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Intravitreal steroids for macular edema in diabetes.
Rittiphairoj, T, Mir, TA, Li, T, Virgili, G
The Cochrane database of systematic reviews. 2020;(11):CD005656
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Abstract
BACKGROUND Diabetic macular edema (DME) is secondary to leakage from diseased retinal capillaries with thickening of central retina, and is an important cause of poor central visual acuity in people with diabetic retinopathy. Intravitreal steroids have been used to reduce retinal thickness and improve vision in people with DME. OBJECTIVES To assess the effectiveness and safety of intravitreal steroid therapy compared with other treatments for DME. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase on 15 May, 2019. We also searched reference lists, Science Citation Index, conference proceedings, and relevant trial registers. We conducted a top up search on 21 October, 2020. SELECTION CRITERIA We included randomized controlled trials that evaluated any type of intravitreal steroids as monotherapy against any other intervention (e.g. observation, laser photocoagulation, anti-vascular endothelial growth factor (antiVEGF) for DME. DATA COLLECTION AND ANALYSIS Two review authors independently assessed study eligibility and risk of bias and extracted data. Where appropriate, we performed meta-analyses. MAIN RESULTS We included 10 trials (4348 participants, 4505 eyes). These trials compared intravitreal steroid therapies versus other treatments, including intravitreal antiVEGF therapy, laser photocoagulation, and sham injection. Most trials had an overall unclear or high risk of bias. One trial (701 eyes ) compared intravitreal dexamethasone implant 0.7mg with sham. We found moderate-certainty evidence that dexamethasone leads to slightly more improvement of visual acuity than sham at 12 months (mean difference [MD] -0.08 logMAR, 95% confidence interval [CI] -0.12 to -0.05 logMAR). Regarding improvement of three or more lines of visual acuity, there was moderate-certainty evidence in favor of dexamethasone at 12 months, but the CI covered the null value (risk ratio (RR) 1.39, 95% CI 0.91 to 2.12). Regarding adverse events, dexamethasone increased by about four times the risk of cataract progression and the risk of using intraocular pressure (IOP)-lowering medications compared to sham (RR 3.89, 95% CI 2.75 to 5.50 and RR 4.54, 95% CI 3.19 to 6.46, respectively; moderate-certainty evidence); about 4 in 10 participants treated with dexamethasone needed IOP-lowering medications. Two trials (451 eyes) compared intravitreal dexamethasone implant 0.7mg with intravitreal antiVEGF (bevacizumab and ranibizumab). There was moderate-certainty evidence that visual acuity improved slightly less with dexamethasone compared with antiVEGF at 12 months (MD 0.07 logMAR, 95% CI 0.04 to 0.09 logMAR; 2 trials; 451 participants/eyes; I2 = 0%). The RR of gain of three or more lines of visual acuity was inconsistent between trials, with one trial finding no evidence of a difference between dexamethasone and bevacizumab at 12 months (RR 0.99, 95% CI 0.70 to 1.40; 1 trial; 88 eyes), and the other, larger trial finding the chances of vision gain were half with dexamethasone compared with ranibizumab (RR 0.50, 95% CI 0.32 to 0.79; 1 trial; 432 participants). The certainty of evidence was low. Cataract progression and the need for IOP-lowering medications increased more than 4 times with dexamethasone implant compared to antiVEGF (moderate-certainty evidence). One trial (560 eyes) compared intravitreal fluocinolone implant 0.19mg with sham. There was moderate-certainty evidence that visual acuity improved slightly more with fluocinolone at 12 months (MD -0.04 logMAR, 95% CI -0.06 to -0.01 logMAR). There was moderate-certainty evidence that an improvement in visual acuity of three or more lines was more common with fluocinolone than with sham at 12 months (RR 1.79, 95% CI 1.16 to 2.78). Fluocinolone also increased the risk of cataract progression (RR 1.63, 95% CI 1.35 to 1.97; participants = 335; moderate-certainty evidence), which occurred in about 8 in 10 participants, and the use of IOP-lowering medications (RR 2.72, 95% CI 1.87 to 3.98; participants = 558; moderate-certainty evidence), which were needed in 2 to 3 out of 10 participants. One small trial with 43 participants (69 eyes) compared intravitreal triamcinolone acetonide injection 4 mg with