Herbal preparations
Are herbal preparations safe?
Many hundreds of my patients over the years have taken various herbal preparations, not on my advice, but usually on the recommendation of well-meaning carers, family, relatives and friends, or by naturopaths or alternative or “traditional” medicine practitioners. I have never witnessed any benefit whatsoever of these treatments. Nonetheless, I have usually said, “It’s probably safe, but I think you’re wasting your money.”
Increasingly, I am beginning to doubt the safety of these treatments and supplements and my advice to you now is:
DO NOT TAKE THEM, THEY ARE USELESS, THEY ARE UNREGULATED, WE DO NOT KNOW WHAT IS IN THEM AND THEY ARE QUITE POSSIBLY DANGEROUS.
Why have a shifted my position on this?
There have been a string of recent Food and Drug Administration (FDA) warnings and recalls on herbal products.
You know more about what is in a bag of potato chips than what's in herbal products. When it comes to herbs, you are quite unprotected and essentially on your own. There's no guarantee these products are safe or effective. While some Australian states, notably Victoria, have begun to legislate about alternative medicines, it is an extremely difficult area to regulate.
The lack of research requirements give herbal makers the freedom to make quite extravagant health claims on their labels. For example, a product can advertise that it has a calming effect but not that it can be used to treat anxiety disorders. The ACCC is extremely concerned about the alternative medicine industry but has so far been relatively powerless to act. Consequently, some manufacturers make unsubstantiated treatment claims leaving countless consumers confused about what these "all-natural" products can and can not do for their health. The Pan Pharmaceuticals disaster shows just how “Natural” these products can be!
With herbal medicines, what is on the label may not be what is in the bottle. In studies of ginseng, for example, the active ginsenoside compounds varied from between 12% and 327% of the amount indicated on the label of different products! (Harkey et al. Am J Clin Nutr 2001;73:1101-6).
While most herbs are probably safe when taken as directed, a series of recent reports underscore the potential ramifications of such loose regulation. Death, liver damage, seizures, heart attacks and stroke have all occurred as a result of using a small number of herbal products, according to FDA alerts and advisories. Such adverse events can be caused by herbal products interacting with other medicines, allergies, impurities, and dangerously high doses.
Ephedra, or ma huang, is a herb taken by millions of Americans annually for weight-loss and body building. A 2001 study published in the New England Journal of Medicine concluded the herb could cause high blood pressure, heart problems, stroke, seizures and death. And the FDA has reports of 100 deaths among ephedra users. Yet manufacturers adamantly claim the reports do not prove the product is risky and ephedra-containing products remain on the market. Three years after unsuccessfully attempting to ban high doses and require warning labels, the controversial sales continue.
Another worrying example is that of the herbal preparation PC-SPES. Until recently, thousands of American men with advanced prostate cancer were using this mixture of eight herbs formulated according to principles of traditional Chinese medicine. Preliminary studies suggested that PC-SPES lowered prostate-specific antigen levels but often at the cost of breast tenderness and loss of libido; these were side effects that many patients considered acceptable. In early February 2002, however, the California Department of Health Services reported that PC-SPES is contaminated with the female sex hormone, diethylstilbestrol and the rat poison, warfarin. The product was withdrawn from stores, the manufacturer ceased operation. The preparation could potentially have deleterious effects against breast cancer also.
Herbal compounds can interfere with the action of anticancer drugs.
Results of a small study on St. John's Wort, a popular product thought to alleviate signs of depression, suggest the supplement can dramatically interfere with a common chemotherapy drug called irinotecan. Researchers from the Netherlands found that when cancer patients took irinotecan and St. John's Wort together, the blood levels of irinotecan decreased by 42 percent compared to when using irinotecan alone. The study was published in the August 2002 issue of the Journal of the National Cancer Institute.
At Medical Grand Rounds at Westmead Hospital on May 20th, 2003 a case of serious and life-threatening liver disease was presented that was caused by Chinese herbal medications. In Britain and Europe two years ago, a large number of patients developed renal failure from herbal medications.
To encourage improvement in standards, the United States Pharmacopeia (USP) has introduced the Comprehensive Dietary Supplement Verification Program. The Program involves USP certification that supplement products: contain the ingredients stated on the label in the declared amount and strength; are within limits for contaminants such as heavy metals, pesticides and microbes; will be absorbed into the body according to USP criteria; and have been manufactured using safe and controlled procedures.
Whether or not you choose to follow my advice, can I strongly advise that you tell your doctor in detail all the alternative medicines that you are taking. It is important that we know so that we can check the preparations you are taking aren't going to interfere with the conventional treatment you may be receiving, or make them work less effectively.
