-
BMC Pediatrics Jun 2016Many clinicians have concerns about the safety of atopic dermatitis (AD) treatments, particularly in children requiring long-term daily maintenance therapy. Topical... (Comparative Study)
Comparative Study Review
BACKGROUND
Many clinicians have concerns about the safety of atopic dermatitis (AD) treatments, particularly in children requiring long-term daily maintenance therapy. Topical corticosteroids (TCS) have been widely used for >5 decades. Long-term TCS monotherapy has been associated with adverse cutaneous effects including atrophy, rebound flares, and increased percutaneous absorption with potential for adverse systemic effects. Topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, available for 1-2 decades, are not associated with atrophy or increased percutaneous absorption after prolonged use and have much lower potential for systemic effects. However, since 2006 TCIs have carried a controversial Boxed Warning based on a theoretical risk of malignancy (eg, skin and lymphoma) that has limited TCI use for standard-of-care maintenance therapy.
METHODS
A comparative systematic search of PubMed was done for long-term (≥12 week) clinical trials of TCS or TCI treatment in patients <12 years with AD. Citations were reviewed for inclusion based on MeSH terms, abstracts, and relevant article text. Studies were excluded if they did not encompass subjects <12 years, or were <12 weeks' duration, retrospective, meta-analyses, or limited to anecdotal case reports.
RESULTS
Of 27 trials meeting criteria, 21 included 5825 pediatric patients treated with TCIs, and 6 included 1999 patients treated with TCS. TCS studies were limited to low- to mid-potency products, and all but one study lacked a vehicle control. Eight TCI studies were vehicle-controlled, and safety data were well reported, with ≤5 % of patients reporting discontinuation due to adverse effects (DAEs). Cutaneous and systemic adverse events (AEs) were similar in TCI and vehicle groups, with no reports of lymphoma. Safety data in TCS trials were less well reported. DAE incidence was addressed in just 2 trials, and systemic and cutaneous AEs were mostly unreported.
CONCLUSIONS
Data supporting long-term use of TCIs are robust, documenting safety and efficacy, while data supporting long-term TCS use are limited to low- to mid-potency products. Our review identifies a lack of information on the safety of commonly prescribed, long-term monotherapy with mid- to high-potency TCS in pediatric AD, and supports standard-of-care maintenance therapy with TCIs and intermittent use of low- to mid-potency TCS for flares.
Topics: Administration, Cutaneous; Adrenal Cortex Hormones; Calcineurin Inhibitors; Child; Dermatitis, Atopic; Dermatologic Agents; Humans; Treatment Outcome
PubMed: 27267134
DOI: 10.1186/s12887-016-0607-9 -
The Cochrane Database of Systematic... Jan 2020Onychomycosis refers to fungal infections of the nail apparatus that may cause pain, discomfort, and disfigurement. This is an update of a Cochrane Review published in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Onychomycosis refers to fungal infections of the nail apparatus that may cause pain, discomfort, and disfigurement. This is an update of a Cochrane Review published in 2007; a substantial amount of new research warrants a review exclusively on toenails.
OBJECTIVES
To assess the clinical and mycological effects of topical drugs and device-based therapies for toenail onychomycosis.
SEARCH METHODS
We searched the following databases up to May 2019: the Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase and LILACS. We also searched five trials registers, and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials.
SELECTION CRITERIA
Randomised controlled trials of topical and device-based therapies for onychomycosis in participants with toenail onychomycosis, confirmed by positive cultures, direct microscopy, or histological nail examination. Eligible comparators were placebo, vehicle, no treatment, or an active topical or device-based treatment.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes were complete cure rate (normal-looking nail plus fungus elimination, determined with laboratory methods) and number of participants reporting treatment-related adverse events.
