Pycnogenol for the treatment of chronic disorders : a systematic review

Thesis (MNutr)-- Stellenbosch University, 2011.ENGLISH ABSTRACT: Background: Oxidative stress has been implicated in the development of a number of conditions including amongst others cancer, arthritic disorders and cardiovascular disease. Pycnogenol is a herbal dietary supplement derived from French maritime pine bark extract. Pycnogenol is standardised to contain 70 ± 5% procyanidin which is a powerful antioxidant. Pycnogenol is marketed as a supplement for preventing or treating a wide range of chronic conditions. Although several randomised controlled trials of Pycnogenol have been conducted to date, this evidence has not yet been systematically reviewed. Objectives: The aim was to carry out a systematic review in order to assess the efficacy and safety of Pycnogenol for the treatment of chronic disorders. Search methods The electronic databases CENTRAL (until 18 September 2010), MEDLINE (until 18 September 2010) and EMBASE (until 13 October 2010) were searched, as well as three trial registries. Furthermore the manufacturer of Pycnogenol was contacted and bibliographies of included studies were hand-searched. Selection criteria: Randomised controlled trials (RCTs) evaluating the effectiveness of Pycnogenol in adults or children with any chronic disorder were included. The primary outcomes were any clinical outcomes directly related to the disorder (stratified as participant- and investigator-reported) as well as all-cause mortality. Adverse events and biomarkers of oxidative stress were also assessed. Data collection and analysis: Two authors independently assessed trial eligibility, extracted all data and judged methodological quality. A third author additionally extracted information on outcomes and results. With two exceptions, results for outcomes across studies could not be pooled mainly due to poor quality reporting. Study authors were contacted for additional information. Results: This review includes 15 RCTs with a total of 791 participants that have evaluated Pycnogenol for the treatment of seven different chronic disorders. The disorders included asthma (2 studies; N = 86), attention deficit hyperactivity disorder (1 study; N = 61), chronic venous insufficiency (2 studies; N = 60), diabetes mellitus (4 studies; N = 201), erectile dysfunction (1 study; N = 21), hypertension (2 studies; N = 69) and osteoarthritis of the knee (3 studies; N = 293). Two of the studies were conducted exclusively in children; the others involved adults. Due to small sample size, limited numbers of trials per condition, variation in selected outcomes and outcomes measures and the risk of bias no definitive conclusions regarding the efficacy or safety of Pycnogenol are possible. Authors’ conclusions: Current evidence is insufficient to support Pycnogenol use for the treatment of any chronic disorder. Well designed, adequately powered trials are recommended to establish the value of this treatment.AFRIKAANSE OPSOMMING: Inleiding: Oksidatiewe stres blyk ’n rol te speel in die ontwikkeling van ’n verskeidenheid siektes onder andere kanker, artritis en kardiovaskulêre siektes. Pycnogenol, ‘n kruie-bevattende dieetaanvulling wat uit Franse denneboombas vervaardig word, is gestandaardiseer om 70 ± 5% prosianidien – ’n kragtige anti-oksidant – te bevat. Die produk word bemark om ‘n wye reeks chroniese siektes te voorkom of te behandel. Alhoewel daar tot op hede verskeie kliniese proewe op Pycnogenol uitgevoer is, is die uitkomstes nog nie met behulp van ‘n stelselmatiese oorsig geëvalueer nie. Doelwitte: Die doel van hierdie studie was om met behulp van ‘n stelselmatiese oorsig die doeltreffendheid en veiligheid van Pycnogenol ten opsigte van die behandeling van chroniese siektes te evalueer. Soektogstrategie: Die elektroniese databasisse CENTRAL (tot 18 September 2010), MEDLINE (tot 18 September 2010) en EMBASE (tot 13 Oktober 2010) is deursoek, asook drie registers met kliniese proewe. Verder is die vervaardiger van Pycnogenol gekontak en is daar met die hand deur bibliografieë van ingeslote studies gesif. Keuringskriteria: Ewekansige gekontroleerde proewe (RCT’s) is ingesluit waarin die effektiwiteit van Pycnogenol in volwassenes of kinders met enige chroniese siekte geëvalueer is. Enige kliniese uitkomste wat direk aan die chroniese siekte verwant is (gesorteer as deelnemer- of ondersoeker-gerapporteerde uitkomstes) asook mortaliteit (enige oorsake) is as die primêre uitkomstes ondersoek. Dataversameling en -ontleding: Twee navorsers het onafhanklik van mekaar proewe gekeur, alle relevante data onttrek en gehalte van die metodiek beoordeel. ‘n Derde navorser het die resultate van die uitkomstes bykomend onttrek. Met twee uitsonderings, kon resultate van uitkomstes van die verskillende ingeslote studies kon nie statisties saamgevoeg word nie, hoofsaaklik as gevolg van swak rapportering. Skrywers van die ingeslote studies is in verband met die verlangde inligting gekontak. Resultate: Vyftien RCT’s met ‘n totaal van 791 deelnemers is ingesluit. In hierdie studies is Pycnogenol vir die behandeling van sewe verskillende chroniese siektes geëvalueer: asma (2 studies; N = 86), aandagafleibaarheid-hiperaktiwiteitsgebreksindroom (1 studie; N = 61), chroniese veneuse ontoereikendheid (2 studies; N = 60), diabetes mellitus (4 studies; N = 201), erektiele disfunksie (1 studie; N = 21), hipertensie (2 studies; N = 69) en osteo-artritis van die knie (3 studies; N = 293). Twee van hierdie studies is uitsluitlik met kinders gedoen; die res was volwassenes. As gevolg van klein steekproewe, ‘n beperkte aantal studies per siekte, wisseling in uitkomstes en die risiko vir sydigheid kan geen definitiewe gevolgtrekking oor die doeltreffendheid en veiligheid van Pycnogenol gemaak word nie. Skrywers se gevolgtrekking: Tans is daar nie voldoende wetenskaplike bewyse om Pycnogenol-gebruik vir die behandeling van enige chroniese siekte aan te beveel nie. Goed ontwerpte proewe met ‘n voldoende aantal deelnemers word aanbeveel om die waarde van hierdie behandeling onomwonde vas te stel

