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The Cochrane Database of Systematic... Nov 2018Acne vulgaris, a chronic inflammatory disease of the pilosebaceous unit associated with socialisation and mental health problems, may affect more than 80% of teenagers.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Acne vulgaris, a chronic inflammatory disease of the pilosebaceous unit associated with socialisation and mental health problems, may affect more than 80% of teenagers. Isotretinoin is the only drug that targets all primary causal factors of acne; however, it may cause adverse effects.
OBJECTIVES
To assess efficacy and safety of oral isotretinoin for acne vulgaris.
SEARCH METHODS
We searched the following databases up to July 2017: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO and LILACS. We updated this search in March 2018, but these results have not yet been incorporated in the review. We also searched five trial registries, checked the reference lists of retrieved studies for further references to relevant trials, and handsearched dermatology conference proceedings. A separate search for adverse effects of oral isotretinoin was undertaken in MEDLINE and Embase up to September 2013.
SELECTION CRITERIA
Randomised clinical trials (RCTs) of oral isotretinoin in participants with clinically diagnosed acne compared against placebo, any other systemic or topical active therapy, and itself in different formulation, doses, regimens, or course duration.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included 31 RCTs, involving 3836 participants (12 to 55 years) with mild to severe acne. There were twice as many male participants as females.Most studies were undertaken in Asia, Europe, and North America. Outcomes were generally measured between eight to 32 weeks (mean 19.7 weeks) of therapy.Assessed comparisons included oral isotretinoin versus placebo or other treatments such as antibiotics. In addition, different doses, regimens, or formulations of oral isotretinoin were assessed, as well as oral isotretinoin with the addition of topical agents.Pharmaceutical companies funded 12 included trials. All, except three studies, had high risk of bias in at least one domain.Oral isotretinoin compared with oral antibiotics plus topical agentsThese studies included participants with moderate or severe acne and assessed outcomes immediately after 20 to 24 weeks of treatment (short-term). Three studies (400 participants) showed isotretinoin makes no difference in terms of decreasing trial investigator-assessed inflammatory lesion count (RR 1.01 95% CI 0.96 to 1.06), with only one serious adverse effect found, which was Stevens-Johnson syndrome in the isotretinoin group (RR 3.00, 95% CI 0.12 to 72.98). However, we are uncertain about these results as they were based on very low-quality evidence.Isotretinoin may slightly improve (by 15%) acne severity, assessed by physician's global evaluation (RR 1.15, 95% CI 1.00 to 1.32; 351 participants; 2 studies), but resulted in more less serious adverse effects (67% higher risk) (RR 1.67, 95% CI 1.42 to 1.98; 351 participants; 2 studies), such as dry lips/skin, cheilitis, vomiting, nausea (both outcomes, low-quality evidence).Different doses/therapeutic regimens of oral isotretinoinFor our primary efficacy outcome, we found three RCTs, but heterogeneity precluded meta-analysis. One study (154 participants) reported 79%, 80% and 84% decrease in total inflammatory lesion count after 20 weeks of 0.05, 0.1, or 0.2 mg/kg/d of oral isotretinoin for severe acne (low-quality evidence). Another trial (150 participants, severe acne) compared 0.1, 0.5, and 1 mg/kg/d oral isotretinoin for 20 weeks and, respectively, 58%, 80% and 90% of participants achieved 95% decrease in total inflammatory lesion count. One RCT, of participants with moderate acne, compared isotretinoin for 24 weeks at (a) continuous low dose (0.25 to 0.4 mg/kg/day), (b) continuous conventional dose (0.5 to 0.7 mg/kg/day), and (c) intermittent regimen (0.5 to 0.7 mg/kg/day, for one week in a month). Continuous low dose (MD 3.72 lesions; 95% CI 2.13 to 5.31; 40 participants; one study) and conventional dose (MD 3.87 lesions; 95% CI 2.31 to 5.43; 40 participants; one study) had a greater decrease in inflammatory lesion counts compared to intermittent treatment (all outcomes, low-quality evidence).Fourteen RCTs (906 participants, severe and moderate acne) reported that no serious adverse events were observed when comparing different doses/therapeutic regimens of oral isotretinoin during treatment (from 12 to 32 weeks) or follow-up after end of treatment (up to 48 weeks). Thirteen RCTs (858 participants) analysed frequency of less serious adverse effects, which included skin dryness, hair loss, and itching, but heterogeneity regarding the assessment of the outcome precluded data pooling; hence, there is uncertainty about the results (low- to very-low quality evidence, where assessed).Improvement in acne severity, assessed by physician's global evaluation, was not measured for this comparison.None of the included RCTs reported birth defects.
