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Frontiers in Human Neuroscience 2023The number of reported cases of anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis has gradually increased since its discovery in 2007, while there are no... (Review)
Review
BACKGROUND
The number of reported cases of anti-N-methyl-D-aspartate receptor (anti-NMDAR) encephalitis has gradually increased since its discovery in 2007, while there are no uniform treatment guidelines.
OBJECTIVE
To summarize the clinical characteristics of patients with anti-NMDAR encephalitis and to analyze the factors affecting the disease prognosis.
METHODS
A systematic analysis of medical records was conducted, and PubMed, Embase, and Cochrane Library were searched from January 1, 2011, to December 31, 2021. Data were extracted, analyzed, and recorded in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.
RESULTS
This study included 472 case reports. Most patients had prodromal symptoms of about 2 weeks, including psychiatric symptoms (53.2%), flu-like symptoms (51.5%), and seizures (23.9%), among others. Poor prognoses were associated with patients who had autonomic instability ( = 0.010), central hypoventilation ( = 0.014), and ICU support ( = 0.002). Patients with a higher age of onset were more likely to develop central hypoventilation (OR 1.024, CI 1.006-1.042, = 0.009), cognitive impairment (OR 1.023, CI 1.009-1.037, = 0.001), and memory impairment (OR 1.034, CI 1.017-1.050, < 0.001), whereas patients with a lower age were more likely to have seizures (OR 0.979, CI 0.965-0.993, = 0.003). In this study, 97.0% of patients received immunotherapy, with the most commonly used treatment regimen being intravenous methylprednisolone (IVGC) and intravenous immunoglobulin (IVIG). When compared with other treatment regimens, the IVGC+IVIG regimen ( < 0.001) resulted in better prognoses.
CONCLUSION
When encountering patients with fever, headache, and initial psychiatric symptoms of unknown etiology, clinicians should test their CSF for antibodies to distinguish autoimmune encephalitis. Patients with autonomic instability, central hypoventilation, and ICU support had poorer prognoses. Clinicians should be aware that older patients are more likely to develop central hypoventilation, cognitive impairment, and memory impairment, while younger patients are more likely to develop seizures. The IVGC+IVIG treatment regimen has better prognoses than others. This study includes case reports, which have obvious selection bias, and there are no unified standards to measure the severity of the disease. Therefore, in the future, larger samples and randomized controlled trials are needed to evaluate the efficacy of different treatment regimens.
PubMed: 38053649
DOI: 10.3389/fnhum.2023.1261638 -
CNS Spectrums Feb 2023The aim of this paper is to review evidence on Interpersonal Psychotherapy (IPT) administered via telephone (IPT-T). (Review)
Review
BACKGROUND
The aim of this paper is to review evidence on Interpersonal Psychotherapy (IPT) administered via telephone (IPT-T).
METHODS
We conducted a systematic review of studies published between January 1, 1990 and June 30, 2020, assessing the efficacy of IPT administered by phone, using PubMed.
RESULTS
Originally, we found 60 papers; the final selection led to 13 papers. Six studies were performed using a randomized clinical trial methodology (6/13, 46.2%), three were prospective open-label not randomized studies (3/13, 15.7%), three were pilot studies (3/13, 23.1%), and one was a feasibility/acceptance study (1/13, 7.7%). The number of subjects included in the studies ranged between 14 and 442 (mean: 140.0 ± 124.9), for a total of 1850 patients. The mean age of the enrolled subjects was 47.8 ± 9.3 years (range: 27.4-70.4). Thirty-four different instruments were utilized. Qualitative synthesis was conducted only on randomized controlled trials (RCTs), namely on six studies. RCTs were almost all of good quality (mean score/standard deviation of the RCT-Psychotherapy Quality Rating Scale omnibus rating: 5.6 ± 1.2 points; range: 3-7).
CONCLUSIONS
IPT-T showed response rates similar to IPT administered in the usual way. Results are limited by small samples sizes, selection bias of the less severe depressed patients, and the heterogeneity of rating scales.
Topics: Humans; Adult; Middle Aged; Aged; Interpersonal Psychotherapy; Psychotherapy; Depression; Telephone; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 34657641
DOI: 10.1017/S1092852921000948 -
The Cochrane Database of Systematic... Jun 2020Pitavastatin is the newest statin on the market, and the dose-related magnitude of effect of pitavastatin on blood lipids is not known. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pitavastatin is the newest statin on the market, and the dose-related magnitude of effect of pitavastatin on blood lipids is not known.
