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The Cochrane Database of Systematic... May 2017Molluscum contagiosum is a common skin infection that is caused by a pox virus and occurs mainly in children. The infection usually resolves within months in people... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Molluscum contagiosum is a common skin infection that is caused by a pox virus and occurs mainly in children. The infection usually resolves within months in people without immune deficiency, but treatment may be preferred for social and cosmetic reasons or to avoid spreading the infection. A clear evidence base supporting the various treatments is lacking.This is an update of a Cochrane Review first published in 2006, and updated previously in 2009.
OBJECTIVES
To assess the effects of specific treatments and management strategies, including waiting for natural resolution, for cutaneous, non-genital molluscum contagiosum in people without immune deficiency.
SEARCH METHODS
We updated our searches of the following databases to July 2016: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, and LILACS. We searched six trial registers and checked the reference lists of included studies and review articles for further references to relevant randomised controlled trials. We contacted pharmaceutical companies and experts in the field to identify further relevant randomised controlled trials.
SELECTION CRITERIA
Randomised controlled trials of any treatment of molluscum contagiosum in people without immune deficiency. We excluded trials on sexually transmitted molluscum contagiosum and in people with immune deficiency (including those with HIV infection).
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies, assessed methodological quality, and extracted data from selected studies. We obtained missing data from study authors where possible.
MAIN RESULTS
We found 11 new studies for this update, resulting in 22 included studies with a total of 1650 participants. The studies examined the effects of topical (20 studies) and systemic interventions (2 studies).Among the new included studies were the full trial reports of three large unpublished studies, brought to our attention by an expert in the field. They all provided moderate-quality evidence for a lack of effect of 5% imiquimod compared to vehicle (placebo) on short-term clinical cure (4 studies, 850 participants, 12 weeks after start of treatment, risk ratio (RR) 1.33, 95% confidence interval (CI) 0.92 to 1.93), medium-term clinical cure (2 studies, 702 participants, 18 weeks after start of treatment, RR 0.88, 95% CI 0.67 to 1.14), and long-term clinical cure (2 studies, 702 participants, 28 weeks after start of treatment, RR 0.97, 95% CI 0.79 to 1.17). We found similar but more certain results for short-term improvement (4 studies, 850 participants, 12 weeks after start of treatment, RR 1.14, 95% CI 0.89 to 1.47; high-quality evidence). For the outcome 'any adverse effect', we found high-quality evidence for little or no difference between topical 5% imiquimod and vehicle (3 studies, 827 participants, RR 0.97, 95% CI 0.88 to 1.07), but application site reactions were more frequent in the groups treated with imiquimod (moderate-quality evidence): any application site reaction (3 studies, 827 participants, RR 1.41, 95% CI 1.13 to 1.77, the number needed to treat for an additional harmful outcome (NNTH) was 11); severe application site reaction (3 studies, 827 participants, RR 4.33, 95% CI 1.16 to 16.19, NNTH over 40).For the following 11 comparisons, there was limited evidence to show which treatment was superior in achieving short-term clinical cure (low-quality evidence): 5% imiquimod less effective than cryospray (1 study, 74 participants, RR 0.60, 95% CI 0.46 to 0.78) and 10% potassium hydroxide (2 studies, 67 participants, RR 0.65, 95% CI 0.46 to 0.93); 10% Australian lemon myrtle oil more effective than olive oil (1 study, 31 participants, RR 17.88, 95% CI 1.13 to 282.72); 10% benzoyl peroxide cream more effective than 0.05% tretinoin (1 study, 30 participants, RR 2.20, 95% CI 1.01 to 4.79); 5% sodium nitrite co-applied with 5% salicylic acid more effective than 5% salicylic acid alone (1 study, 30 participants, RR 3.50, 95% CI 1.23 to 9.92); and iodine plus tea tree oil more effective than tea tree oil (1 study, 37 participants, RR 0.20, 95% CI 0.07 to 0.57) or iodine alone (1 study, 37 participants, RR 0.07, 95% CI 0.01 to 0.50). Although there is some uncertainty, 10% potassium hydroxide appears to be more effective than saline (1 study, 20 participants, RR 3.50, 95% CI 0.95 to 12.90); homeopathic calcarea carbonica appears to be more effective than placebo (1 study, 20 participants, RR 5.57, 95% CI 0.93 to 33.54); 2.5% appears to be less effective than 5% solution of potassium hydroxide (1 study, 25 participants, RR 0.35, 95% CI 0.12 to 1.01); and 10% povidone iodine solution plus 50% salicylic acid plaster appears to be more effective than salicylic acid plaster alone (1 study, 30 participants, RR 1.43, 95% CI 0.95 to 2.16).We found no statistically significant differences for other comparisons (most of which addressed two different topical treatments). We found no randomised controlled trial evidence for expressing lesions or topical hydrogen peroxide.Study limitations included no blinding, many dropouts, and no intention-to-treat analysis. Except for the severe application site reactions of imiquimod, none of the evaluated treatments described above were associated with serious adverse effects (low-quality evidence). Among the most common adverse events were pain during application, erythema, and itching. Included studies of the following comparisons did not report adverse effects: calcarea carbonica versus placebo, 10% povidone iodine plus 50% salicylic acid plaster versus salicylic acid plaster, and 10% benzoyl peroxide versus 0.05% tretinoin.We were unable to judge the risk of bias in most studies due to insufficient information, especially regarding concealment of allocation and possible selective reporting. We considered five studies to be at low risk of bias.
