Open Access Journal of Clinical Trials · 2010 · 21 citations · 35 references
PharmacyPharmacotherapyClinical MedicineEvidence-based PracticeGood Clinical PracticeClinical TrialsEfficacy EvaluationRandomized Controlled TrialsStudy DesignBest Available Evidence ComparatorsEvidence-based Herbal SafetyHerbal Medicine Safety MonitoringHerbal Product StandardizationHerbal SupplementsMethodological RigorStandardization Of Herbal PreparationsStudy Endpoints
Research methodological issues in evaluating herbal interventions Dipika Bansal, Debasish Hota, Amitava ChakrabartiPostgraduate Institute of Medical Education and Research, Chandigarh, IndiaAbstract: Randomized controlled trials provide the best evidence, and is seen as the gold standard for allopathic research. Herbal therapies are not an integral part of conventional care although they are still used by patients in their health care management. These medicines need to be subjected to rigorous research to establish their effectiveness and safety. Clearly defined treatments are required and should be recorded in a manner that enables other suitably trained researchers to reproduce them reliably. Quality control of herbal products is also a prerequisite of credible clinical trials. Methodological strategies for investigating the herbal interventions and the issues regarding appropriate patient selection, randomization and blinding, placebo effects and choice of comparator, occupational standardization and the selection of appropriate study endpoints to prove efficacy are being discussed. This paper will review research options and propose some suggestions for future research design.Keywords: CAM research, herbal therapies, methodology, clinical trial
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Arthur Kleinman · Annals of Internal Medicine · 1978 · 2.9K citations
Why we need observational studies to evaluate the effectiveness of health care
BMJ · 1996 · 1.6K citations