Therapy ◽  
Sensitivity Analyses ◽  
Leg Ulcers ◽  
Venous Ulceration ◽  
Venous Leg Ulcers ◽  
Compression Bandaging ◽  
Randomised Controlled

<p>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.</p>

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

2021 ◽  
Author(s):  
◽  
Andrew B Jull
Keyword(s):  
Adverse Effects ◽  
Meta Analysis ◽  
Vascular Diseases ◽  
Compression Therapy ◽  
Sensitivity Analyses ◽  
Leg Ulcers ◽  
Venous Ulceration ◽  
Venous Leg Ulcers ◽  
Compression Bandaging ◽  
Randomised Controlled

<p>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.</p>

Open-Label Study to Evaluate the Healing Rate and Safety of the Profore™ Extra Four-Layer Bandage System in Patients with Venous Leg Ulceration

2000 ◽  
Vol 4 (1) ◽  
pp. 8-11 ◽  
Author(s):  
Aditya K. Gupta ◽  
Joel De Koven ◽  
Robert Lester ◽  
Neil H. Shear ◽  
Daniel N. Sauder
Keyword(s):  
Healing Rate ◽  
The Elderly ◽  
Leg Ulcers ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Venous Leg Ulcers ◽  
Initial Event ◽  
Venous Ulcers ◽  
High Compression

Background: Venous ulcers are increasing in prevalence, especially since these are observed more frequently in the elderly, and the number of individuals in this age group is becoming a larger portion of the population. Objective: To determine the healing rate and safety of the Profore™ Extra Four-Layer Bandage System in the management of venous leg ulcers. Methods: In an open-label study, patients aged 18 years or older with venous leg ulcers were treated with a high compression four-layer bandage system in which a hydrocellular dressing was placed in contact with the wound. The combination is designated the “Profore Extra Four-Layer Bandage System.” Follow-up visits took place weekly unless there was heavy exudation from the ulcer or if there was marked edema of the leg at the start of the study requiring reapplication of the bandage system. Results: Fifteen patients were entered into the study (men 8, women 7, mean age 66 years, mean duration of ulcers 1.3 years). Thirteen of the 15 patients completed the study, with two withdrawals. In one patient who withdrew, the ulcer became infected and required treatment with antibiotics. The other termination from the study occurred for reasons unrelated to treatment. The ulcer in this patient healed in 7 weeks. Ten of the 13 patients (77%) who completed the study, and 10 (67%) of 15, who had enrolled experienced complete (100%) healing. Healing of > 80% of the ulcers occurred in 11 of 13 patients (85%) who completed the study and in 12 (80%) of 15 enrolled patients. No patient experienced a study-related adverse event. One patient developed contact dermatitis and was later found to have stasis dermatitis. It is unclear whether the initial event was contact or stasis dermatitis. Conclusion: In this open-label study, a high compression system, using the Profore Extra Four-Layer Bandage with a hydrocellular dressing in contact with the wound, was found to be effective and safe for the treatment of venous leg ulcers.

Abstract 3789: Nessun Dorma : Have the Risks of Rosiglitazone been Exaggerated?

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
George A Diamond ◽  
Sanjay Kaul
Keyword(s):  
Confidence Intervals ◽  
Effect Size ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Cardiovascular Death ◽  
Sensitivity Analyses ◽  
Odds Ratios ◽  
True Effect Size ◽  
Index Study ◽  
The Stability

Background A highly publicized meta-analysis of 42 clinical trials comprising 27,844 diabetics ignited a firestorm of controversy by charging that treatment with rosiglitazone was associated with a “…worrisome…” 43% greater risk of myocardial infarction ( p =0.03) and a 64% greater risk of cardiovascular death ( p =0.06). Objective The investigators excluded 4 trials from the infarction analysis and 19 trials from the mortality analysis in which no events were observed. We sought to determine if these exclusions biased the results. Methods We compared the index study to a Bayesian meta-analysis of the entire 42 trials (using odds ratio as the measure of effect size) and to fixed-effects and random-effects analyses with and without a continuity correction that adjusts for values of zero. Results The odds ratios and confidence intervals for the analyses are summarized in the Table . Odds ratios for infarction ranged from 1.43 to 1.22 and for death from 1.64 to 1.13. Corrected models resulted in substantially smaller odds ratios and narrower confidence intervals than did uncorrected models. Although corrected risks remain elevated, none are statistically significant (*p<0.05). Conclusions Given the fragility of the effect sizes and confidence intervals, the charge that roziglitazone increases the risk of adverse events is not supported by these additional analyses. The exaggerated values observed in the index study are likely the result of excluding the zero-event trials from analysis. Continuity adjustments mitigate this error and provide more consistent and reliable assessments of true effect size. Transparent sensitivity analyses should therefore be performed over a realistic range of the operative assumptions to verify the stability of such assessments especially when outcome events are rare. Given the relatively wide confidence intervals, additional data will be required to adjudicate these inconclusive results.

