Editorial Principles and Process

Executive Summary

We do...

Use an evidence-based approach 
Systematically review the literature 
Critically appraise the literature 
Utilize the most relevant and valid data 
Give more weight to higher quality data and less weight to lesser quality data 
Peer review 
Focus on practical, clinically relevant data 
Monitor and review new literature on a daily basis 
Update the Database daily 
Invite users to communicate with our editors about the content of the Database

We do NOT...

Use traditional beliefs or folklore as "evidence" 
Rely on product manufacturer promotional material for our scientific data 
Base ratings on unpublished manufacturer-sponsored studies 
Base our data on non-scientific material from Internet sites 
Have a bias for or against natural products 
Take any advertising or sponsorship...ever 

Evidence-Based Foundation

Natural Medicines is built strictly on the evidence. Many aspects of medicine are influenced by tradition and beliefs passed from one person to another. This is especially true in the area of natural medicines. Some natural medicines are used due to traditional or folkloric beliefs, and some are the subject of excessive marketing claims or excessive extrapolations from test tube or animal studies.

Natural Medicines approaches the subject of natural medicines from a completely objective and unbiased perspective. It seeks to answer questions about natural medicines by systematically identifying, evaluating, and applying scientific information. As a result, it curtails perpetuation of myths and age-old beliefs and replaces them with reliable scientific data.

In addition to providing reliable scientific data, Natural Medicines provides information that is clinically practical for health professionals. Health professionals need information that is soundly grounded in the evidence, but also need practical information that can support the clinical decision making process.

To achieve these goals, Natural Medicines relies on a solid evidence-based foundation. Each product monograph in the Database and its associated Safety Ratings, Effectiveness Ratings, and Interaction Ratings are supported by the best available scientific evidence. This evidence is systematically identified, critically evaluated, and applied using the same high standards used to evaluate evidence related to other therapies. We do not believe that there should be different standards of evidence for conventional therapies compared to alternative therapies. Therefore, we do not consider anecdote, tradition or folklore to be scientific “evidence.”

We recognize several different levels of evidence. Evidence that is highly relevant and valid is given greater weight than evidence that is less relevant or reliable.

When evidence does not exist or is severely deficient, which is often the case, this deficiency is clearly acknowledged in the Database with a statement indicating a lack of data.

Editorial Process

Natural Medicines is different than other publications on the subject. One important difference is that it is updated literally on a daily basis. New information is being identified, evaluated, and added to the Database every business day.

For many publications, the editorial process works as follows: A review of the literature is conducted. Some data are gathered and evaluated, and a monograph or chapter is written or updated. This process is then repeated periodically. This process has significant limitations because the review of the literature is often not systematic. Therefore, important pieces of literature are often excluded. This process commonly leads to biased findings. Authors tend to find literature to support their preconceived opinions rather than objectively and systematically finding the best information. This process is also limited because new information is not immediately added when new discoveries are made. Therefore, important new data might be excluded until months, or sometimes years later.

We do it differently. First and foremost, our approach is objective and systematic. Our editorial process involves a thorough, systematic search of the literature in order to identify relevant data. Then, on a daily basis, we continue to look for new data through a variety of mechanisms. As new information is discovered, it is critically assessed and if relevant, added to the Database. The new data is integrated and evaluated in the context of the previous findings.

This approach gives users of Natural Medicines access to the most relevant, reliable, and current information on natural medicines available anywhere.

The following sections outline the details of the Natural Medicines editorial process.

Contributors: Researchers, Writers, & Editors

Each contributor to Natural Medicines, including every researcher, writer, and editor is a health professional who is licensed to practice in their specialty area. Most contributors hold the Doctor of Pharmacy (PharmD) degree or Doctor of Medicine degree (MD) and have significant clinical experience in addition to expertise in evaluating medical research. Many contributors are active or previous faculty or have significant faculty affiliation with universities and academic medical centers.

Contributors approach natural medicines in an objective manor without bias in favor or against natural medicine products. The primary mission of contributors is to objectively evaluate data for relevancy and validity.

Editors must be free of conflicts of interest. In order to further minimize potential conflicts, editors are not permitted to hold stock in pharmaceutical industry or the natural product or food industries.

Identifying the Literature

A systematic approach is used to identify data related to natural medicines. For each new monograph a thorough literature search is conducted through several bibliographic databases using specific search criteria.

Databases are searched using scientific or botanical names, synonyms, or chemical names when appropriate. Other alternative names are also searched as required. Searches may also be conducted for disease-oriented topics when a product is known to be commonly used for a particular disease.