sham. There may be a benefit in visual acuity at 24 months (MD -0.11 logMAR, 95% CI -0.20 to -0.03 logMAR), but the certainty of evidence is low. Differences in adverse effects were poorly reported in this trial. Two trials (615 eyes) compared intravitreal triamcinolone acetonide injection 4mg with laser photocoagulation and reached discordant results. The smaller trial (31 eyes followed up to 9 months) found more visual acuity improvement with triamcinolone (MD -0.18 logMAR, 95% CI -0.29 to -0.07 logMAR), but a larger, multicenter trial (584 eyes, 12-month follow-up) found no evidence of a difference regarding change in visual acuity (MD 0.02 logMAR, 95% CI -0.03 to 0.07 logMAR) or gain of three or more lines of visual acuity (RR 0.85, 95% CI 0.55 to 1.30) (overall low-certainty evidence). Cataract progression was about three times more likely (RR 2.68, 95% CI 2.21 to 3.24; moderate-certainty evidence) and the use of IOP-lowering medications was about four times more likely (RR 3.92, 95% CI 2.59 to 5.96; participants = 627; studies = 2; I2 = 0%; moderate-certainty evidence) with triamcinolone. About 1 in 3 participants needed IOP-lowering medication. One small trial (30 eyes) compared intravitreal triamcinolone acetonide injection 4mg with intravitreal antiVEGF (bevacizumab or ranibizumab). Visual acuity may be worse with triamcinolone at 12 months (MD 0.18 logMAR, 95% CI 0.10 to 0.26 logMAR); the certainty of evidence is low. Adverse effects were poorly reported in this trial. Four trials reported data on pseudophakic participants, for whom cataract is not a concern. These trials found no decrease in visual acuity in the second treatment year due to cataract progression. AUTHORS' CONCLUSIONS Intravitreal steroids may improve vision in people with DME compared to sham or control. Effects were small, about one line of vision or less in most comparisons. More evidence is available for dexamethasone or fluocinolone implants when compared to sham, and the evidence is limited and inconsistent for the comparison of dexamethasone with antiVEGF treatment. Any benefits should be weighed against IOP elevation, the use of IOP-lowering medication and, in phakic patients, the progression of cataract. The need for glaucoma surgery is also increased, but remains rare.
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Systematic review with network meta-analysis: comparative effectiveness of topical steroids vs. PPIs for the treatment of the spectrum of eosinophilic oesophagitis.
Lipka, S, Kumar, A, Miladinovic, B, Richter, JE
Alimentary pharmacology & therapeutics. 2016;(6):663-73
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Abstract
BACKGROUND Controversy surrounds the clinical and histological response to topical steroids in patients with eosinophilic oesophagitis (EoE). AIM: To perform a systematic review and network meta-analysis of randomised controlled trials to assess the efficacy of topical steroids compared with placebo or proton pump inhibitor (PPIs) for the management of eosinophilic oesophagitis. METHODS Cochrane Central Register of Controlled Trials and MEDLINE from inception to 1 July 2015 was searched. Data were extracted independently by two authors. Methodological quality was assessed using the Cochrane risk of bias tool. A network meta-analysis was performed using the Bayesian methods under random-effects multiple treatment comparisons. Results were summarised as odds ratio along with credibility intervals. We also calculated the ranking probability for each treatment based on surface under the cumulative ranking curve (SUCRA). RESULTS The overall methodological quality of included studies was low. SUCRA ranking probability indicated that PPI had the highest probability of being the best treatment for achieving histological remission and mean change in eosinophils (0.81 and 0.85, respectively), followed by budesonide (0.74 and 0.63, respectively) and fluticasone (0.5 and 0.5, respectively). None of the comparisons indicated a statistically signicant difference. CONCLUSIONS The results from network meta-analysis show that there is no statistically significant difference between PPI, budesonide and fluticasone for the treatment of EoE as assessed by the histological and clinical response. The evidence is limited by serious risk of bias and imprecision, which emphasises the urgent need for large RCTs with adequate sample size and methodological rigour to provide conclusive evidence.