MAIN RESULTS
We included 56 studies (12,501 participants, average age: 27 to 68 years), with mainly mild-to-moderate onychomycosis without matrix involvement (where reported). Participants had more than one toenail affected. Most studies lasted 48 to 52 weeks; 23% reported disease duration (variable). Thirty-five studies specifically examined dermatophyte-caused onychomycosis. Forty-three studies were carried out in outpatient settings. Most studies assessed topical treatments, 9% devices, and 11% both. We rated three studies at low risk of bias across all domains. The most common high-risk domain was performance bias. We present results for key comparisons, where treatment duration was 36 or 48 weeks, and clinical outcomes were measured at 40 to 52 weeks. Based on two studies (460 participants), compared with vehicle, ciclopirox 8% lacquer may be more effective in achieving complete cure (risk ratio (RR) 9.29, 95% confidence interval (CI) 1.72 to 50.14; low-quality evidence) and is probably more effective in achieving mycological cure (RR 3.15, 95% CI 1.93 to 5.12; moderate-quality evidence). Ciclopirox lacquer may lead to increased adverse events, commonly application reactions, rashes, and nail alteration (e.g. colour, shape). However, the 95% CI indicates that ciclopirox lacquer may actually make little or no difference (RR 1.61, 95% CI 0.89 to 2.92; low-quality evidence). Efinaconazole 10% solution is more effective than vehicle in achieving complete cure (RR 3.54, 95% CI 2.24 to 5.60; 3 studies, 1716 participants) and clinical cure (RR 3.07, 95% CI 2.08 to 4.53; 2 studies, 1655 participants) (both high-quality evidence) and is probably more effective in achieving mycological cure (RR 2.31, 95% CI 1.08 to 4.94; 3 studies, 1716 participants; moderate-quality evidence). Risk of adverse events (such as dermatitis and vesicles) was slightly higher with efinaconazole (RR 1.10, 95% CI 1.01 to 1.20; 3 studies, 1701 participants; high-quality evidence). No other key comparison measured clinical cure. Based on two studies, compared with vehicle, tavaborole 5% solution is probably more effective in achieving complete cure (RR 7.40, 95% CI 2.71 to 20.24; 1198 participants), but probably has a higher risk of adverse events (application site reactions were most commonly reported) (RR 3.82, 95% CI 1.65 to 8.85; 1186 participants (both moderate-quality evidence)). Tavaborole improves mycological cure (RR 3.40, 95% CI 2.34 to 4.93; 1198 participants; high-quality evidence). Moderate-quality evidence from two studies (490 participants) indicates that P-3051 (ciclopirox 8% hydrolacquer) is probably more effective than the comparators ciclopirox 8% lacquer or amorolfine 5% in achieving complete cure (RR 2.43, 95% CI 1.32 to 4.48), but there is probably little or no difference between the treatments in achieving mycological cure (RR 1.08, 95% CI 0.85 to 1.37). We found no difference in the risk of adverse events (RR 0.60, 95% CI 0.19 to 1.92; 2 studies, 487 participants; low-quality evidence). The most common events were erythema, rash, and burning. Three studies (112 participants) compared 1064-nm Nd:YAG laser to no treatment or sham treatment. We are uncertain if there is a difference in adverse events (very low-quality evidence) (two studies; 85 participants). There may be little or no difference in mycological cure at 52 weeks (RR 1.04, 95% CI 0.59 to 1.85; 2 studies, 85 participants; low-quality evidence). Complete cure was not measured. One study (293 participants) compared luliconazole 5% solution to vehicle. We are uncertain whether luliconazole leads to higher rates of complete cure (very low-quality evidence). Low-quality evidence indicates there may be little or no difference in adverse events (RR 1.02, 95% CI 0.90 to 1.16) and there may be increased mycological cure with luliconazole; however, the 95% CI indicates that luliconazole may make little or no difference to mycological cure (RR 1.39, 95% CI 0.98 to 1.97). Commonly-reported adverse events were dry skin, paronychia, eczema, and hyperkeratosis, which improved or resolved post-treatment.