AUTHORS' CONCLUSIONS
No single intervention has been shown to be convincingly effective in the treatment of molluscum contagiosum. We found moderate-quality evidence that topical 5% imiquimod was no more effective than vehicle in terms of clinical cure, but led to more application site reactions, and high-quality evidence that there was no difference between the treatments in terms of short-term improvement. However, high-quality evidence showed a similar number of general side effects in both groups. As the evidence found did not favour any one treatment, the natural resolution of molluscum contagiosum remains a strong method for dealing with the condition.
Topics: Adjuvants, Immunologic; Aminoquinolines; Anti-Infective Agents, Local; Benzoyl Peroxide; Cimetidine; Humans; Hydroxides; Imiquimod; Molluscum Contagiosum; Myrtus; Olive Oil; Phytotherapy; Plant Oils; Potassium Compounds; Povidone-Iodine; Randomized Controlled Trials as Topic; Remission, Spontaneous; Salicylic Acid; Sodium Nitrite
PubMed: 28513067
DOI: 10.1002/14651858.CD004767.pub4 -
Revista Do Colegio Brasileiro de... 2016The damage control surgery, with emphasis on laparostomy, usually results in shrinkage of the aponeurosis and loss of the ability to close the abdominal wall, leading to... (Comparative Study)
Comparative Study Review
The damage control surgery, with emphasis on laparostomy, usually results in shrinkage of the aponeurosis and loss of the ability to close the abdominal wall, leading to the formation of ventral incisional hernias. Currently, various techniques offer greater chances of closing the abdominal cavity with less tension. Thus, this study aims to evaluate three temporary closure techniques of the abdominal cavity: the Vacuum-Assisted Closure Therapy - VAC, the Bogotá Bag and the Vacuum-pack. We conducted a systematic review of the literature, selecting 28 articles published in the last 20 years. The techniques of the bag Bogotá and Vacuum-pack had the advantage of easy access to the material in most centers and low cost, contrary to VAC, which, besides presenting high cost, is not available in most hospitals. On the other hand, the VAC technique was more effective in reducing stress at the edges of lesions, removing stagnant fluids and waste, in addition to acting at the cellular level by increasing proliferation and cell division rates, and showed the highest rates of primary closure of the abdominal cavity. RESUMO A cirurgia de controle de danos, com ênfase em peritoneostomia, geralmente resulta em retração da aponeurose e perda da capacidade de fechar a parede abdominal, levando à formação de hérnias ventrais incisionais. Atualmente, várias técnicas oferecem maiores chances de fechamento da cavidade abdominal, com menor tensão. Deste modo, este estudo tem por objetivo avaliar três técnicas de fechamento temporário da cavidade abdominal: fechamento a vácuo (Vacuum-Assisted Closure Therapy - VAC), Bolsa de Bogotá e Vacuum-pack. Realizou-se uma revisão sistemática da literatura com seleção de 28 artigos publicados nos últimos 20 anos. As técnicas de Bolsa de Bogotá e Vacuum-pack tiveram como vantagem o acesso fácil ao material, na maioria dos centros, e baixo custo, ao contrário do que se observa na terapia a vácuo, VAC, que além de apresentar alto custo, não está disponível em grande parte dos hospitais. A técnica VAC, por outro lado, foi mais eficaz na redução da tensão nas bordas das lesões, ao remover fluidos estagnados e detritos, além de exercer ação a nível celular, aumentando as taxas de proliferação e divisão celular, e apresentou as maiores taxas de fechamento primário da cavidade abdominal.
Topics: Abdominal Cavity; Abdominal Wound Closure Techniques; Humans; Negative-Pressure Wound Therapy; Polyvinyl Chloride; Time Factors
PubMed: 27982331
DOI: 10.1590/0100-69912016005015 -
The Cochrane Database of Systematic... Jul 2016The central venous catheter (CVC) is a device used for many functions, including monitoring haemodynamic indicators and administering intravenous medications, fluids,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The central venous catheter (CVC) is a device used for many functions, including monitoring haemodynamic indicators and administering intravenous medications, fluids, blood products and parenteral nutrition. However, as a foreign object, it is susceptible to colonisation by micro-organisms, which may lead to catheter-related blood stream infection (BSI) and in turn, increased mortality, morbidities and health care costs.
