nnlm.gov · Web viewAlthough alternative medicine is gaining in popularity, to date there have been no clinical trials conducted on this type of therapy. Instructor: You can pass

Instructor Guide

Let’s take a quick True/False pre-test to assess your current knowledge of CAM. You do not need to share your results, but at the end of class compare where you started, and what you have learned!

True or False: The Food and Drug Administration (FDA) regulates dietary supplements.Chiropractic care is still considered a type of complementary and alternative medicine therapy.Manufacturers need to register a dietary supplement with the FDA before producing or selling it.Although alternative medicine is gaining in popularity, to date there have been no clinical trials conducted on this type of therapy.

Instructor: You can pass sheets out with questions, create an online quiz, or place questions on a PPT slide.

There are lots of reported ways to remove warts. From toothpaste, to castor oil, to duct tape. We will be looking at resources to help us understand what works, and what doesn’t work.

Here’s our agenda for today. We will take a quick trip through the evolution of CAM in the United States, do some hands-on work evaluating websites, and investigate ways to search for evidence-based information.

You may have seen the words “complementary” and “alternative,” but what do they really mean?

If a non-mainstream practice is used together with conventional medicine, it’s considered “complementary.”If a non-mainstream practice is used in place of conventional medicine, it’s considered “alternative.”

You may also have heard the term “integrative.” There are many definitions, but they all involve bringing conventional and complementary approaches together in a coordinated way.

According to NCCIH, defining CAM is difficult, because the field is very broad and constantly changing. NCCIH defines CAM as a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine. Conventional medicine (also called Western or allopathic medicine) is medicine as practiced by holders of M.D. (medical doctor) and D.O. (doctor of osteopathy) degrees and

by allied health professionals, such as physical therapists, psychologists, and registered nurses. The boundaries between CAM and conventional medicine are not absolute, and specific CAM practices may, over time, become widely accepted.

SOURCE: https://nccih.nih.gov/health/integrative-health HIDE SLIDE IF 4-HR CLASS

4-hour classLet’s take a few minutes to talk about why a definition of CAM might be important.

Some prompts to get things started:1. CAM covers a large number of

options, and in order for them to have legitimacy, acceptance, and uptake in research and practice, CAM needs to be understandable and recognizable.

2. Definitions seem to matter to insurance companies, Medicare, and 3rd party payers.

3. Having a definition can help facilitate conversations about the treatments, products, and systems. It helps make sure everyone is on the same page at the get-go.

4. Researchers will want to classify, quantify and analyze CAM practices and trends, so it would be important to have consensus on definitions.

1990 – Chiropractor Dr. Chester Wilk and 9 others bring a federal antitrust suit against the American Medical Association. The AMA had long termed chiropractic “an unscientific cult.” The proceedings went through 2 lengthy trials, culminating in a decision that the AMA had unlawfully conspired to “contain and eliminate the chiropractic profession.”

1991 - The U.S. Congress passes legislation (Public Law 102-170) that provides $2 million

in funding for fiscal year 1992 to establish an office within the National Institutes of Health (NIH) to investigate and evaluate promising unconventional medical practices. (In FY 2017, the now NCCIH received $130.5 million.)

1994 - The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements.[1] Under the act, supplements are effectively regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111.1995 - The Office of Dietary Supplements was established at NIH in November 1995 as a result of the Dietary Supplement Health and Education Act passed by Congress in 1994. Among their goals is to promote scientific study of dietary supplements. Also this year, the FDA declassified acupuncture needles as an experimental product. (There are over 18,000 licensed acupuncturist in the U.S.).

1996 – The NIH Consensus Conference on Acupuncture found that Acupuncture was effective in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. Useful in other areas such as addiction, stroke rehabilitation, headache, back pain, etc. as an adjunct treatment or acceptable alternative or to be included in a comprehensive management program.

1997 - First large trial of CAM therapy, St. John's Wort for depression. The trial ran from December 1998 through June 2000 with 340 participants. Analysis of results was completed in 2001. (Unfortunately, the results of this study indicated that St. John's wort is not effective in treating major depression of moderate severity.)

1998 – NCCAM (NCCIH) is established along with the Office of Cancer Complimentary and Alternative Medicine (OCCAM), and JAMA publishes first full-scale article on herbal medicine.

