Herbs – a Good Investment or a Waste of Money?

I once took a series of courses from the University Of Colorado School Of Pharmacy, leading up to a certification in Botanical Medicine.  Truth be told, I have forgotten 99% of the information and know little more than any of you reading this.  But one point was strongly emphasized and so important that I want to share it here.

However, first we are going to explore whether herbs are a good investment or a ‘waste of money.’  Personally, I think the answer is both (and NO, I am not just ‘hedging’).  Let’s begin with the ‘waste of money’ portion.

The Skeptics

One of the most well-known “skeptics” of herbal supplements I could find was Dr. Arthur Grollman, a professor of pharmacological sciences at Stony Brook University School of Medicine, in New York. Surprisingly enough, I agree with a good portion of what he has to say. On the other hand, he seems pretty adamant that botanical remedies don’t work and that (he claims) never demonstrate more results than placebos. He asserts that if any herb was introduced as a drug (meaning having to go through the same rigorous process) it would never be approved. NONE would pass muster. If I understand him correctly, he doesn’t trust anything but pharmacological medications.

Grollman isn’t just giving an opinion; he has headed much research showing risks with herbal remedies around the world. In studies of ‘birthwort’ (aka Aristolochia clematitis ) he and his associates demonstrated a link between it and kidney disease and urinary tract infection. He says that their research “highlights the importance of a long-overlooked disease that affects many individuals in Taiwan, and, by extension, in China and other countries worldwide…..” [His other work on birthwort was conducted in the Balkans.] He said that their study findings “show that public health officials need to take action to stop kidney damage and upper urinary tract cancer related to aristolochic acid.” [Published in the Proceedings of the National Academy of Sciences.]

While this demonstrates only one herb, I think it is fair to deduce that there are both contraindications and risks from many botanical substances. However we do have to put that in perspective given that, according to Harvard Medical School, prescription drugs cause 125,000 deaths/years.   I think Dr. Grollman may be hard-pressed to find that many deaths related to herbs, although I wouldn’t doubt he might try.

Generally physicians and researchers are most comfortable with what is called EBM or evidence-based medicine. In unofficial lay terms, this translates to ‘the well-done studies,’ although the discerning reader is always going to ask who paid for that study.   We all like to rely on EMB, most particularly when it validates the point we are already trying to make. On the other hand, Dr. Barbara North, MD, PhD biologist and lecturer, who practices in northern California feels that adherence to strict EBM alone is leading to a demise of the art part in the ‘art and science of medicine’ –perhaps closing some open-mindedness to patient needs and alternatives. A good point. What first occurs to me about Dr. Grollman’s position that herbs are no better than placebos is that he is dismissing much research from other countries (Germany to note) which disagree with that conclusion. Compelling research is one of the reasons that botanicals are used in many national-based health care systems (and you may be interested to know that their success rate of heath compared to ours in the US is good. *[1] )

Yet, I said I agreed with Dr. Grollman about a good deal. Doesn’t sound like it, right? Well, I do. Let me explain a little.

With new DNA profiles and other tests there is pretty firm evidence that many herbs used over the ages HAVE been debunked (or at least it appears that way). Conversely, others are brilliant gems. Still, just because it is ‘ancient’ doesn’t mean it is advisable to use.

Efficacy isn’t clear on all these products, yet the supplement industry in the US alone is a huge business. The sales of herbal products in the US during 2011 were estimated at $5.3 billion (with a ‘b’) [2] When any industry starts making that much money it needs a closer look, don’t you think?

Busted

When living in Arizona I often got the feeling that the Wild Wild West was alive and well. When it comes to the less-reputable promoters of dietary supplements [3] they might fit right in. With their guns drawn and their blazin’ saddles, passing wind around the campfire – they stink up the area a bit with rotten results. Now don’t forget I actually do believe in the efficacy of some herbal remedies.  Nevertheless, we still have a problem.

Do you remember just a few months ago when the NY State Attorney General sent cease and desist notifications to four (4) retailers?   After DNA testing of herbal supplements, GNC, Wal-mart, Target and Walgreens got busted (euphemistically) for selling herbs with either no active ingredient or not even containing the herb? It was on the label, but what you didn’t know was that it wasn’t in the bottle. Not just inactive ingredients – but imaginary ingredients. Fraud is evidently not uncommon in this industry; supplements are often falsely labeled, contain no active ingredients or are sometimes even tainted.

While such fraud has been significant, the continued growth of the herbal ‘pharmaceutical’ industry is undoubtedly dependent on their success of selling products (therapeutic or prophylactic) that actually work. The role of R&D is pivotal for them (as well as it should be for Big Pharma, which exaggerates the percentages of its expenses invested for that purpose). But currently, overcoming outright fraud is vital.

Well, you might ask ‘doesn’t the FDA oversee this.’   Hmmmm.   Yes and No.