OBJECTIVES
Primary objective To quantify the effects of various doses of pitavastatin on the surrogate markers: LDL cholesterol, total cholesterol, HDL cholesterol and triglycerides in participants with and without cardiovascular disease. To compare the effect of pitavastatin on surrogate markers with other statins. Secondary objectives To quantify the effect of various doses of pitavastatin on withdrawals due to adverse effects. SEARCH METHODS: The Cochrane Hypertension Information Specialist searched the following databases for trials up to March 2019: the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 2, 2019), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions.
SELECTION CRITERIA
RCT and controlled before-and-after studies evaluating the dose response of different fixed doses of pitavastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without cardiovascular disease.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered data from RCT and controlled before-and-after studies into Review Manager 5 as continuous and generic inverse variance data, respectively. Withdrawals due to adverse effects (WDAE) information was collected from the RCTs. We assessed all included trials using the Cochrane 'Risk of bias' tool under the categories of allocation (selection bias), blinding (performance bias and detection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), and other potential sources of bias.
MAIN RESULTS
Forty-seven studies (five RCTs and 42 before-and-after studies) evaluated the dose-related efficacy of pitavastatin in 5436 participants. The participants were of any age with and without cardiovascular disease, and pitavastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 1 mg to 16 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and triglycerides. There was no dose-related effect of pitavastatin on blood HDL cholesterol, which was increased by 4% on average by pitavastatin. Pitavastatin 1 mg/day to 16 mg/day reduced LDL cholesterol by 33.3% to 54.7%, total cholesterol by 23.3% to 39.0% and triglycerides by 13.0% to 28.1%. For every two-fold dose increase, there was a 5.35% (95% CI 3.32 to 7.38) decrease in blood LDL cholesterol, a 3.93% (95% CI 2.35 to 5.50) decrease in blood total cholesterol and a 3.76% (95% CI 1.03 to 6.48) decrease in blood triglycerides. The certainty of evidence for these effects was judged to be high. When compared to other statins for its effect to reduce LDL cholesterol, pitavastatin is about 6-fold more potent than atorvastatin, 1.7-fold more potent than rosuvastatin, 77-fold more potent than fluvastatin and 3.3-fold less potent than cerivastatin. For the placebo group, there were no participants who withdrew due to an adverse effect per 109 subjects and for all doses of pitavastatin, there were three participants who withdrew due to an adverse effect per 262 subjects.
AUTHORS' CONCLUSIONS
Pitavastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, pitavastatin is about 6-fold more potent than atorvastatin, 1.7-fold more potent than rosuvastatin, 77-fold more potent than fluvastatin and 3.3-fold less potent than cerivastatin. There were not enough data to determine risk of withdrawal due to adverse effects due to pitavastatin.
Topics: Atorvastatin; Cardiovascular Diseases; Cholesterol, HDL; Cholesterol, LDL; Controlled Before-After Studies; Drug Administration Schedule; Female; Fluvastatin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipids; Male; Pyridines; Quinolines; Randomized Controlled Trials as Topic; Rosuvastatin Calcium; Sex Factors; Triglycerides
PubMed: 32557581
DOI: 10.1002/14651858.CD012735.pub2 -
The Journal of Hand Surgery Jun 2022Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to...
PURPOSE
Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to evaluate how often hand surgical randomized controlled trials (RCTs) use and report adequate methods to ensure internal validity, and whether inadequate reporting or methods are associated with the magnitude of treatment effect estimates.
METHODS
Data Sources were the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase databases until November 2020. We included published RCTs investigating the effects of any surgical intervention in the hand and wrist region. We assessed internal validity using the Cochrane Risk of Bias (RoB) tool for 6 domains: selection, performance, detection, attrition, selective reporting, and "other" bias. We extracted the primary outcome and calculated the effect size for each study. We used mixed-effect meta-regression to assess whether the RoB modified the magnitude of the effects.
