Complimentary and Alternative Medications: Fact Sheet

This Fact Sheet accompanies the Complimentary and Alternative Medications class in the classroom.

What are complimentary and alternative medications (CAM)?

There is not a standard definition, but it usually refers to practices that are not traditional parts of conventional medicine. Conventional medicine refers to using products that have been proven to treat a condition, such as prescription drugs 4.

Where can I find more information about CAM use in Alzheimer's Disease?

http://www.alz.org/AboutAD/Treatment/Alternative.asp - provided by the Alzheimer's Association and includes information about specific CAM's that have been used in Alzheimer's disease. This website ncludes information about Coenzyme Q10, Ginkgo Biloba, Huperzine A, Phosphatidylserine, and Coral Calcium 1.

Help or Hurt?

Are CAM 's effective in the treatment of Alzheimer's?

There is a lack of agreement about the effectiveness of any CAM in the treatment or prevention of Alzheimer's. However, there is enough interest for a number of different CAM 's to undergo formal testing by the National Institute of Health and National Institute on Aging just like prescription drugs undergo testing. This may mean that there is a CAM out there that may have unknown benefits. For example, Huperzine A is undergoing clinical trials currently to test its effectiveness in Alzheimer's 16.

Questions to Ask

What questions should I ask before starting my loved one on a CAM?

From Iowa State University Extension Office. Available at http://www.extension.iastate.edu/nutrition/supplements/

Summary

What other things should I know about CAM?

Other topics of Interest are:

CAM Regulation and Product testing

Is there a government agency that evaluates CAM?

Yes, a federal agency called the National Center for Complementary and Alternative Medicine (NCCAM) is involved in reviewing CAM's. They study and test these treatments to check their safety and effectiveness. The NCCAM is currently conducting a trial testing fish oil and alpha lipoic acid in Alzheimer's disease 19. You can access their website at http://nccam.nih.gov/

How are dietary supplements regulated?

Congress passed an act called the Dietary Supplement Health and Education Act (DSHEA) in 1994. This act limited the Food and Drug Administration's (FDA) control over products labeled as a dietary supplement. It allows manufacturers to place products on the market without proving that they work or are safe. The thought behind this act is to let people make their own decisions about using complimentary and alternative medications 13.

How does this differ from the way that prescription only and OTC drugs are regulated?

Prescription drugs must undergo rigorous trials to prove that they are safe and effective before the FDA will allow them to be marketed. There is also close monitoring of the prescription drugs once they are available. OTC drugs must also undergo testing to ensure that they are safe and effective when used to treat the conditions and by the directions listed on the label 6. For more information about OTC drugs visit the FDA site for the Safe Use of Over-the-Counter Drug Products at http://www.fda.gov/cder/offices/otc/consumer. htm.

Can the FDA remove a dangerous CAM from the market?

Manufacturers can make claims about their product without the FDA's approval. However, the FDA can ban a product if they feel it is dangerous. Ephedra is an example of an herbal medication that has been banned in the United States after several people were injured and some even died from using it. The FDA also sends warning letters about claims that they feel are not backed by proper research and testing 10. To see these letters and check if your CAMs are on the list, visit http://www.fda.gov/foi/warning.htm

How are homeopathic medications regulated?

Homeopathic medications or remedies fall under a different category than other CAM's. They are regulated the same way as either prescription or OTC drugs. In order to buy prescription only homeopathic drugs, you must see a licensed homeopathic doctor and then go to a homeopathic pharmacy 15. A limited amount of OTC homeopathic drugs are available at regular pharmacies and grocery stores. For additional information about the regulation of homeopathic medication, please visit the Homeopathic Pharmacopoeia of the United States at http://www.hpus.com/

CAM Labeling

What is required to be on a CAM label?

  • Products name
  • Quantity of product (eg. 60 capsules)
  • Ingredients and amount
  • Disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
  • Supplement Facts panel that includes serving size, amount of active ingredient
  • Other ingredients
  • Name and address of manufacturer, packer or distributor 13

What should I look for on a label?

