|Level of Evidence Grade Criteria||Level of Evidence Grade Criteria|
|A - Strong Positive||Statistically significant evidence of benefit from >2 properly randomized trials (RCTs), OR evidence from one properly conducted RCT AND one properly conducted meta-analysis, OR evidence from multiple RCTs with a clear majority of the properly conducted trials showing statistically significant evidence of benefit AND with supporting evidence in basic science, animal studies, or theory.|
|B - Good|
Statistically significant evidence of benefit from 1-2 properly randomized trials, OR evidence of benefit from >1 properly conducted meta-analysis OR evidence of benefit from >1 cohort/case-control/non-randomized trials AND with supporting evidence in basic science, animal studies, or theory. This grade applies to situations in which a well designed randomized controlled trial reports negative results but stands in contrast to the positive efficacy results of multiple other less well designed trials or a well designed meta-analysis, while awaiting confirmatory evidence from an additional well designed randomized controlled trial.
|C - Unclear||Evidence of benefit from >1 small RCT(s) without adequate size, power, statistical significance, or quality of design by objective criteria,* OR conflicting evidence from multiple RCTs without a clear majority of the properly conducted trials showing evidence of benefit or ineffectiveness, OR evidence of benefit from >1 cohort/case-control/non-randomized trials AND without supporting evidence in basic science, animal studies, or theory, OR evidence of efficacy only from basic science, animal studies, or theory.|
|D - Fair Negative||Statistically significant negative evidence (i.e., lack of evidence of benefit) from cohort/case-control/non-randomized trials, AND evidence in basic science, animal studies, or theory suggesting a lack of benefit. This grade also applies to situations in which >1 well designed randomized controlled trial reports negative results, notwithstanding the existence of positive efficacy results reported from other less well designed trials or a meta-analysis. (Note: if there is >1 negative randomized controlled trials that are well designed and highly compelling, this will result in a grade of "F" notwithstanding positive results from other less well designed studies.)|
|E - Strong Negative||Statistically significant negative evidence (i.e., lack of evidence of benefit) from >1 properly randomized adequately powered trial(s) of high-quality design by objective criteria.*|
|X||Unable to evaluate efficacy due to lack of adequate available human data.|
Our customers are able to complete their own MyHealth Profile once registered at our website wherein they can specify their health/fitness goals, medical conditions and/or prescription/OTC drug usage. Our patent-pending methodology delivers a list of products based upon the efficacy of the ingredients in any given product in achieving health/fitness goals and/or preventing/treating medical conditions according to the clinical studies. Furthermore, our methodology eliminates any products whose ingredients are contraindicative with prescription/OTC drugs our customer is taking where the customer has completed thier MyPrescription Profile.
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The Natural Standard (www.naturalstandard.com) compiles extensive research on a multitude of ingredients found in products Fitness Formulary may offer along with contraindications with and amongst these products and prescription pharmaceuticals and over-the-counter preparations. Their research methodology is as follows:
Systematic Aggregation, Analysis, and Review of the Literature
To prepare each Natural Standard monograph, electronic searches are conducted in many databases, including AMED, CANCERLIT, CINAHL, CISCOM, the Cochrane Library, EMBASE, HerbMed, International Pharmaceutical Abstracts, Medline, and NAPRALERT. Search terms include the common name(s), scientific name(s), and all listed synonyms for each topic. Hand searches are conducted of 20 additional journals (not indexed in common databases), and of bibliographies from 50 selected secondary references. No restrictions are placed on language or quality of publications. Researchers in the field of complementary and alternative medicine (CAM) are consulted for access to additional references or ongoing research.
All literature is collected pertaining to efficacy in humans (regardless of study design, quality, or language), dosing, precautions, adverse effects, use in pregnancy/lactation, interactions, alteration of laboratory assays, and mechanism of action (in vitro, animal research, human data). Standardized inclusion/exclusion criteria are utilized for selection.
Data extraction and analysis are performed by health care professionals conducting clinical work and/or research at academic centers, using standardized instruments that pertain to each monograph section (defining inclusion/exclusion criteria and analytic techniques, including validated measures of study quality). Data are verified by a second reviewer.
Blinded review of monographs is conducted by multidisciplinary research-clinical faculty at major academic centers with expertise in epidemiology and biostatistics, pharmacology, toxicology, complementary and alternative medicine (CAM) research, and clinical practice. In cases of editorial disagreement, a three-member panel of the Editorial Board addresses conflicts, and consults experts when applicable. Authors of studies are contacted when clarification is required.
Natural Standard regularly monitors scientific literature and industry warnings. When clinically relevant new data emerge, best efforts are made to update content immediately. In addition, regular updates with renewed searches occur every 3-18 months, variable by topic.
Natural Standard evidence-based validated grading rationale ™
Grades reflect the level of available scientific evidence in support of the efficacy of a given therapy for a specific indication.
Expert opinion and folkloric precedent are not included in this assessment, and are reflected in a separate section of each monograph ("Strength of Expert Opinion and Historic / Folkloric Precedent")
Evidence of harm is considered separately; the below grades apply only to evidence of benefit.
* Objective criteria are derived from validated instruments for evaluating study quality, including the 5-point scale developed by Jadad et al., in which a score below 4 is considered to indicate lesser quality methodologically (Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Controlled Clinical Trials 1996; 17:1-12).
† Listed separately in monographs in the "Historical or Theoretical Uses which Lack Sufficient Evidence" section.Type your paragraph here.
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