Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement

Gagnier, Joel; Boon, Heather; Rochon, Paula A.; Moher, David; Barnes, Joanne; Bombardier, Claire

doi:10.7326/0003-4819-144-5-200603070-00013

Cited by 502 publications

(352 citation statements)

References 23 publications

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“…scandens preparations are very important step for clinical evaluation of herbal medicines (Gagnier et al, 2006). Since active ingredients in herbal products are influenced by several factors such as place, season or preparation, this may result in different clinical effects (Puttarak and Panichayupakaranant, 2012).…”

Section: Discussionmentioning

confidence: 99%

“…Data extraction was undertaken by PP and RS using a data extraction form in accordance with the CONSORT statement for reporting herbal medicinal interventions (Gagnier et al, 2006). The data extracted included: study design; number of participants; age of participants; pain score of participants; characteristics of the intervention; and outcome measurement.…”

Section: Data Extraction and Quality Assessmentmentioning

confidence: 99%

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Efficacy and safety of Derris scandens (Roxb.) Benth. for musculoskeletal pain treatment: A systematic review and meta-analysis of randomized controlled trials

Puttarak

Sawangjit

Chaiyakunapruk

2016

Journal of Ethnopharmacology

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This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. scandens showed no different relative risk with NSAIDs. The major adverse events were gastrointestinal symptoms. ConclusionD. scandens may be considered as an alternative for musculoskeletal pain reduction. 3 Graphical abstractAbbreviations

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Section: Discussionmentioning

confidence: 99%

Section: Data Extraction and Quality Assessmentmentioning

confidence: 99%

Efficacy and safety of Derris scandens (Roxb.) Benth. for musculoskeletal pain treatment: A systematic review and meta-analysis of randomized controlled trials

Puttarak

Sawangjit

Chaiyakunapruk

2016

Journal of Ethnopharmacology

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“…62 The CONSORT extensions for reporting herbal medicinal interventions, 63 non-pharmacologic treatment interventions, 64 acupuncture interventions, 65 non-inferiority and equivalence trials, 66 and pragmatic trials, 67 will be used if relevant.…”

Section: Quality Assessmentmentioning

confidence: 99%

Protocol for a Rapid Evidence Review of Traditional and Complementary Medicine for People with Diabetes Receiving Palliative or End-of-Life Care

Hunter¹,

Arentz²,

Deed³

2017

HPMIJ

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Abbreviations: T&CM, traditional and complementary medicine;PICO, patient/population/problem, intervention, comparison, outcome; UK, united kingdom; USA, united states of America; SR, systematic reviews; AMED, allied and complementary medicine database IntroductionThis paper presents a protocol using rapid review methods that will be used to select a limited number of traditional and complementary medicine (T&CM) interventions and evaluate the available evidence. The results from this review will be used to inform an update of the Australian Guidelines for Managing Diabetes at the end of life (Guidelines). Rapid review methods were chosen to maximise the number of T&CM interventions and different problems that could realistically be reviewed in a timely manner given the resources available to the research team.Rapid review methods are increasingly used as an alternative to systematic reviews (SR) when there are time, resource or other logistical constraints.1-5 Estimated costs of a comprehensive SR exceed USD$100,000 with an average of 1,139 hours to complete. 6For many research teams, pragmatic decisions must be made that may compromise the accepted 'gold standard' systematic review methods used to minimise bias, which in turn impacts the validity and generalisability of the results. As such, a rapid review is not a replacement for a full systematic review and meta-analysis. Notwithstanding methodological constraints, rapid reviews should endeavour to be transparent, systematic and reproducible. 4 Most Rapid Reviews do not publish a protocol.3 However, the recent establishment of a Cochrane Rapid Reviews Methods Group highlights the need to develop methods that minimise bias despite project constraints. Outlining the objectives and methodology a priori will further improve the transparency and quality of the methods used to frame the review questions, help reduce bias arising from the rapid review study design, and enhance the reproducibility of the results. AbstractBackground: Rapid review methods are increasingly used as an alternative to systematic reviews when there is time, resource or other logistical constraints. The Cochrane Rapid Reviews Methods Group recommends further methodological development and publishing protocols to improve the transparency and quality of the review. The authors of this paper were invited to provide timely, expert input for the revision of the 2010 Guidelines for Providing Palliative and End of Life Care for People with Diabetes (Guidelines), Australia, regarding the evidence-based use of traditional and complementary medicine (T&CM). The inclusion and consideration of T&CM in guidelines is often ad-hoc and would benefit from more systematic methods. Evidence of efficacy on clinical outcomes is not the only reason to review an intervention. Other reasons relevant to the T&CM context is: interventions that are commonly used by people with diabetes in the palliative care setting, have potentially high costs or risks, or present a conflict in choices between individual and societ...