  • Manufactured in the United States
    • Toxic ingredients and even prescription drugs have been found in some CAM products manufactured in other countries.
  • Scientific Testing
    • The label usually states if the brand has undergone scientific testing.
  • Standardized
    • Product meets standard of quality, label accurately states what is actually in bottle, product is reasonably free of contaminants, and it was produced and packaged under clean and safe conditions 14.

The following chart compares some of the organizations that test or standardize CAM's 18.

Organizations Consumer Lab
consumerlab.com
Good Housekeeping
www.goodhouse keepingseal.com
National Sanitation Foundation (NSF)
nsf.org
United States Pharmacopoeia (USP)
www.uspverified.org
Sample Mark that appears on bottle pic of consumerlab.com mark good housekeeping seal NSF mark USP seal
Tests that amount of product on label is in bottle Yes Yes Yes Yes
Tests for contaminants Yes Yes Yes Yes
Reviews manufacturing processes No No Yes Yes
Conducts random after marketing testing Yes Yes Yes Yes
Tests products for effectiveness No Yes No No
Tests products for safety No Yes No No
Confirms claims made on label No Yes No No
Additional information Must subscribe at a cost of $24 per year to view information 7 Very few products actually tested, probably will not find CAM you are looking for 9. Allows you to search for certain CAM, but only has a limited number of products 20. Provides a list of products that have been “verified”. Also, has a lot of CAM information 22.
Date accessed Dec. 3, 2004 Dec. 3, 2004 Dec. 3, 2004 Dec. 4, 2004

CAM Drug Interactions, adverse events, reporting problems

Are there any known dangerous CAM and prescription drug interactions

The following table lists some of the known dietary supplement and prescription drug interactions. However, due to the lack of regulation and monitoring of non-prescription drugs, we may not yet know about many interactions 12. Please always consult your health care provider to discuss any CAM that you are considering for your loved one before you start using it.

CAM's Prescription Drugs to Avoid
Capsicum ACEi (used for high blood pressure, diabetes, kidney disease, heart failure), theophylline (used for asthma), sedatives, antidepressants
Coenzyme Q-10 Warfarin (Coumadin), chemotherapy agents
Dong quai Warfarin (Coumadin), St. John's Wort, antibiotics (sulfa and quinolones)
Echinacea Amiodarone, methotrexate, , ketoconazole, cyclosporine, HIV protease inhibitors, benzodiazepines (used for anxiety, sleep), calcium channel blockers (used for high blood pressure, heart conditions)
Feverfew Aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), dipyridamole (Persantine), warfarin (Coumadin)
Garlic Aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), dipyridamole (Persantine), warfarin (Coumadin), cyclosporine, saquinavir (Fortovase)
Ginger Aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), dipyridamole (Persantine), warfarin (Coumadin), H2 blockers (Pepcid, Zantac, Tagament, Axid), PPI (Prilosec, Nexium, Protonix, Prevacid)
Ginkgo Aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), dipyridamole (Persantine), warfarin (Coumadin), antidepressants, antipsychotic medications, insulin
Ginseng Warfarin (Coumadin), MAOIs, digoxin (Lanoxin), insulin, diabetic medications
Magnesium Thiazide diuretics (hydrochlorothiazide), loop diuretics (Lasix-furosemide), some chemotherapy agents
Kava Sedatives, sleeping pills, antipsychotic medications, alcohol, drugs for anxiety or Parkinson's disease
Melatonin Nifedipine (Adalat, Procardia), fluvoxamine (Luvox)
St. John's Wort Antidepressants, HIV protease inhibitors, digoxin (Lanoxin), cyclosprorine, chemotherapy agents, oral contraceptives, nifedipine (Adalat, Procardia), warfarin (Coumadin), alcohol, tamoxifen
Vitamin K Warfarin (Coumadin)

Are there any websites to check possible CAM and drug interactions?

