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All About Efficacy

All About Efficacy
Category: Learn
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Synopsis:

All About Efficacy

Deffinition of Efficacy:

The word "efficacy" is a term most comonly used in medicine with a specific meaning: "The extent to which a specific intervention, procedure, regimen, or service produces a beneficial result under ideal conditions". The word applies to prescription pharmaceuticals where the claims are supported by extensive clinical studies that must pass the scrutiny of the FDA before being certified as legitimate.

In a world of products unregulated by the FDA, the word has equal meaning but potentially greater importance as to the legitimacy of product claims.

Fitness Formulary is comitted to delivering products whose ingredients have efficacy and are legitimately effective in the pursuit of a fitness goal and/or the treatment or prevention of a medical condition. Our MyHealth Efficacy Engine uses graded medical evidence to provide a list of products  that have the intended effect. Consumers are empowered with the knowledge as to what to expect the results could be. 

At the same time, it is important that, even in pharmacology, prescription medications may not have equal effectiveness from person to person. We rely upon the physicians, pharmacists and chemists to deliver the most likely results. Each person has her/his unique chemistry that results in the efficacy of pharmaceutical medications or those products we recommend here.

Formulary Panel Mission:

The Formulary Panel is comprised of leading physicians, surgeons, pharmacists, scientists, philosophers, chemists and nutritionists focused on health, wellness, fitness and nutrition. They are responsible for authentication of the Efficacy Engine, approving sources of scientific evidence by use by the Efficacy Engine, governance and oversight. They share the ideal that prevention is the first objective in the pursuit of health and wellness and that integrative medicine and behavioral modification are key considerations in disease treatment.

Authentication of the Efficacy Engine means randomized testing of the underlying algorithms to verify that results delivered consist of products containing ingredients wherein the clinical studies support the efficacy of the ingredient shown within the subject product. The Formulary Panel does NOT have any responsibility to verify, authenticate, approve or endorse clinical studies utilized by the Efficacy Engine; it only recommends legitimate sources of medical facts to be considered for use by the Efficacy Engine.  

Formulary Panel Roles

  • Authentication of the Efficacy Engine algorithm
  • Review and recommendation of sources for clinical studies
  • Brand recommendations where applicable
  • Preparation, participation and feedback in panel meetings
  • Impartiality and objectivity
  • Support and endorsement of Efficacy Engine
  • Testimonials for media and public relations
  • Advice for enhancement of the Efficacy Engine
  • Submission of practice area articles for publishing if appropriate
  • Attract and inspire other leading experts to join the Panel

Our Methodology:

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. 

The technology works like this in delivering the product list:

  1. Every ingredient for every product we sell is listed in a database.
     
  2. Our customer provides information to us in the MyHealth Assessment.
     
  3. Ingredients are rated using the Natural Standard methodology.
     
  4. Products with Ingredients ranked A, B or C are shown in descending order of relevant efficacy.
     The methodology works somewhat differently when browsing products at random through the website:
  1. Every ingredient for every product we sell is listed in a database
     
  2. User enters their Health Profile information
     
  3. Grades show up beside each product based upon the methodology described above. Products with D and F ingredients are visible as the user is browsing all products

The methodology and system are fully dependent upon our customer entering complete data and is limited to the clinical studies and efficacy ratings of ingredients currently in our database.

Our Grading System

 

 
 

 

Level of Evidence Grade

A  (Strong Scientific Evidence)

B  (Good Scientific Evidence)

C  (Unclear or Conflicting
       Scientific Evidence)

D  (Fair Negative
       Scientific Evidence)

F  (Strong Negative
       Scientific Evidence)

X    Lack of Evidence

Criteria

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.

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.

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.

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.)

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.*

Unable to evaluate efficacy due to lack of adequate available human data.