Regulations

In 1994 (October) when President Bill Clinton signed the Dietary Supplement Health and Education Act (DSHEA) into law he declared:

“After several years of intense efforts,
manufacturers, experts in nutrition, and legislators,
acting in a conscientious alliance with consumers at the grassroots level,
have moved successfully to bring common sense to the treatment of
dietary supplements under regulation and law.”

Uh………..…… that may have been a bit of an optimist statement. At that time I was happy to see the bill pass, and was more sympathetic to the herbal industry. I am now less so (because of fraud), and see some of the weakness of the law. After passage, the Center for Science in the Public Interest CSPI) pointed out that there were more pluses than minuses. Bonnie Liebman, director of nutrition at CSPI said:

”clearly some people may mistakenly believe that this
stamp of approval guarantees safety and effectiveness,
but it is still better to have the testing
than have consumers buy these products blind,
because we know there are some products that give you
less than what they claim.”

She certainly called that number right. Remember again about Walmart and its cohorts. “Less than what they claim” was actually NOTHING.

Dr. Jeffrey Asher (Consumer Reports) also appeared to be in the camp of ‘don’t let the perfect be the enemy of the good’ when he said that despite the caveats, 3^rd party certification is a step forward. ”If there is a seal from a reputable organization, on balance it’s a good thing because purity and potency would be known even if people think it covers more.”

Still, this DSHEA law has lots of critics and one of their complaints stem from the fact that it doesn’t treat herbs the same as drugs. That may be a fair point, although I think we also have to be wary and critical of Big Pharma paying for its results. Money can often buy the ‘truth’ you seek. Perhaps there should not be total equality. At least one ‘skeptic’ would disagree with me.

Steven Novella, in contrast to Dr. Grollman, doesn’t doubt that herbs can work.   His stance is that they ARE drugs and should be treated that way. Novella, an MD and assistant professor of neurology at Yale, is the host of the Skeptics Guide to the Universe podcast and president of the New England Skeptical Society. His statement gives his opinion clearly:

There is nothing inherently implausible about the usefulness of plant-based remedies. Many modern drugs are derived from plants. Plant parts contain many substances, some of which are pharmacologically active and can be exploited for medical use..…The deception inherent to the herbal product industry, in my opinion, is the notion that herbs are something other than drugs.
(from his work: the Science of Medicine Volume 37.2 March/April 2013)

No surprise, Dr. Novella is a skeptic of the DSHEA law as well. His well-taken point is that the law does not really ‘regulate’ the products. They can hit the market before review, assurance of product quality is not overseen and compliance to standards is voluntary. The FDA appears only to step in and ban an herbal substance if there is a clear and present safety issue. [Although I have to wonder if they are any better at banning dangerous pharmaceutical products.]

The bottom line for me is that herbal products are not being monitored well enough and the FDA doesn’t have the authority it should (or doesn’t use it) to make sure we don’t waste our money. Still, that doesn’t make me a skeptic about their usage. In part, because I worry more about the influence Big Pharma can have on the issue. Their railing against a smaller but growing and competing industry that takes money away from their bottom line can certainly feel disingenuous.

 

The Other Side – a possible good investment

ALL THIS BEING SAID, there is another side with positive advantages.

• Some people find botanical medicines a major help. The studies may not always verify their ‘feelings,’ but the anecdotal accounts are innumerable for some remedies.
• Various countries DO have research showing botanical effectiveness.
• The cost of botanicals compared to some prescription drugs is much less. If they work, or are the preferred choice by the consumer, this can be a significant cost-cutting advantage to the ever growing costs of health care in the US.
  [Note: to date costs appear to be continuing on an upward slope even AFTER Obamacare.]
• Side effects of herbs on the body are often far less extreme.
  [This is minus the ‘death’ side effect that Dr. Grollman documented for some herbs. A side-effect, I might add, that is shared by many big pharma drugs and is admitted in numerous speed-reading exercises during TV commercials.]

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So where do we go from here?

Those who have read my booklet 100 Choice Smorgasbord, a Blueprint for Aging with Pizzazz, may already have a clue.

What to look for? 
My one tip is one word – STANDARDIZATION

Standardization is kind of like an identity check. If I go on the computer and play a game in which I have to invent an ‘avatar’ and I don’t admit that I am a middle-class white female and instead claim to be a wealthy young black male, who cares? But if I try to set up a bank account with the same ploy there could be a major problem. Sometimes true identity matters.

Standardization of herbs is the only safe play we have if we HOPE to get something for our money. The goal of the process is to assure us we have a legitimate product of good quality by identifying the active ingredients needed for it to function as promised.

These ‘fingerprints’ of an herb reference the physicochemical properties of it. The chemistry determines the active ingredients, and major compounds through spectroscopic and chromatographic testing (several different testing types, including DNA). Similar to how we provide proof of our own identify, it is the authentication and detailed ‘identity’ of the drug or herb to make sure it is ‘who’ (meaning what) the label says it is.