RESULTS
For 207 assessed trials, the RoB was unclear or high for 72% in selection, 93% in performance, 88% in detection, 25% in attrition, 22% in selective reporting, and 34% in the "other" bias domain. Trials with a high or unclear risk of selection bias yielded 0.28 standardized mean difference (95% confidence interval, 0.02-0.55) larger effect sizes compared to studies with a low risk. Risks of bias for other domains did not modify the intervention effects. The risk for selection bias declined over time: the odds ratio for a high or unclear RoB was 0.90 (95% confidence interval, 0.85-0.95) per additional year of publication CONCLUSIONS: The internal validity and credibility of hand surgical RCTs can be improved by using established methods to achieve true randomization, blinding of the participants and study personnel, publishing the trial protocol and avoiding selective reporting of the outcomes, and reporting the trial as recommended in the Consolidated Standards of Reporting Trials statement.
CLINICAL RELEVANCE
Clinicians should be aware that RCTs that do not use or report proper randomization and allocation concealment may overestimate the treatment effects.
Topics: Bias; Epidemiologic Studies; Humans; Odds Ratio; Randomized Controlled Trials as Topic
PubMed: 35341627
DOI: 10.1016/j.jhsa.2022.01.027 -
The Lancet Regional Health. Western... Jun 2023Previous systematic reviews naïvely combined biased effects of screening radiography or endoscopy observed in studies with various designs. We aimed to synthesize...
BACKGROUND
Previous systematic reviews naïvely combined biased effects of screening radiography or endoscopy observed in studies with various designs. We aimed to synthesize currently available comparative data on gastric cancer mortality in healthy, asymptomatic adults by explicitly classifying the screening effects through study designs and types of intervention effects.
METHODS
We searched multiple databases through October 31, 2022 for this systematic review and meta-analysis. Studies of any design that compared gastric cancer mortality among radiographic or endoscopic screening and no screening in a community-dwelling adult population were included. The method included a duplicate assessment of eligibility, double extraction of summary data, and validity assessment using the Risk Of Bias In Non-randomized Studies of Interventions tool. Bayesian three-level hierarchical random-effects meta-analysis synthesized data corrected for self-selection bias on the relative risk (RR) for per-protocol (PP) and intention-to-screen (ITS) effects. The study registration number at PROSPERO is CRD42021277126.
FINDINGS
We included seven studies in which a screening program was newly introduced (median attendance rate, 31%; at moderate-to-critical risk of bias), and seven cohort and eight case-control studies with ongoing screening programs (median attendance rate, 21%; all at critical risk of bias); thus, data of 1,667,117 subjects were included. For the PP effect, the average risk reduction was significant for endoscopy (RR 0.52; 95% credible interval: 0.39-0.79) but nonsignificant for radiography (0.80; 0.60-1.06). The ITS effect was not significant for both radiography (0.98; 0.86-1.09) and endoscopy (0.94; 0.71-1.28). The magnitude of the effects depended on the assumptions for the self-selection bias correction. Restricting the scope to East Asian studies only did not change the results.
INTERPRETATION
In limited-quality observational evidence from high-prevalence regions, screening reduced gastric cancer mortality; however, the effects diminished at a program level.
FUNDING
National Cancer Center Japan; and Japan Agency for Medical Research and Development.
PubMed: 37424675
DOI: 10.1016/j.lanwpc.2023.100741 -
Tobacco Induced Diseases 2023Cigarette smoking is a well-known cancer-causing behavior and a leading cause of death from cancer. However, according to previously published research and... (Review)
Review
INTRODUCTION
Cigarette smoking is a well-known cancer-causing behavior and a leading cause of death from cancer. However, according to previously published research and meta-analyses, cigarette smoking has a significant inverse association with prostate cancer incidence. Therefore, this study aims to investigate this association based on updated evidence by conducting a systematic review and meta-analysis.
METHODS
A search for relevant articles was performed in PubMed and Scopus databases to obtain the pooled relative risk (RR) and the corresponding 95% confidence intervals (CIs) for the risk of prostate cancer incidence among smokers compared to non-smokers. Our search was limited to prospective cohort studies.
RESULTS
A total of 17 cohort studies were included in the systematic review. Fifteen studies were included in the meta-analysis and showed that cigarette smoking has an inverse association with prostate cancer incidence with a relative risk of 0.84 (95% CI: 0.78-0.91). From all cohorts included in this systematic review, five studies examined the association between current smokers and the risk of death from prostate cancer. Therefore, a meta-analysis of these cohort studies was performed and showed that current smokers had a 42% higher risk of death from prostate cancer when compared to non-smokers with a relative risk of 1.42 (95% CI: 1.20-1.68).
