Article By Brent Murphy

Dietary supplements, nutraceuticals and herbal medicines, better described as health products or complementary medicines, are in the grey area between food and medicines. Millions of South Africans spend in excess of R3 billion a year on complementary medicines. For the most part these are safe and effective, and freely available without prescription. However, with this freedom comes the responsibility to use them wisely and with caution.

Evidence shows that the benefits of complementary medicines far outweigh the risks. Annual side-effect reporting shows only a modest number of negative reactions with their use, yet the media, medical organisations, public interest groups and governments regularly raise safety concerns related to them.

Evidence of this is the recent kava-kava ban, attributed to its reported liver toxicity. Kava-kava is a herbal complementary medicine used for anxiety. Yes, kava-kava can damage the liver, if taken with liver-damaging substances such as alcohol. There has been one confirmed case of liver damage caused by kava-kava in 2 years (out of more than half a million kava users). This has resulted in a worldwide frenzy and ban on kava-kava in many countries, including South Africa. This overreaction is hypocritical when one considers that paracetamol causes 10 000 deaths from liver failure every year, and it is still freely available on our shelves.

Another example is the pharmaceutical laxative, phenolphthalein. The Medicines Control Council is well aware that it causes cancer (it has published this fact in a government gazette), yet it has not banned phenolphthalein – even though safe alternatives such as aloe are freely available. Balance is key here: yes, kava-kava should carry a warning, namely that it should not be mixed with alcohol or other liver-toxic substances, but it should hardly be banned.

What about food safety?
To give some perspective, one doesn’t consider peanut butter a killer, yet life-threatening allergic reactions to peanuts are common, causing many deaths worldwide every year. Similarly, milk is a staple of the South African diet. Yet lactose intolerance is another common cause of illness. One should also look at the effects of certain high-fat, refined foods, and their effects on long-term health. High levels of saturated fat and refined carbohydrates cause heart disease, vascular disease, cancer, obesity, diabetes and other illnesses. On such evidence, should we limit public access to, or better still, ban peanuts, milk and high-fat/sugar foods?

What about medicine safety?
Consider prescription medication: in April of 1998, the Journal of the American Medical Association (JAMA) reported that properly prescribed pharmaceutical medicines killed over 106 000 hospital patients in the preceding year due to toxic reactions.1

What about complementary medicine safety?
Incidents resulting in death from complementary medicines are extremely small: about 50 deaths from all causes over the past 10 years can be attributed to complementary medicines worldwide. Compare this with many other causes of death (table I). This means that for every one person who dies from a complementary medicine, thousands die from a prescription drug. Why such a difference? Well, most complementary medicines are derived from natural substances that have been used and evaluated for centuries, and are less concentrated and therefore less dangerous than new synthetic medicines.

However, even though complementary medicines are generally safe, consumers occasionally report side-effects with their use. It is important to know of possible problems and how to avoid them. The two categories of concern regarding safety of complementary medicines are toxicity (the possible adverse effects inherent in a substance) and contamination (impurities introduced during production).

Toxicity
Anything, even water, can be toxic if consumed in large amounts. Most complementary medicines have a very low toxicity. In the USA, about one death per year is caused by a toxic dose of a complementary medicine. Compare this with over 100 000 deaths per year caused by the toxic effects of prescription medicines.

Complementary medicines that need to be taken with caution include vitamins A and D, niacin, all minerals, and some herbal products (table II), so stick to recommended doses. Some people are allergic to dietary supplements, similar to food or drugs. Some complementary medicines such as comfrey are contraindicated for conditions such as pregnancy. Some can interact with other medicines causing negative side-effects.

To avoid these problems, read all warnings on the product label. Ask a doctor or pharmacist to assess whether any other medicine you are taking, or any medical condition you are experiencing, precludes the safe use of a complementary medicine. Alternatively, Fine Pharmaceuticals offers a free unbiased public and professional complementary medicine advisory service. Contact their pharmacist at pharmacist@finepharmaceuticals.com or phone 021 702 2771.

Contamination
Food, medicines and complementary medicines can all potentially become contaminated. Some foods especially chicken, soft cheese, meat, and fish are particularly at risk. Contamination of complementary medicines is extremely rare. Only two contaminations of a complementary medicine have occurred in the USA over the past 15 years. This is statistically insignificant when compared with food contamination, which kills thousands of people every year.

