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Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments.

ABSTRACT: Fumaric acid esters (FAEs) are licensed for the treatment of moderate-to-severe psoriasis in Germany but are also used off-label in many other countries. We conducted this systematic review to synthesize the highest-quality evidence for the benefits and risks of FAEs for psoriasis. Our primary outcomes were change in Psoriasis Area and Severity Index score and dropout rates due to adverse effects. Randomized controlled trials (RCTs) of FAEs or dimethylfumarate were included, with no restriction on age or psoriasis subtype. We searched the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library, Medline, Embase, LILACS and five trials registers, and hand searched six conference proceedings. Six RCTs with a total of 544 participants were included, four of which were published only as abstracts or brief reports, limiting study reporting. Five RCTs compared FAEs with placebo, and all demonstrated benefit in favour of FAEs. However, meta-analysis was possible only for PASI 50 response after 12-16 weeks, which was achieved by 64% of participants on FAEs compared with 14% on placebo: risk ratio (RR) 4·55, 95% confidence interval (CI) 2·80-7·40; two studies; 247 participants; low-quality evidence). There was no difference in dropout rates due to adverse effects (RR 5·36, 95% CI 0·28-102·12; one study; 27 participants; very low-quality evidence and wide CI). More participants experienced nuisance adverse effects with FAEs (76%) than with placebo (16%) (RR 4·72, 95% CI 2·45-9·08; one study; 99 participants; moderate-quality evidence), mainly abdominal pain, diarrhoea and flushing. One head-to-head study of very low-quality evidence comparing FAEs with methotrexate reported comparable efficacy and dropout rates, although FAEs caused more flushing. The evidence in this review was limited and must be interpreted with caution; studies with better design and outcome reporting are needed.

SUBMITTER: Atwan A

PROVIDER: S-EPMC5095877 | biostudies-other | 2016 Nov

REPOSITORIES: biostudies-other

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Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments.

Atwan A A Ingram J R JR Abbott R R Kelson M J MJ Pickles T T Bauer A A Piguet V V

The British journal of dermatology 20160829 5

Fumaric acid esters (FAEs) are licensed for the treatment of moderate-to-severe psoriasis in Germany but are also used off-label in many other countries. We conducted this systematic review to synthesize the highest-quality evidence for the benefits and risks of FAEs for psoriasis. Our primary outcomes were change in Psoriasis Area and Severity Index score and dropout rates due to adverse effects. Randomized controlled trials (RCTs) of FAEs or dimethylfumarate were included, with no restriction ...[more]

PMID: 27087044

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Project description:BackgroundRegular consumption of sugar-sweetened beverages (SSB) can increase the risk for obesity, type 2 diabetes, cardiovascular disease, and dental caries. Interventions that alter the physical or social environment in which individuals make beverage choices have been proposed to reduce the consumption of SSB.MethodsWe included randomised controlled, non-randomised controlled, and interrupted time series studies on environmental interventions, with or without behavioural co-interventions, implemented in real-world settings, lasting at least 12 weeks, and including at least 40 individuals. Studies on the taxation of SSB were not included, as these are subject of a separate Cochrane review. We used standard Cochrane methods for data extraction, risk of bias assessment, and evidence grading and synthesis. Searches were updated to January 24, 2018.ResultsWe identified 14,488 unique records and assessed 1,030 full texts for eligibility. We included 58 studies comprising a total of 1,180,096 participants and a median length of follow-up of 10 months. We found moderate-certainty evidence for consistent associations with decreases in SSB consumption or sales for the following interventions: traffic light labelling, price increases on SSB, in-store promotion of healthier beverages in supermarkets, government food benefit programs with incentives for purchasing fruits and vegetables and restrictions on SSB purchases, multi-component community campaigns focused on SSB, and interventions improving the availability of low-calorie beverages in the home environment. For the remaining interventions we found low- to very-low-certainty evidence for associations showing varying degrees of consistency.ConclusionsWith observed benefits outweighing observed harms, we suggest that environmental interventions to reduce the consumption of SSB be considered as part of a wider set of measures to improve population-level nutrition. Implementation should be accompanied by evaluations using appropriate methods. Future studies should examine population-level effects of interventions suitable for large-scale implementation, and interventions and settings not yet studied thoroughly.

Project description:ObjectiveTo examine the effectiveness of screening for intimate partner violence conducted within healthcare settings to determine whether or not screening increases identification and referral to support agencies, improves women's wellbeing, decreases further violence, or causes harm.DesignSystematic review and meta-analysis of trials assessing effectiveness of screening. Study assessment, data abstraction, and quality assessment were conducted independently by two of the authors. Standardised estimations of the risk ratios and 95% confidence intervals were calculated.Data sourcesNine databases searched up to July 2012 (CENTRAL, Medline, Medline(R), Embase, DARE, CINAHL, PsycINFO, Sociological Abstracts, and ASSIA), and five trials registers searched up to 2010.Eligibility criteria for selecting studiesRandomised or quasi-randomised trials of screening programmes for intimate partner violence involving all women aged ≥ 16 attending a healthcare setting. We included only studies in which clinicians in the intervention arm personally conducted the screening, or were informed of the screening result at the time of the consultation, compared with usual care (or no screening). Studies of screening programmes that were followed by structured interventions such as advocacy or therapeutic intervention were excluded.Results11 eligible trials (n=13,027) were identified. In six pooled studies (n=3564), screening increased the identification of intimate partner violence (risk ratio 2.33, 95% confidence interval 1.39 to 3.89), particularly in antenatal settings (4.26, 1.76 to 10.31). Based on three studies (n=1400), we detected no evidence that screening increases referrals to domestic violence support services (2.67, 0.99 to 7.20). Only two studies measured women's experience of violence after screening (three to 18 months after screening) and found no reduction in intimate partner violence. One study reported that screening does not cause harm.ConclusionsThough screening is likely to increase identification of intimate partner violence in healthcare settings, rates of identification from screening interventions were low relative to best estimates of prevalence of such violence. It is uncertain whether screening increases effective referral to supportive agencies. Screening does not seem to cause harm in the short term, but harm was measured in only one study. As the primary studies did not detect improved outcomes for women screened for intimate partner violence, there is insufficient evidence for screening in healthcare settings. Studies comparing screening versus case finding, or screening in combination with therapeutic intervention for women's long term wellbeing, are needed to inform the implementation of identification policies in healthcare settings.

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Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments.

Publications

Oral fumaric acid esters for psoriasis: abridged Cochrane systematic review including GRADE assessments.

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