scholarly journals Statins and/or fibrates for diabetic retinopathy: a systematic review and meta-analysis

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Vânia Mozetic ◽  
Rafael Leite Pacheco ◽  
Carolina de Oliveira Cruz Latorraca ◽  
Rachel Riera

Abstract Evidence from observational studies have found a relationship between serum cholesterol and diabetic retinopathy (DR). Apart of the assumption that cholesterolemic control has benefits for patients with diabetes with or without retinopathy, the effects of lipid-lowering drugs have not been properly mapped and critically assessed so far. The objective of this study was to evaluate the effects of statins and/or fibrates on prevention and progression of DR. We conducted a Systematic review of randomized controlled trials (RCTs) following the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. GRADE approach was used to summarize the certainty of the evidence. Eight RCTs that fulfilled our eligibility criteria were included, assessing the effects of fibrates (n = 4), statins (n = 3) and fibrate plus statins (n = 1) for therapy (n = 8) or prevention (n = 4) of DR. Overall, the main concern regarding risk of bias assessment was due to incomplete outcome data because high rate of losses in five RCTs. Furthermore, the risk of reporting bias was rated unclear due the lack of previously published protocol in seven RCTs. Fibrates seemed to be associated with a 45% risk reduction of macular edema incidence (Relative Risk 0.55, 95% confidence interval of 0.38 to 0.81, 1309 participants, 2 RCTs, I2 = 0%, low certainty of the evidence). The certainty of evidence for other outcomes was also very low or low, and we are uncertain regarding the effects of fibrates for DR. Overall, adverse events seemed to be similar between fibrate and placebo, but again based on the width of the confidence intervals, an important increase of adverse events cannot be rule out. The combination statin/fibrate did not seem to have benefit for visual acuity but is likely that further studies can modify this estimate since the current evidence is limited. Adverse events and quality of life were not measured or reported. Concluding, this study found eight RCTs, with limited methodological quality, that assessed the effects of fibrates and/or statins for DR. Based on these findings, we are uncertain about the effects of statins for DR. Fibrates seemed to reduce the incidence of macular edema (low certainty evidence) without increase adverse events (low to very low certainty evidence). Number of Protocol registration PROSPERO CRD42016029746.

Author(s):  
D. Rowe ◽  
A. Rudkin

Lifestyle planning (LP) for people with learning disabilities is largely supported by qualitative rather than quantitative research. LP is a time-consuming and potentially resource-intensive area of practice which is becoming more prevalent in the UK. We present the first systematic review of the qualitative evidence base for the use of LP in people with learning disabilities. Such evidence concerns the special characteristics of LP and its outcomes in descriptive rather than quantitative terms. Qualitative research is usually aimed at enhancing validity by grounding theory in data collected. Twenty-one studies passed eligibility criteria for inclusion in this review, but only ten provided any outcome data, the others being concerned with process only. A replicable search strategy was employed and the resulting original data sources were critically reviewed with respect to major concepts and categories in the areas of: planning process, choices and preferences, ethics and outcomes. Explicitly person-centred approaches such as essential lifestyle planning are contrasted with more service-led methods such as individual programme planning. There are major methodological limitations in much of the available literature and suggestions for future research to clarify matters are made. The current evidence base suggests that no form of LP has significantly better outcomes than any other form and that it is not clear if LP in general enhances outcomes. Ongoing use of person centred planning in particular is informed by ethical considerations and is evolving in its structure and function.


2020 ◽  
Vol 38 (1) ◽  
pp. 16-25
Author(s):  
Janice S. Withycombe ◽  
Aimee Carlson ◽  
Carly Coleman ◽  
Sharon L. Leslie ◽  
Micah Skeens ◽  
...  