OBJECTIVES
To assess the effects of skin antisepsis as part of CVC care for reducing catheter-related BSIs, catheter colonisation, and patient mortality and morbidities.
SEARCH METHODS
In May 2016 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations and Epub Ahead of Print); Ovid EMBASE and EBSCO CINAHL Plus. We also searched clinical trial registries for ongoing and unpublished studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that assessed any type of skin antiseptic agent used either alone or in combination, compared with one or more other skin antiseptic agent(s), placebo or no skin antisepsis in patients with a CVC in place.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed the studies for their eligibility, extracted data and assessed risk of bias. We expressed our results in terms of risk ratio (RR), absolute risk reduction (ARR) and number need to treat for an additional beneficial outcome (NNTB) for dichotomous data, and mean difference (MD) for continuous data, with 95% confidence intervals (CIs).
MAIN RESULTS
Thirteen studies were eligible for inclusion, but only 12 studies contributed data, with a total of 3446 CVCs assessed. The total number of participants enrolled was unclear as some studies did not provide such information. The participants were mainly adults admitted to intensive care units, haematology oncology units or general wards. Most studies assessed skin antisepsis prior to insertion and regularly thereafter during the in-dwelling period of the CVC, ranging from every 24 h to every 72 h. The methodological quality of the included studies was mixed due to wide variation in their risk of bias. Most trials did not adequately blind the participants or personnel, and four of the 12 studies had a high risk of bias for incomplete outcome data.Three studies compared different antisepsis regimens with no antisepsis. There was no clear evidence of a difference in all outcomes examined, including catheter-related BSI, septicaemia, catheter colonisation and number of patients who required systemic antibiotics for any of the three comparisons involving three different antisepsis regimens (aqueous povidone-iodine, aqueous chlorhexidine and alcohol compared with no skin antisepsis). However, there were great uncertainties in all estimates due to underpowered analyses and the overall very low quality of evidence presented.There were multiple head-to-head comparisons between different skin antiseptic agents, with different combinations of active substance and base solutions. The most frequent comparison was chlorhexidine solution versus povidone-iodine solution (any base). There was very low quality evidence (downgraded for risk of bias and imprecision) that chlorhexidine may reduce catheter-related BSI compared with povidone-iodine (RR of 0.64, 95% CI 0.41 to 0.99; ARR 2.30%, 95% CI 0.06 to 3.70%). This evidence came from four studies involving 1436 catheters. None of the individual subgroup comparisons of aqueous chlorhexidine versus aqueous povidone-iodine, alcoholic chlorhexidine versus aqueous povidone-iodine and alcoholic chlorhexidine versus alcoholic povidone-iodine showed clear differences for catheter-related BSI or mortality (and were generally underpowered). Mortality was only reported in a single study.There was very low quality evidence that skin antisepsis with chlorhexidine may also reduce catheter colonisation relative to povidone-iodine (RR of 0.68, 95% CI 0.56 to 0.84; ARR 8%, 95% CI 3% to 12%; ; five studies, 1533 catheters, downgraded for risk of bias, indirectness and inconsistency).Evaluations of other skin antiseptic agents were generally in single, small studies, many of which did not report the primary outcome of catheter-related BSI. Trials also poorly reported other outcomes, such as skin infections and adverse events.
AUTHORS' CONCLUSIONS
It is not clear whether cleaning the skin around CVC insertion sites with antiseptic reduces catheter related blood stream infection compared with no skin cleansing. Skin cleansing with chlorhexidine solution may reduce rates of CRBSI and catheter colonisation compared with cleaning with povidone iodine. These results are based on very low quality evidence, which means the true effects may be very different. Moreover these results may be influenced by the nature of the antiseptic solution (i.e. aqueous or alcohol-based). Further RCTs are needed to assess the effectiveness and safety of different skin antisepsis regimens in CVC care; these should measure and report critical clinical outcomes such as sepsis, catheter-related BSI and mortality.
Topics: Adult; Anti-Infective Agents, Local; Antisepsis; Catheter-Related Infections; Central Venous Catheters; Chlorhexidine; Ethanol; Humans; Povidone-Iodine; Randomized Controlled Trials as Topic; Skin
PubMed: 27410189
DOI: 10.1002/14651858.CD010140.pub2 -
Critical Care (London, England) Jun 2016When conventional high-volume, low-pressure cuffs of endotracheal tubes (ETTs) are inflated, channel formation due to folds in the cuff wall can occur. These channels... (Review)
Review
BACKGROUND
When conventional high-volume, low-pressure cuffs of endotracheal tubes (ETTs) are inflated, channel formation due to folds in the cuff wall can occur. These channels facilitate microaspiration of subglottic secretions, which is the main pathogenic mechanism leading to intubation-related pneumonia. Ultrathin polyurethane (PU)-cuffed ETTs are developed to minimize channel formation in the cuff wall and therefore the risk of microaspiration and respiratory infections.