2001 – Launch of CAM subset of a larger medical literature database PubMed to provide free, web-based access to CAM sources of information.

2009 – Results of the first survey from NHIS are published on U.S. spending on CAM.

2015 - Congress renames NCCAM the National Center for Complementary and Integrative Health (NCCIH). The change reflects the importance of studying the approaches to health and wellness that the public is using, often without the benefit of rigorous scientific study.2012 is the most current report. The next few slides will help us understand how much usage of certain CAM modalities are used in the U.S.

Top four mind/body practices reported by adults in the 2012 report.The most common disease/condition for seeking CAM therapies was for pain (back, neck, migraines).

HIDE SLIDE IF 4-HR CLASS

4-hour class

Let’s take a few minutes to talk about the relationship between CAM and Western medicine.

When a therapy is tested and proves to be effective, does it leave the CAM category and become conventional medicine?

Sometimes doctors do CAM therapies, and CAM practitioners do conventional therapies. When is it CAM and when is it conventional?

Is CAM the appropriate term for medicines that are considered the dominant medical practice in their own country?

Now let’s look at how CAM is categorized.

Most complementary health approaches fall into one of two subgroups—natural products or mind and body practices.

Natural ProductsThis group includes a variety of products, such as herbs (also known as botanicals), vitamins and minerals, and probiotics. They are widely marketed, readily available to consumers, and often sold as dietary supplements.

Mind and Body PracticesMind and body practices include a large and diverse group of procedures or techniques administered or taught by a trained practitioner or teacher. Example include yoga, chiropractic, meditation, massage therapy, acupuncture, relaxation techniques tai chi, and movement therapies.

Other Complementary Health ApproachesSome approaches may not neatly fit into either of these groups—for example, the practices of traditional healers, Ayurvedic medicine, traditional Chinese medicine, homeopathy, and naturopathy.

HIDE SLIDE IF 4-HR CLASS

4-hour class Prompts:

1. Are there too many categories? Not enough?

2. Should areas like Chinese Medicine, traditional healers be more prominent? Not just “Other”?

3. Should we have categories that tie to Western medicine to help patients and doctors, like CAM for cardiology, pain management, reproduction?

Bad science is often called pseudoscience. According to Wikipedia, pseudoscience is a claim, belief, or practice which is presented as scientific, but which does not adhere to a valid scientific methodology, lacks supporting evidence or plausibility, cannot be reliably tested, or otherwise lacks scientific status.

Pseudoscience is often characterized by the use of vague, exaggerated or unprovable claims, an over-reliance on confirmation rather than rigorous attempts at refutation, a lack of openness to evaluation by other experts, and a general absence of systematic processes to rationally develop theories. The term "pseudoscience" is inherently pejorative, because it suggests that something is being inaccurately or deceptively portrayed as science.

The following are some of the indicators of the possible presence of pseudoscience:

1. Use of vague, exaggerated, or untested claims.

2. Over-reliance on confirmation rather than refutation.

3. Lack of openness to testing by other experts.

4. Absence of progress.5. Use of misleading language.6. Absence from citation databases.

The following are some of the indicators of the possible presence of pseudoscience.Use of vague, exaggerated or untestable claims

Assertion of scientific claims that are vague rather than precise, and that lack specific measurements.[28]

Failure to make use of operational definitions (i.e. publicly accessible definitions of the variables, terms, or objects of interest so that persons other than the definer can independently measure or test them).[29] (See also: Reproducibility)

Failure to make reasonable use of the principle of parsimony, i.e. failing to

seek an explanation that requires the fewest possible additional assumptions when multiple viable explanations are possible (see: Occam's razor)[30]

Use of obscurantist language, and use of apparently technical jargon in an effort to give claims the superficial trappings of science.

Lack of boundary conditions: Most well-supported scientific theories possess well-articulated limitations under which the predicted phenomena do and do not apply.[31]

Lack of effective controls, such as placebo and double-blind, in experimental design.