Background: Immunotherapy is a new and promising approach to treating pediatric cancers. These types of therapies have unique mechanisms of action for identifying and fighting cancer, as compared with traditional chemotherapy, and therefore are associated with different therapy-related adverse events (AEs). The purpose of this systematic review was to review available evidence to: (a) identify commonly reported AEs associated with immunotherapy agents frequently used in pediatric oncology and (b) generate recommendations for nursing practice. Method: A clinical question was developed and used to guide the systematic literature review. Five immunotherapy agents (dinutuximab, blinatumomab, rituximab, inotuzumab ozogamicin, brentuximab vedotin) were selected for inclusion secondary to their high relevance to pediatric oncology. A literature search was conducted to locate articles published between January 1, 2003 and October 31, 2018. Results: Seventeen articles met eligibility criteria for inclusion and were evaluated using the Grading of Recommendations Assessment, Development, and Evaluation criteria. The most commonly reported AEs for the selected immunotherapy agents were identified and summarized. Strong recommendations are made for nurses to become familiar with the unique AE profiles associated with individual immunotherapy agents. Agent-specific recommendations for nursing practice regarding AEs associated with dinutuximab and rituximab were generated. Conclusions: Immunotherapy is rapidly emerging as an effective therapy for pediatric cancers. Nurses need to be aware of the breadth of agent-specific, immunotherapy-related AEs to appropriately monitor and manage patients receiving these therapies. Additional work is needed to confidently profile immunotherapy-related AEs in pediatric oncology and to develop agent-specific educational materials for patients/families.


2019 ◽  
Vol 53 (17) ◽  
pp. 1070-1077 ◽  
Author(s):  
Myles Calder Murphy ◽  
Mervyn J Travers ◽  
Paola Chivers ◽  
James Robert Debenham ◽  
Sean Iain Docking ◽  
...  

ObjectiveTo assess the effectiveness of heavy eccentric calf training (HECT) in comparison with natural history, traditional physiotherapy, sham interventions or other exercise interventions for improvements in pain and function in mid-portion Achilles tendinopathy.DesignA systematic review and meta-analysis were conducted as per the PRISMA guidelines.Data sourcesPUBMED, CINAHL (Ovid) and CINAHL (EBSCO) were searched from inception until 24 September 2018.Eligibility criteriaRandomised controlled trials comparing HECT to natural history, sham exercise, traditional physiotherapy and other exercise interventions were included. Primary outcome assessing pain and function was the Victorian Institute of Sports Assessment-Achilles.ResultsSeven studies met the inclusion criteria. This review suggests HECT may be superior to both natural history, mean difference (MD) (95% CI) of 20.6 (11.7 to 29.5, one study) and traditional physiotherapy, MD (95% CI) of 17.70 (3.75 to 31.66, two studies). Following removal of one study, at high risk of bias, due to pre-planned sensitivity analysis, this review suggests HECT may be inferior to other exercise interventions, MD (95% CI) of −5.65 (-10.51 to −0.79, three studies). However, this difference is unlikely to be clinically significant.ConclusionCurrent evidence suggests that HECT may be superior to natural history and traditional physiotherapy while HECT may be inferior to other exercise interventions. However, due to methodological limitations, small sample size and a lack of data we are unable to be confident in the results of the estimate of the effect, as the true effect is likely to be substantially different.Systematic review registryPROSPERO registration number: CRD4201804493Protocol referenceThis protocol has been published open access: Murphy M, Travers MJ, Gibson, W. Is heavy eccentric calf training superior to natural history, sham rehabilitation, traditional physiotherapy and other exercise interventions for pain and function in mid-portion Achilles tendinopathy? Systematic Reviews 2018; 7: 58


BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036575
Author(s):  
Claire Fitzpatrick ◽  
Clare Gillies ◽  
Samuel Seidu ◽  
Debasish Kar ◽  
Ekaterini Ioannidou ◽  
...  