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Is it safe to withdraw steroids within seven days of renal transplantation?
Zhang, X, Huang, H, Han, S, Fu, S, Wang, L
Clinical transplantation. 2013;(1):1-8
Abstract
BACKGROUND The safety of very early steroid withdrawal (VESW) in renal transplant recipients remains unclear. METHODS Literature searches for all randomized controlled trials comparing VESW with steroid maintenance regimens were performed using MEDLINE, EMBASE, and the Cochrane Library. Quality assessment was performed in each trial. Meta-analyses were performed to demonstrate the pooled effects of relative risk (RR) and weighted mean difference with 95% confidence intervals (CI). RESULTS A total of 3520 participants from 15 RCTs were included. VESW regimen increased the incidence of acute rejection (AR) over controls (RR = 1.46, CI = 1.20-1.79, p = 0.04). Subsequent analysis demonstrated that such difference lost significance in patients receiving tacrolimus (p = 0.16), but remained significant in patients with cyclosporin (p < 0.00001). The increased AR episodes were predominantly mild. VESW was associated with an increased incidence of delayed graft function (DGF) when steroids were withdrawn within three d post-transplantation. Cardiovascular risk factors, including incidence of new onset diabetes and total cholesterol, were significantly reduced under VESW regimen. CONCLUSIONS It is safe and practical to withdraw steroids very early after renal transplantation. However, a three- to seven-d course of steroids may decrease the risk for DGF relative to steroid withdrawal in <3 d. Antibody induction is effective in preventing early AR.
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Intravitreal steroids for macular edema in diabetes.
Grover, D, Li, TJ, Chong, CC
The Cochrane database of systematic reviews. 2008;(1):CD005656
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BACKGROUND Macular edema is secondary to leakage from diseased retinal capillaries and is an important cause of poor central visual acuity in patients with diabetic retinopathy. OBJECTIVES This review evaluated the effectiveness and safety of intraocular steroids in treating diabetic macular edema (DME). SEARCH STRATEGY We searched CENTRAL, MEDLINE, EMBASE in June 2007, reference lists, Science Citation Index and conference proceedings. SELECTION CRITERIA We included randomized clinical trials (RCTs) evaluating any form of intravitreal steroids for treating DME. DATA COLLECTION AND ANALYSIS Two authors independently assessed eligibility, methodological quality and extracted data. We performed meta-analyses when appropriate. MAIN RESULTS Seven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias and the remaining two were at unclear risk of bias. The preponderance of data suggest a beneficial effect from IVTA. Comparing IVTA with controls, the mean difference in visual acuity was -0.15 LogMAR (95% CI -0.21 to -0.09) at 3 months (based on three trials), -0.23 LogMAR (95% CI -0.33 to -0.13) at 6 months (two trials), -0.29 LogMAR (95% CI -0.47 to -0.11) at 9 months (one trial), and -0.11 LogMAR (95% CI -0.20 to -0.03) at 24 months (one trial), all in favor of IVTA. The relative risk (RR) for one or more lines improvement in visual acuity was 2.85 (95% CI 1.59 to 5.10) at 3 months (two trials), 1.25 (95% CI 0.66 to 2.38) at 6 months (one trial), and 2.17 (95% CI 1.15 to 4.11) at 24 months (one trial), all in favor of IVTA. We did not find evidence for three or more lines improvement in visual acuity. The mean difference in retinal thickness was -131.97 um (95% CI -169.08 to -94.86) at 3 months (two trials), -135.00 um (95% CI -194.50 to -75.50) at 6 months (one trial), -133.00 um (95% CI -199.86 to -66.14) at 9 months (one trial), and -59.00 um (95% CI -103.50 to -14.50) at 24 months (one trial), all in favor of IVTA. The RR for at least one grade macular edema resolution was 5.15 (95% CI 2.23 to 11.88) at 3 months in favor of IVTA (one trial). Two trials reported improved clinical outcome when FAI was compared to standard of care. Beneficial effect was also observed in one dexamethasone DDS trial. Increased intraocular pressure and cataract formation were side effects requiring monitoring and management. AUTHORS' CONCLUSIONS RCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME. Since the studies in our report focused on chronic or refractory DME, the question arises whether intravitreal steroids therapy could be of value in other stages of DME, especially the earlier stages either as standalone therapy or in combination with other therapies, such as laser photocoagulation.