Drug Digest provides a service where you can add all of the drugs and CAM's that your loved one takes and checks for potential interactions. It gives you the information about the type and severity of the interaction. It also provides additional information about specific CAM's 8. This website can be found at http://www.drugdigest.org /DD/Interaction/ChooseDrugs/1,4109,,00.html

What are some diseases or conditions that I should use extra caution when selecting a CAM?

You should discuss any CAM that you are considering starting your loved one on with their doctor before beginning. The following are some of the known diseases and conditions that are known to interact with CAMs: high blood pressure, thyroid problems, depression or other psychiatric problems, Parkinson's disease, enlarged prostate gland, blood clotting problems, diabetes, heart disease, epilepsy, glaucoma, previous stroke, and organ transplant 12.

What are some problems that may occur from taking CAM?

Almost anything from an upset stomach to severe allergic reaction to death can occur from taking CAM. Due to the lack of research and testing on most CAM's, we do not know what problems may occur. Some CAM's may also interfere with blood clotting and healing processes, so it is very important to discuss them with your doctor before any type of surgery or lab procedure 12.

Who should I contact if I think a CAM has harmed my loved one?

You should first seek medical treatment if the problem is life threatening, if it is not, you should contact your loved one's doctor and discuss the problem with them. Then you can contact the FDA's MedWatch Program at 1-800-332-1088 or www.fda.gov/medwatch/ They will ask for the:

  • Name, address and telephone number of the person who became ill
  • Name and address of the doctor or hospital providing medical treatment for the illness
  • Description of the problem
  • Name of the herbal product and the store or website from which it was purchased

This problem will go into the FDA's database and they will monitor to see if other people are also getting sick from the product. Reporting any problems to the FDA MedWatch helps to make sure that dangerous products do not stay on the market and continue to harm people.

Gathering CAM Information from the Internet

What should I watch out for when looking for information online?

A study that was published in the September 17, 2003 issue of the Journal of the American Medical Association (JAMA), found that 351 of the 433 websites examined made misleading or unproven health claims. The sites that were trying to sell a product almost always made one of these claims 5. You can learn more about this article at http://www.ncahf.org/digest03/03-36.html. Because of this it is important to investigate a website before using it to make a healthcare decision. Some things that you should look for:

  • Website sponsor-Most websites created by major medical centers, national organizations, universities, and government agencies are credible sources of information. Many websites that their sole purpose is to sell products and make money have a lack of reliable information. However, some large companies that sell many different vitamins and herbals may have reliable information that is produced by a secondary company. It is best to try to find out where they get their information, and then research the source.
  • Website purpose-Do not rely solely on information from websites that are trying to sell you something. They often try to confuse you with advertisements instead of scientific evidence.
  • Date of website-Look at the date the website was last updated, which is usually at the bottom of the website home page. Information is always changing, so try to find recent information.
  • Information source-Look at who the information is coming from. The qualifications of the person providing the information should be given. Evaluate if they are qualified to be giving out healthcare advice 4.

What are some words to look out for?

  • Red flag words-Be cautious of words such as satisfaction guaranteed, miracle cure, or new discovery. If this treatment was truly a cure it would be reported on television and doctors would recommend it.
  • Cure-alls-Do not believe that one product is able to cure any disease and especially not many different diseases. For example, some herbal products claim to cure a wide range of diseases such as cancer, arthritis, and even HIV. These claims are not backed by scientific evidence.
  • Testimonials-People's personal experiences are not a substitute for actual scientific evidence such as clinical trials, facts, figures, and research. If the product is truly worthwhile, there will be a large amount scientific evidence on the website 4.

Where can I find more information about CAM?

The following websites are useful for additional information about CAM options.