The World Health Organization (WHO) guidelines cover four parts: Quality – Stability – Efficacy – and Safety (the later including pesticide residues, contaminations like microbes, and heavy metals or radioactive contaminates). Like a fine tea, some herbs even have to be collected at the right time. Further, it matters not only when you collect the plant, but how it is delivered or what delivery system problems exist, or what part of the plant is used, where the area of collection was located, the season of the crop, whether it is fresh or dried. For those who work seriously with botanicals, they know these and many other issues affect the four guidelines of quality, stability, efficacy and safety.

Brain Hetrich, a naturopathic doctor at the Hippocrates Health Institute in West Palm Beach, Florida, has another suggestion – grow your own. He worries about things like collection times and freshness and says “half of the nutritional value of plants is lost within thirty minutes of harvesting…When you grow your own herbs you can use what you need at the moment by harvesting small amounts, fresh from the plant.” My question is ‘so it might be fresh, but how do you know it is really ‘active.’ I agree that it is valuable to use these for cooking but what if you really need the active ingredient for some treatment?   I don’t know the answer to this, aside from personally paying for testing which seems impractical.

What does Standardization tell us?

Standardization involves making sure the herbs are not only safe but are quality merchandise, providing the expected amount of active chemical compounds, and that each product has the same concentration of it. For example, a standardized level of black cohosh ( therapy for hormonal problems during menopause) is usually based on the amount of the compound 26-deoxyactein [4] with a dosage value a bit more complicated.[5]

One of the major references for the quality and purity of these botanicals is the Pharmacopeia. There are different sources in different regions of the world; the Pharmacopeia for the US is 180 years old. The World Health Organization has sought to harmonize the many sources of Pharmacopeias. Most of these sources describe the standards needed for these ‘drugs’ with numerical values.

Many herbal products are standardized, but some are not. Additionally, there are some possible problems with the standardization process. The product can be standardized to a compound later found not to be the active ingredient, or to be one of several. Also, different companies sometimes use different markers. Further, to be totally brutal about the batch-to-batch consistency, because dietary supplements and herbal medicines are not required to be standardized in the US, it is possible that manufactures may claim something not quite true. Still the best bet to get a worthwhile herb is to make sure it is standardized.

Directions

To quote myself from the 100 Choice Smorgasbord:

Buy only herbs that list their ‘standardized’ level (most of them have one). Otherwise you can be purchasing a rather bogus item and have no idea whether it will perform as it would ‘in the lab’ or even if it actually contains the substance. …… But before you go you need to look up the standardization for THAT herb……So it takes some homework but it is definitely worth it if you plan on using a product with the expectation of a good outcome.

Then there is the issue of Synergy. Many conditions (like Diabetes) that respond to herbs do even better when combined with a group of different herbs or even minerals. Best to look at your own concern (or condition) and then research what it may need. Check out educational institutions and studies funded by the National Center for Complimentary and Integrative Medicine (formerly the National Center for Complementary and Alternative Medicine – NCCAM), which reports both positive and negative findings even though they might be considered ‘in the industry’. Don’t look just at alternative sites that sell the products in question. To make sure you hear (at least) two sides of the story, view both holistic and allopathic resources, the latter which is often gleeful to find dysfunctional herbs.

 

Examples of Standardization levels.  How to understand it?

Whether it is a well-known herb or not-so-well-known, most (although not all) have a standardization level.  So if you do your own research for something that ails you, what do you look for?  The good news is that if you ask Mr. Google about the word ‘standardization’ and add the name of the herb, you will get an answer fairly quickly.  Do be aware that two numerical figures are usually given: the DOSE and the standardization (which is usually given as a percentage of some substance).

 

You can skip this part if you ‘get it.’  Otherwise, examples below demonstrate the range of complexity.

A not-so-well-known herb: Gugulipid

Gugulipid is used for a variety of things like arthritis, but primarily lipid (fat) disorders related to cholesterol and heart disease.  It is typically prescribed for 12-24 weeks.  The dose is generally given as 25 mg tid (3 times a day) of an extract containing 5-10% guggulsterones.   It is that latter part ‘5-10% guggulsterones’ that is the standardization level.

A somewhat-known herb: Feverfew

Feverfew is not well known except to those who suffer from migraine headaches – its primary use.  Most of the studies have come from Great Britain, but different countries recommend different standardizations (something I don’t see often).  The Canadian Government (Protection Branch of the Health and Welfare Dept.) proposed a standard preparation containing at least 0.2% parthenolide content.  In India most companies seem to require a different desired level of 0.7%.  Canada recommended dosage of 125 mg (dried) or 250 mcg (tincture) for at least 4-6 weeks.  One American company, Natural Science Corp of America, recommended 300-400 mg.
[Note: there are not many, but a few side effects include mouth ulcerations or dermatitis if used too long.  Most migraine suffers are willing to deal with this.  A more serious warning is that users have to be careful of abrupt halt when feverfew is showing success, as it can make matters worse if quickly discontinued. Also some drugs interact with it.]