Mapping oral cancer research in South Africa

The aim of the present study was to review the scope of oral squamous cell carcinoma (OSCC) research in South Africa, including its epidemiology, diagnosis, associated risk factors and management. All publications relating to OSCC on the South African population were sought. A total of 72 studies were included and classified into seven categories; most studies were case reports or case series

Key Concepts for making informed Choices

Teach people to think critically about claims and comparisons — they will make better decisions

Mapping existing global strategies to improve health intervention research reporting (HIRR) in mass media: a scoping review protocol

The objectives are to scope the existing body of literature to (a) map existing global strategies or interventions aimed at improving HIRR in mass media and to (b) identify knowledge gaps for systematic reviews in this field

Methods used and lessons learnt in conducting document reviews of medical and allied health curricula : a key step in curriculum evaluation

CITATION: Rohwer, A., Schoonees, A. & Young, T. 2014. Methods used and lessons learnt in conducting document reviews of medical and allied health curricula - a key step in curriculum evaluation. BMC Medical Education, 14:236, doi:10.1186/1472-6920-14-236.The original publication is available at http://www.biomedcentral.com/1472-6920/14/236Publication of this article was funded by the Stellenbosch University Open Access Fund.Background: This paper describes the process, our experience and the lessons learnt in doing document reviews of health science curricula. Since we could not find relevant literature to guide us on how to approach these reviews, we feel that sharing our experience would benefit researchers embarking on similar projects. Methods: We followed a rigorous, transparent, pre-specified approach that included the preparation of a protocol, a pre-piloted data extraction form and coding schedule. Data were extracted, analysed and synthesised. Quality checks were included at all stages of the process. Results: The main lessons we learnt related to time and project management, continuous quality assurance, selecting the software that meets the needs of the project, involving experts as needed and disseminating the findings to relevant stakeholders. Conclusion: A complete curriculum evaluation comprises, apart from a document review, interviews with students and lecturers to assess the learnt and taught curricula respectively. Rigorous methods must be used to ensure an objective assessment.Publishers' Versio

Antiviral efficacy and safety of abacavir-containing combination antiretroviral therapy as first-line treatment of HIV-infected children and adolescents : a systematic review protocol

Publication of this article was funded by the Stellenbosch University Open Access Fund.The original publication is available at http://www.systematicreviewsjournal.com/content/3/1/87Adetokunboh, O.O., Schoonees, A. & Wiysonge, C.S. 2014. Antiviral efficacy and safety of abacavir-containing combination antiretroviral therapy as first-line treatment of HIV-infected children and adolescents: a systematic review protocol. Systematic Reviews, 3(87), doi:10.1186/2046-4053-3-87.Abstract Background: Abacavir is one of the recommended nucleoside reverse transcriptase inhibitors (NRTIs) for the treatment of HIV infections among children and adolescents. However, there are concerns that the antiviral efficacy of abacavir might be low when compared to other NRTIs especially among children. There are also concerns that abacavir use may lead to serious adverse events such as hypersensitivity reactions and has potential predisposition to developing cardiovascular diseases. Methods: We plan to do a systematic review to evaluate the antiviral efficacy and safety of abacavir-containing combination antiretroviral therapy as first-line treatment of HIV-infected children aged between 3 months and 18 years, compared with other NRTIs. We will search Scopus, Cochrane Central Register of Controlled Trials, MEDLINE, and Web of Science databases for eligible studies regardless of language or publication status. We will check the reference lists of included studies, search relevant conference proceedings, email the authors of included studies and also look for unpublished and ongoing trials in prospective clinical trial registries. Two authors will independently screen search outputs, select studies, extract data and assess the risk of bias in included studies. All disagreements will be resolved by discussion and consensus. Where data allow, we will conduct meta-analysis for similar types of participants, study designs, interventions, and outcome measures. If the results are statistically homogeneous, we will use the fixed-effect model; otherwise, we will use the random-effects model and explore the reasons for heterogeneity using subgroup analyses. Heterogeneity will be assessed with the Chi-squared test and quantified with the I-squared statistic. Discussion: The findings will be useful to policy makers and programme managers to inform treatment and management of HIV in children and adolescents and to point out research gaps for future research. Trial registration: This review is registered with PROSPERO, registration number CRD42014009157.Stellenbosch UniversityPublishers' Versio