What you will find about CAMs at: Drug Digest
www.drugdigest.org
MayoClinic.com
www.mayoclinic.com
National Center for Complimentary and Alternative Medicine (NCCAM)
http://nccam.nih.gov/
Uses Yes Yes Yes
Evidence Yes Yes Yes
Safety Yes Yes Yes
Warnings Yes Yes Yes
Dosing No Yes Yes
Side Effects Yes Yes Yes
Drug Interactions Yes No No
Effectiveness Yes Yes Yes
Additional Information Good website for finding information about specific CAM's. It includes a large amount of CAM's 8. Good website to find information and links about CAM's and many other health conditions 14. Good website about CAM's including clinical trials and public health advisories. Not a very good source of information about specific CAM's .
Website accessed Dec. 15, 2004 Dec. 3, 2004 Dec. 11, 2004

References

1. Alternative Treatments for Alzheimer's. Available at http://www.alz.org/AboutAD/Treatment/Alternative.asp Accessed on December 14, 2004.

2. The American Association of Naturopathic Physicians. Available at http://www.naturopathic.org/ Accessed on December 15, 2004.

3. American College of Traditional Chinese Medicine. Available at http://www.actcm.edu/ Accessed on December 13, 2004.

4. Complimentary and Alternative Medicine: What is it? Available at http://www.mayoclinic.com/invoke.cfm?objectid=49C26ECB-ED10-4E26-88B0C95077FF855B Accessed on December 3, 2004.

5. Consumer Health Digest #03-36. Available at http://www.ncahf.org/digest03/03-36.html Accessed on December 10, 2004.

6. Consumer Information: Safe Use of Over-the-Counter Drug Products. Available at http://www.fda.gov/cder/offices/otc/consumer.htm. Accessed on December 12, 2004

7. Consumer Lab. Available at www.consumerlab.com Accessed on December 3, 2004.

8. Drug Digest: Check Interactions. Available at http://www.drugdigest.org/DD/Interaction/ChooseDrugs/1,4109,,00.html Accessed on December 15, 2004.

9. FDA Warning Letters and Responses. Available at http://www.fda.gov/foi/warning.htm Accessed on December 14, 2004.

10. FDA MedWatch. Available at www.fda.gov/medwatch/report.hcp.htm Accessed December 10, 2004.

11. Food and Nutrition: Choices for Health. Iowa State University. Available at http://www.extension.iastate.edu/nutrition/supplements/ Accessed on December 14, 2004.

12 . Herb and drug interactions: ‘Natural' products not always safe. Mayo Clinic. Available at http://www.mayoclinic.com/invoke.cfm?objectid=9F7C4783-8C98-4FF1-90CA8C470E032926 Accessed on December 14, 2004.

13. Herbal Supplements: How they're labeled and regulated. Mayo Clinic. Available at http://www.mayoclinic.com/invoke.cfm?objectid=AA08B116-819D-4B5A-B1762D54761490D9 Accessed on December 9, 2004.

14. Herbal Supplements: What to know before you buy. Mayo Clinic. Available at http://www.mayoclinic.com/invoke.cfm?id=SA00044 Accessed on December 16, 2004.

15. Homeopathic Pharmacopoeia of the United States. Available at http://www.hpcus.com/ Accessed on December 12, 2004.

16. Huperzine A in Alzheimer's Disease. Available at http://www.clinicaltrials.gov/ct/show /NCT00083590?order=1 Accessed on December 15, 2004.

17. Huperzine A. Available at http://www.drugdigest.org/DD/DVH/HerbsWho/0,3923,552633|Huperzine%2BA,00.html Accessed on December 14, 2004.

18. National Association of Chain Drug Stores Foundation, January 2003 Practice Memo. Available at http://www.nacds.org/user-assets/PDF_files/010103cppm.pdf Accessed December, 14, 2004.

19. National Center for Complimentary and Alternative Medicine. Available at http://nccam.nih.gov/ Accessed on December 14, 2004.

20. National Sanitation Foundation. Available at www.nsf.org Accessed on December 3, 2004.

21. Questions and Answers About Homeopathy. Available at http://nccam.nih.gov/health/ homeopathy/index.htm. Accessed on December 14, 2004.

22. United States Pharmacopoeia. Available at http://www.uspverified.org/ Accessed on December 4, 2004.

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College of Public Health and Health Professions, University of Florida