Over-reliance on confirmation rather than refutation

Assertions that do not allow the logical possibility that they can be shown to be false by observation or physical experiment (see also: falsifiability)[32]

Assertion of claims that a theory predicts something that it has not been shown to predict.[33] Scientific claims that do not confer any predictive power are considered at best "conjectures", or at worst "pseudoscience" (e.g. Ignoratio elenchi)[34]

Assertion that claims which have not been proven false must be true, and vice versa (see: Argument from ignorance)[35]

Over-reliance on testimonial, anecdotal evidence, or personal experience. This evidence may be useful for the context of discovery (i.e. hypothesis generation) but should not be used in the context of justification (e.g. Statistical hypothesis testing).[36]

Presentation of data that seems to support its claims while suppressing or refusing to consider data that conflict with its claims.[37] This is an

example of selection bias, a distortion of evidence or data that arises from the way that the data are collected. It is sometimes referred to as the selection effect.

Reversed burden of proof . In science, the burden of proof rests on those making a claim, not on the critic. "Pseudoscientific" arguments may neglect this principle and demand that skeptics demonstrate beyond a reasonable doubt that a claim (e.g. an assertion regarding the efficacy of a novel therapeutic technique) is false. It is essentially impossible to prove a universal negative, so this tactic incorrectly places the burden of proof on the skeptic rather than the claimant.[38]

Appeals to holism as opposed to reductionism: Proponents of pseudoscientific claims, especially in organic medicine, alternative medicine, naturopathy and mental health, often resort to the "mantra of holism" to explain negative findings.[39]

Lack of openness to testing by other experts Evasion of peer review before

publicizing results (called "science by press conference").[40] Some proponents of theories that contradict accepted scientific theories avoid subjecting their ideas to peer review, sometimes on the grounds that peer review is biased towards established paradigms, and sometimes on the grounds that assertions cannot be evaluated adequately using standard scientific methods. By remaining insulated from the peer review process, these proponents forgo the opportunity of corrective feedback from informed colleagues.[41]

Some agencies, institutions, and publications that fund scientific research require authors to share

data so that others can evaluate a paper independently. Failure to provide adequate information for other researchers to reproduce the claims contributes to a lack of openness.[42]

Appealing to the need for secrecy or proprietary knowledge when an independent review of data or methodology is requested.[42]

Absence of progress Failure to progress towards

additional evidence of its claims.[43] Terence Hines has identified astrology as a subject that has changed very little in the past two millennia.[44] (see also: Scientific progress)

Lack of self-correction: scientific research programs make mistakes, but they tend to eliminate these errors over time.[45] By contrast, theories may be accused of being pseudoscientific because they have remained unaltered despite contradictory evidence. The work Scientists Confront Velikovsky (1976) Cornell University, also delves into these features in some detail, as does the work of Thomas Kuhn, e.g. The Structure of Scientific Revolutions (1962) which also discusses some of the items on the list of characteristics of pseudoscience.

Statistical significance of supporting experimental results does not improve over time and are usually close to the cutoff for statistical significance. Normally, experimental techniques improve or the experiments are repeated and this gives ever stronger evidence. If statistical significance does not improve, this typically shows that the experiments have just been repeated until a success occurs due to chance variations.

Personalization of issues

Tight social groups and authoritarian personality, suppression of dissent, and groupthink can enhance the adoption of beliefs that have no rational basis. In attempting to confirm their beliefs, the group tends to identify their critics as enemies.[46]

Assertion of claims of a conspiracy on the part of the scientific community to suppress the results.[47]

Attacking the motives or character of anyone who questions the claims (see Ad hominem fallacy).[48]

Use of misleading language Creating scientific-sounding terms in

order to add weight to claims and persuade non-experts to believe statements that may be false or meaningless. For example, a long-standing hoax refers to water by the rarely used formal name "dihydrogen monoxide" (DHMO) and describes it as the main constituent in most poisonous solutions to show how easily the general public can be misled.

Using established terms in idiosyncratic ways, thereby demonstrating unfamiliarity with mainstream work in the discipline.

Absence from citation databases One way of assessing whether a

subject is accepted as part of the scientific mainstream is to examine citations to it and its proponents in citation databases like Google Scholar, Scopus and Web of Science. These databases record how many times the topic or person is referred to in scholarly publications that are peer refereed. A subject that is accepted as part of the mainstream is likely to have many thousands of citations, one that is not accepted very few.