AUTHORS' CONCLUSIONS
Evidence was low-quality for most assessed outcomes.We are unsure if isotretinoin improves acne severity compared with standard oral antibiotic and topical treatment when assessed by a decrease in total inflammatory lesion count, but it may slightly improve physician-assessed acne severity. Only one serious adverse event was reported in the isotretinoin group, which means we are uncertain of the risk of serious adverse effects; however, isotretinoin may result in more minor adverse effects.Heterogeneity in the studies comparing different regimens, doses, or formulations of oral isotretinoin meant we were unable to undertake meta-analysis. Daily treatment may be more effective than treatment for one week each month. None of the studies in this comparison reported serious adverse effects, or measured improvement in acne severity assessed by physician's global evaluation. We are uncertain if there is a difference in number of minor adverse effects, such as skin dryness, between doses/regimens.Evidence quality was lessened due to imprecision and attrition bias. Further studies should ensure clearly reported long- and short-term standardised assessment of improvement in total inflammatory lesion counts, participant-reported outcomes, and full safety accounts. Oral isotretinoin for acne that has not responded to oral antibiotics plus topical agents needs further assessment, as well as different dose/regimens of oral isotretinoin in acne of all severities.
Topics: Administration, Oral; Adolescent; Adult; Anti-Bacterial Agents; Child; Dermatologic Agents; Female; Humans; Isotretinoin; Male; Middle Aged; Randomized Controlled Trials as Topic; Young Adult
PubMed: 30484286
DOI: 10.1002/14651858.CD009435.pub2 -
Midwifery Jan 2018to identify what skin practices are important for the protection of baby skin in healthy term babies (0-6 months) and generate evidence-based conclusions to inform... (Review)
Review
OBJECTIVES
to identify what skin practices are important for the protection of baby skin in healthy term babies (0-6 months) and generate evidence-based conclusions to inform health professionals and parents.
DESIGN
eleven databases were searched for all empirical quantitative and qualitative research published between 2000-2015 which explored baby skin care for bathing and cleansing, nappy care, hair and scalp care, management of dry skin or baby massage, for healthy term babies up to 6 months old. Papers not published in English were excluded. A total of 3062 papers were identified. Pairs of reviewers assessed all citations and extracted data independently. There were 26 included papers: 16 RCTs, 3 non-randomised experimental studies, 1 mixed-methods study and 6 qualitative studies. Primary and secondary outcome measures were analysed using meta-analysis or narrative descriptive statistics. Synthesis of qualitative data was not possible due to disparity of the evidence.
FINDINGS
from the small numbers of studies with comparable data, there was no evidence of any significant differences between tested wash products and water or tested baby wipes and water. There was some evidence to suggest that daily use of full-body emollient therapy may help to reduce the risk of atopic eczema in high risk babies with a genetic predisposition to eczema; however, the use of olive oil or sunflower oil for baby dry skin may adversely affect skin barrier function. There was no evidence about hair/scalp care or baby massage. Qualitative research indicates that parents and health professionals believe that water alone is best.
KEY CONCLUSIONS
meta-analysis was restricted due to the lack of consistency of study outcome measures. Although there is considerable RCT evidence comparing the use of specific products against water alone, or another product, for bathing, cleansing and nappy care, the power of this evidence is reduced due to inconsistency of outcome measures in terms of outcome, treatment site or time-point. The development of a core outcome measure set is advocated for trials assessing skin care practices.
IMPLICATIONS FOR PRACTICE
this review offers health professionals best evidence available on which to base their advice. Of those studies with comparative outcomes, the evidence indicates no difference between the specific products tested and water alone; offering parents a choice in their baby skin care regimen. Protocol available: http://www.crd.york.ac.uk/PROSPEROFILES/28054_PROTOCOL_20151009.pdf.
Topics: Baths; Female; Hair; Humans; Infant; Infant Care; Infant, Newborn; Outcome Assessment, Health Care; Pregnancy; Skin Care
PubMed: 29055852
DOI: 10.1016/j.midw.2017.10.001 -
The Cochrane Database of Systematic... Jun 2017Scalpels or electrosurgery can be used to make abdominal incisions. The potential benefits of electrosurgery may include reduced blood loss, dry and rapid separation of... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Scalpels or electrosurgery can be used to make abdominal incisions. The potential benefits of electrosurgery may include reduced blood loss, dry and rapid separation of tissue, and reduced risk of cutting injury to surgeons. Postsurgery risks possibly associated with electrosurgery may include poor wound healing and complications such as surgical site infection.
OBJECTIVES
To assess the effects of electrosurgery compared with scalpel for major abdominal incisions.
SEARCH METHODS
The first version of this review included studies published up to February 2012. In October 2016, for this first update, we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, EBSCO CINAHL Plus, and the registry for ongoing trials (www.clinicaltrials.gov). We did not apply date or language restrictions.