Sources of contamination
Contamination can occur anywhere in the production cycle. Pesticide residues and heavy metal pollutants can be introduced to herbal complementary medicines by growers, or they can seep in from the groundwater, especially near industrialised areas. Minerals can be contaminated by the chemicals applied to them. Raw materials might be stored in places that previously contained harmful substances. The manufacturing process itself could expose a product to whatever substances were previously put through a particular machine.

Manufacturers should follow procedures ensuring that contaminants do not enter the manufacturing plant in the form of raw materials, and are not introduced during manufacture. Testing of materials, regular cleaning of machinery, and tracking of materials by batch number should be used, to ensure purity. These controls are known as Good Manufacturing Practices (GMP).

Manufacturers should be able to supply documentation proving that they adhere to GMP, as well as original (not transcribed onto their own letterhead) certificates of analysis (COAs) on all raw materials used. These COAs should show the strength, method of extraction and analysis of each raw material used, and should exclude toxins such as bacteria, moulds and heavy metals. Any company that refuses to (or can’t) supply this information should be treated with circumspection.

Some interesting facts:

• Conventional (non-complementary) medicines are the fourth most common cause of death in the USA – but they are never reported (range 90 000 - 160 000 deaths per year).1 That’s a Boeing 747 crashing every day! Forty-six people die every day from aspirin alone in the USA.
• Avoidable medical procedure error is the sixth most common cause of death (range 40 000 - 90 000 deaths per year).2 In Australia 9 000 people die from avoidable medical procedure errors every year, and 50 000 people are maimed by medical procedure errors every year.3
• Food poisoning/adverse reactions causes between 5 000 and 9 000 deaths per year in the USA alone.4
• Complementary medicines have averaged approximately 1 confirmed death per year over the past 15 years in the USA.5,6
• Complementary medicines have the potential to reduce deaths from cancers and heart disease by over 50% – a huge risk-benefit ratio.7,8
• 26 000 times more people die from preventable medical procedure errors and conventional (non-complementary) medicines than from complementary medicines.4-8
  

• Complementary medicines 0.0001%[-]
• Honey bee stings 0.0008%[-]
• Insect stings (all) 0.0020%[-]
• Sports injuries 0.0020%[-]
• Lightning 0.0041%[-]
• Animal bites (dogs, etc.) 0.0048%[-]
• Horse/animal riding 0.0052%[-]
• Penicillin allergy 0.0144%[-]
• Slips/falls while walking 0.019%[-]
• Electrical accidents 0.038%[-]
• Freezing 0.048%[-]
• Firearm accidents 0.079%[-]
• Poisoning 0.17%[-]
• Asthma 0.19%[-]
• Home fires 0.19%[-]
• Drowning 0.21%[-]
• Food 0.24%[-]
• Pedestrians – vehicle 0.37%[-]
• Radon gas 0.62%[-]
• Murder 0.94%[-]
• Suicide 1.41%[-]
• Motor vehicle accidents 2.2%[-]
• Preventable medical procedure errors 2.4%[-]
• Alcohol 4.49%[-]
• Properly prescribed and used drugs 5.18%[-]
• Smoking 7.19%[-]
• Cancer 22.11%[-]
• Cardiovascular disease 47%

• Chaparral (Larrea tridentata): possible liver toxicity
• Comfrey (Symphytum officinale) (common comfrey), S. asperum (prickly comfrey), S. uplandicum (Russian comfrey): possible liver toxicity
• Yohimbe (Pausinystalia yohimbe): can lead to kidney failure, seizures, and death at high dose
• Lobelia (Lobelia inflata): can lead to palpitations, sweating, low blood pressure, and respiratory depression
• Germander (Teucrium genus): possible liver toxicity
• Kava: possible liver toxicity, at high doses or if combined with liver toxic substances (e.g. alcohol)
• Willow Bark (Salix species): contains salicylic acid, an aspirin precursor (not for use in children with viral fever)
• Jin Bu Huan: slowed heart rate, and possible poisoning
• Stephania and Magnolia species: possible kidney failure
• Ma huang (Ephedra, Sida Cordifolia): raises blood pressure, could contribute towards heart attack, stroke, and mood swings
• Vitamin A: doses greater than 25 000 IUs per day – liver toxicity
• Vitamin B6 (pyridoxine): doses greater than 100 mg per day – nerve damage
• Niacin (also known as vitamin B3, nicotinic acid and nicotinamide): doses greater than 500 mg per day – liver damage
• Selenium: at doses greater than 800 mcg (micrograms) per day – organ damage
• Germanium: kidney damage