It seems that the more attention herbs receive, the more some people want to discredit their effectiveness. In fact, a Google search indicates that the word “herbal” is often associated with the word “myth”.  Why would this be?

Undoubtedly, certain authors want us to believe that herbs are useless and ineffective.  Ironically, in the same paragraph that herbs are proclaimed wholly ineffective, they are, in the same paragraph, also described as “unsafe” because they “interact with drugs” and are harmful to the body.   Aren’t the authors contradicting themselves to suggest that herbs are both ineffective AND have a biological activity in the body?  Either they do something, or they don’t, right?

Published data estimates that approximately 40% of the US population use dietary supplements on a regular basis.  In spite of the constant negative publicity regarding supplements, a large proportion of our population are able to look beyond the hyped-up headlines and seek the truth.

As for the potential for harm, it seems that maybe herb critics have their facts confused with the track record of pharmaceuticals.  Each year, an average of 106,000 people die from an adverse drug reaction.  Compare this figure with the average of 9 annual cases that are attributed to dietary supplement use.

A shocking article was published in January 2009 in the New York Times.  The numbers of deaths and adverse reactions were so incorrect that the New York Times published a correction one month later(1).  Unfortunately the inflated number remains published and anti-supplement believers like to quote it in their case to prove how "dangerous" supplements are(2).

The primary reasons why people are apprehensive about taking supplements are:

1. They are not certain that dietary supplements are safe.
2. They are not certain that dietary supplements are well regulated.
3. They are not certain that dietary supplements work (efficacy).

Safety

The risk of an adverse effect from a supplement is seven hundred times less than that of a drug.  To put this into perspective, a good analogy would be comparing the mortality rates from transportation accidents to deaths as a result of animal bites (excluding dog bites) (3,4).  The truth is that dietary supplements are much safer than the drugs and many of the foods that we consume on a daily basis without any thought.

For example, ibuprofen (Advil) is responsible for 17,000 deaths annually(5).  Mandatory reporting of all serious adverse effects due to dietary supplements has been enforced by the FDA since December 2007.  The FDA monitors this information and uses it to remove potentially dangerous supplements from the market and possibly ban their use.  According to the FDA there were 596 case reports that were submitted in the first 10 months(3).  40% of these adverse case reports were a response to vitamins whereas only 6.5% were a response to herbs and teas.  Given the US population and the assumption that 40% of the population uses supplements(6), this means that 0.000038% of supplement users had an adverse reaction.

It is quite possible that there are more reactions that are not being reported, just as it is possible that the cases reported are in fact coincidence and may be due to the individual’s health not related to the supplement taken, or due to a drug reaction that is not investigated.  We can only speculate.

Still, the bottom line is that these numbers are very small—almost infinitesimal-- as the risk of dying from a supplement is 42 times less than being struck by lightning!

Some supplements are not as safe as others, it is true.   This link provides a good reference:  Module 15: Last and Least...  Dangerous Herbs

In the past, the adverse effects that have been attributed to herbs can be classified according to the following circumstances:

Long-term use of herbs with higher toxicity.

Some herbs have to be used more cautiously than others.  For example licorice should not be used consistently at very high doses.  There have been case studies where people have had blood pressure and edema due to extremely high doses of licorice taken for many weeks(7).  This reaction is difficult to replicate when considering that most capsules contain 500mg of herb.  However, a manufacturer with good integrity will have this information available on their label and provide a toll free number for customer questions.

Mis-identification of herbs/substitution of herbs.
 
Sometimes herbs were either unintentionally, or intentionally, substituted for another herb.  A famous example is the case of Skullcap (Scullateria lateriflora) which was once substituted by Germander in Europe during the 1980’s. This caused liver toxicity in Skullcap users, and investigators attributed the toxicity to the herb until it was realized that the herb was adulterated with Germander.  Further investigation revealed that American skullcap was completely safe and caused no liver damage(8).  However, if you were to search for skullcap AND toxic using a search engine, you would get thousands of results because the myth is still propagated by authors who have apparently not read the scientific papers of the published case reports.

Since the recent enforcement of the new dietary supplement CGMP’s (Current Good Manufacturing Practices), cases like this will be eliminated as it is now necessary for each manufacturer to positively identify the herb in a scientific manner.  We encourage you to call the company behind your brand of supplements and inquire about their identification method.

Excessive dose consumed.  If one is good then four is better, right?

This is definitely what happened with Ephedra (Ma Huang), which has since been banned by the FDA.   Although this herb had been used safety for thousands of years, it fell into the hands of people who formulated it in large doses, combined it with caffeine and marketed in a way which resulted in a number of deaths.   This was never seen in brands that respect herbs and formulate them responsibly.

Regulation

Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).  They can and do take action on products that do not comply with federal regulations.  A new regulation addressing good manufacturing practices for dietary supplements that ensures their quality and purity is now being enforced and companies are being audited by the FDA.

Furthermore, new ingredients that are brought to the market are required to have proven safety; the FDA is the authority that evaluates and approves these ingredients.

The process by which new ingredients are approved is far less vigorous than is the process for approving drugs.  This is because, unlike drugs, dietary supplements do not have the same potential to cause serious adverse drug reactions.  Drugs work by blocking a very specific biochemical pathway in the body to prevent a symptom or action.  Although this activity is extremely powerful and useful, it often brings about a myriad of side-effects.  In contrast, herbs have multiple active ingredients that have less conspicuous effects upon multiple pathways in the body.  This mode of action is more like the body’s own natural mechanisms.  For example, if the body needs to protect itself from the hunger, there are many chemical changes that take place in the body to sustain function.  This multi-faceted approach creates fewer side-effects – and is often preferred for the same reasons that investors are advised to invest their money in diverse funds rather than in one place.

Included in the GMP’s are regulations to assure potency, purity and efficacy.  There is a very scientific basis to many of the products that are being sold.

Efficacy

There are studies being published every week that validate the efficacy of dietary supplements.  Many of them are small and are based on animal or test- tube studies.  However, a significant number of studies employ good study designs such as human clinical, double-blind, random, placebo-controlled studies.   A public database (CARDS) is accessible on the website of the Office of Dietary Supplements(10).  This resource is a database of federally funded research projects pertaining to dietary supplements.

In addition to this database and scientific studies comprised within, or those that are ongoing, there exists a compelling history or herb use, dating back several hundred centuries, which is difficult to account for if not for the efficacy of the herbs.  It is hard to imagine that hundreds of thousands of people over thousands of years would continue to use an herb for a desired effect if that effect was never achieved.  Certainly our ancestors used herbs because they worked.

References

1. http://www.nytimes.com/2007/01/16/health/16diet.html?_r=1&pagewanted=2
2. http://www.nytimes.com/2007/02/06/science/06dietcxn.html
3. Government and Accountability Office:  GAO-09-250 January 29, 2009
4. National Safety Council:  Data from National Center for Health Statistics and U.S. Census Bureau
5. Wolfe MM, Lichtenstein DR, Singh G, Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs.  New N Engl J Med. 1999 Jun 17;340(24):1888-99
6. Survey participants in the Third National Health and Nutrition Examination Survey (NHANES III), conducted between 1988 and 1994
7. www.naturalstandard.com
8. MacGregor, F.B et al.  Hepatotoxicity of herbal remedies. BMJ. 1989 November 4; 299(6708): 1156–1157. 
9. Sara Schulman, MPH.  Addressing the Potential Risks Associated with Ephedra Use: A Review of Recent Efforts.Public Health Rep. 2003 Nov-Dec;118(6):487-92.
10. http://ods.od.nih.gov/Research/CARDS_Database.aspx