AUTHORS' CONCLUSIONS
Assessing complete cure, high-quality evidence supports the effectiveness of efinaconazole, moderate-quality evidence supports P-3051 (ciclopirox 8% hydrolacquer) and tavaborole, and low-quality evidence supports ciclopirox 8% lacquer. We are uncertain whether luliconazole 5% solution leads to complete cure (very low-quality evidence); this outcome was not measured by the 1064-nm Nd:YAG laser comparison. Although evidence supports topical treatments, complete cure rates with topical treatments are relatively low. We are uncertain if 1064-nm Nd:YAG laser increases adverse events compared with no treatment or sham treatment (very low-quality evidence). Low-quality evidence indicates that there is no difference in adverse events between P-3051 (ciclopirox hydrolacquer), luliconazole 5% solution, and their comparators. Ciclopirox 8% lacquer may increase adverse events (low-quality evidence). High- to moderate-quality evidence suggests increased adverse events with efinaconazole 10% solution or tavaborole 5% solution. We downgraded evidence for heterogeneity, lack of blinding, and small sample sizes. There is uncertainty about the effectiveness of device-based treatments, which were under-represented; 80% of studies assessed topical treatments, but we were unable to evaluate all of the currently relevant topical treatments. Future studies of topical and device-based therapies should be blinded, with patient-centred outcomes and an adequate sample size. They should specify the causative organism and directly compare treatments.
Topics: Administration, Topical; Adult; Aged; Antifungal Agents; Female; Humans; Male; Middle Aged; Onychomycosis; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 31978269
DOI: 10.1002/14651858.CD012093.pub2 -
Journal of Drugs in Dermatology : JDD May 2023Allergic contact dermatitis (ACD) may occur secondary to topical corticosteroids. This may be due to topical corticosteroids containing potential allergens in their...
BACKGROUND
Allergic contact dermatitis (ACD) may occur secondary to topical corticosteroids. This may be due to topical corticosteroids containing potential allergens in their vehicles. Variation of allergenic ingredients among various brands of a product has not been well characterized.
OBJECTIVE
This study aimed to assess the frequency of allergenic ingredients in various brands and manufacturers of clobetasol propionate.
METHODS
Common brands of clobetasol propionate were identified online on GoodRx website. Then, ingredient lists for these products were obtained from the US Food & Drug Administration’s Online Label Repository via a proprietary name search. A systematic literature review was performed using the ingredient name on Medline (PubMed) database to find reports of ACD confirmed by patch testing.
CONCLUSIONS
Forty-nine different ingredients were identified among all 18 products included, with an average of 8.4 ingredients per product; 19 of these ingredients have allergenic potential, while one has protective effects. Two branded foam formulations contained the greatest number of potential allergens (5), while a shampoo formulation contained no potential allergens. Knowing which allergens are present in different products may be helpful when treating a patient with an allergy or suspected allergy to one of these ingredients. J Drugs Dermatol. 2023;22(5): doi:10.36849/JDD.4651.
Topics: Humans; Allergens; Clobetasol; Dermatitis, Allergic Contact; Glucocorticoids; Pharmaceutical Vehicles
PubMed: 37133477
DOI: 10.36849/JDD.4651 -
Cardiovascular & Hematological... 2017Atherosclerosis is a chronic inflammatory condition causing very high morbidity and mortality. It is characterized by accumulation of plaques within arteries.... (Review)
Review
BACKGROUND
Atherosclerosis is a chronic inflammatory condition causing very high morbidity and mortality. It is characterized by accumulation of plaques within arteries. Nanomedicine is an emerging field of medicine utilizing nanotechnology for advanced imaging and therapy. Nanomedicine has led to significant developments in the field of cardiovascular diseases, including atherosclerosis. Many nanoformulations have been developed with anti-atherosclerotic effects. Nanomedicine tools have been used in the imaging of atherosclerosis. Various nanocarriers have been employed for successful localization in atherosclerotic lesions. The biggest challenge for such delivery vehicles has been localization to atherosclerosis lesions. Several strategies have been employed to overcome these defects. Strategies have also been developed for stabilization of atherosclerotic lesions.
CONCLUSION
Nanotechnology is also an important tool for the development of novel biomarkers. At the same time there are also potential limitations. Toxicity, lack of translation from preclinical phase to clinical development, and the inability to address the chronic phase of atherosclerosis are the most important among them. Future toxicity studies shall enlighten us further on this exciting research area.