In additional to bibliographic databases, the reference lists of relevant articles and studies are also searched to identify articles that may not be indexed in common databases.

Experts and/or authors of papers are also routinely contacted as a source of additional information regarding research in specific subject areas.

Research is selected that has the potential to provide relevant information related to safety, effectiveness, clinical usage, mechanism of action or pharmacology, interactions with drugs, lab test interference, or other practice information that is relevant to health professionals.

Literature is excluded if it does not have the potential to provide relevant information.

Critical Appraisal of the Literature

All literature that is initially identified is critically evaluated based specific criteria:

  • Relevance. Upon initial screening, literature that provides relevant data is retained for further evaluation of validity. In order to be relevant literature must adequately address an issue of importance to health professionals. This primarily includes information about the safety or effectiveness of a product. It also includes information about mechanism of action or pharmacology, adverse reactions, interactions, lab test interference, etc. Literature that does not address relevant, practical issues is excluded.
  • Validity. Literature that provides relevant information is then assessed for validity. Each study is critically evaluated based on methodology and study conduct to determine if the design is adequate to provide valid results. As a part of this step, the level of evidence and quality of evidence is assessed.

Level of evidence is assessed using the following scale:

Level Definition
A High-quality randomized controlled trial (RCT) or High-quality meta-analysis (quantitative systematic review)
B Nonrandomized clinical trial; Nonquantitative systematic review; Lower quality RCT; Clinical cohort study; Case-control study; Historical control; or Epidemiologic study
C Consensus or expert opinion
D Anecdotal evidence; In vitro or animal research

Study quality is assessed using the following scale:

Quality Definition
A Meets assessment criteria; low risk of bias                                           
B Partially meets assessment; low to moderate risk of bias
C Does not meet assessment criteria; moderate to high risk of bias          
  • Consistency. All new literature is assessed in the context of previous findings to determine the consistency of the data. A high level of consistency provides a higher level of confidence in the reliability of the body of evidence as a whole. On the other hand, inconsistent findings may be due to a number of factors including inconsistent study designs, differences in patients studied, differences in product formulations, etc. Inconsistencies in findings indicate a lower level of reliability of the body of evidence.

Evidence-Based Safety & Effectiveness Ratings

Each natural medicine monograph contained in Natural Medicines provides Safety Ratings, Effectiveness Ratings, and Interaction Ratings. These ratings are assigned based on strict evidence-based criteria and represent a “strength of recommendation” rating.

Many resources assign a simple level of evidence which indicates the type of evidence that exists for a given condition or use. For example, a level of evidence might indicate that a randomized, placebo-controlled trial was conducted. Or it might indicate that only epidemiological evidence exists. This type of rating is limited because it only discusses one of many aspects of evidence that are needed to make a clinical decision.

The strength of the recommendation rating system used by Natural Medicines encompasses multiple critical aspects of an entire body of evidence. It includes the LEVEL of evidence plus the QUALITY of evidence and the overall CONSISTENCY of evidence. This is very important for making clinical decisions about natural medicines and other therapies. A product might be supported by a high level of evidence, but if the evidence is inconsistent, the product is not likely appropriate to recommend.

Natural medicines with a high level of evidence plus high quality and highly consistent evidence receive the highest ratings in Natural Medicines. Due to the high level of quality evidence needed to achieve this high rating, relatively few products fall into this category.

In some cases, there simply is not enough evidence, positive or negative, to assign a rating. In these cases, Natural Medicines clearly indicates that evidence is significantly lacking and a meaningful rating cannot be made.

Safety Ratings

Different Safety Ratings are assigned for different routes of administration and other specific factors. For example, a product might be “Likely Safe” when used short-term, but have insufficient data about long-term use. Similarly, a product might be “Possibly Unsafe” when taken orally, but “Likely Safe” when applied topically.

The evidence-based criteria for Safety Ratings is as follows:

LIKELY SAFE = This product has a very high level of reliable clinical evidence showing its safe use when used appropriately. Products rated Likely Safe are generally considered appropriate to recommend.

To achieve this Safety Rating a product is supported by all of the following:

  • Safety data is available from multiple (2+) randomized clinical trials or meta-analysis or large-scale post-marketing surveillance including several hundred patients (level of evidence = A). Or the product has undergone a safety review consistent with or equivalent to passing a review by the Food and Drug Administration (FDA), Health Canada, or similarly rigorous approval process.
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Studies adequately measure and report safety and adverse outcomes data and consistently show no significant serious adverse effects without valid evidence to the contrary.