CONCLUSIONS
Data from observational studies suggest that cigarette smoking has an inverse association with prostate cancer incidence. However, smokers have an increased risk of death from prostate cancer. Important to realize that this lower risk for smokers might be attributed to low prostate cancer screening uptake among smokers, misclassification bias, or selection bias from the included original studies. In summary, our results indicate that the incidence of prostate cancer is lower among smokers. Nevertheless, smokers who develop the disease have a significantly worse prognosis.
PubMed: 36762260
DOI: 10.18332/tid/157231 -
Obstetrics and Gynecology Jul 2022To assess whether antenatal corticosteroid treatment is associated with improved neonatal outcomes in twins. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess whether antenatal corticosteroid treatment is associated with improved neonatal outcomes in twins.
DATA SOURCES
We searched MEDLINE, PubMed, EMBASE, and the Cochrane Library, from inception through August 12, 2021. We did not search ClinicalTrials.gov because our inclusion criteria were restricted to nonrandomized studies.
METHODS OF STUDY SELECTION
Records (n=7,802) were screened in Rayyan by two independent reviewers. We included all nonrandomized studies that compared antenatal corticosteroid treatment with no treatment in twins. Our outcomes of interest were neonatal mortality, respiratory distress syndrome (RDS), intraventricular hemorrhage, bronchopulmonary dysplasia, necrotizing enterocolitis, periventricular leukomalacia, and retinopathy of prematurity.
TABULATION, INTEGRATION, AND RESULTS
We used the ROBINS-I tool (Risk Of Bias In Non-randomised Studies - of Interventions) to assess risk of bias. We performed random-effects meta-analyses of estimates from studies without critical risk of bias due to confounding, and reported summary adjusted odds ratios (aORs) and 95% CIs. Eighteen cohort studies (that reported on 33,152 neonates) met inclusion criteria. Sixteen studies restricted to preterm gestational ages, and 11 defined exposed neonates based on an optimal corticosteroid administration-to-birth interval. Limitations due to confounding and selection bias were common concerns for the risk-of-bias assessments (n=14 at critical or higher), and 11 studies did not account for clustering within twin pairs in their analyses. All included studies had at least moderate risk of bias. Meta-analysis showed that antenatal corticosteroid administration was associated with lower odds of neonatal mortality (aOR 0.59, 95% CI 0.43-0.80, I2 69%, five studies, 20,312 neonates) and RDS (aOR 0.70, 95% CI 0.57-0.86, I2 67%, seven studies, 20,628 neonates) in twins. Results were inconclusive for the other outcomes.
CONCLUSION
Evidence from nonrandomized studies suggests antenatal corticosteroids are associated with lower incidence of neonatal mortality and RDS in twins.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020205302.
Topics: Adrenal Cortex Hormones; Bronchopulmonary Dysplasia; Child; Female; Humans; Infant, Newborn; Infant, Newborn, Diseases; Pregnancy; Prenatal Care; Respiratory Distress Syndrome, Newborn; Twins
PubMed: 35849452
DOI: 10.1097/AOG.0000000000004835 -
The Cochrane Database of Systematic... Jun 2021Evidence indicates that reducing dietary salt may reduce the incidence of heart disease and delay decline in kidney function in people with chronic kidney disease (CKD).... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Evidence indicates that reducing dietary salt may reduce the incidence of heart disease and delay decline in kidney function in people with chronic kidney disease (CKD). This is an update of a review first published in 2015.
OBJECTIVES
To evaluate the benefits and harms of altering dietary salt for adults with CKD.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant Register of Studies up to 6 October 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA
Randomised controlled trials comparing two or more levels of salt intake in adults with any stage of CKD.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed studies for eligibility, conducted risk of bias evaluation and evaluated confidence in the evidence using GRADE. Results were summarised using random effects models as risk ratios (RR) for dichotomous outcomes or mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI).