SELECTION CRITERIA
Studies considered in this analysis were randomised controlled trials (RCTs) that compared electrosurgery to scalpel for creating abdominal incisions during major open abdominal surgery. Incisions could be any orientation (vertical, oblique, or transverse) and surgical setting (elective or emergency). Electrosurgical incisions were made through major layers of the abdominal wall, including subcutaneous tissue and the musculoaponeurosis (a sheet of connective tissue that attaches muscles), regardless of the technique used to incise the skin and peritoneum. Scalpel incisions were made through major layers of abdominal wall including skin, subcutaneous tissue, and musculoaponeurosis, regardless of the technique used to incise the abdominal peritoneum. Primary outcomes analysed were wound infection, time to wound healing, and wound dehiscence. Secondary outcomes were postoperative pain, wound incision time, wound-related blood loss, and adhesion or scar formation.
DATA COLLECTION AND ANALYSIS
Two review authors independently carried out study selection, data extraction, and risk of bias assessment. When necessary, we contacted trial authors for missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) for dichotomous data, and mean differences (MD) and 95% CI for continuous data.
MAIN RESULTS
The updated search found seven additional RCTs making a total of 16 included studies (2769 participants). All studies compared electrosurgery to scalpel and were considered in one comparison. Eleven studies, analysing 2178 participants, reported on wound infection. There was no clear difference in wound infections between electrosurgery and scalpel (7.7% for electrosurgery versus 7.4% for scalpel; RR 1.07, 95% CI 0.74 to 1.54; low-certainty evidence downgraded for risk of bias and serious imprecision). None of the included studies reported time to wound healing.It is uncertain whether electrosurgery decreases wound dehiscence compared to scalpel (2.7% for electrosurgery versus 2.4% for scalpel; RR 1.21, 95% CI 0.58 to 2.50; 1064 participants; 6 studies; very low-certainty evidence downgraded for risk of bias and very serious imprecision).There was no clinically important difference in incision time between electrosurgery and scalpel (MD -45.74 seconds, 95% CI -88.41 to -3.07; 325 participants; 4 studies; moderate-certainty evidence downgraded for serious imprecision). There was no clear difference in incision time per wound area between electrosurgery and scalpel (MD -0.58 seconds/cm, 95% CI -1.26 to 0.09; 282 participants; 3 studies; low-certainty evidence downgraded for very serious imprecision).There was no clinically important difference in mean blood loss between electrosurgery and scalpel (MD -20.10 mL, 95% CI -28.16 to -12.05; 241 participants; 3 studies; moderate-certainty evidence downgraded for serious imprecision). Two studies reported on mean wound-related blood loss per wound area; however, we were unable to pool the studies due to considerable heterogeneity. It was uncertain whether electrosurgery decreased wound-related blood loss per wound area. We could not reach a conclusion on the effects of the two interventions on pain and appearance of scars for various reasons such as small number of studies, insufficient data, the presence of conflicting data, and different measurement methods.
AUTHORS' CONCLUSIONS
The certainty of evidence was moderate to very low due to risk of bias and imprecise results. Low-certainty evidence shows no clear difference in wound infection between the scalpel and electrosurgery. There is a need for more research to determine the relative effectiveness of scalpel compared with electrosurgery for major abdominal incisions.
Topics: Abdominal Wall; Blood Loss, Surgical; Cicatrix; Electrosurgery; Humans; Operative Time; Randomized Controlled Trials as Topic; Surgical Instruments; Surgical Wound Dehiscence; Surgical Wound Infection; Tissue Adhesions; Wound Healing
PubMed: 28931203
DOI: 10.1002/14651858.CD005987.pub3 -
The Cochrane Database of Systematic... Jul 2017Extravasation injury, a complication commonly seen in the neonatal intensive care unit, can result in scarring with cosmetic and functional sequelae. A wide variety of... (Review)
Review
BACKGROUND
Extravasation injury, a complication commonly seen in the neonatal intensive care unit, can result in scarring with cosmetic and functional sequelae. A wide variety of treatments are available, including subcutaneous irrigation with saline (with or without hyaluronidase), liposuction, use of specific antidotes, topical applications, and normal wound care with dry or wet dressings. All such treatments aim to prevent or reduce the severity of complications.
OBJECTIVES
Primary objective To compare the efficacy and safety of saline irrigation or saline irrigation with prior hyaluronidase infiltration versus no intervention or normal wound care for tissue healing in neonates with extravasation injury. Secondary objectives To evaluate by subgroup analysis of controlled trials the influence of type of extravasate, timing of irrigation following extravasation, and postmenstrual age (PMA) of the neonate at the time of injury on outcomes and adverse effects.Specifically, we planned to perform subgroup analysis for the primary outcome, if appropriate, by examining:1. time to irrigation from identified extravasation injury (< 1 hour or ≥ 1 hour);2. type of extravasate (parenteral nutrition fluid or other fluids or medications);3. amount of saline used (< 500 mL or ≥ 500 mL); and4. PMA at injury (< 37 completed weeks or ≥ 37 completed weeks).
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1), MEDLINE via PubMed (1966 to 2 February 2017), Embase (1980 to 2 February 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to 2 February 2017). We also searched clinical trial databases, conference proceedings, and reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. We used the Google Scholar search tool for reverse citations of relevant articles.