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“…The CONSORT organization works to standardize the way in which clinical trials are conducted, including the way in which results are reported. The organization recently published Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement 3 . This important paper emphasizes the need for authentication of the product to be used in a clinical trial before that trial is started.…”

Section: Research On Nhpsmentioning

confidence: 99%

“…Quality-assured products are being developed through the same U.S. Food and Drug Administration (FDA) and Health Canada approval processes that are used for other drugs. Standards for the development and reporting of clinical trials of NHPs have been developed 3 . Many professionals involved in clinical research are currently involved in CAM studies.…”

Section: S54mentioning

confidence: 99%

Research and Regulatory Issues for Integrative Oncology

Sagar

Wong

2008

Current Oncology

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Many oncology patients are empowering themselves to self-treat with herbs, nutritional supplements, and mind-body techniques. Other practitioners, such as acupuncturists, are becoming involved in the supportive care of cancer patients. Government research agencies are supporting studies that evaluate complementary therapies. This educational article provides an overview of the challenges in designing appropriate studies of complementary and alternative therapies, evaluating the results, and regulating implementation of useful therapies. KEY WORDSIntegrative oncology, CAM, research, regulation, acupuncture, natural health products, herbs INTRODUCTIONPublic interest in, and research into, complementary and alternative medicine (generally called CAM) are both increasing. However, many medical practitioners would like to eliminate the term "alternative medicine." However, "alternative" is a useful anthropologic term for examining paradigms of practice such as Chinese medicine or Ayurveda.Complementary therapies are any therapies that are used with mainstream treatments (primarily surgery, drug treatments, chemotherapy, and radiotherapy). Complementary therapies are used in addition to mainstream treatments to improve outcomes. Complementary therapies can reduce side effects in patients and improve quality of life."Integrative medicine" is the current term for the evidence-based association of complementary therapies with mainstream medicine. There is great interest in conducting clinical trials to evaluate complementary therapies for use in a program of integrative medicine for cancer patients. Research and regulatory issues for integrative oncology S.M. Sagar MD* and R.K.W. Wong MB BS* PROBLEMS AND APPROACHES IN DESIGNING CLINICAL RESEARCH FOR CAM"Alternative therapies" are typically promoted as viable treatment options-that is, "alternatives" to socalled mainstream therapies such as chemotherapy, radiation, and surgery. Alternative therapies are unproven, seldom based on a credible scientific rationale, and potentially harmful-especially when patients are led away from effective, proven therapies by the lure of false promises and an emphasis on a lack of adverse side effects as compared with conventional therapies. In contrast, "complementary therapies" are to be distinguished from alternative therapies. In the context of cancer, complementary therapies are combined with conventional medicine into an "integrative oncology" program. Integrative oncology focuses on the roles of massage and other touch therapies, acupuncture, music therapy, botanicals, meditation and other mind-body approaches, nutrition, and fitness therapies, among others, in a research-orientated program. Treatment programs aim to reduce symptoms and to improve quality of life for cancer patients. Complementary therapies enhance the efficacy of conventional therapies and are evidence-based.Using modern research techniques, some so-called alternative therapies may be proved effective, at which point they will no longer be called "alternativ...

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Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement

Cited by 502 publications

References 23 publications

Efficacy and safety of Derris scandens (Roxb.) Benth. for musculoskeletal pain treatment: A systematic review and meta-analysis of randomized controlled trials

Efficacy and safety of Derris scandens (Roxb.) Benth. for musculoskeletal pain treatment: A systematic review and meta-analysis of randomized controlled trials

Protocol for a Rapid Evidence Review of Traditional and Complementary Medicine for People with Diabetes Receiving Palliative or End-of-Life Care

Research and Regulatory Issues for Integrative Oncology

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