MAIN RESULTS
We included 21 studies (1197 randomised participants), 12 in the earlier stages of CKD (779 randomised participants), seven in dialysis (363 randomised participants) and two in post-transplant (55 randomised participants). Selection bias was low in seven studies, high in one and unclear in 13. Performance and detection biases were low in four studies, high in two, and unclear in 15. Attrition and reporting biases were low in 10 studies, high in three and unclear in eight. Because duration of the included studies was too short (1 to 36 weeks) to test the effect of salt restriction on endpoints such as death, cardiovascular events or CKD progression, changes in salt intake on blood pressure and other secondary risk factors were examined. Reducing salt by mean -73.51 mmol/day (95% CI -92.76 to -54.27), equivalent to 4.2 g or 1690 mg sodium/day, reduced systolic/diastolic blood pressure by -6.91/-3.91 mm Hg (95% CI -8.82 to -4.99/-4.80 to -3.02; 19 studies, 1405 participants; high certainty evidence). Albuminuria was reduced by 36% (95% CI 26 to 44) in six studies, five of which were carried out in people in the earlier stages of CKD (MD -0.44, 95% CI -0.58 to -0.30; 501 participants; high certainty evidence). The evidence is very uncertain about the effect of lower salt intake on weight, as the weight change observed (-1.32 kg, 95% CI -1.94 to -0.70; 12 studies, 759 participants) may have been due to fluid volume, lean tissue, or body fat. Lower salt intake may reduce extracellular fluid volume in the earlier stages of CKD (-0.87 L, 95% CI -1.17 to -0.58; 3 studies; 187 participants; low certainty evidence). The evidence is very uncertain about the effect of lower salt intake on reduction in antihypertensive dose (RR 2.45, 95% CI 0.98 to 6.08; 8 studies; 754 participants). Lower salt intake may lead to symptomatic hypotension (RR 6.70, 95% CI 2.40 to 18.69; 6 studies; 678 participants; moderate certainty evidence). Data were sparse for other types of adverse events.
AUTHORS' CONCLUSIONS
We found high certainty evidence that salt reduction reduced blood pressure in people with CKD, and albuminuria in people with earlier stage CKD in the short-term. If such reductions could be maintained long-term, this effect may translate to clinically significant reductions in CKD progression and cardiovascular events. Research into the long-term effects of sodium-restricted diet for people with CKD is warranted.
Topics: Antihypertensive Agents; Bias; Blood Pressure; Body Weight; Diet, Sodium-Restricted; Edema; Humans; Hypertension; Randomized Controlled Trials as Topic; Renal Insufficiency, Chronic; Selection Bias; Sodium Chloride, Dietary
PubMed: 34164803
DOI: 10.1002/14651858.CD010070.pub3 -
The Journal of Foot and Ankle Surgery :... 2021Orthobiologics are biologically-derived materials intended to promote bone formation and union. We review evidence on effectiveness and harms of orthobiologics compared... (Review)
Review
Orthobiologics are biologically-derived materials intended to promote bone formation and union. We review evidence on effectiveness and harms of orthobiologics compared to no orthobiologics for foot and ankle arthrodesis. We searched multiple databases (1995-2019) and included clinical trials and other studies with concurrent controls, English language, and reporting patient-centered outcomes, union/time to union, costs/resource utilization, or harms. Studies were organized by orthobiologic used. We describe quality and limitations of available evidence but did not formally rate risk of bias or certainty of evidence. Most of the 21 studies included were retrospective chart reviews with orthobiologics used at surgeon's discretion for patients considered at higher risk for nonunion. Ten studies compared autologous bone graft versus no graft and 2 compared remote versus local graft with few studies of other orthobiologics. All studies reported a measure of fusion and about half reported on function/quality of life. Few studies reported harms. Due to limited reporting, we were unable to assess whether effectiveness varies by risk factors for nonunion (eg, age, gender, smoking status, obesity, diabetes) or whether orthobiologics were cost-effective. Available evidence is of poor quality with small sample sizes, inadequate reporting of risk factors for nonunion, variations in orthobiologics, surgical techniques used, and outcome assessment, and potential selection bias. Research is needed to adequately inform surgeons about benefits and harms and guide patient selection for use, or type, of orthobiologics. Careful assessment of individual patient risk for nonunion is critical prior to orthobiologic use.