SELECTION CRITERIA
Randomised controlled trials (RCTs) and quasi-randomised controlled trials comparing saline irrigation with or without hyaluronidase infiltration versus no intervention or normal wound care for the management of extravasation injury in neonates.
DATA COLLECTION AND ANALYSIS
Three review authors independently reviewed and identified articles for possible inclusion in this review. We used the GRADE approach to assess the quality of evidence.
MAIN RESULTS
We found no eligible studies. Our search revealed 10 case reports or case series describing successful outcomes with different interventions for this condition.
AUTHORS' CONCLUSIONS
To date, no RCTs have examined the effects of saline irrigation with or without prior hyaluronidase infiltration for management of extravasation injury in neonates. Saline irrigation is frequently reported in the literature as an intervention for management of extravasation injury in neonates. Research should focus first on evaluating the efficacy and safety of this intervention through RCTs. It will also be important for investigators to determine effect size by examining the timing of the intervention, the nature of the infusate, and severity of injury at the time of intervention.
Topics: Extravasation of Diagnostic and Therapeutic Materials; Humans; Hyaluronoglucosaminidase; Infant, Newborn; Medical Records; Skin; Sodium Chloride; Solutions; Therapeutic Irrigation
PubMed: 28724193
DOI: 10.1002/14651858.CD008404.pub3 -
The Cochrane Database of Systematic... May 2017Discoid lupus erythematosus (DLE) is a chronic form of cutaneous lupus, which can cause scarring. Many drugs have been used to treat this disease and some (such as... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Discoid lupus erythematosus (DLE) is a chronic form of cutaneous lupus, which can cause scarring. Many drugs have been used to treat this disease and some (such as thalidomide, cyclophosphamide and azathioprine) are potentially toxic. This is an update of a Cochrane Review first published in 2000, and previously updated in 2009. We wanted to update the review to assess whether any new information was available to treat DLE, as we were still unsure of the effectiveness of available drugs and how to select the most appropriate treatment for an individual with DLE.
OBJECTIVES
To assess the effects of drugs for discoid lupus erythematosus.
SEARCH METHODS
We updated our searches of the following databases to 22 September 2016: the Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials databases, and checked the reference lists of included studies for further references to relevant trials. Index Medicus (1956 to 1966) was handsearched and we approached authors for information about unpublished trials.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) of drugs to treat people with DLE in any population group and of either gender. Comparisons included any drug used for DLE against either another drug or against placebo cream. We excluded laser treatment, surgery, phototherapy, other forms of physical therapy, and photoprotection as we did not consider them drug treatments.
DATA COLLECTION AND ANALYSIS
At least two reviewers independently extracted data onto a data extraction sheet, resolving disagreements by discussion. We used standard methods to assess risk of bias, as expected by Cochrane.
MAIN RESULTS
Five trials involving 197 participants were included. Three new trials were included in this update. None of the five trials were of high quality.'Risk of bias' assessments identified potential sources of bias in each study. One study used an inappropriate randomisation method, and incomplete outcome data were a concern in another as 15 people did not complete the trial. We found most of the trials to be at low risk in terms of blinding, but three of the five did not describe allocation concealment.The included trials inadequately addressed the primary outcome measures of this review (percentage with complete resolution of skin lesions, percentage with clearing of erythema in at least 50% of lesions, and improvement in patient satisfaction/quality of life measures).One study of fluocinonide cream 0.05% (potent steroid) compared with hydrocortisone cream 1% (low-potency steroid) in 78 people reported complete resolution of skin lesions in 27% (10/37) of participants in the fluocinonide cream group and in 10% (4/41) in the hydrocortisone group, giving a 17% absolute benefit in favour of fluocinonide (risk ratio (RR) 2.77, 95% CI 0.95 to 8.08, 1 study, n = 78, low-quality evidence). The other primary outcome measures were not reported. Adverse events did not require discontinuation of the drug. Skin irritation occurred in three people using hydrocortisone, and one person developed acne. Burning occurred in two people using fluocinonide (moderate-quality evidence).A comparative trial of two oral agents, acitretin (50 mg daily) and hydroxychloroquine (400 mg daily), reported two of the outcomes of interest: complete resolution was seen in 13 of 28 participants (46%) on acitretin and 15 of 30 participants (50%) on hydoxychloroquine (RR 0.93, 95% CI 0.54 to 1.59, 1 study, n = 58, low-quality evidence). Clearing of erythema in at least 50% of lesions was reported in 10 of 24 participants (42%) on acitretin and 17 of 25 (68%) on hydroxychloroquine (RR 0.61, 95% CI 0.36 to 1.06, 1 study, n = 49, low-quality evidence). This comparison did not assess improvement in patient satisfaction/quality of life measures. Participants taking acitretin showed a small increase in serum triglyceride, not sufficient to require withdrawal of the drug. The main adverse effects were dry lips (93% of the acitretin group and 20% of the hydroxychloroquine group) and gastrointestinal disturbance (11% of the acitretin group and 17% of the hydroxychloroquine group). Four participants on acitretin withdrew due to gastrointestinal events or dry lips (moderate-quality evidence).One trial randomised 10 people with DLE to apply a calcineurin inhibitor, pimecrolimus 1% cream, or a potent steroid, betamethasone 17-valerate 0.1% cream, for eight weeks. The study reported none of the primary outcome measures, nor did it present data on adverse events.A trial of calcineurin inhibitors compared tacrolimus cream 0.1% with placebo (vehicle) over 12 weeks in 14 people, but reported none of our primary outcome measures. In the tacrolimus group, five participants complained of slight burning and itching, and for one participant, a herpes simplex infection was reactivated (moderate-quality evidence).Topical R-salbutamol 0.5% cream was compared with placebo (vehicle) over eight weeks in one trial of 37 people with DLE. There was a significant improvement in pain and itch in the salbutamol group at two, four, six, and eight weeks compared to placebo, but the trial did not record a formal measure of quality of life. None of the primary outcome measures were reported. Changes in erythema did not show benefit of salbutamol over placebo, but we could not obtain from the trial report the number of participants with clearing of erythema in at least 50% of lesions. There were 15 events in the placebo group (experienced by 12 participants) and 24 in the salbutamol group (experienced by nine participants). None of the adverse events were considered serious (moderate-quality evidence).