Let’s take a look at some websites and we will discuss how they meet the “bad science” criteria.

2-hour class – have students count off 1-5. Each student will review the website matching their number. Have students report their impressions back to the group. 4-hour class – have students select at least 3 sites. Have students report their impressions back to the group.

*The personal testimonials site is no longer, but it’s a great example, and thanks to the Way Back Machine for archiving. (Original website: http ://www.getslimslippers.com / ).

*Kratom is a plant that grows in Asia -- poses serious health risks, according to the FDA. In February 2018, the agency declared that kratom acts like an opioid in the human brain.

Now that we have reviewed some more obvious examples of bad science, let’s look at some that might be more difficult to determine its authoritativeness.

These five criteria are standard for evaluating any website, including health sites. MedlinePlus has some pulled together some great resources for evaluating health information (https://medlineplus.gov/evaluatinghealthinformation.html#cat_51).

Accuracy Is there a discrepancy between

the claim and the research? (ex: “Stem Cells cure Arthritis!” vs. “Stem Cells Put Woman’s Arthritis in Remission”)

Are there footnotes, bibliographies, or references so that you can verify the

information? Does the report give numbers and

statistics in context so you can determine their relevance?

Has this study been repeated by anyone else? If not, further research will be needed to determine that the results are valid.

Does the story state the evidence upon which the material is based?

Are opinions or advice presented as “evidence based?”

Authority Was the article published in a

peer-reviewed journal? If so, it has more credibility than when posted on a website or a brochure. Even if it has been announced at a research conference, if it has not been published in a journal, additional studies will probably be needed.

Is a reputable research organization doing the study? Do the researchers have the appropriate experience?

Bias Has the story been

sensationalized? Do the study findings happen to

support one of the advertisers? Who conducted the study? Is it

the same people who are selling the product, or is it a reputable research agency?

Who funded the study? While the funding of the project will not necessarily bias the results, studies may be more credible if the funding agency does not profit by one result over the other.

Currency/Timeliness

When will the drugs or procedures studied be available to the public?

Was the study done with animals or with people? In general, research done on animals is still a long way from having the product available for humans.

Coverage How many people participated in

the study? Often if it is just a small number of participants, more research will be needed before the product or treatment is available.

What kinds of people were in the study? Sometimes a study is just done on a particular age group or ethnic group or gender. Just because this study demonstrates something about one group doesn’t mean that the information is transferable to another.

How long was the study? Has there been time to determine all of the side effects?

According to the National Center for Complementary and Integrative Health (NCCIH), the number of web sites offering health-related resources, including CAM, continues to grow every day. Many sites are useful, but others may present information that is inaccurate or misleading. When you visit a site for the first time, it's important to evaluate how reliable it is. This short guide from NCCIH outlines things to consider in your evaluation:Who Runs the Web-Based Health Resource SiteAny reliable health-related Web site should make it easy for you to learn who is responsible for the site and its information. On the National Institutes of Health (NIH) Web site, for example, each

major page clearly identifies NIH and includes a link to the site's homepage. The National Center for Complementary and Integrative Health (NCCIH) Web site follows the same practice; because NCCIH is part of NIH, the NCCIH site's major pages also link to the NIH homepage.Who Pays for the Health Web SiteIt costs money to run a Web site. The source of a Web site's funding should be clearly stated or readily apparent. Examples of web address endings:

.gov = Government sponsored site, such as NCCIH site.

.edu = Educational institution, such at the University of Utah site.

.org = Noncommercial organization, such as the Public Health Partners site

.com = Commercial organization, such as Amazon's site.

You should know how the site pays for its existence.