Topics: Animals; Atherosclerosis; Biomarkers; Drug Delivery Systems; Humans; Magnetic Resonance Imaging; Nanomedicine; Nanoparticles; Tomography, Emission-Computed
PubMed: 28925905
DOI: 10.2174/1871529X17666170918142653 -
Medication use and the risk of motor vehicle collisions among licensed drivers: A systematic review.Accident; Analysis and Prevention Nov 2016Driving under the influence of prescription and over-the-counter medication is a growing public health concern. A systematic review of the literature was performed to... (Review)
Review
OBJECTIVES
Driving under the influence of prescription and over-the-counter medication is a growing public health concern. A systematic review of the literature was performed to investigate which specific medications were associated with increased risk of motor vehicle collision (MVC).
METHODS
The a priori inclusion criteria were: (1) studies published from English-language sources on or after January 1, 1960, (2) licensed drivers 15 years of age and older, (3) peer-reviewed publications, master's theses, doctoral dissertations, and conference papers, (4) studies limited to randomized control trials, cohort studies, case-control studies, or case-control type studies (5) outcome measure reported for at least one specific medication, (6) outcome measure reported as the odds or risk of a motor vehicle collision. Fourteen databases were examined along with hand-searching. Independent, dual selection of studies and data abstraction was performed.
RESULTS
Fifty-three medications were investigated by 27 studies included in the review. Fifteen (28.3%) were associated with an increased risk of MVC. These included Buprenorphine, Codeine, Dihydrocodeine, Methadone, Tramadol, Levocitirizine, Diazepam, Flunitrazepam, Flurazepam, Lorazepam, Temazepam, Triazolam, Carisoprodol, Zolpidem, and Zopiclone.
CONCLUSIONS
Several medications were associated with an increased risk of MVC and decreased driving ability. The associations between specific medication use and the increased risk of MVC and/or affected driving ability are complex. Future research opportunities are plentiful and worthy of such investigation.
Topics: Accidents, Traffic; Adult; Analgesics, Opioid; Antidepressive Agents; Automobile Driving; Cohort Studies; Dose-Response Relationship, Drug; Driving Under the Influence; Humans; Male; Middle Aged; Motor Vehicles; Risk Factors; Young Adult
PubMed: 27569655
DOI: 10.1016/j.aap.2016.08.001 -
International Journal of Dental Hygiene Aug 2014The purpose of this review was to systematically evaluate the effects of an alcohol vehicle solution (V-Sol) compared with an essential-oils mouthwash (EOMW) and if... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
The purpose of this review was to systematically evaluate the effects of an alcohol vehicle solution (V-Sol) compared with an essential-oils mouthwash (EOMW) and if available with a water-based control (WC) on plaque, gingival inflammation parameters and extrinsic tooth staining.
MATERIALS AND METHODS
The PubMed-MEDLINE, Cochrane-CENTRAL and EMBASE databases were searched. Where appropriate, a meta-analysis was performed, and difference of means (DIFFM) as calculated.
RESULTS
In total, 971 unique papers were found of which five met the eligibility criteria. The DIFFM of the meta-analysis of four 6-month studies showed that the EOMW provided significantly better plaque control (DIFFM = 0.39, P < 0.00001) and gingival inflammation reduction as measured by the Löe and Silness Index (DIFFM = 0.36, P = 0.00001) as compared to the V-Sol. Regarding extrinsic tooth staining, a small but significant difference (DIFFM = -0.08, P = 0.03) was observed.
CONCLUSION
Limited data, but with a low risk of bias, were available to assess the potential benefit of the alcohol-containing V-Sol. 'High'- and 'moderate'-quality data were available for the analysis of plaque and gingivitis, respectively. Within these limitations, EOMW appears to provide a significant oral health benefit during the 6 months of use. The data retrieved for this review suggest that the essential oils produce an effect on plaque and gingivitis that extends beyond the V-Sol. Furthermore, the V-Sol proved to be no different from a WC.