A well-known herb: Echinacea

Echinacea is loved and scorned.  Good to know that there are 300 different species –  only 3 of which are medicinal.  Some people swear it helps in prevention or easing of common cold and flu although there is little evidence supporting that.  Conversely there is some demonstration that it does help with infections in the ear, respiratory tract, urinary tract and with recurrent vulvovaginal candidiasis.  Anyway, back to the colds – maybe it helps and maybe it doesn’t but certainly poor quality products are going to do nothing.  [By the way, Echinacea is one to avoid in autoimmune illness or systemic diseases like TB or multiple sclerosis.]

Echinacea standardization and dosing can vary because of the preparation, and depending on what part of the plant is used or which species.  It will seem complex.  The dosages (all usually prescribed for 3 times daily) are more complicated than the standardization itself.  The ‘prescriptions’ are based on whether it is dried, tablet type or liquid extract (or tincture).  It always appears more convoluted than it really is when the information is all bunched up like this (and just needs some fine sorting after the form of product is chosen).  Common examples include 300 mg of dry powered or tablet variety (standardized to 3.5% echinacoside).  For a liquid extraction 0.25 to 1.25 mL with ratio of 1:1 in a solution of 45% alcohol; 1-2 mL tincture (if 1:5 in 45% alcohol), 2-3 mL ‘expressed’ juice of E.purpurea; or 0.5-1 gram dried root or tea type.  Certainly this can vary some based on the source.
Obviously, I chose a complicated example.  I wanted to make a point.  If you want to spend your money to buy an herb for a particular issue you need to take the FEW minutes it will take to sort and figure this out for yourself.

Final Thought

I realize that this can be baffling, but I hope that it is at least more enlightening than confusing.  There are no guarantees, until regulations of this industry are a bit more helpful to the consumer.  At least standardization levels AND A BIT OF YOUR OWN RESEARCH will allow you the best bang for your buck if you decide to use an herb.

————————

Endnotes

[1] If Aging with Pizzazz is one of your goals, you might ask “Are Americans Healthier?” or want to know “Do I Stand a Better Chance Here?” Neither statistics for life expectancy (nor infant survival) rates show we have better health.  Instead our rates are not good.  While these charts compare our poor standing with just a few equivalent countries, surprisingly adding less-well off countries does NOT improve our standing much.

Source: Chart draws upon data from a 2007 report by the Organization for Economic Co-operation and Development (OECD), which collects economic statistics on its 30 member countries.  Noted on website for PBS FRONTLINE episode: Sick Around the World.

[2] Blumenthal, M., A. Lindstrom, C. Ooyen, et al. 2012. Herb supplement sales increase 4.5% in 2011. HerbalGram 95: 60–64. Online at http://cms.herbalgram.org/herbalgram/issue95/hg95-mktrpt.html .

[3] A Dietary supplement is often defined as a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.

[4] The National Institute of Health says that the Black Cohosh standardization is often inaccurately listed as referenced to 27-deoxyactein, instead of 26-deoxyactein.

[5] [Black Cohosh]. The British Herbal Compendium recommends 4-200 milligrams (dried root) daily or 0.4-2 milliliters of a tincture made up of 1:10 60% ethanol; or 40% by value if extracted instead with isopropyl alcohol.

 

Resources

The two links immediately below have extensive references: http://www.pharmainfo.net/reviews/who-guidelines-herbal-drug-standardization

Concept of standardization, extraction and pre phytochemical screening strategies for herbal drug. Journal of Pharmacognosy and Phytochemistry JPP 2014:2(5):115-119  (http://www.phtyojournal.com/) .  Amita Pandey, Research student of Rameshwaram Inst. of Technology and Management, Sitapur Road,  Lucknow, U.P.  Shalini Tripathi, Professor of Rameshwaram Inst. of Technology and Management,Sitapur Road, Lucknow, U.P.

Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century.   Raman Chawla¹, Pallavi Thakur¹, Ayush Chowdhry¹, Sarita Jaiswal², Anamika Sharma¹, Rajeev Goel¹, Jyoti Sharma¹, Smruti Sagar Priyadarshi¹, Vinod Kumar¹, Rakesh Kumar Sharma¹ and Rajesh Arora^3* [* Corresponding author: Rajesh Arora rajesharoradr@gmail.com ]

Resource on herbal safety.  http://www.herb-health-guide.com/herb-safety-guidelines.html  (Caution: gives guidelines for 90 herbs, although biased toward their effectiveness.  Does NOT give standardizations of herbs.)

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