-
The Annals of Pharmacotherapy Mar 2022This article reviews the pharmacology, safety, efficacy, and clinical importance of abametapir 0.74% (Xeglyze) for the treatment of head lice.
OBJECTIVE
This article reviews the pharmacology, safety, efficacy, and clinical importance of abametapir 0.74% (Xeglyze) for the treatment of head lice.
DATA SOURCES
From 2020 to May 2021, a systematic review of the MEDLINE and EMBASE databases was conducted using the terms , , , and . Bibliographies, Food and Drug Administration (FDA) drug package inserts, and ClinicalTrials.gov were searched for further information.
STUDY SELECTION AND DATA EXTRACTION
All relevant full-text articles in English were considered for inclusion, with a final article date range of 1999 to 2020.
DATA SYNTHESIS
Abametapir chelates heavy metal cations and inhibits metalloproteinases critical to louse ova development, hatching, and adult survival. In phase II, abametapir had direct ovicidal activity inhibiting 100% of treated louse eggs from hatching, compared with 64% in the vehicle-treated group. In two identical phase III clinical trials, subjects treated with a single 10-minute application of abametapir had greater treatment success compared with vehicle-treated subjects, with 81.1% success versus 50.9% in study 1 ( = 0.001) and 81.8% versus 47.2% in study 2 ( < 0.001). Abametapir was well tolerated, with only mild adverse effects.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE
Abametapir is a newly FDA-approved, single-application treatment for head lice in patients aged 6 months and older. This review highlights the safety and efficacy of abametapir in the treatment of head lice.
CONCLUSIONS
In the wake of increasing widespread resistance to first-line treatment options, abametapir offers a safe and effective new treatment option for head lice infestations.
Topics: Adult; Animals; Humans; Infant; Insecticides; Lice Infestations; Pediculus; Pharmaceutical Preparations; Treatment Outcome
PubMed: 34157881
DOI: 10.1177/10600280211027968 -
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 -
The British Journal of Dermatology Sep 2008Placebo-controlled trials are useful in identifying effective treatments where none has existed, but their continued use once efficacy is established arguably... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Placebo-controlled trials are useful in identifying effective treatments where none has existed, but their continued use once efficacy is established arguably contravenes ethical standards for medical research.
OBJECTIVES
To consider whether sufficient evidence exists to recommend the abandonment of vehicle-controlled studies in trials of topical treatments for athlete's foot.
METHODS
We searched nine electronic databases and bibliographies of review articles as part of an ongoing Cochrane systematic review from 1966 to 2007. Randomized controlled trials (RCTs) using a vehicle control design involving participants with a mycological diagnosis of a dermatophyte infection of the skin of the foot were included.
RESULTS
Allylamines, azoles, ciclopiroxolamine, tolnaftate, butenafine and undecanoates were all more effective than vehicle controls. Evidence of the superiority of azole creams over vehicle controls was fairly consistent from 1975 onwards. Data from patients treated with allylamines have shown their superior effects relative to vehicle controls since 1991 for even short-term outcomes.
CONCLUSIONS
The superiority of allylamines and azoles over vehicle in vehicle-controlled trials has been well established, and data demonstrating this fact have been available since the completion of early RCTs. These preparations are effective and safe, and investigators of RCTs evaluating topical treatments for athlete's foot need to choose potential comparators as control interventions in the light of this knowledge and to consider the ethics of withholding effective treatment from patients who seek treatment for this common foot infection.
Topics: Administration, Topical; Antifungal Agents; Emollients; Humans; Placebos; Randomized Controlled Trials as Topic; Tinea Pedis
PubMed: 18834482
DOI: 10.1111/j.1365-2133.2008.08806.x -
The Cochrane Database of Systematic... Jul 2007Scabies is an intensely itchy parasitic infection of the skin caused by the Sarcoptes scabiei mite. It is a common public health problem with an estimated global... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Scabies is an intensely itchy parasitic infection of the skin caused by the Sarcoptes scabiei mite. It is a common public health problem with an estimated global prevalence of 300 million cases. Serious adverse effects have been reported for some drugs used to treat scabies.
OBJECTIVES
To evaluate topical and systemic drugs for treating scabies.
SEARCH STRATEGY
In February 2007, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE, EMBASE, LILACS, and INDMED. In March 2007, we also searched the grey literature and sources for registered trials. We also checked the reference lists of retrieved studies.
SELECTION CRITERIA
Randomized controlled trials of drug treatments for scabies.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted data. Results were presented as relative risks with 95% confidence intervals and data combined where appropriate.
MAIN RESULTS
Twenty small trials involving 2392 people were included. One trial was placebo controlled, 16 compared two or more drug treatments, two compared treatment regimens, and one compared different drug vehicles.Fewer treatment failures occurred by day seven with oral ivermectin in one small trial (55 participants). Topical permethrin appeared more effective than oral ivermectin (85 participants, 1 trial), topical crotamiton (194 participants, 2 trials), and topical lindane (753 participants, 5 trials). Permethrin also appeared more effective in reducing itch persistence than either crotamiton (94 participants, 1 trial) or lindane (490 participants, 2 trials). One small trial did not detect a difference between permethrin (a synthetic pyrethroid) and a natural pyrethrin-based topical treatment (40 participants). No significant difference was detected in the number of treatment failures between crotamiton and lindane (100 participants, 1 trial), lindane and sulfur (68 participants, 1 trial), benzyl benzoate and sulfur (158 participants, 1 trial), and benzyl benzoate and natural synergized pyrethrins (240 participants, 1 trial); all were topical treatments. No trials of malathion were identified. No serious adverse events were reported. A number of trials reported skin reactions in participants randomized to topical treatments. There were occasional reports of headache, abdominal pain, diarrhoea, vomiting, and hypotension.