Low Carbohydrate versus Isoenergetic Balanced Diets for Reducing Weight and Cardiovascular Risk: A Systematic Review and Meta-Analysis

Background Some popular weight loss diets restricting carbohydrates (CHO) claim to be more effective, and have additional health benefits in preventing cardiovascular disease compared to balanced weight loss diets. Methods and Findings We compared the effects of low CHO and isoenergetic balanced weight loss diets in overweight and obese adults assessed in randomised controlled trials (minimum follow-up of 12 weeks), and summarised the effects on weight, as well as cardiovascular and diabetes risk. Dietary criteria were derived from existing macronutrient recommendations. We searched Medline, EMBASE and CENTRAL (19 March 2014). Analysis was stratified by outcomes at 3–6 months and 1–2 years, and participants with diabetes were analysed separately. We evaluated dietary adherence and used GRADE to assess the quality of evidence. We calculated mean differences (MD) and performed random-effects meta-analysis. Nineteen trials were included (n = 3209); 3 had adequate allocation concealment. In non-diabetic participants, our analysis showed little or no difference in mean weight loss in the two groups at 3–6 months (MD 0.74 kg, 95%CI −1.49 to 0.01 kg; I2 = 53%; n = 1745, 14 trials; moderate quality evidence) and 1–2 years (MD 0.48 kg, 95%CI −1.44 kg to 0.49 kg; I2 = 12%; n = 1025; 7 trials, moderate quality evidence). Furthermore, little or no difference was detected at 3–6 months and 1–2 years for blood pressure, LDL, HDL and total cholesterol, triglycerides and fasting blood glucose (>914 participants). In diabetic participants, findings showed a similar pattern. Conclusions Trials show weight loss in the short-term irrespective of whether the diet is low CHO or balanced. There is probably little or no difference in weight loss and changes in cardiovascular risk factors up to two years of follow-up when overweight and obese adults, with or without type 2 diabetes, are randomised to low CHO diets and isoenergetic balanced weight loss diets

Evaluating evidence-based health care teaching and learning in the undergraduate human nutrition; occupational therapy; physiotherapy; and speech, language and hearing therapy programs at a sub-Saharan African academic institution

<div><p>Background</p><p>It is important that all undergraduate healthcare students are equipped with evidence-based health care (EBHC) knowledge and skills to encourage evidence-informed decision-making after graduation. We assessed EBHC teaching and learning in undergraduate human nutrition (HN); occupational therapy (OT); physiotherapy (PT); and speech, language and hearing therapy (SPLH) programs at a sub-Saharan African university.</p><p>Methods</p><p>We used methodological triangulation to obtain a comprehensive understanding of EBHC teaching and learning: (1) through a document review of module guides, we identified learning outcomes related to pre-specified EBHC competencies; we conducted (2) focus group discussions and interviews of lecturers to obtain their perspectives on EBHC and on EBHC teaching and learning; and we (3) invited final year students (2013) and 2012 graduates to complete an online survey on EBHC attitudes, self-perceived EBHC competence, and their experience of EBHC teaching and learning.</p><p>Results</p><p>We reviewed all module outlines (n = 89) from HN, PT and SLHT. The OT curriculum was being revised at that time and could not be included. Six lecturers each from HN and OT, and five lecturers each from PT and SLHT participated in the focus groups. Thirty percent (53/176) of invited students responded to the survey. EBHC competencies were addressed to varying degrees in the four programs, although EBHC teaching and learning mostly occurred implicitly. Learning outcomes referring to EBHC focused on enabling competencies (e.g., critical thinking, biostatistics, epidemiology) and were concentrated in theoretical modules. Key competencies (e.g., asking questions, searching databases, critical appraisal) were rarely addressed explicitly. Students felt that EBHC learning should be integrated throughout the four year study period to allow for repetition, consolidation and application of knowledge and skills. Lecturers highlighted several challenges to teaching and practising EBHC, including lack of evidence relevant to the African context and lack of time within curricula.</p></div