Many hundreds of my patients over the years have taken various herbal preparations, not on my advice, but usually on the recommendation of well-meaning carers, family, relatives and friends, or by naturopaths or alternative or “traditional” medicine practitioners. I have never witnessed any benefit whatsoever of these treatments. Nonetheless, I have usually said, “It’s probably safe, but I think you’re wasting your money.”
Increasingly, I am beginning to doubt the safety of these treatments and supplements and my advice to you now is:
DO NOT TAKE THEM, THEY ARE USELESS, THEY ARE UNREGULATED, WE DO NOT KNOW WHAT IS IN THEM AND THEY ARE QUITE POSSIBLY DANGEROUS.
Why have a shifted my position on this?
There have been a string of recent Food and Drug Administration (FDA) warnings and recalls on herbal products.
You know more about what is in a bag of potato chips than what's in herbal products. When it comes to herbs, you are quite unprotected and essentially on your own. There's no guarantee these products are safe or effective. While some Australian states, notably Victoria, have begun to legislate about alternative medicines, it is an extremely difficult area to regulate.
The lack of research requirements give herbal makers the freedom to make quite extravagant health claims on their labels. For example, a product can advertise that it has a calming effect but not that it can be used to treat anxiety disorders. The ACCC is extremely concerned about the alternative medicine industry but has so far been relatively powerless to act. Consequently, some manufacturers make unsubstantiated treatment claims leaving countless consumers confused about what these "all-natural" products can and can not do for their health. The Pan Pharmaceuticals disaster shows just how “Natural” these products can be!
With herbal medicines, what is on the label may not be what is in the bottle. In studies of ginseng, for example, the active ginsenoside compounds varied from between 12% and 327% of the amount indicated on the label of different products! (Harkey et al. Am J Clin Nutr 2001;73:1101-6).
While most herbs are probably safe when taken as directed, a series of recent reports underscore the potential ramifications of such loose regulation. Death, liver damage, seizures, heart attacks and stroke have all occurred as a result of using a small number of herbal products, according to FDA alerts and advisories. Such adverse events can be caused by herbal products interacting with other medicines, allergies, impurities, and dangerously high doses.
Ephedra, or ma huang, is a herb taken by millions of Americans annually for weight-loss and body building. A 2001 study published in the New England Journal of Medicine concluded the herb could cause high blood pressure, heart problems, stroke, seizures and death. And the FDA has reports of 100 deaths among ephedra users. Yet manufacturers adamantly claim the reports do not prove the product is risky and ephedra-containing products remain on the market. Three years after unsuccessfully attempting to ban high doses and require warning labels, the controversial sales continue.
Another worrying example is that of the herbal preparation PC-SPES. Until recently, thousands of American men with advanced prostate cancer were using this mixture of eight herbs formulated according to principles of traditional Chinese medicine. Preliminary studies suggested that PC-SPES lowered prostate-specific antigen levels but often at the cost of breast tenderness and loss of libido; these were side effects that many patients considered acceptable. In early February 2002, however, the California Department of Health Services reported that PC-SPES is contaminated with the female sex hormone, diethylstilbestrol and the rat poison, warfarin. The product was withdrawn from stores, the manufacturer ceased operation. The preparation could potentially have deleterious effects against breast cancer also.
Herbal compounds can interfere with the action of anticancer drugs.
Results of a small study on St. John's Wort, a popular product thought to alleviate signs of depression, suggest the supplement can dramatically interfere with a common chemotherapy drug called irinotecan. Researchers from the Netherlands found that when cancer patients took irinotecan and St. John's Wort together, the blood levels of irinotecan decreased by 42 percent compared to when using irinotecan alone. The study was published in the August 2002 issue of the Journal of the National Cancer Institute.
At Medical Grand Rounds at Westmead Hospital on May 20th, 2003 a case of serious and life-threatening liver disease was presented that was caused by Chinese herbal medications. In Britain and Europe two years ago, a large number of patients developed renal failure from herbal medications.
To encourage improvement in standards, the United States Pharmacopeia (USP) has introduced the Comprehensive Dietary Supplement Verification Program. The Program involves USP certification that supplement products: contain the ingredients stated on the label in the declared amount and strength; are within limits for contaminants such as heavy metals, pesticides and microbes; will be absorbed into the body according to USP criteria; and have been manufactured using safe and controlled procedures.
Whether or not you choose to follow my advice, can I strongly advise that you tell your doctor in detail all the alternative medicines that you are taking. It is important that we know so that we can check the preparations you are taking aren't going to interfere with the conventional treatment you may be receiving, or make them work less effectively.