Challenges in systematic reviews of complementary and alternative medicine topics. Ann Intern Med

Southern California Evidence-based Practice Center, RAND Corporation, Santa Monica, California 90401, USA.
Annals of internal medicine (Impact Factor: 17.81). 07/2005; 142(12 Pt 2):1042-7.
Source: PubMed


The use of complementary and alternative medicine (CAM) continues to grow in the United States. The Agency for Healthcare Research and Quality has devoted a substantial proportion of the Evidence-based Practice Center (EPC) program to systematic reviews of CAM. Such syntheses present different challenges from those conducted on western medicine topics, and in many ways are more difficult. We discuss 3 challenges: identifying evidence about CAM, assessing the quality of individual studies, and addressing rare serious adverse events. We use illustrations from EPC evidence reports to show readers approaches to the 3 areas and then present specific recommendations for each issue.

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    • "Communicating with experts in the field has been established as another means of locating grey literature [10]. Two experts, Lord Nigel Crisp (Independent Crossbencher and Author of the Crisp Report, 2007 [1]), and Graeme Chisholm (Volunteer Engagement Manager, THET: The Tropical Health and Education Trust, responsible for working with individuals participating in health partnerships) were emailed explaining the aims and purpose of the review and requesting information about any relevant past or current projects about which they might be aware. "
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    ABSTRACT: Health partnerships between institutions in the UK and Low or Lower- middle Income Countries are an increasingly important model of development, yet analysis of partnerships has focused on benefits and costs to the Low and Lower- Middle Income partner. We reviewed the evidence on benefits and costs of health partnerships to UK individuals, institutions & the NHS and sought to understand how volunteering within partnerships might impact on workforce development and service delivery. A systematic review of both published literature and grey literature was conducted. Content relating to costs or benefits to the UK at an individual, institutional or system level was extracted and analysed by thematic synthesis. The benefits of volunteering described were mapped to the key outcome indicators for five different UK professional development structures. A framework was developed to demonstrate the link between volunteer experience within partnerships and improved UK service delivery outcomes. The literature review (including citation mapping) returned 9 published papers and 32 pieces of grey literature that met all inclusion criteria. 95% of sources cited benefits and 32% cited costs. Most literature does not meet high standards of formal academic rigor. Forty initial individual benefits codes were elicited. These were then grouped into 7 key domains: clinical skills; management skills; communication & teamwork; patient experience & dignity; policy; academic skills; and personal satisfaction & interest. A high degree of concordance was shown between professional benefits cited and professional development indicators within UK work force development frameworks. A theoretical trajectory from volunteer experience to UK service delivery outcomes was demonstrated in most areas, but not all. 32% of sources cited costs, yielding 15 initial codes which were grouped into 5 domains: financial; reputational; health & security; loss of staff; and opportunity costs. There is little published or unpublished literature on the impact of volunteering within health partnerships to British individuals, institutions or the UK. The existing evidence base is descriptive and focuses on the benefits of volunteering. More work is required to quantify the costs and benefits of volunteering within health partnerships for individuals and institutions, and the associated challenges and barriers. Despite these limitations our analysis suggests that there is a strong theoretical argument that the skills acquired through volunteering are transferable to service delivery within the NHS and that the benefits to individuals and institutions could be maximised when volunteering is formally embedded within continuing professional development processes.
    Full-text · Article · Aug 2013 · Globalization and Health
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    • "The World Health Organization (WHO) insists that the safety of herbal medicines is a critical component in the quality control of healthcare products. However, lack of adequate regulations , the pharmacological complexity of herbal products, and the insufficiency of information on the pharmacology and toxicity of these compounds are sometimes becoming medical issues, even though the side effects are minimal [4] [5]. "
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    ABSTRACT: UP446 has been used in both joint supplements and prescription medical food. The purpose of this study was to evalu-ate the pharmaceutical safety of UP446 via acute and 26-week repeated oral dose toxicity study in SD rats. In acute tox-icity study, UP446 was administered by oral gavage to Sprague-Dawley rats (5 males and 5 females) at a dose of 5000 mg/kg. In 26-week repeated oral dose toxicity study, UP446 at doses of 500, 1000 and 2000 mg/kg/day were given orally to groups of rats (10 rats/dose/sex) for 26-week. UP446 at a dose of 5000 mg/kg produced no treatment-related acute toxicity or mortality in any of the animals tested during 14 days of the study. In 26-week repeated dose toxicity study, there was no significant difference in body weight between the control and all treatment groups. Blackish stool and soft stool was observed in one male in the 1000 mg/kg group and in some males and females of 2000 mg/kg group. However, these changes of stool were not considered to be toxic effects because neither histopathological change in gastrointestinal tracks (GIT) nor body weight change were detected. No drug induced abnormalities were found as of body weights, food consumption, ophthalmological examinations, urinalysis, hematology, clinical chemistry, organ weights and gross necropsy in any animals in the dosing groups. These results suggest that the oral lethal dose of UP446 for male and female rats is in excess of 5000 mg/kg and the no observed adverse effect level (NOAEL) of the UP446 for both male and female rats is considered to be greater than 2000 mg/kg/day.
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    • "A comparative study was eligible if it was published in English or German; other languages were excluded due to concerns with study quality [15] or applicability [16]. We included German language publications given the well-developed regulations for research, practice and use of dietary supplements in Germany [17-19]. "
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    ABSTRACT: Background The objective of this systematic review was to examine the benefits, harms and pharmacokinetic interactions arising from the co-administration of commonly used dietary supplements with cardiovascular drugs. Many patients on cardiovascular drugs take dietary supplements for presumed benefits and may be at risk for adverse supplement-drug interactions. Methods The Allied and Complementary Medicine Database, the Cochrane Library, EMBASE, International Bibliographic Information on Dietary Supplements and MEDLINE were searched from the inception of the review to October 2011. Grey literature was also reviewed. Two reviewers independently screened records to identify studies comparing a supplement plus cardiovascular drug(s) with the drug(s) alone. Reviewers extracted data using standardized forms, assessed the study risk of bias, graded the strength of evidence and reported applicability. Evidence was obtained from 65 randomized clinical trials, 2 controlled clinical trials and 1 observational study. With only a few small studies available per supplement, evidence was insufficient for all predefined gradable clinical efficacy and harms outcomes, such as mortality and serious adverse events. One long-term pragmatic trial showed no benefit from co-administering vitamin E with aspirin on a composite cardiovascular outcome. Evidence for most intermediate outcomes was insufficient or of low strength, suggesting no effect. Incremental benefits were noted for triglyceridemia with omega-3 fatty acid added to statins; and there was an improvement in levels of high-density lipoprotein cholesterol with garlic supplementation when people also consumed nitrates Evidence of low-strength indicates benefits of omega-3 fatty acids (plus statin, or calcium channel blockers and antiplatelets) and garlic (plus nitrates or warfarin) on triglycerides and HDL-C, respectively. Safety concerns, however, persist.
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