METHODS
We systematically reviewed the available literature for laboratory and clinical studies comparing fluid leakage or microaspiration and/or rates of respiratory infections between ETTs with polyvinyl chloride (PVC) cuffs and ETTs with PU cuffs.
RESULTS
The literature search revealed nine in vitro experiments, one in vivo (animal) experiment, and five clinical studies. Among the 9 in vitro studies, 10 types of PU-cuffed ETTs were compared with 17 types of PVC-cuffed tubes, accounting for 67 vs. 108 experiments with 36 PU-cuffed tubes and 42 PVC-cuffed tubes, respectively. Among the clinical studies, three randomized controlled trials (RCTs) were identified that involved 708 patients. In this review, we provide evidence that PU cuffs protect more efficiently than PVC cuffs against fluid leakage or microaspiration. All studies with leakage and/or microaspiration as the primary outcome demonstrated significantly less leakage (eight in vitro and two clinical studies) or at least a tendency toward more efficient sealing (one in vivo animal experiment). In particular, high-risk patients intubated for shorter periods may benefit from the more effective sealing capacity afforded by PU cuffs. For example, cardiac surgery patients experienced a lower risk of early postoperative pneumonia in one RCT. The evidence that PU-cuffed tubes prevent ventilator-associated pneumonia (VAP) is less robust, probably because microaspiration is postponed rather than eliminated. One RCT demonstrated no difference in VAP risk between patients intubated with either PU-cuffed or PVC-cuffed tubes, and one before-after trial demonstrated a favorable reduction in VAP rates following the introduction of PU-cuffed tubes.
CONCLUSIONS
Current evidence can support the use of PU-cuffed ETTs in high-risk surgical patients, while there is only very limited evidence that PU cuffs prevent pneumonia in patients ventilated for prolonged periods.
Topics: Equipment Design; Humans; Intubation, Intratracheal; Pneumonia, Ventilator-Associated; Polyurethanes; Respiration, Artificial
PubMed: 27342802
DOI: 10.1186/s13054-016-1380-8 -
European Journal of Vascular and... Jun 2016Endoleak remains the Achilles heel of endovascular aneurysm repair and the exclusion of Type II endoleaks, in particular, remains challenging. This systematic review... (Review)
Review
OBJECTIVE
Endoleak remains the Achilles heel of endovascular aneurysm repair and the exclusion of Type II endoleaks, in particular, remains challenging. This systematic review presents the evidence for ethylene-vinyl-alcohol-copolymer liquid embolic agent as a monotherapy in the treatment of endoleaks.
METHODS
A systematic literature search was performed for all studies reporting the use of liquid embolic agent as a sole agent in the treatment of endoleaks. Patient numbers, clinical details (endoleak type, route of delivery) and outcome in terms of survival, technical and clinical success with freedom from endoleak together with follow-up period were examined.
RESULTS
Only 12 articles reporting the use of liquid embolic as the sole treatment modality for endoleaks in 174 patients were identified. All but 21 patients had a Type II endoleak. Transarterial embolization was attempted in 73% of patients with 48 patients having direct sac puncture. Technical success was high at 96%, but in patients with adequate imaging, the clinical success rate dropped to 79%. Complications were sparsely reported and follow-up ranged from 0 to 75 months.
CONCLUSIONS
This review highlights the lack of data regarding the use of liquid embolic agent as a monotherapy with only 4 studies including more than 10 patients. Data from the largest series suggests a learning curve exists and no study reports on cost effectiveness. Technical success does not always translate into clinical success and with the largest series only reporting median 4-month follow-up no claims regarding durability can be made. In problematic Type II endoleaks, however, liquid embolic agent is a welcome addition to the treatment armamentarium.
Topics: Aortic Aneurysm, Abdominal; Endoleak; Endovascular Procedures; Humans; Polyvinyls; Treatment Outcome
PubMed: 27040505
DOI: 10.1016/j.ejvs.2016.02.015 -
The Cochrane Database of Systematic... Mar 2016Central venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce... (Review)
Review
BACKGROUND
Central venous catheters (CVCs) provide secured venous access in neonates. Antimicrobial dressings applied over the CVC sites have been proposed to reduce catheter-related blood stream infection (CRBSI) by decreasing colonisation. However, there may be concerns on the local and systemic adverse effects of these dressings in neonates.