AUTHORS' CONCLUSIONS
Fluocinonide cream may be more effective than hydrocortisone in clearing DLE skin lesions. Hydroxychloroquine and acitretin appear to be of equal efficacy in terms of complete resolution, although adverse effects might be more frequent with acitretin, and clearing of erythema in at least 50% of lesions occurred less often in participants applying acitretin. Moderate-quality evidence found adverse events were minor on the whole. There is not enough reliable evidence about other drugs used to treat DLE. Overall, the quality of the trials and levels of uncertainty were such that there is a need for further trials of sufficient duration comparing, in particular, topical steroids with other agents.
Topics: Acitretin; Albuterol; Calcineurin Inhibitors; Dermatologic Agents; Fluocinonide; Humans; Hydrocortisone; Hydroxychloroquine; Lupus Erythematosus, Discoid; Randomized Controlled Trials as Topic; Tacrolimus; Treatment Outcome
PubMed: 28476075
DOI: 10.1002/14651858.CD002954.pub3 -
Epidemiology and Health 2017Various allergens are implicated in the pathogenesis of allergic diseases in different regions. This study attempted to identify the most common allergens among patients... (Meta-Analysis)
Meta-Analysis Review
Various allergens are implicated in the pathogenesis of allergic diseases in different regions. This study attempted to identify the most common allergens among patients with allergies based on the results of skin prick tests in different parts of Iran. Relevant studies conducted from 2000 to 2016 were identified from the MEDLINE database. Six common groups of allergen types, including animal, cockroach, food, fungus, house dust mite, and pollen were considered. Subgroup analysis was performed to determine the prevalence of each type of allergen. The Egger test was used to assess publication bias. We included 44 studies in this meta-analysis. The overall prevalence of positive skin test results for at least one allergen was estimated to be 59% in patients with allergies in various parts of Iran. The number of patients was 11,646 (56% male and 44% female), with a mean age of 17.46±11.12 years. The most common allergen sources were pollen (47.0%), mites (35.2%), and food (15.3%). The prevalence of sensitization to food and cockroach allergens among children was greater than among adults. Pollen is the most common allergen sensitization in cities of Iran with a warm and dry climate; however, sensitization to house dust mites is predominant in northern and southern coastal areas of Iran.
Topics: Allergens; Animals; Food Hypersensitivity; Humans; Hypersensitivity; Iran; Skin Tests; Urban Health; Urban Population
PubMed: 28171712
DOI: 10.4178/epih.e2017007 -
The Cochrane Database of Systematic... Feb 2017Eczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and a considerable impact on quality of life. Moisturisation is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Eczema is a chronic skin disease characterised by dry skin, intense itching, inflammatory skin lesions, and a considerable impact on quality of life. Moisturisation is an integral part of treatment, but it is unclear if moisturisers are effective.
OBJECTIVES
To assess the effects of moisturisers for eczema.
SEARCH METHODS
We searched the following databases to December 2015: Cochrane Skin Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, the GREAT database. We searched five trials registers and checked references of included and excluded studies for further relevant trials.
SELECTION CRITERIA
Randomised controlled trials in people with eczema.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures.