ObjectiveTo synthesise findings from randomised controlled trials (RCTs) of interventions aimed at increasing medication adherence in individuals with type 2 diabetes (T2DM) and/or cardiovascular disease (CVD). And, in a novel approach, to compare the intervention effect of studies which were categorised as being more pragmatic or more explanatory using the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool, to identify whether study design affects outcomes. As explanatory trials are typically held under controlled conditions, findings from such trials may not be relatable to real-world clinical practice. In comparison, pragmatic trials are designed to replicate real-world conditions and therefore findings are more likely to represent those found if the intervention were to be implemented in routine care.DesignSystematic review and meta-analysis.Data sourcesOvid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.Eligibility criteria for selecting studiesRCTs lasting ≥3 months (90 days), involving ≥200 patients in the analysis, with either established CVD and/or T2DM and which measured medication adherence. From 4403 citations, 103 proceeded to full text review. Studies published in any language other than English and conference abstracts were excluded.Main outcome measureChange in medication adherence.ResultsOf 4403 records identified, 34 studies were considered eligible, of which 28, including 30 861 participants, contained comparable outcome data for inclusion in the meta-analysis. Overall interventions were associated with an increase in medication adherence (OR 1.57 (95% CI: 1.33 to 1.84), p<0.001; standardised mean difference 0.24 (95% CI: −0.10 to 0.59) p=0.101). The effectiveness of interventions did not differ significantly between studies considered pragmatic versus explanatory (p=0.598), but did differ by intervention type, with studies that included a multifaceted rather than a single-faceted intervention having a more significant effect (p=0.010). The analysis used random effect models and used the revised Cochrane Risk of Bias Tool to assess study quality.ConclusionsIn this meta-analysis, interventions were associated with a significant increase in medication adherence. Overall multifaceted interventions which included an element of education alongside regular patient contact or follow-up showed the most promise. Effectiveness of interventions between pragmatic and explanatory trials was comparable, suggesting that findings can be transferred from idealised to real-word conditions.PROSPERO registration numberCRD42017059460.


Author(s):  
Yang Song ◽  
Dong Sun ◽  
Bíró István ◽  
Anand Thirupathi ◽  
Minjun Liang ◽  
...  

Traditional Chinese exercise (TCE) has gradually become one of the widespread complementary therapies for treatment and recovery of cancers. However, evidence based on the systematic evaluation of its efficacy is lacking, and there appears to be no conclusion regarding the setting of TCE interventions. The purpose of this systematic review is to summarize the current randomized controlled trials (RCTs) that outline the effects of TCE on cancer patients. Relevant studies were searched by GOOGLE SCHOLAR, SCIENCEDIRECT, and WEB OF SCIENCE using “traditional Chinese exercise” and “cancer.” Only RCTs published in peer-reviewed English journals were included. A total of 27 studies covering 1616 cancer patients satisfied the eligibility criteria for this review. Despite the methodological limitation and relatively high risk of bias possessed by some included studies, positive evidence was still detected on the effects of TCE on these cancer-related health outcomes in physical, psychological, and physiological parameters. The 60-min or 90-min course of TCE intervention for two to three times per week for 10 to 12 weeks was found to be the most common setting in these studies and has effectively benefited cancer patients. These findings add scientific support to encourage cancer patients to practice TCE during or after conventional medical treatment. Nevertheless, future well-designed RCTs with improved methodology and larger sample size on this field are much warranted for further verification.


Nutrients ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 2070 ◽  
Author(s):  
Fatma Ilgaz ◽  
Alex Pinto ◽  
Hülya Gökmen-Özel ◽  
Julio César Rocha ◽  
Esther van Dam ◽  
...  

There is an ongoing debate regarding the impact of phenylketonuria (PKU) and its treatment on growth. To date, evidence from studies is inconsistent, and data on the whole developmental period is limited. The primary aim of this systematic review was to investigate the effects of a phenylalanine (Phe)-restricted diet on long-term growth in patients with PKU. Four electronic databases were searched for articles published until September 2018. A total of 887 results were found, but only 13 articles met eligibility criteria. Only three studies had an adequate methodology for meta-analysis. Although the results indicate normal growth at birth and during infancy, children with PKU were significantly shorter and had lower weight for age than reference populations during the first four years of life. Impaired linear growth was observed until the end of adolescence in PKU. In contrast, growth impairment was not reported in patients with mild hyperphenylalaninemia, not requiring dietary restriction. Current evidence indicates that even with advances in dietary treatments, “optimal” growth outcomes are not attained in PKU. The majority of studies include children born before 1990s, so further research is needed to show the effects of recent dietary practices on growth in PKU.