Does it sell advertising? Is it sponsored by a drug

company?The source of funding can affect what content is presented, how the content is presented, and what the site owners want to accomplish on the site. Take this sitution:A site about osteoarthritis is funded by a manufacturer of a drug or dietary supplement, a product that contains vitamins, minerals, herbs or other botanicals, amino acids, enzymes, and/or other ingredients intended to supplement the diet.The U.S. Food and Drug Administration has special labeling requirements for dietary supplements and treats them as foods, not drugs, that people might use for this condition, that could affect the site’s content. If the funding source is

unclear, or if it is a person or an organization with a proprietary interest in the information presented, try to confirm the information elsewhere, for instance, studies published in scientific journals, or government-sponsored Web sites.Purpose of the Online Health ResourceThe site's purpose is related to who runs and pays for it. Look for an "About This Site" link on the home page. There you should find a clear statement of purpose, which will help you evaluate the trustworthiness of the information.Health Information SourcesMany health/medical sites post information collected from other Web sites or sources. If the person or organization in charge of the site did not create the information, the original source should be clearly labeled.Basis of the Health InformationIn addition to identifying who wrote the material you are reading, the site should describe the evidence, such as articles in medical journals that the material is based on. Also, opinions or advice should be clearly set apart from information that is evidence-based, that is, based on research results. For example, if a site discusses health benefits people can expect from treatment, look for references to scientific research that clearly supports what is said. Keep in mind that testimonials, anecdotes, unsupported claims, and opinions are not the same as objective, evidence-based information. Remember: if something sounds too good to be true, it probably is.How the Health Information Is Selected and ReviewedIf a Web site is presenting medical information, people with credible professional and scientific qualifications should review the material before it is

posted. Check for the presence of an editorial board, or other indications of how information is selected and reviewed.Whether the Health Information Is CurrentWeb sites should be reviewed and updated on a regular basis. It is particularly important that medical information be current—outdated content can be misleading or even dangerous. The most recent update or review date should be clearly posted. For example, this information appears at the end of all of the fact sheets posted on NCCIH's Web site. Even if the information has not changed, you will see whether the site owners have reviewed it recently to ensure that it is still valid.Links to Other SitesWeb sites usually have a policy about establishing links to other sites. Some medical sites take a conservative approach and don't link to any other sites. Some link to any site that asks, or pays, for a link. Others only link to sites that have met certain criteria.Personal Health InformationWeb sites routinely track visitors' paths to determine what pages are being viewed. A health Web site may ask you to "subscribe" or "become a member." In some cases, this may be so that it can collect a user fee or select information for you that is relevant to your concerns. In all cases, this will give the site personal information about you.Any credible site asking for this kind of information should tell you exactly what it will and will not do with it. Many commercial sites sell aggregate or collected data about their users to other companies—information such as what percentage of their users are women

older than 40, for example. In some cases, they may collect and reuse information that is personally identifiable, such as your ZIP code, gender, and birth date. Be sure to read any privacy policy or similar language on the site, and don't sign up for anything you don't fully understand.

2-hour and 4-hour

Select 2 (or more if time permits) of the following resources and write short evaluations of them based on criteria discussed in the class (accuracy, authority, bias, currency, and coverage).

Optional: Evaluate any health information website you use regularly (except MedlinePlus).

Websites to Evaluate:1. http://www.drweil.com/ 2. https://integrativeonc.org/ 3. http://www.dr-gonzalez.com/

index.htm4. http://

www.alexanderschool.edu.au/the-alexander-technique

2-hour – answer 2 of the questions4-hour – answer at least 4 of the questions.

Using the recommended websites, answer the following questions. Don't spend too much time on the detailed answer. The important part of the exercises is to delve into the resources and poke around. Please answer each question briefly and site your source for the answer. If you find a better source for answering the question, please cite that as well so we can all learn.

1. What conditions have been treated with the herb European Mistletoe? Is

European Mistletoe the same as American Mistletoe? What are the side effects of European Mistletoe? Have there been any documented Clinical Trials on this treatment?

2. What are some alternative therapies to manage the side effects of menopause? Have any been shown to be effective?

3. What is laetrile? What conditions has it been used to treat? What are the side effects? Extra credit: What famous actor used laetrile?

4. Besides melatonin, what are some commonly used alternative medicine treatments for insomnia?

5. Locate information and a picture of the plant black cohosh. What conditions has it been used to treat?

6. Is there any evidence to show that olive leaf extract can be used to fight infections?

7. Using the recommended resources, could you find some literature on clinical trials that have been done with omega-3 fatty acids?

8. What is a good food source for Vitamin D?

Before we look at a couple of resources for locating published CAM research, let’s take a look at ClinicalTrials.gov – a great resource for locating clinical trials being conducted in the U.S. and around the world.

