CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials

Family Health International, Research Triangle Park, North Carolina, United States of America.
Journal of pharmacology & pharmacotherapeutics 07/2010; 1(2):100-7. DOI: 10.4103/0976-500X.72352
Source: PubMed
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    ABSTRACT: Introduction Many different dietary supplements are currently marketed for the management of hypertension, but the evidence for effectiveness is mixed. The aim of this systematic review was to evaluate the evidence for or against the effectiveness of green tea (Camellia sinensis) on blood pressure and lipid parameters. Methods Electronic searches were conducted in Medline, Embase, Amed, Cinahl and the Cochrane Library to identify relevant human randomized clinical trials (RCTs). Hand searches of bibliographies were also conducted. The reporting quality of included studies was assessed using a checklist adapted from the CONSORT Statement. Two reviewers independently determined eligibility, assessed the reporting quality of the included studies, and extracted the data. Results 474 citations were identified and 20 RCTs comprising 1,536 participants were included. There were variations in the designs of the RCTs. A meta-analysis revealed a significant reduction in systolic blood pressure favouring green tea (MD: -1.94 mmHg; 95% CI: -2.95 to -0.93; I2=8%; p = 0.0002). Similar results were also observed for total cholesterol (MD: -0.13 mmol/l; 95% CI: -0.2 to -0.07; I2=8%; p < 0.0001) and LDL cholesterol (MD: -0.19 mmol/l; 95% CI: -0.3 to -0.09; I2=70%; p = 0.0004). Adverse events included rash, elevated blood pressure, and abdominal discomfort. Conclusion Green tea intake results in significant reductions in systolic blood pressure, total cholesterol, and LDL cholesterol. The effect size on systolic blood pressure is small, but the effects on total and LDL cholesterol appear moderate. Longer-term independent clinical trials evaluating the effects of green tea are warranted.
    Nutrition, metabolism, and cardiovascular diseases: NMCD 08/2014; 24(8). DOI:10.1016/j.numecd.2014.01.016 · 3.88 Impact Factor
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    ABSTRACT: Background and purposeRegular rehabilitation is not sufficient for regaining function after a hip fracture, and more targeted interventions for home-dwelling elderly hip-fracture patients are needed. This paper describes the protocol of a study assessing the effectiveness and cost effectiveness of a task specific progressive gait and balance exercise programme for hip-fracture patients, performed 4 months after the fracture.Methods/designA single blind two-arm pragmatic randomised controlled trial was conducted with 142 hip-fracture patients randomized to a 10-week home-based exercise programme or to practice as usual 4 months following the surgery. Inclusion criteria were age >70 years and being home dwelling prior to the fracture. Exclusion criteria are life expectancy <3 months and inability to walk 10 m prior to the fracture. The content and organization of the programme was developed in collaboration between physiotherapy researchers and primary health-care physiotherapists. Participants were followed for 1 year post-surgery, evaluating short-term and long-term effects of the programme. The primary outcome is gait speed, and the secondary outcomes are spatial and temporal gait parameters, free living physical behaviour by activity monitoring, mobility performance, activities of daily living, fear of falling, cognitive function, depression and health-related quality of life. Cost-effectiveness analysis is planned.DiscussionThis paper describes a task specific exercise programme aimed to improve gait and balance after a hip fracture. Inclusion started in February 2011, and the last 1-year follow-up is performed in March 2014. Broad inclusion criteria and physiotherapy-guided home-based exercises may facilitate the participation from frail patients and thereby increase the generalizability of the findings. Development and completion of the intervention within routine clinical practice will enlighten the implementation of results into clinical practice. Results may add new insight into how physiotherapy can improve gait and thereby activity and functioning in everyday life and have implications on future content and organization of physiotherapy after a hip fracture. Copyright © 2014 John Wiley & Sons, Ltd.
    Physiotherapy Research International 07/2014; 20(2). DOI:10.1002/pri.1599