MAIN RESULTS
We included 77 studies (6603 participants, mean age: 18.6 years, mean duration: 6.7 weeks). We assessed 36 studies as at a high risk of bias, 34 at unclear risk, and seven at low risk. Twenty-four studies assessed our primary outcome 'participant-assessed disease severity', 13 assessed 'satisfaction', and 41 assessed 'adverse events'. Secondary outcomes included investigator-assessed disease severity (addressed in 65 studies), skin barrier function (29), flare prevention (16), quality of life (10), and corticosteroid use (eight). Adverse events reporting was limited (smarting, stinging, pruritus, erythema, folliculitis).Six studies evaluated moisturiser versus no moisturiser. 'Participant-assessed disease severity' and 'satisfaction' were not assessed. Moisturiser use yielded lower SCORAD than no moisturiser (three studies, 276 participants, mean difference (MD) -2.42, 95% confidence interval (CI) -4.55 to -0.28), but the minimal important difference (MID) (8.7) was unmet. There were fewer flares with moisturisers (two studies, 87 participants, RR 0.40, 95% CI 0.23 to 0.70), time to flare was prolonged (median: 180 versus 30 days), and less topical corticosteroids were needed (two studies, 222 participants, MD -9.30 g, 95% CI -15.3 to -3.27). There was no statistically significant difference in adverse events (one study, 173 participants, risk ratio (RR) 15.34, 95% CI 0.90 to 261.64). Evidence for these outcomes was low quality.With Atopiclair (three studies), 174/232 participants experienced improvement in participant-assessed disease severity versus 27/158 allocated to vehicle (RR 4.51, 95% CI 2.19 to 9.29). Atopiclair decreased itching (four studies, 396 participants, MD -2.65, 95% CI -4.21 to -1.09) and achieved more frequent satisfaction (two studies, 248 participants, RR 2.14, 95% CI 1.58 to 2.89), fewer flares (three studies, 397 participants, RR 0.18, 95% CI 0.11 to 0.31), and lower EASI (four studies, 426 participants, MD -4.0, 95% CI -5.42 to -2.57), but MID (6.6) was unmet. The number of participants reporting adverse events was not statistically different (four studies, 430 participants, RR 1.03, 95% CI 0.79 to 1.33). Evidence for these outcomes was moderate quality.Participants reported skin improvement more frequently with urea-containing cream than placebo (one study, 129 participants, RR 1.28, 95% CI 1.06 to 1.53; low-quality evidence), with equal satisfaction between the two groups (one study, 38 participants, low-quality evidence). Urea-containing cream improved dryness (investigator-assessed) more frequently (one study, 128 participants, RR 1.40, 95% CI 1.14 to 1.71; moderate-quality evidence) with fewer flares (one study, 44 participants, RR 0.47, 95% CI 0.24 to 0.92; low-quality evidence), but more participants in this group reported adverse events (one study, 129 participants, RR 1.65, 95% CI 1.16 to 2.34; moderate-quality evidence).Three studies assessed glycerol-containing moisturiser versus vehicle or placebo. More participants in the glycerol group noticed skin improvement (one study, 134 participants, RR 1.22, 95% CI 1.01 to 1.48; moderate-quality evidence), and this group saw improved investigator-assessed SCORAD (one study, 249 participants, MD -2.20, 95% CI -3.44 to -0.96; high-quality evidence), but MID was unmet. Participant satisfaction was not addressed. The number of participants reporting adverse events was not statistically significant (two studies, 385 participants, RR 0.90, 95% CI 0.68 to 1.19; moderate-quality evidence).Four studies investigated oat-containing moisturisers versus no treatment or vehicle. No significant differences between groups were reported for participant-assessed disease severity (one study, 50 participants, RR 1.11, 95% CI 0.84 to 1.46; low-quality evidence), satisfaction (one study, 50 participants, RR 1.06, 95% CI 0.74 to 1.52; very low-quality evidence), and investigator-assessed disease severity (three studies, 272 participants, standardised mean difference (SMD) -0.23, 95% CI -0.66 to 0.21; low-quality evidence). In the oat group, there were fewer flares (one study, 43 participants, RR 0.31, 95% CI 0.12 to 0.7; low-quality evidence) and less topical corticosteroids needed (two studies, 222 participants, MD -9.30g, 95% CI 15.3 to -3.27; low-quality evidence), but more adverse events were reported (one study, 173 participants; Peto odds ratio (OR) 7.26, 95% CI 1.76 to 29.92; low-quality evidence).All moisturisers above were compared to placebo, vehicle, or no moisturiser. Participants considered moisturisers more effective in reducing eczema (five studies, 572 participants, RR 2.46, 95% CI 1.16 to 5.23; low-quality evidence) and itch (seven studies, 749 participants, SMD -1.10, 95% CI -1.83 to -0.38) than control. Participants in both treatment arms reported comparable satisfaction (three studies, 296 participants, RR 1.35, 95% CI 0.77 to 2.26; low-quality evidence). Moisturisers led to lower investigator-assessed disease severity (12 studies, 1281 participants, SMD -1.04, 95% CI -1.57 to -0.51; high-quality evidence) and fewer flares (six studies, 607 participants, RR 0.33, 95% CI 0.17 to 0.62; moderate-quality evidence), but there was no difference in adverse events (10 studies, 1275 participants, RR 1.03, 95% CI 0.82 to 1.30; moderate-quality evidence).Topical active treatment combined with moisturiser was more effective than active treatment alone in reducing investigator-assessed disease severity (three studies, 192 participants, SMD -0.87, 95% CI -1.17 to -0.57; moderate-quality evidence) and flares (one study, 105 participants, RR 0.43, 95% CI 0.20 to 0.93), and was preferred by participants (both low-quality evidence). There was no statistically significant difference in number of adverse events (one study, 125 participants, RR 0.39, 95% CI 0.13 to 1.19; very low-quality evidence). Participant-assessed disease severity was not addressed.