OBJECTIVES
We assessed the effectiveness and safety of antimicrobial (antiseptic or antibiotic) dressings in reducing CVC-related infections in newborn infants. Had there been relevant data, we would have evaluated the effects of antimicrobial dressings in different subgroups, including infants who received different types of CVCs, infants who required CVC for different durations, infants with CVCs with and without other antimicrobial modifications, and infants who received an antimicrobial dressing with and without a clearly defined co-intervention.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group (CNRG). We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2015, Issue 9), MEDLINE (PubMed), EMBASE (EBCHOST), CINAHL and references cited in our short-listed articles using keywords and MeSH headings, up to September 2015.
SELECTION CRITERIA
We included randomised controlled trials that compared an antimicrobial CVC dressing against no dressing or another dressing in newborn infants.
DATA COLLECTION AND ANALYSIS
We extracted data using the standard methods of the CNRG. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using risk difference (RD) and risk ratio (RR) with 95% confidence intervals (CIs).
MAIN RESULTS
Out of 173 articles screened, three studies were included. There were two comparisons: chlorhexidine dressing following alcohol cleansing versus polyurethane dressing following povidone-iodine cleansing (one study); and silver-alginate patch versus control (two studies). A total of 855 infants from level III neonatal intensive care units (NICUs) were evaluated, 705 of whom were from a single study. All studies were at high risk of bias for blinding of care personnel or unclear risk of bias for blinding of outcome assessors. There was moderate-quality evidence for all major outcomes.The single study comparing chlorhexidine dressing/alcohol cleansing against polyurethane dressing/povidone-iodine cleansing showed no significant difference in the risk of CRBSI (RR 1.18, 95% CI 0.53 to 2.65; RD 0.01, 95% CI -0.02 to 0.03; 655 infants, moderate-quality evidence) and sepsis without a source (RR 1.06, 95% CI 0.75 to 1.52; RD 0.01, 95% CI -0.04 to 0.06; 705 infants, moderate-quality evidence). There was a significant reduction in the risk of catheter colonisation favouring chlorhexidine dressing/alcohol cleansing group (RR 0.62, 95% CI 0.45 to 0.86; RD -0.09, 95% CI -0.15 to -0.03; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 7 to 33; 655 infants, moderate-quality evidence). However, infants in the chlorhexidine dressing/alcohol cleansing group were significantly more likely to develop contact dermatitis, with 19 infants in the chlorhexidine dressing/alcohol cleansing group having developed contact dermatitis compared to none in the polyurethane dressing/povidone-iodine cleansing group (RR 43.06, 95% CI 2.61 to 710.44; RD 0.06, 95% CI 0.03 to 0.08; number needed to treat for an additional harmful outcome (NNTH) 17, 95% CI 13 to 33; 705 infants, moderate-quality evidence). The roles of chlorhexidine dressing in the outcomes reported were unclear, as the two assigned groups received different co-interventions in the form of different skin cleansing agents prior to catheter insertion and during each dressing change.In the other comparison, silver-alginate patch versus control, the data for CRBSI were analysed separately in two subgroups as the two included studies reported the outcome using different denominators: one using infants and another using catheters. There were no significant differences between infants who received silver-alginate patch against infants who received standard line dressing in CRBSI, whether expressed as the number of infants (RR 0.50, 95% CI 0.14 to 1.78; RD -0.12, 95% CI -0.33 to 0.09; 1 study, 50 participants, moderate-quality evidence) or as the number of catheters (RR 0.72, 95% CI 0.27 to 1.89; RD -0.05, 95% CI -0.20 to 0.10; 1 study, 118 participants, moderate-quality evidence). There was also no significant difference between the two groups in mortality (RR 0.55, 95% CI 0.15 to 2.05; RD -0.04, 95% CI -0.13 to 0.05; two studies, 150 infants, I² = 0%, moderate-quality evidence). No adverse skin reaction was recorded in either group.
AUTHORS' CONCLUSIONS
Based on moderate-quality evidence, chlorhexidine dressing/alcohol skin cleansing reduced catheter colonisation, but made no significant difference in major outcomes like sepsis and CRBSI compared to polyurethane dressing/povidone-iodine cleansing. Chlorhexidine dressing/alcohol cleansing posed a substantial risk of contact dermatitis in preterm infants, although it was unclear whether this was contributed mainly by the dressing material or the cleansing agent. While silver-alginate patch appeared safe, evidence is still insufficient for a recommendation in practice. Future research that evaluates antimicrobial dressing should ensure blinding of caregivers and outcome assessors and ensure that all participants receive the same co-interventions, such as the skin cleansing agent. Major outcomes like sepsis, CRBSI and mortality should be assessed in infants of different gestation and birth weight.