Instructors: Visit the Learn about Clinical Studies section of ClinicalTrials.gov and review what an observational study is, as well as the various kinds of clinical trials/studies.Do a sample search and show students what kind of information they will see in a trial record.

Here’s a couple of ideas:1. Search for “Complementary and

Alternative.”2. Search for “acupuncture.”3. Search for “yoga.”

Clinical Trials and CAM

Why are there so few CAM clinical trials? Drug companies are required to

conduct studies before taking a drug to the market. Supplement companies do not, so clinical trials sponsored by supplement companies are rare.

Alternative treatments are often customized for a specific person. Clinical trials try to prove something works for most people.

Belief systems of some CAM practitioners do not agree with the idea of Western studies, so they do not participate.

CAM has only recently become "legit" in the scientific community.

According to Cancer Research UK:Research into complementary and alternative cancer therapies is important for several reasons, including

To find out if they interact with conventional medicines.

To assess whether specific therapies work and do what they claim to do.

To test them against other already accepted treatments to see if they work as well or better.

To find out if they improve quality of life for people with cancer.

To understand how they work. To check whether they are safe. To find out if they are cost effective.

Research is important for any medical intervention because from anecdotal evidence alone you can’t be sure that something works or if it is safe. One person, or even a dozen people, believing that a particular diet or herb helped them is not enough. An improvement in their health could be

A coincidence. Due to another medicine they have

taken. Due to something else they have

done.

Medicines used to treat or cure health problems must be developed and tested in laboratories. For ethical and safety reasons, experimental treatments must be tested in the laboratory before they can be tried in people. This applies to therapies that use herbs, vitamins, minerals, and any other substances.

Although other types of complementary therapies such as massage or yoga aren’t tested in the laboratory, they still need to be researched to test their benefits and safety.Read more about the challenges researching complementary and alternative therapies poses here.

Not everyone is a fan of CAM, including physicians and researchers. Here’s a few alternative viewpoints.

Now we will look a two resources for locating evidence-based information on CAM, NCCIH and the CAM subset search in PubMed. Let’s not forget about MedlinePlus, it’s a great resource to quickly find all sorts of health information including CAM. We won’t be covering it in this class, but just remember it’s always there for you!

Instructor: Navigate to NCCIH.

If this is a 2-hour class, highlight the key points of the site:

1. The menu bar2. Under “Health Information,” click on

one of the “Featured Health Topics”3. Note that all health information

pages are laid out the same, so it’s easy to navigate. Note the “What the Science Says About Safety and Side Effects.”

4. Revisit the menu bar and select “News and Events.” This area provides alerts and advisories as well as links to multimedia.

If this is a 4-hour class, highlight the key points of the site:

1. The menu bar2. Under “Health Information,” click on

one of the “Featured Health Topics”3. Note that all health information

pages are laid out the same, so it’s easy to navigate. Note the “What the Science Says About Safety and Side Effects.”

4. Revisit the menu bar and select “News and Events.” This area provides alerts and advisories as well as links to multimedia.

5. Have students conduct a search:1. Peppermint Oil – is it good

for tension headaches?2. Magnets – are they good for

osteoarthritis?3. Acupuncture – is it good for

chronic pain?

CAM on PubMedFor the 2-hour class:

1. Show students how to access the CAM subset (through the filter bar, under Subjects; through Topic Specific Queries.

2. Have students search for:a. Alternative therapies for

arthritis.b. Citations about using St.

John’s wort for depression in the elderly.

c. Citations to articles written by author Brian M. Berman

(Berman BM).

For the 4-hour class:Show students how to access the CAM subset (through the filter bar, under Subjects; through Topic Specific Queries. Have them try the CAM Subset for the following searches. They can also compare the same searches using PubMed without the CAM subset.

1. I have heard that people are using shark cartilage to treat cancer. Is there any evidence to prove this works?

2. I want to find scientific articles on the treatment of insomnia with melatonin.

3. What are the adverse effects of ephedra?

4. I want to find scientific articles on alternative medicine treatment for fibromyalgia.

5. I want to find articles on the use of garlic to treat high blood pressure.