AUTHORS' CONCLUSIONS
Most moisturisers showed some beneficial effects, producing better results when used with active treatment, prolonging time to flare, and reducing the number of flares and amount of topical corticosteroids needed to achieve similar reductions in eczema severity. We did not find reliable evidence that one moisturiser is better than another.
Topics: Adrenal Cortex Hormones; Eczema; Emollients; Humans; Patient Satisfaction; Randomized Controlled Trials as Topic; Severity of Illness Index; Symptom Flare Up
PubMed: 28166390
DOI: 10.1002/14651858.CD012119.pub2 -
European Clinical Respiratory Journal 2015Fabry disease is an X-linked disorder caused by a deficiency of the lysosomal enzyme α-galactosidase A, resulting in accumulation of glycosphingolipids in multiple... (Review)
Review
BACKGROUND
Fabry disease is an X-linked disorder caused by a deficiency of the lysosomal enzyme α-galactosidase A, resulting in accumulation of glycosphingolipids in multiple organs, primarily heart, kidneys, skin, CNS, and lungs.
MATERIALS AND METHOD
A systematic literature search was performed using the PubMed database, leading to a total number of 154 hits. Due to language restriction, this number was reduced to 135; 53 papers did not concern Fabry disease, 19 were either animal studies or gene therapy studies, and 36 papers did not have lung involvement in Fabry disease as a topic. The remaining 27 articles were relevant for this review.
RESULTS
The current literature concerning lung manifestations describes various respiratory symptoms such as dyspnoea or shortness of breath, wheezing, and dry cough. These symptoms are often related to cardiac involvement in Fabry disease as respiratory examinations are seldom performed. Pulmonary function tests primarily show obstructive airway limitation, but a few articles also report of patients with restrictive limitation and a mixture of both. No significant association has been found between smoking and the development of symptoms or spirometry abnormalities in patients with Fabry disease. Electron microscopy of lung biopsy and induced sputum show lamellar inclusion bodies (Zebra bodies) in the cytoplasm of cells in the airway wall. X-ray and CT scan have shown patchy ground-glass pulmonary infiltrations, fibrosis, and air trapping. Fibrosis diagnosed by high-resolution CT has not been significantly correlated with lung spirometry.
CONCLUSION
Consistent findings have not been shown in the current literature. Pulmonary function tests and registration of symptoms showed various results; however, there is a trend towards obstructive airway limitation in patients with Fabry disease. Further studies are needed to evaluate pathogenesis, progression, and the effects of treatment.
PubMed: 26557248
DOI: 10.3402/ecrj.v2.26721 -
International Wound Journal Dec 2016Advances in preoperative care, surgical techniques and technologies have enabled surgeons to achieve primary closure in a high percentage of surgical procedures.... (Review)
Review
Improving wound healing and preventing surgical site complications of closed surgical incisions: a possible role of Incisional Negative Pressure Wound Therapy. A systematic review of the literature.
Advances in preoperative care, surgical techniques and technologies have enabled surgeons to achieve primary closure in a high percentage of surgical procedures. However, often, underlying patient comorbidities in addition to surgical-related factors make the management of surgical wounds primary closure challenging because of the higher risk of developing complications. To date, extensive evidence exists, which demonstrate the benefits of negative pressure dressing in the treatment of open wounds; recently, Incisional Negative Pressure Wound Therapy (INPWT) technology as delivered by Prevena™ (KCI USA, Inc., San Antonio, TX) and Pico (Smith & Nephew Inc, Andover, MA) systems has been the focus of a new investigation on possible prophylactic measures to prevent complications via application immediately after surgery in high-risk, clean, closed surgical incisions. A systematic review was performed to evaluate INPWT's effect on surgical sites healing by primary intention. The primary outcomes of interest are an understanding of INPWT functioning and mechanisms of action, extrapolated from animal and biomedical engineering studies and incidence of complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence or blistering) and other variables influenced by applying INPWT (re-operation and re-hospitalization rates, time to dry wound, cost saving) extrapolated from human studies. A search was conducted for published articles in various databases including PubMed, Google Scholar and Scopus Database from 2006 to March 2014. Supplemental searches were performed using reference lists and conference proceedings. Studies selection was based on predetermined inclusion and exclusion criteria and data extraction regarding study quality, model investigated, epidemiological and clinical characteristics and type of surgery, and the outcomes were applied to all the articles included. 1 biomedical engineering study, 2 animal studies, 15 human studies for a total of 6 randomized controlled trials, 5 prospective cohort studies, 7 retrospective analyses, were included. Human studies investigated the outcomes of 1042 incisions on 1003 patients. The literature shows a decrease in the incidence of infection, sero-haematoma formation and on the re-operation rates when using INPWT. Lower level of evidence was found on dehiscence, decreased in some studies, and was inconsistent to make a conclusion. Because of limited studies, it is difficult to make any assertions on the other variables, suggesting a requirement for further studies for proper recommendations on INPWT.