2015 ◽  
Vol 3 ◽  
pp. 1-8 ◽  
Author(s):  
Kai Wang ◽  
Mingwei Sun ◽  
Hua Jiang ◽  
Xiao-ping Cao ◽  
Jun Zeng

Abstract Background We aimed to systematically review the efficacy of mannitol (MTL) on patients with acute severe traumatic brain injury (TBI). Methods Databases such as PubMed (US National Library of Medicine), CENTRAL (The Cochrane Library 2014, Issue 3), ISI (Web of Science: Science Citation Index Expanded), Chinese Biomedicine Database (CBM), and China Knowledge Resource Integrated Database (CNKI) have been searched for relevant studies published between 1 January 2003 and 1 October 2014. We have established inclusion and exclusion criteria to identify RCTs, which were suitable to be enrolled in the systematic review. The comparison group could be hypertonic saline (HS), hydroxyethyl starch, or others. The quality assessment was based on the Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 and modified Jadad score scale. The major outcome was mortality, followed by the secondary outcomes such as neurological outcome, days on intensive care unit (ICU), and ventilator day. In addition, intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) were used as the surrogate endpoints. Data synthesis and meta-analysis was conducted by using R (version 3.7-0.). Results When 176 potential relevant literatures and abstracts have been screened, four RCTs met all the inclusion criteria and were enrolled for the meta-analysis. Amongst all the enrolled studies, two trials have provided the primary outcome data. There was no heterogeneity between two studies (I2 = 0 %) and a fixed model was used for meta-analysis (n = 53), pooled result indicated that the mortality was similar in mannitol intervention and control treatment, OR = 0.80, 95 % CI [0.27, 2.37], P = 0.38. We found that both mannitol and HS were efficient in decreasing the ICP. Furthermore, the effect of the HS on the ICP appeared to be more effective in the patients with diffuse brain injuries than mannitol did. Conclusions As a conclusion, the mannitol therapy cannot reduce the mortality risk of acute severe traumatic brain injury. Current evidence does not support the mannitol as an effective treatment of acute severe traumatic brain injury. The well-designed randomized controlled trials are in urgent need to demonstrate the adoption of mannitol to acute severe traumatic brain injury.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e047273
Author(s):  
Mei-Ying Kwan ◽  
Kit-Lun Yick ◽  
Joanne Yip ◽  
Chi-Yung Tse

ObjectiveThe treatment effect of orthoses for hallux valgus (HV) is unclear with little interventional studies, the design involves multiple complex factors, and therefore a systematic analysis with meta-analysis is necessary. The objective of this systematic review and meta-analysis is to determine whether current foot orthoses are effective in treating HV.DesignSystematic review with meta-analysis.Data sourcesElectronic databases (PubMed, Scopus, Cinahl and Medline) are searched up to February 2020.Eligibility criteria for selecting studiesInterventional studies with content focus on HV orthosis design and any of the outcomes related to effectiveness for treating HV are included. The standardised mean differences are calculated. The risk of bias in included studies is assessed using the Cochrane Collaboration’s risk of bias tools.ResultsIn total, 2066 articles are identified. Among them, nine are selected and quality rated, and data are extracted and closely examined. A meta-analysis is conducted, where appropriate. The main causes of potential bias are missing outcome data and outcome measurement error. The results show that orthosis with a toe separator has the best effect of correcting the HV angle (standardised mean difference: 0.50, 95% CI: 0.189 to 0.803).ConclusionThe orthoses design with a toe separator or an element that allows for the foot anatomic alignment is critical for reducing the HV angle and relieving foot pain. The results contribute to a better selection of treatment for patients.PROSPERO registration numberCRD42021260403.