AUTHORS' CONCLUSIONS
Topical permethrin appears to be the most effective treatment for scabies. Ivermectin appears to be an effective oral treatment. More research is needed on the effectiveness of malathion, particularly when compared to permethrin, and on the management of scabies in an institutional setting and at a community level.
Topics: Adult; Benzoates; Child; Hexachlorocyclohexane; Humans; Insecticides; Ivermectin; Pyrethrins; Scabies; Sulfur; Toluidines
PubMed: 17636630
DOI: 10.1002/14651858.CD000320.pub2 -
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 -
Drug and Alcohol Review Nov 2022Policy enforcement is crucial to achieve impacts on alcohol-related harm. It is not clear what level of enforcement intensity or 'dosage' is necessary for addressing... (Review)
Review
ISSUES
Policy enforcement is crucial to achieve impacts on alcohol-related harm. It is not clear what level of enforcement intensity or 'dosage' is necessary for addressing drink driving and related harms. Given competing enforcement demands and agencies' resource constraints, understanding how much enforcement is sufficient to deter drink driving is critical.
APPROACH
This systematic literature review followed Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA) guidelines to examine research about dosage effects of enforcement and related visibility on drink-driving outcomes, including motor vehicle crashes and fatalities. Risk of bias was assessed using the Cochrane Collaboration Effective Practice and Organization of Care tool and the JBI checklist.
KEY FINDINGS
The 21 studies that met the inclusion criteria for this review differed in measures of enforcement dosage and outcomes, making it difficult to synthesise results across studies and draw conclusions about a threshold or optimal level of enforcement. Although most included studies found that sustained enforcement was associated with reductions in drink driving or related harms, only two studies tested an optimal dosage. Due to study design limitations, a substantial percentage of these studies must be considered with caution.
IMPLICATIONS
Additional research with rigorous study designs with appropriate controls is needed to determine an optimal high visibility enforcement dosage level to help law enforcement agencies make realistic decisions about allocating enforcement resources to address drink driving.
CONCLUSION
Consistent evidence about a drink-driving enforcement dosage threshold is lacking, partly due to an insufficient number of well-designed studies. Addressing challenges of conducting rigorous studies in community settings is crucial.
Topics: Humans; Accidents, Traffic; Alcohol Drinking; Automobile Driving; Driving Under the Influence; Law Enforcement
PubMed: 35894270
DOI: 10.1111/dar.13519 -
Frontiers in Immunology 2018Crystalline/particulate substances trigger a plethora of signaling events in host cells. The most prominent consequence is the inflammatory reactions that underlie...
Crystalline/particulate substances trigger a plethora of signaling events in host cells. The most prominent consequence is the inflammatory reactions that underlie crystal arthropathies, such as gout and pseudogout. However, their impact on our health was underestimated. Recent work on the role of cholesterol crystal in the development of atherosclerosis and the harm of environmental particulates has set up new frontiers in our defense against their detrimental effects. On the other hand, in the last 100 years, crystalline/particulate substances have been used with increasing frequencies in our daily lives as a part of new industrial manufacturing and engineering. Importantly, they have become a tool in modern medicine, used as vaccine adjuvants and drug delivery vehicles. Their biological effects are also being dissected in great detail, particularly with regard to their inflammatory signaling pathways. Solid structure interaction with host cells is far from being uniform, with outcomes dependent on cell types and chemical/physical properties of the particles involved. In this review, we offer a systematic and broad outlook of this landscape and a sage analysis of the complex nature of this topic.
Topics: Adjuvants, Immunologic; Animals; Drug Delivery Systems; Humans; Inflammation; Particulate Matter; Signal Transduction
PubMed: 29892295
DOI: 10.3389/fimmu.2018.01157 -
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 -
Canadian Journal on Aging = La Revue... Jun 2016With an increasing number of older drivers who are prescribed antidepressants, the potential consequences of antidepressant use on driving skills in an aging population... (Review)
Review
With an increasing number of older drivers who are prescribed antidepressants, the potential consequences of antidepressant use on driving skills in an aging population are becoming a pressing issue. We conducted a systematic review using MEDLINE, targeting articles specifically pertaining to antidepressants and driving in a population or subgroup of older adults (≥ 55 years of age). The search yielded 267 references, nine of which pertained to the effects of antidepressants on driving in older adults. The single experimental study found imipramine to have detrimental effects on highway driving, whereas nefazodone did not. Seven of eight population-based studies reported a significant increased risk of involvement in a collision associated with antidepressant use. Although the studies indicated a negative effect of antidepressants on driving, the epidemiological designs cannot exclude the possibility that the underlying illness, generally major depression, is the culprit.
Topics: Age Factors; Aged; Aged, 80 and over; Aging; Antidepressive Agents; Automobile Driving; Cohort Studies; Cross-Over Studies; Depression; Humans; Middle Aged; Retrospective Studies; Risk Factors
PubMed: 27091414
DOI: 10.1017/S0714980816000064 -
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