Topics: Dental Plaque; Drug Combinations; Gingivitis; Humans; Mouthwashes; Oils, Volatile; Periodontal Index; Pharmaceutical Vehicles; Phenols; Salicylates; Terpenes
PubMed: 24720368
DOI: 10.1111/idh.12069 -
The International Journal on Drug Policy Mar 2022Children are often exposed to increased rates of secondary harm such as physical harm, motor vehicle incidents, maltreatment, and neglect because of others' or their own... (Review)
Review
BACKGROUND
Children are often exposed to increased rates of secondary harm such as physical harm, motor vehicle incidents, maltreatment, and neglect because of others' or their own alcohol consumption. Alcohol supply reduction, or alcohol control policies, are often enacted to mitigate alcohol harms within the community. The current systematic narrative review aims to synthesise recent literature that examines how alcohol supply reduction policies impact the physical health, mental health, and offending behaviour of children and adolescents.
METHODS
Eight databases and grey literature sources were systematically searched, and results were synthesised by policy under evaluation. Twenty-one peer reviewed articles and ten grey literature articles were included after screening of 7,135 original articles. Included articles examined the alcohol control policies of the minimum legal drinking age, price control, and trading restrictions, with the most common outcomes under evaluation being related to the physical health or offending behaviour of adolescents.
RESULTS
Overall, the current review identified that the impact of alcohol policy on children and adolescents varied depending on the policy type, policy environment and assessed outcome. Common limitations within the literature include inability to control for covariates, use of alcohol related outcomes unsuitable to children and adolescents, and use of cross-sectional data and regression-discontinuity analysis in lieu of actual policy changes.
CONCLUSIONS
The current review highlights the need to further evaluate the impact of actual alcohol-related policy changes on children and adolescents.
Topics: Adolescent; Alcohol Drinking; Child; Cross-Sectional Studies; Humans; Public Policy; Underage Drinking
PubMed: 35065451
DOI: 10.1016/j.drugpo.2022.103581 -
Addiction Biology Jan 2024Driving is a critical everyday task necessitating the rapid and seamless integration of dynamic visually derived information to guide neurobehaviour. Biological markers... (Review)
Review
Driving is a critical everyday task necessitating the rapid and seamless integration of dynamic visually derived information to guide neurobehaviour. Biological markers are frequently employed to detect Δ9-tetrahydrocannabinol (THC) consumption among drivers during roadside tests, despite not necessarily indicating impairment. Characterising THC-specific alterations to oculomotor behaviour may offer a more sensitive measure for indexing drug-related impairment, necessitating discrimination between acute THC effects, chronic use and potential tolerance effects. The present review aims to synthesise current evidence on the acute and chronic effects of THC on driving-relevant oculomotor behaviour. The review was prospectively registered (10.17605/OSF.IO/A4H9W), and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines informed reporting standards. Overall, 20 included articles comprising 12 experimental acute dosing trials, 5 cross-sectional chronic use studies and 3 roadside epidemiological studies examined the effects of cannabis/THC on oculomotor parameters including saccadic activity gaze behaviour, nystagmus, smooth pursuit and eyelid/blink characteristics. Acute THC consumption selectively impacts oculomotor control, notably increasing saccadic latency and inaccuracy and impairing inhibitory control. Chronic cannabis users, especially those with early age of use onset, display enduring oculomotor deficits that affect visual scanning efficiency. The presence of eyelid tremors appears to be a reliable indicator of cannabis consumption while remaining distinct from direct impairment associated with visual attention and motor control. Cannabis selectively influences oculomotor activity relevant to driving, highlighting the role of cannabinoid systems in these processes. Defining cannabis/THC-specific changes in oculomotor control may enhance the precision of roadside impairment assessments and vehicle safety systems to detect drug-related impairment and assess driving fitness.