scholarly journals Risk Factors for Delayed Healing and Recurrence of Chronic Venous Leg Ulcers—An Analysis of 1324 Legs

2005 ◽  
Vol 29 (1) ◽  
pp. 74-77 ◽  
Author(s):  
M.S. Gohel ◽  
M. Taylor ◽  
J.J. Earnshaw ◽  
B.P. Heather ◽  
K.R. Poskitt ◽  
...  
Keyword(s):  
Risk Factors ◽  
Leg Ulcers ◽  
Venous Leg Ulcers ◽  
Delayed Healing

scholarly journals Investigating gateway effects using the PATH study

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 264 ◽  
Author(s):  
Peter Lee ◽  
John Fry
Keyword(s):  
Cigarette Smoking ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Smoking Initiation ◽  
Continuous Variable ◽  
Sensitivity Analyses ◽  
Health Study ◽  
Cigarette Use ◽  
Tobacco Products ◽  
Residual Confounding

Background: A recent meta-analysis of nine cohort studies in youths reported that baseline ever e-cigarette use strongly predicted cigarette smoking initiation in the next 6-18 months, with an adjusted odds ratio of 3.62 (95% confidence interval 2.42-5.41).  A recent review of e-cigarettes agreed there was substantial evidence for this “gateway effect”.  However, the number of confounders considered in the studies was limited, so we investigated whether the effect might have resulted from inadequate adjustment, using Waves 1 and 2 of the Population Assessment of Tobacco and Health study. Methods: Our main analyses considered Wave 1 never cigarette smokers who, at Wave 2, had information available on smoking initiation.  We constructed a propensity score for ever e-cigarette use from Wave 1 variables, using this to predict ever cigarette smoking.  Sensitivity analyses accounted for use of other tobacco products, linked current e-cigarette use to subsequent current smoking, or used propensity scores for ever smoking or ever tobacco product use as predictors.  We also considered predictors using data from both waves to attempt to control for residual confounding from misclassified responses. Results: Adjustment for propensity dramatically reduced the unadjusted odds ratio (OR) of 5.70 (4.33-7.50) to 2.48 (1.85-3.31), 2.47 (1.79-3.42) or 1.85 (1.35-2.53), whether adjustment was made as quintiles, as a continuous variable or for the individual variables.  Additional adjustment for other tobacco products reduced this last OR to 1.59 (1.14-2.20).  Sensitivity analyses confirmed adjustment removed most of the gateway effect.  Control for residual confounding also reduced the association. Conclusions: We found that confounding is a major factor, explaining most of the observed gateway effect.  However, our analyses are limited by small numbers of new smokers considered and the possibility of over-adjustment if taking up e-cigarettes affects some predictor variables.  Further analyses are intended using Wave 3 data which should avoid these problems.

scholarly journals CHA2DS2-VASc risk factors as predictors of stroke after acute coronary syndrome: A systematic review and meta-analysis

2016 ◽  
Vol 7 (3) ◽  
pp. 264-274 ◽  
Author(s):  
Federico Guerra ◽  
Lorena Scappini ◽  
Alessandro Maolo ◽  
Gianluca Campo ◽  
Rita Pavasini ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Acute Coronary Syndrome ◽  
Confidence Interval ◽  
Transient Ischemic Attack ◽  
Odds Ratio ◽  
Observational Studies ◽  
Meta Analysis ◽  
Odds Ratios ◽  
Coronary Syndrome ◽  
Ischemic Attack

Background: Stroke is a rare but serious complication of acute coronary syndrome. At present, no specific score exists to identify patients at higher risk. The aim of the present study is to test whether each clinical variable included in the CHA2DS2-VASc score retains its predictive value in patients with recent acute coronary syndrome, irrespective of atrial fibrillation. Methods: The meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines. All clinical trials and observational studies presenting data on the association between stroke/transient ischemic attack incidence and at least one CHA2DS2-VASc item in patients with a recent acute coronary syndrome were considered in the analysis. Atrial fibrillation diagnosis was also considered. Results: The whole cohort included 558,193 patients of which 7108 (1.3%) had an acute stroke and/or transient ischemic attack during follow-up (median nine months; 1st–3rd quartile 1–12 months). Age and previous stroke had the highest odds ratios (odds ratio 2.60; 95% confidence interval 2.21–3.06 and odds ratio 2.74; 95% confidence interval 2.19–3.42 respectively), in accordance with the two-point value given in the CHA2DS2-VASc score. All other factors were positively associated with stroke, although with lower odds ratios. Atrial fibrillation, while present in only 11.2% of the population, confirmed its association with an increased risk of stroke and/or transient ischemic attack (odds ratio 2.04; 95% confidence interval 1.71–2.44). Conclusions: All risk factors included in the CHA2DS2-VASc score are associated with stroke/ transient ischemic attack in patients with recent acute coronary syndrome, and retain similar odds ratios to what already seen in atrial fibrillation. The utility of CHA2DS2-VASc score for risk stratification of stroke in patients with acute coronary syndrome remains to be determined.

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