Topics: Ankle; Arthrodesis; Bone Transplantation; Humans; Quality of Life; Retrospective Studies
PubMed: 34039511
DOI: 10.1053/j.jfas.2020.09.022 -
The Cochrane Database of Systematic... Aug 2022Venous leg ulcers are a chronic health problem that cause considerable economic impact and affect quality of life for those who have them. Primary wound contact... (Review)
Review
BACKGROUND
Venous leg ulcers are a chronic health problem that cause considerable economic impact and affect quality of life for those who have them. Primary wound contact dressings are usually applied to ulcers beneath compression therapy to aid healing, promote comfort and control exudate. There are numerous dressing products available for venous leg ulcers and hydrogel is often prescribed for this condition; however, the evidence base to guide dressing choice is sparse.
OBJECTIVES
To assess the effects of hydrogel wound dressings on the healing of venous leg ulcers in any care setting.
SEARCH METHODS
In May 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies, reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), either published or unpublished, that compared the effects of hydrogel dressing with other dressings on the healing of venous leg ulcers. We excluded trials evaluating hydrogel dressings impregnated with antimicrobial, antiseptic or analgesic agents as these interventions are evaluated in other Cochrane Reviews.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included four RCTs (10 articles) in a qualitative analysis. Overall, 272 participants were randomised, in sample sizes ranging from 20 to 156 participants. The mean age of the included population in the trials ranged from 55 to 68 years, 37% were women based on studies that reported the sex of participants. The studies compared hydrogel dressings with the following: gauze and saline, alginate dressing, manuka honey and hydrocolloid. Two studies were multicentre and the others were single-centre trials. Length of treatment using hydrogel dressing was four weeks in three studies and two weeks in one study. The follow-up period was the same as the duration of treatment in three studies and in one study the follow-up for wound healing was at 12 weeks after four weeks of treatment. Overall risk of bias was high for all trials because at least one of the three key criteria (selection bias, detection bias and attrition bias) was at high risk. Hydrogel compared with gauze and saline It is uncertain whether there is a difference in complete wound healing (risk ratio (RR) 5.33, 95% confidence interval (CI) 1.73 to 16.42; 1 trial, 60 participants) or change in ulcer size (mean difference (MD) -1.50, 95% CI -1.86 to -1.14; 1 trial, 60 participants) between interventions because the certainty of the evidence is very low. Data reported from one trial were incomplete for time-to-ulcer healing. Hydrogel compared with alginate dressing It is uncertain whether there is a difference in change in ulcer size between hydrogel and alginate gel because the certainty of the evidence is very low (MD -41.80, 95% CI -63.95 to -19.65; 1 trial, 20 participants). Hydrogel compared with manuka honey It is uncertain whether there is a difference in complete wound healing (RR 0.75, 95% CI 0.46 to 1.21; 1 trial, 108 participants) or incidence of wound infection (RR 2.00, 95% CI 0.81 to 4.94; 1 trial, 108 participants) between interventions because the certainty of the evidence is very low. Hydrogel compared with hydrocolloid One study (84 participants) reported on change in ulcer size between hydrogel and hydrocolloid; however, further analysis was not possible because authors did not report standard errors or any other measurement of variance of a set of data from the means. Therefore, it is also uncertain whether there is a difference in change in ulcer size between hydrogel and hydrocolloid because the certainty of the evidence is very low. No studies provided evidence for the outcomes: recurrence of ulcer, health-related quality of life, pain and costs. Overall, independent of the comparison, the certainty of evidence is very low and downgraded twice due to risk of bias and once or twice due to imprecision for all comparisons and outcomes.
AUTHORS' CONCLUSIONS
There is inconclusive evidence to determine the effectiveness of hydrogel dressings compared with gauze and saline, alginate dressing, manuka honey or hydrocolloid on venous leg ulcer healing. Practitioners may, therefore, consider other characteristics such as costs and symptom management when choosing between dressings. Any future studies assessing the effects of hydrogel on venous wound healing should consider using all the steps from CONSORT, and consider key points such as appropriate sample size with the power to detect expected differences, appropriate outcomes (such as time-to-event analysis) and adverse effects. If time-to-event analysis is not used, at least a longer follow-up (e.g. 12 weeks and above) should be adopted. Future studies should also address important outcomes that the studies we included did not investigate, such as health-related quality of life, pain and wound recurrence.
Topics: Aged; Alginates; Bandages; Female; Humans; Hydrogels; Male; Middle Aged; Pain; Randomized Controlled Trials as Topic; Ulcer; Varicose Ulcer
PubMed: 35930364
DOI: 10.1002/14651858.CD010738.pub2