Topics: Cannabis; Dronabinol; Cross-Sectional Studies; Cannabinoids; Cannabinoid Receptor Agonists
PubMed: 38221807
DOI: 10.1111/adb.13359 -
Accident; Analysis and Prevention May 2017Driving simulators are used in a wide range of research settings to help develop an understanding of driver behavior in complex environments. Acute alcohol impairment is... (Meta-Analysis)
Meta-Analysis Review
Driving simulators are used in a wide range of research settings to help develop an understanding of driver behavior in complex environments. Acute alcohol impairment is an important research topic for traffic safety and a large number of studies have indicated levels of simulated driving impairment imposed by alcohol across a range of performance outcome variables. The aim of the present study was to examine the impact of acute alcohol consumption on simulated driving performance by conducting a systematic review and meta-analysis of the available evidence. The online databases PubMed (MEDLINE), Web of Science (via Thomas Reuters) and Scopus were searched to identify studies that measured simulated car driving performance under control ('no alcohol' or 'placebo alcohol' ingestion) and intervention (acute alcohol ingestion) conditions, using repeated-measures experimental designs. Primary research outcomes were standard deviation of lane position (SDLP) and standard deviation of speed (SDSP); (total number of lane crossings (LC) and average speed (Speed) were secondary research outcomes). Meta-analytic procedures were used to quantify the effect of acute alcohol consumption on vehicle control, and to determine the influence of methodological variables (i.e. the duration of the simulated driving task, the limb of the BAC curve (ascending vs. descending) and the type of driving simulator employed (i.e. car vs. PC-based)) on the magnitude of the performance change due to alcohol consumption. 423 records were screened, and 50 repeated-measures trials (n=962 participants, 62% male) derived from 17 original publications were reviewed. 37 trials (n=721 participants) used a 'placebo alcohol' comparator to determine the effect of alcohol consumption on SDLP (32/37) and SDSP (22/37). Alcohol consumption significantly increased SDLP by 4.0±0.5cm (95% CI: 3.0, 5.1) and SDSP by 0.38±0.10km⋅h (95% CI: 0.19, 0.57). Regression analyses indicate BAC (p=0.004) and driving simulator platform (p<0.001) influence the magnitude of the SDLP change, such that higher BAC levels and the use of PC-based driving simulators were associated with larger performance decrements (R=0.80). The limb of the BAC curve and the duration of the driving task did not significantly alter the magnitude of the performance change. Eleven trials (n=205 participants) used a 'no alcohol' comparator to measure the effect of alcohol consumption on SDLP (10/11); few trials assessed SDSP (3/11). Alcohol consumption resulted in a small significant increase in SDLP under these conditions (standardized difference in means=0.23, 95% CI: 0.06, 0.39). These results demonstrate that lateral (SDLP and LC) and longitudinal (SDSP) vehicle control measures in a driving simulator are impaired with acute alcohol consumption. However, SDLP appears to be a more sensitive indicator of driving impairment than other driving performance variables and the results of the present study support its use as a performance outcome when examining alcohol-induced simulated driving impairment.
Topics: Adult; Alcohol Drinking; Blood Alcohol Content; Computer Simulation; Dangerous Behavior; Driving Under the Influence; Ethanol; Female; Humans; Male; Psychomotor Performance; Young Adult
PubMed: 28343124
DOI: 10.1016/j.aap.2017.03.001 -
The Cochrane Database of Systematic... May 2015Seborrhoeic dermatitis is a chronic inflammatory skin condition that is distributed worldwide. It commonly affects the scalp, face and flexures of the body. Treatment... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Seborrhoeic dermatitis is a chronic inflammatory skin condition that is distributed worldwide. It commonly affects the scalp, face and flexures of the body. Treatment options include antifungal drugs, steroids, calcineurin inhibitors, keratolytic agents and phototherapy.
OBJECTIVES
To assess the effects of antifungal agents for seborrhoeic dermatitis of the face and scalp in adolescents and adults.A secondary objective is to assess whether the same interventions are effective in the management of seborrhoeic dermatitis in patients with HIV/AIDS.
SEARCH METHODS
We searched the following databases up to December 2014: the Cochrane Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 11), MEDLINE (from 1946), EMBASE (from 1974) and Latin American Caribbean Health Sciences Literature (LILACS) (from 1982). We also searched trials registries and checked the bibliographies of published studies for further trials.
SELECTION CRITERIA
Randomised controlled trials of topical antifungals used for treatment of seborrhoeic dermatitis in adolescents and adults, with primary outcome measures of complete clearance of symptoms and improved quality of life.