POSSIBLY SAFE = This product has some clinical evidence showing its safe use when used appropriately; however, the evidence is limited by quantity, quality, or contradictory findings. Products rated “Possibly Safe” appear to be safe, but do not have enough high-quality evidence to recommend for most people.

To achieve this Safety Rating a product is supported by all of the following:

  • Safety data is available from one or more randomized clinical trials, meta-analysis (level of evidence = A or B), case series, two or more population based or epidemiological studies (level of evidence = B), or limited post-marketing surveillance data.
  • Studies have a low to moderate risk of bias and moderate to high level of validity by meeting or partially meeting assessment criteria (quality rating A or B).
  • Studies adequately measure and report safety and adverse outcomes data and show no significant serious adverse effects without substantial evidence to the contrary. Some contrary evidence may exist; however, valid evidence supporting safety outweighs contrary evidence.

POSSIBLY UNSAFE = This product has some clinical evidence showing safety concerns or significant adverse outcomes; however, the evidence is limited by quantity, quality, or contradictory findings. People should be advised NOT to take products with a “Possibly Unsafe” rating.

To achieve this Safety Rating a product is supported by all of the following:

  • Safety data is available from one or more randomized clinical trials, meta-analysis (level of evidence = A or B), two or more population based or epidemiological studies (level of evidence = B), or limited post-marketing surveillance data. Or multiple, reliable case reports show a potential causal relationship between a product and serious adverse outcome.
  • Studies have a low to moderate risk of bias and moderate to high level of validity by meeting or partially meeting assessment criteria (quality rating A or B).
  • Studies adequately measure and report safety and adverse outcomes data and show significant serious adverse effects without substantial evidence to the contrary. Some contrary evidence may exist; however, valid evidence supporting potential safety concerns outweigh contrary evidence.

LIKELY UNSAFE = This product has a very high level of reliable clinical evidence showing safety concerns or significant adverse outcomes. People should be discouraged from taking products with a “Likely Unsafe” rating.

To achieve this Safety Rating a product is supported by all of the following:

  • Safety data is available from multiple (2+) randomized clinical trials, meta-analysis, or large-scale post-marketing surveillance including several hundred patients (level of evidence = A).
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Studies adequately measure and report safety and adverse outcomes data and consistently show significant serious adverse effects without valid evidence to the contrary.

UNSAFE = This product has a very high level of reliable clinical evidence showing safety concerns or significant adverse outcomes. People should be discouraged from taking products with an Unsafe rating.

To achieve this Safety Rating a product is supported by all of the following:

  • Safety data is available from multiple (2+) randomized clinical trials, meta-analysis, or large-scale post-marketing surveillance including several hundred to several thousand patients (level of evidence = A).
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Studies adequately measure and report safety and adverse outcomes data and consistently show significant serious adverse effects without valid evidence to the contrary.

Effectiveness Ratings

Effectiveness Ratings are assigned for specific indications. A product might be rated “Possibly Effective” for one condition, but be rated “Likely Ineffective” for another condition, depending on the evidence.

The evidence-based criteria for Effectiveness Ratings is as follows:

EFFECTIVE = This product has a very high level of reliable clinical evidence supporting its use for a specific indication. Products rated Effective are generally considered appropriate to recommend.

To achieve this Effectiveness Rating a product is supported by all of the following:

  • Evidence consistent with or equivalent to passing a review by the Food and Drug Administration (FDA), Health Canada, or similarly rigorous approval process.
  • Evidence from multiple (2+) randomized clinical trials or meta-analysis including several hundred to several thousand patients (level of evidence = A).
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Evidence consistently shows POSITIVE outcomes for a given indication without valid evidence to the contrary.

LIKELY EFFECTIVE = This product has a very high level of reliable clinical evidence supporting its use for a specific indication. Products rated “Likely Effective” are generally considered appropriate to recommend.

To achieve this Effectiveness Rating a product is supported by all of the following:

  • Evidence from multiple (2+) randomized clinical trials or meta-analysis including several hundred patients (level of evidence = A).
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Evidence consistently shows POSITIVE outcomes for a given indication without significant valid evidence to the contrary.

POSSIBLY EFFECTIVE = This product has some clinical evidence supporting its use for a specific indication; however, the evidence is limited by quantity, quality, or contradictory findings. Products rated “Possibly Effective” might be beneficial, but do not have enough high-quality evidence to recommend for most people.