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Current state of vitiligo therapy--evidence-based analysis of the literature.
Forschner, T, Buchholtz, S, Stockfleth, E
Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG. 2007;(6):467-75
Abstract
UNLABELLED Vitiligo is a skin disease with a worldwide prevalence ranging from 0.5% to 4%. Conservative therapies include photochemotherapy, phototherapy with UVB radiation (broadband UVB 290-320 nm, narrow band UVB 311 nm), systemic steroids and pseudocatalase. Modern therapeutic options include treatment with topical immunomodulators (tacrolimus, pimecrolimus), analogues of vitamin D3, excimer laser and surgery/transplantation. Our analysis compares these therapies for vitiligo and the evidence levels supporting their effectiveness. CONCLUSIONS The face and neck respond best to all therapeutic approaches, while the acral areas are least responsive. For generalized vitiligo, phototherapy with UVB radiation is most effective with the fewest side effects; PUVA is the second best choice.Topical corticosteroids are the preferred drugs for localized vitiligo. They may be replaced by topical immunomodulators which display comparable effectiveness and fewer side effects. The effectiveness of vitamin D analogues is controversial with limited data. Surgical therapy can be very successful, but requires an experienced surgeon and is very demanding of time and facilities, thus limiting its widespread use. L-phenylalanine therapy appears effective on the face but enjoys neither widespread use nor extensive data support. No single therapy for vitiligo can be regarded as the most effective as the success of each treatment modality depends on the type and location of vitiligo.
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Efficacy of interventions for bronchiolitis in critically ill infants: a systematic review and meta-analysis.
Davison, C, Ventre, KM, Luchetti, M, Randolph, AG
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 2004;(5):482-9
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BACKGROUND Viral bronchiolitis is the leading cause of respiratory failure among infants in the United States. Currently, the mainstay of treatment is supportive care. The effectiveness of treatments used for mechanically ventilated infants with bronchiolitis is unclear. OBJECTIVE To evaluate the strength of the evidence supporting the use of currently available treatments for critically ill infants with bronchiolitis. DATA SOURCE We searched PubMed, citations of relevant articles, personal files, and conference proceedings, and we contacted experts in the field. STUDY SELECTION Randomized, controlled trials evaluating any therapy for bronchiolitis that included children in an intensive care unit. DATA EXTRACTION Two reviewers independently extracted data and assessed methodologic quality. DATA SYNTHESIS A total of 2,319 citations were screened, and 16 randomized, controlled trials were included. There were three trials of surfactant, three of ribavirin, three of immune globulin, three of systemic corticosteroids, and one each of vitamin A, interferon, erythropoietin, and heliox. A meta-analysis of the three surfactant studies showed a strong trend toward a decrease in duration of mechanical ventilation of 2.58 days (95% confidence interval, -5.34 to 0.18 days; p =.07) and a significant decrease of 3.3 intensive care unit days (95% confidence interval, -6.38 to -0.23 days; p =.04). A meta-analysis of the three systemic corticosteroid studies showed no overall effect on duration of mechanical ventilation when all three trials were combined (-0.62 day; 95% confidence interval, -2.78 to 1.53 days; p =.57). We identified one published meta-analysis of three ribavirin studies showing a significant decrease in ventilator days with ribavirin (-1.2 days; 95% confidence interval, -0.2 to -3.4 days; p =.2). CONCLUSIONS Currently, there are no clearly effective interventions available to improve the outcome of critically ill infants with bronchiolitis. Surfactant seems to be a promising intervention, and corticosteroids or ribavirin may also be beneficial.