Topics: Animals; Female; Humans; Male; Negative-Pressure Wound Therapy; Prognosis; Quality Improvement; Risk Assessment; Surgical Wound; Surgical Wound Infection; Wound Healing
PubMed: 26424609
DOI: 10.1111/iwj.12492 -
The Cochrane Database of Systematic... Sep 2015Most surgical procedures involve a cut in the skin that allows the surgeon to gain access to the deeper tissues or organs. Most surgical wounds are closed fully at the... (Review)
Review
BACKGROUND
Most surgical procedures involve a cut in the skin that allows the surgeon to gain access to the deeper tissues or organs. Most surgical wounds are closed fully at the end of the procedure (primary closure). The surgeon covers the closed surgical wound with either a dressing or adhesive tape. The dressing can act as a physical barrier to protect the wound until the continuity of the skin is restored (within about 48 hours) and to absorb exudate from the wound, keeping it dry and clean, and preventing bacterial contamination from the external environment. Some studies have found that the moist environment created by some dressings accelerates wound healing, although others believe that the moist environment can be a disadvantage, as excessive exudate can cause maceration (softening and deterioration) of the wound and the surrounding healthy tissue. The utility of dressing surgical wounds beyond 48 hours of surgery is, therefore, controversial.
OBJECTIVES
To evaluate the benefits and risks of removing a dressing covering a closed surgical incision site within 48 hours permanently (early dressing removal) or beyond 48 hours of surgery permanently with interim dressing changes allowed (delayed dressing removal), on surgical site infection.
SEARCH METHODS
In March 2015 we searched the following electronic databases: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also searched the references of included trials to identify further potentially-relevant trials.
SELECTION CRITERIA
Two review authors independently identified studies for inclusion. We included all randomised clinical trials (RCTs) conducted with people of any age and sex, undergoing a surgical procedure, who had their wound closed and a dressing applied. We included only trials that compared early versus delayed dressing removal. We excluded trials that included people with contaminated or dirty wounds. We also excluded quasi-randomised studies, and other study designs.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data on the characteristics of the trial participants, risk of bias in the trials and outcomes for each trial. We calculated risk ratios (RR) with 95% confidence intervals (CI) for binary outcomes and mean difference (MD) with 95% CI for continuous outcomes. We used RevMan 5 software to perform these calculations.
MAIN RESULTS
Four trials were identified for inclusion in this review. All the trials were at high risk of bias. Three trials provided information for this review. Overall, this review included 280 people undergoing planned surgery. Participants were randomised to early dressing removal (removal of the wound dressing within the 48 hours following surgery) (n = 140) or delayed dressing removal (continued dressing of the wound beyond 48 hours) (n = 140) in the three trials. There were no statistically significant differences between the early dressing removal group and delayed dressing removal group in the proportion of people who developed superficial surgical site infection within 30 days (RR 0.64; 95% CI 0.32 to 1.28), superficial wound dehiscence within 30 days (RR 2.00; 95% CI 0.19 to 21.16) or serious adverse events within 30 days (RR 0.83; 95% CI 0.28 to 2.51). No deep wound infection or deep wound dehiscence occurred in any of the participants in the trials that reported this outcome. None of the trials reported quality of life. The hospital stay was significantly shorter (MD -2.00 days; 95% CI -2.82 to -1.18) and the total cost of treatment significantly less (MD EUR -36.00; 95% CI -59.81 to -12.19) in the early dressing removal group than in the delayed dressing removal group in the only trial that reported these outcomes.
AUTHORS' CONCLUSIONS
The early removal of dressings from clean or clean contaminated surgical wounds appears to have no detrimental effect on outcomes. However, it should be noted that the point estimate supporting this statement is based on very low quality evidence from three small randomised controlled trials, and the confidence intervals around this estimate were wide. Early dressing removal may result in a significantly shorter hospital stay, and significantly reduced costs, than covering the surgical wound with wound dressings beyond the first 48 hours after surgery, according to very low quality evidence from one small randomised controlled trial. Further randomised controlled trials of low risk of bias are necessary to investigate whether dressings are necessary after 48 hours in different types of surgery and levels of contamination and investigate whether antibiotic therapy influences the outcome.
Topics: Bandages; Early Medical Intervention; Hospital Costs; Humans; Length of Stay; Randomized Controlled Trials as Topic; Surgical Wound Dehiscence; Surgical Wound Infection; Time Factors; Wound Closure Techniques; Wound Healing
PubMed: 26331392
DOI: 10.1002/14651858.CD010259.pub3