DATA COLLECTION AND ANALYSIS
Review author pairs independently assessed eligibility for inclusion, extracted study data and assessed risk of bias of included studies. We performed fixed-effect meta-analysis for studies with low statistical heterogeneity and used a random-effects model when heterogeneity was high.
MAIN RESULTS
We included 51 studies with 9052 participants. Of these, 45 trials assessed treatment outcomes at five weeks or less after commencement of treatment, and six trials assessed outcomes over a longer time frame. We believe that 24 trials had some form of conflict of interest, such as funding by pharmaceutical companies.Among the included studies were 12 ketoconazole trials (N = 3253), 11 ciclopirox trials (N = 3029), two lithium trials (N = 141), two bifonazole trials (N = 136) and one clotrimazole trial (N = 126) that compared the effectiveness of these treatments versus placebo or vehicle. Nine ketoconazole trials (N = 632) and one miconazole trial (N = 47) compared these treatments versus steroids. Fourteen studies (N = 1541) compared one antifungal versus another or compared different doses or schedules of administration of the same agent versus one another. KetoconazoleTopical ketoconazole 2% treatment showed a 31% lower risk of failed clearance of rashes compared with placebo (risk ratio (RR) 0.69, 95% confidence interval (CI) 0.59 to 0.81, eight studies, low-quality evidence) at four weeks of follow-up, but the effect on side effects was uncertain because evidence was of very low quality (RR 0.97, 95% CI 0.58 to 1.64, six studies); heterogeneity between studies was substantial (I² = 74%). The median proportion of those who did not have clearance in the placebo groups was 69%.Ketoconazole treatment resulted in a remission rate similar to that of steroids (RR 1.17, 95% CI 0.95 to 1.44, six studies, low-quality evidence), but occurrence of side effects was 44% lower in the ketoconazole group than in the steroid group (RR 0.56, 95% CI 0.32 to 0.96, eight studies, moderate-quality evidence).Ketoconozale yielded a similar remission failure rate as ciclopirox (RR 1.09, 95% CI 0.95 to 1.26, three studies, low-quality evidence). Most comparisons between ketoconazole and other antifungals were based on single studies that showed comparability of treatment effects. CiclopiroxCiclopirox 1% led to a lower failed remission rate than placebo at four weeks of follow-up (RR 0.79, 95% CI 0.67 to 0.94, eight studies, moderate-quality evidence) with similar rates of side effects (RR 0.9, 95% CI 0.72 to 1.11, four studies, moderate-quality evidence). Other antifungalsClotrimazole and miconazole efficacies were comparable with those of steroids on short-term assessment in single studies.Treatment effects on individual symptoms were less clear and were inconsistent, possibly because of difficulties encountered in measuring these symptoms.Evidence was insufficient to conclude that dose or mode of delivery influenced treatment outcome. Only one study reported on treatment compliance. No study assessed quality of life. One study assessed the maximum rash-free period but provided insufficient data for analysis. One small study in patients with HIV compared the effect of lithium versus placebo on seborrhoeic dermatitis of the face, but treatment outcomes were similar.
AUTHORS' CONCLUSIONS
Ketoconazole and ciclopirox are more effective than placebo, but limited evidence suggests that either of these agents is more effective than any other agent within the same class. Very few studies have assessed symptom clearance for longer periods than four weeks. Ketoconazole produced findings similar to those of steroids, but side effects were fewer. Treatment effect on overall quality of life remains unknown. Better outcome measures, studies of better quality and better reporting are all needed to improve the evidence base for antifungals for seborrhoeic dermatitis.
Topics: Adolescent; Adult; Antifungal Agents; Ciclopirox; Clotrimazole; Dermatitis, Seborrheic; Facial Dermatoses; Humans; Ketoconazole; Lithium Compounds; Miconazole; Pyridones; Randomized Controlled Trials as Topic; Scalp Dermatoses; Solanum; Steroids
PubMed: 25933684
DOI: 10.1002/14651858.CD008138.pub3