Topics: Alginates; Anti-Bacterial Agents; Anti-Infective Agents; Bandages; Catheter-Related Infections; Catheterization, Central Venous; Central Venous Catheters; Chlorhexidine; Dermatitis, Contact; Ethanol; Glucuronic Acid; Hexuronic Acids; Humans; Infant, Newborn; Polyurethanes; Povidone-Iodine; Randomized Controlled Trials as Topic; Silver Compounds
PubMed: 27007217
DOI: 10.1002/14651858.CD011082.pub2 -
The Cochrane Database of Systematic... Feb 2016Over the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Over the counter (OTC) artificial tears historically have been the first line of treatment for dry eye syndrome and dry eye-related conditions like contact lens discomfort, yet currently we know little regarding the overall efficacy of individual, commercially available artificial tears. This review provides a much needed meta-analytical look at all randomized and quasi-randomized clinical trials that have analyzed head-to-head comparisons of OTC artificial tears.
OBJECTIVES
To evaluate the effectiveness and toxicity of OTC artificial tear applications in the treatment of dry eye syndrome compared with another class of OTC artificial tears, no treatment, or placebo.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2015), EMBASE (January 1980 to December 2015), Latin American and Caribbean Health Sciences (LILACS) (January 1982 to December 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the US Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 4 December 2015. We searched reference lists of included trials for any additional trials not identified by the electronic searches.
SELECTION CRITERIA
This review includes randomized controlled trials with adult participants who were diagnosed with dry eye, regardless of race and gender. We included trials in which the age of participants was not reported, and clinical trials comparing OTC artificial tears with another class of OTC artificial tears, placebo, or no treatment. This review did not consider head-to-head comparisons of artificial tears with another type of dry-eye therapy.
DATA COLLECTION AND ANALYSIS
We followed the standard methodological procedures expected by Cochrane. Two authors independently screened the search results, reviewed full-text copies for eligibility, examined risk of bias, and extracted data. We performed meta-analysis for trials that compared similar interventions and reported comparable outcomes with sufficient data. We summarized all other included trial results in the text.
MAIN RESULTS
We included 43 randomized controlled trials (3497 participants with dry eye). Due to the heterogeneity of study characteristics among the included trials with respect to types of diagnostic criteria, interventions, comparisons, and measurements taken, our ability to perform meta-analyses was limited. The review found that, in general, there was uncertainty whether different OTC artificial tears provide similar relief of signs and symptoms when compared with each other or placebo. Nevertheless, we found that 0.2% polyacrylic acid-based artificial tears were consistently more effective at treating dry eye symptoms than 1.4% polyvinyl alcohol-based artificial tears in two trials assessing this comparison (175 participants). All other included artificial tears produced contradictory between-group results or found no between-group differences. Our review also found that OTC artificial tears may be generally safe, but not without adverse events. Overall, we assessed the quality of evidence as low due to high risks of bias among included trials and poor reporting of outcome measures which were insufficient for quantitative analysis. Furthermore, we identified an additional 18 potentially eligible trials that were reported only in clinical trial registers with no associated results or publications. These trials reportedly enrolled 2079 total participants for whom no data are available. Such lack of reporting of trial results represents a high risk of publication bias.
AUTHORS' CONCLUSIONS
OTC artificial tears may be safe and effective means for treating dry eye syndrome; the literature indicates that the majority of OTC artificial tears may have similar efficacies. This conclusion could be greatly skewed by the inconsistencies in study designs and inconsistencies in reporting trial results. Additional research is therefore needed before we can draw robust conclusions about the effectiveness of individual OTC artificial tear formulations.
Topics: Acrylic Resins; Dry Eye Syndromes; Humans; Lubricant Eye Drops; Nonprescription Drugs; Polyvinyl Alcohol; Randomized Controlled Trials as Topic
PubMed: 26905373
DOI: 10.1002/14651858.CD009729.pub2 -
The Cochrane Database of Systematic... Jul 2015Faecal incontinence is a distressing disorder with high social stigma. Not all people with faecal incontinence can be cured with conservative or surgical treatment and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Faecal incontinence is a distressing disorder with high social stigma. Not all people with faecal incontinence can be cured with conservative or surgical treatment and they may need to rely on containment products, such as anal plugs.
OBJECTIVES
To assess the performance of different types of anal plugs for containment of faecal incontinence.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, ClinicalTrials.gov, World Health Organization (WHO) ICTRP and handsearching of journals and conference proceedings (searched 26 May 2015). Reference lists of identified trials were searched and plug manufacturers were contacted for trials. No language or other limitations were imposed.
SELECTION CRITERIA
Types of studies: this review was limited to randomised and quasi-randomised controlled trials (including crossovers) of anal plug use for the management of faecal incontinence.