Author(s):  
Madonna Nader Adly ◽  
Mahmoud Fawzy Mandour ◽  
Mahmoud Foad Abd Elaziz ◽  
Magdy Eisa Saafan

Background: Allergic rhinitis is a common disease that affect nose causing sneezing, watery nose, nasal itching and redness that affect quality of life, productivity at work or school and may underlies complications (e.g. Asthma) for patients and are often accompanied by itchy eye, redness and lacrimation. Aim of the Work: The objective of this study is to systematically assess the efficacy and safety of immunotherapy treatment for patients with Allergic Rhinitis. Method: Our initial search generated a total of 23330 possible relevant titles. Titles, abstracts were preliminary screening so that 22565 were excluded. 154 articles were retrieved in full text the number of studies excluded after assessment of the full text 145, 9 articles met the eligibility criteria and fulfilled the inclusion and exclusion criteria for the review. Data Sources: Medline databases (PubMed, Medscape, ScienceDirect. EMF-Portal) and all materials available on the Internet upto 2018. Data Extraction: If the studies did not fulfill the inclusion criteria, they were excluded. Study quality assessment included whether ethical approval was gained, eligibility criteria specified, appropriate controls, and adequate information and defined assessment measures. Conclusion: Our systematic review provides evidence that Sublingual Immunotherapy (SLIT) tablets effectively relieve rhinitis symptoms in adults with allergic rhinitis, improve their quality of life and provide data about safety of Sublingual Immunotherapy as there were no serious side effects of using SLIT tablets. Nevertheless, the current evidence may be limited due to sample size and the heterogeneity between studies. Large sample size and multiple center RCTs on the efficacy of different formulations of SLIT drugs are still needed to provide further evidence and more precise recommendations.


2019 ◽  
Vol 2 (22.2) ◽  
pp. E55-E70 ◽  
Author(s):  
Ian D. Coulter

Background: Mobilization and manipulation therapies are widely used by patients with chronic nonspecific neck pain; however, questions remain around efficacy, dosing, and safety, as well as how these approaches compare to other therapies. Objectives: Based on published trials, to determine the efficacy, effectiveness, and safety of various mobilization and manipulation therapies for treatment of chronic nonspecific neck pain. Study Design: A systematic literature review and meta-analysis. Methods: We identified studies published between January 2000 and September 2017, by searching multiple electronic databases, examining reference lists, and communicating with experts. We selected randomized controlled trials comparing manipulation and/or mobilization therapies to sham, no treatment, each other, and other active therapies, or when combined as multimodal therapeutic approaches. We assessed risk of bias by using the Scottish Intercollegiate Guidelines Network criteria. When possible, we pooled data using random-effects meta-analysis. Grading of Recommendations, Assessment, Development, and Evaluation was applied to determine the confidence in effect estimates. This project was funded by the National Center for Complementary and Integrative Health under award number U19AT007912 and ultimately used to inform an appropriateness panel. Results: A total of 47 randomized trials (47 unique trials in 53 publications) were included in the systematic review. These studies were rated as having low risk of bias and included a total of 4,460 patients with nonspecific chronic neck pain who were being treated by a practitioner using various types of manipulation and/or mobilization interventions. A total of 37 trials were categorized as unimodal approaches and involved thrust or nonthrust compared with sham, no treatment, or other active comparators. Of these, only 6 trials with similar intervention styles, comparators, and outcome measures/timepoints were pooled for meta-analysis at 1, 3, and 6 months, showing a small effect in favor of thrust plus exercise compared to an exercise regimen alone for a reduction in pain and disability. Multimodal approaches appeared to be effective at reducing pain and improving function from the 10 studies evaluated. Health-related quality of life was seldom reported. Some 22/47 studies did not report or mention adverse events. Of the 25 that did, either no or minor events occurred. Limitations: The current evidence is heterogeneous, and sample sizes are generally small. Conclusions: Studies published since January 2000 provide low-moderate quality evidence that various types of manipulation and/or mobilization will reduce pain and improve function for chronic nonspecific neck pain compared to other interventions. It appears that multimodal approaches, in which multiple treatment approaches are integrated, might have the greatest potential impact. The studies comparing to no treatment or sham were mostly testing the effect of a single dose, which may or may not be helpful to inform practice. According to the published trials reviewed, manipulation and mobilization appear safe. However, given the low rate of serious adverse events, other types of studies with much larger sample sizes would be required to fully describe the safety of manipulation and/or mobilization for nonspecific chronic neck pain. Key words: Chronic neck pain, nonspecific, chiropractic, manipulation, mobilization, systematic review, meta-analysis, appropriateness


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