To achieve this Effectiveness Rating a product is supported by all of the following:

  • One or more randomized clinical trials or meta-analysis (level of evidence = A or B) or two or more population based or epidemiological studies (level of evidence = B).
  • Studies have a low to moderate risk of bias and moderate to high level of validity by meeting or partially meeting assessment criteria (quality rating A or B).
  • Evidence shows POSITIVE outcomes for a given indication without substantial valid evidence to the contrary. Some contrary evidence may exist; however, valid positive evidence outweighs contrary evidence.

POSSIBLY INEFFECTIVE = This product has some clinical evidence showing ineffectiveness for a specific indication; however, the evidence is limited by quantity, quality, or contradictory findings. People should be advised NOT to take products with a “Possibly Ineffective” rating.

To achieve this Effectiveness Rating a product is supported by all of the following:

  • One or more randomized clinical trials or meta-analysis (level of evidence = A or B) or two or more population based or epidemiological studies (level of evidence = B).
  • Studies have a low to moderate risk of bias and moderate to high level of validity by meeting or partially meeting assessment criteria (quality rating A or B).
  • Evidence shows NEGATIVE outcomes for a given indication without substantial valid evidence to the contrary. Some contrary evidence may exist; however, valid positive evidence outweighs contrary evidence.

LIKELY INEFFECTIVE = This product has a very high level of reliable clinical evidence showing ineffectiveness for its use for a specific indication. People should be discouraged from taking products with a “Likely Ineffective” rating.

To achieve this Effectiveness Rating a product is supported by all of the following:

  • Evidence from multiple (2+) randomized clinical trials or meta-analysis including several hundred patients (level of evidence = A).
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Evidence consistently shows NEGATIVE outcomes for a given indication without significant valid evidence to the contrary.

INEFFECTIVE = This product has a very high level of reliable clinical evidence showing ineffectiveness for its use for a specific indication. People should be discouraged from taking products with an “Ineffective” rating.

To achieve this Effectiveness Rating a product is supported by all of the following:

  • Evidence from multiple (2+) randomized clinical trials or meta-analysis including several hundred to several thousand patients (level of evidence = A).
  • Studies have a low risk of bias and high level of validity by meeting stringent assessment criteria (quality rating = A).
  • Evidence consistently shows NEGATIVE outcomes for a given indication without valid evidence to the contrary.

Peer Review

Natural Medicines uses a multi-disciplinary, multi-pronged approach to peer review for all content contained in the Database. The Editorial Review Board consists of practitioners from multiple disciplines including pharmacy, medicine, nutrition, research, nursing, and others.

Peer review occurs through a multi-pronged approach. As new content is developed, it goes through an extensive internal review process in conjunction with external peer review by health practitioners and appropriate content-area experts. Particular attention is focused on assigning Safety and Effectiveness Ratings based on specific rating criteria described above.

Peer review is conducted to ensure that content is not only accurate and reliable, but also practical and relevant to practitioners who use Natural Medicines on a daily basis to make clinical decisions.

Peer review is also conducted on an ongoing basis to continually assess the content already contained in the Database. Experts affiliated with Therapeutic Research Faculty, including health practitioners and content experts, routinely review Database content and participate in the process of continuous quality improvement.

The multidisciplinary and multi-pronged approach results in extensively reviewed and refined content that is not only highly reliable, but very practical.

Current Content

In addition to providing evidence-based information that is unbiased, reliable, and very practical, an important priority of the editorial process is to provide the most current information available on natural medicines. To stay current, literature from around the world is reviewed on a daily basis. Literature is reviewed from over 100 journals worldwide. New literature is prioritized based on its potential practice impact. Patient safety comes first; therefore, safety concerns get top priority. A newly discovered drug interaction or serious adverse event is often added to the Database within 24 hours. New clinical trials that document either positive or negative outcome are also given a high priority and are typically added to the Database within a week. Other information regarding mechanisms of action and pharmacologically active constituents are typically added within 1-4 weeks, depending on significance.

Continuous Updates, Innovation, and Improvement

The Natural Medicines team is constantly improving the user experience by improving accessibility to information and expanding and enhancing the clinical tools contained in the Database. Research in the area of natural medicines is booming. The volume of information available is growing rapidly. By focusing on the most practical information, Natural Medicines helps users get the most relevant information as efficiently as possible. Through continuing technological and editorial enhancements the Database is also helping users pinpoint answers to clinical questions as quickly as possible.