TYPES OF PARTICIPANTS
children and adults with faecal incontinence.Types of interventions: any type of anal plug. Comparison interventions might include no treatment, conservative (physical) treatments, nutritional interventions, surgery, pads and other types or sizes of plugs.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed methodological quality and extracted data from the included trials. Authors of all included trials were contacted for clarification concerning methodological issues.
MAIN RESULTS
Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs, one study compared two sizes of the same brand of plug, and one study compared two brands of plugs. In all included studies there was considerable dropout (in total 48 (35%) dropped out before the end of the study) for varying reasons. Data presented are thus subject to potential bias. 'Pseudo-continence' was, however, achieved by some of those who continued to use plugs, at least in the short-term. In a comparison of two different types of plug, plug loss was less often reported and overall satisfaction was greater during use of polyurethane plugs than polyvinyl-alcohol plugs.
AUTHORS' CONCLUSIONS
The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.
Topics: Adult; Child; Equipment Design; Fecal Incontinence; Humans; Patient Dropouts; Randomized Controlled Trials as Topic; Tampons, Surgical
PubMed: 26193665
DOI: 10.1002/14651858.CD005086.pub4 -
The Cochrane Database of Systematic... Apr 2015Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgical site infection rates in the month following clean surgery vary from 0.6% (knee prosthesis) to 5% (limb amputation). Due to the large number of clean surgical procedures conducted annually the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Preoperative skin antisepsis using antiseptics is performed to reduce the risk of SSIs by removing soil and transient organisms from the skin where a surgical incision will be made. Antiseptics are thought to be toxic to bacteria and therefore aid their mechanical removal. The effectiveness of preoperative skin preparation is thought to be dependent on both the antiseptic used and the method of application, however, it is unclear whether preoperative skin antisepsis actually reduces postoperative wound infection, and, if so, which antiseptic is most effective.
OBJECTIVES
To determine whether preoperative skin antisepsis immediately prior to surgical incision for clean surgery prevents SSI and to determine the comparative effectiveness of alternative antiseptics.
SEARCH METHODS
For this third update we searched just the Cochrane Wounds Group Specialised Register (searched 27 January 2015); The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 12).
SELECTION CRITERIA
Randomised controlled trials evaluating the use of preoperative skin antiseptics applied immediately prior to incision in clean surgery. There was no restriction on the inclusion of reports based on language of publication, date or publication status.
DATA COLLECTION AND ANALYSIS
Data extraction and assessment of risk of bias were undertaken independently by two review authors.
MAIN RESULTS
There were no new studies added to the review in the third updateThirteen studies were included in this review (2,623 participants). These evaluated several different types of skin antiseptics - leading to 11 different comparisons being made. Although the antiseptics evaluated differed between studies, all trials involved some form of iodine. Iodine in alcohol was compared to alcohol alone in one trial; one trial compared povidone iodine paint (solution type not reported) with soap and alcohol. Six studies compared different types of iodine-containing products with each other and five compared iodine-containing products with chlorhexidine-containing products.There was evidence from one study suggesting that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits led to a reduced risk of SSI compared with an alcohol based povidone iodine solution: RR 0.47 (95% CI 0.27 to 0.82). However, it is important to note that the trial does not report important details regarding the interventions (such as the concentration of povidone iodine paint used) and trial conduct, such that risk of bias was unclear.There were no other statistically significant differences in SSI rates in the other comparisons of skin antisepsis. Overall the risk of bias in included studies was unclear.A mixed treatment comparison meta-analysis was conducted and this suggested that alcohol-containing products had the highest probability of being effective - however, again the quality of this evidence was low.
AUTHORS' CONCLUSIONS
A comprehensive review of current evidence found some evidence that preoperative skin preparation with 0.5% chlorhexidine in methylated spirits was associated with lower rates of SSIs following clean surgery than alcohol-based povidone iodine paint. However this single study was poorly reported. Practitioners may therefore elect to consider other characteristics such as costs and potential side effects when choosing between alternatives.The design of future trials should be driven by the questions of high priority to decision makers. It may be that investment in at least one large trial (in terms of participants) is warranted in order to add definitive and hopefully conclusive data to the current evidence base. Ideally any future trial would evaluate the iodine-containing and chlorhexidine-containing solutions relevant to current practice as well as the type of solution used (alcohol vs. aqueous).
Topics: Anti-Infective Agents, Local; Chlorhexidine; Ethanol; Humans; Iodine Compounds; Povidone-Iodine; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Wound Infection
PubMed: 25897764
DOI: 10.1002/14651858.CD003949.pub4 -
The Cochrane Database of Systematic... Dec 2014Intermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Intermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically effective or cost-effective intervention in the management of this disease.
OBJECTIVES
The purpose of this review is to evaluate the clinical effectiveness and cost-effectiveness of intermittent self-dilatation after urethral stricture surgery in males compared to no intervention. We also compared different programmes of, and devices for, intermittent self-dilatation. .
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Register (searched 7 May 2014), CENTRAL (2014, Issue 4), MEDLINE (1 January 1946 to Week 3 April 2014), PREMEDLINE (covering 29 April 2014), EMBASE (1 January 1947 to Week 17 2014), CINAHL (31 December 1981 to 30 April 2014) OpenGrey (searched 6 May 2014), ClinicalTrials.gov (6 May 2014), WHO International Clinical Trials Registry Platform (6 May 2014), Current Controlled Trials (6 May 2014) and the reference lists of relevant articles.
SELECTION CRITERIA
Randomised and quasi-randomised trials where one arm was a programme of intermittent self-dilatation for urethral stricture were identified. Studies were excluded if they were not randomised or quasi-randomised trials, or if they pertained to clean intermittent self-catheterisation for bladder emptying.
DATA COLLECTION AND ANALYSIS
Two authors screened the records for relevance and methodological quality. Data extraction was performed according to predetermined criteria using data extraction forms. Analyses were carried out in Cochrane Review Manager (RevMan 5). The primary outcomes were patient-reported symptoms and health-related quality of life, and risk of recurrence; secondary outcomes were adverse events, acceptability of the intervention to patients and cost-effectiveness. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
MAIN RESULTS
Eleven trials were selected for inclusion in the review, including a total of 776 men. They were generally small; all were of poor quality and all were deemed to have high risk of bias. Performing intermittent self-dilatation versus not performing intermittent self-dilatation The data from six trials were heterogeneous, imprecise and had a high risk of bias, but indicated that recurrent urethral stricture was less likely in men who performed intermittent self-dilatation than men who did not perform intermittent self-dilatation (RR 0.70, 95% CI 0.48 to 1.00; very low quality evidence). Adverse events were generally poorly reported: two trials did not report adverse events and two trials reported adverse events only for the intervention group. Meta-analysis of the remaining two trials found no evidence of a difference between performing intermittent self-dilatation and not performing it (RR 0.60, 95% CI 0.11 to 3.26). No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness. One programme of intermittent self-dilatation versus another We identified two trials that compared different durations of intermittent self-dilatation, but data were not combined. One study could not draw robust conclusions owing to cross-over, protocol deviation, administrative error, post-hoc analysis and incomplete outcome reporting. The other study found no evidence of a difference between intermittent self-dilatation for six months versus for 12 months after optical urethrotomy (RR 0.67, 95% CI 0.12 to 3.64), although again the evidence is limited by the small sample size and risk of bias in the included study. Adverse events were reported narratively and were not stratified by group. No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness. One device for performing intermittent self-dilatation versus another Three trials compared one device for performing intermittent self-dilatation with another. Results from one trial at a high risk of bias were too uncertain to determine the effects of a low friction hydrophilic catheter and a standard polyvinyl chloride catheter on the risk of recurrent urethral stricture (RR 0.32, 95% CI 0.07 to 1.40). Similarly one study did not find evidence of a difference between one percent triamcinolone gel for lubricating the intermittent self-dilatation catheter versus water-based gel on risk of recurrent urethral stricture (RR 0.68, 95% CI 0.35 to 1.32). Two trials reported adverse events, but one did not provide sufficient detail for analysis. The other small study reported fewer instances of prostatitis, urethral bleeding or bacteriuria with a low friction hydrophilic catheter compared with a standard polyvinyl chloride catheter (RR 0.13, 95% CI 0.02 to 0.98). 'Happiness with the intervention' was assessed using a non-validated scale in one study, but no trials formally assessed patient-reported health-related quality of life or acceptability. No trials reported on patient-reported lower urinary tract symptoms or cost-effectiveness. GRADE quality assessment The evidence that intermittent self-dilatation reduces the risk of recurrent urethral stricture after surgical intervention was downgraded to 'very low' on the basis that the studies comprising the meta-analysis were deemed to have high risk of bias, and the data was imprecise and inconsistent. Insufficient evidence No trials provided cost-effectiveness data or used a validated patient-reported outcome measure, and adverse events were not reported rigorously. Acceptability of the intervention to patients has not been assessed quantitatively or qualitatively.
AUTHORS' CONCLUSIONS
Performing intermittent self-dilatation may confer a reduced risk of recurrent urethral stricture after endoscopic treatment. We have very little confidence in the estimate of the effect owing to the very low quality of the evidence. Evidence for other comparisons and outcomes is limited. Further research is required to determine whether the apparent benefit is sufficient to make the intervention worthwhile, and in whom.
Topics: Dilatation; Humans; Male; Patient Satisfaction; Postoperative Complications; Randomized Controlled Trials as Topic; Recurrence; Self Care; Urethral Stricture
PubMed: 25523166
DOI: 10.1002/14651858.CD010258.pub2