Should we be concerned about herbal remedies

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Abstract

During the latter part of this century the practice of herbalism has become mainstream throughout the world. This is due in part to the recognition of the value of traditional medical systems, particularly of Asian origin, and the identification of medicinal plants from indigenous pharmacopeias that have been shown to have significant healing power, either in their natural state or as the source of new pharmaceuticals. Generally these formulations are considered moderate in efficacy and thus less toxic than most pharmaceutical agents. In the Western world, in particular, the developing concept that ‘natural’ is better than ‘chemical’ or ‘synthetic’ has led to the evolution of Neo-Western herbalism that is the basis of an ever expanding industry. In the US, often guised as food, or food supplements, known as nutriceuticals, these formulations are readily available for those that wish to self-medicate. Within this system, in particular, are plants that lack ethnomedical verification of efficacy or safety. Unfortunately there is no universal regulatory system in place that insures that any of these plant remedies are what they say they are, do what is claimed, or most importantly are safe. Data will be presented in this context, outlining how adulteration, inappropriate formulation, or lack of understanding of plant and drug interactions have led to adverse reactions that are sometimes life-threatening or lethal.

Introduction

During the latter part of the 20th century herbalism has become mainstream worldwide. This is due in part to the recognition of the value of traditional and indigenous pharmacopeias, the incorporation of some derived from these sources into pharmaceuticals (DeSmet et al., 1992a, DeSmet, 1997, Winslow and Kroll, 1998), the need to make health care affordable for all, and the perception that natural remedies are somehow safer and more efficacious than remedies that are pharmaceutically derived (Bateman et al., 1998, Murphy, 1999). For a variety of reasons more individuals are nowadays preferring to take personal control over their health, not only in the prevention of diseases but also to treat them. This is particularly true for a wide variety of chronic or incurable diseases (cancer, diabetes, arthritis) or acute illnesses readily treated at home (common cold etc.) (Kincheloe, 1997). In this respect many individuals have become disenchanted with the worth of allopathic treatments, and the adverse effects that can be anticipated. They are seemingly unaware of the potential problems associated with herbal use or the fact that their limited diagnostic skills, or of those prescribing treatment for them, may prevent the detection of serious underlying conditions like malignancies (Saxe, 1987, Youngkin and Israel, 1996, Donaldson, 1998, Winslow and Kroll, 1998, Shaw et al., 1999, Stewart et al., 1999).

Most allopathic practitioners have traditionally considered herbal treatments to be innocuous or alternately, potentially problematical. Three decades ago only a few had any appreciation of the number of remedies that had their origins in herbal medicine and most had a vague impression of what herbalism, or other forms of alternate medicinal practices implied (Lipp, 1996). There was still a great deal of carry-over from the beginning of the 20th century when the introduction of wire services allowed for the dissemination of adverse effects of ‘snake-root’ concoctions and the like. As early as 1906, misbranding and adulteration were disallowed in the US Herbal remedies, not a part of ‘The Dispensatory of the United States of America’, were shunned as if the danger associated with one remedy was common to all much like the notion that if ‘one mushroom is poisonous, all must be’ and by 1938, safety testing was mandated under the Federal Food, Drug and Cosmetic Act. By mid-century, pharmacognosy (study of plants affecting health) was a dying science. Dicta of the day, as outlined in a 1962 law (Kefauver–Harris Drug Amendments) required proof of safety and efficacy. This policy determined that only chemically defined and clinically evaluated medicines had value, and if pharmaceutically derived, must be prescribed by allopathic physicians. (Murphy, 1999). Licensure to practice in the US was confined to allopathic clinicians and others in naturopathy and homeopathy whose traditional use of herbs was well defined. Some leeway was also given to practicing traditional healers within Asian and indigenous communities. On the whole, other types of herbalists were not recognized (O'Hara et al., 1998).

Such was the case for decades, until the ‘age of Aquarius’ arrived, and the ‘return to nature’ was the driving force of every ‘flower child’. In this wake, self-medication became the rule as old European herbals and indigenous remedies were revisited, and were used with impunity, without concern for adverse effects. In addition, hallucinogens, particularly from American indigenous cultures, became popular as many trying to escape the reality of a war-torn and ‘hide-bound’ world, experimented with ‘altered states’. Soon ‘health food stores’ appeared, specializing in unrefined food, organic-grown vegetables, herbs and herbal preparations. With the opening up of Asian markets, other types of medicines were introduced, and were permitted since they were considered already ‘culturally acceptable’. A synthesis of all these types of herbal medicinal practices evolved into what can be called, ‘Neo-Western’ herbalism. Formulae found in this system are based upon both ethnomedical worth or are simply serendipitous inventions of the formulator. A belief of benefit over single-ingredient drugs is the corner stone of this form of herbalism that subscribes to the notion that ‘primary active ingredients in herbs are synergized by secondary compounds, and secondary compounds mitigate the side effects caused by primary active ingredients’ (McPartland and Pruitt, 1999). Since it is possible for single taxa to contain a family of related bioreactive compounds varying in potency, it is logical to presume that one or more of these will contribute to the totality of the effects observed (Lewis and Elvin-Lewis, 1994, Elvin-Lewis and Lewis, 1995). It would follow that when mixtures of several crude extracts are used in formulations, enhancement of beneficial effects (or greater toxicity) is expected through either synergistic amplification or diminishment of possible adverse side effects. It is also presumed that their combination could prevent the gradual decline in efficacy that is frequently observed when single drugs are given over long periods of time (Borchers et al., 1997). Nowadays such remedies can be still found in ethnic and health food stores, but are also available in pharmacies and grocery stores. Unfortunately there is no universal regulatory system that ensures that these remedies are what they say they are, do what is claimed, or most importantly, are safe (Angell and Kassirer, 1998, DeSmet, 1993, DeSmet et al., 1997).

Section snippets

Major types of herbal medicine

Four general types of Herbal Medicine exist which are Asian, European, Indigenous and Neo-Western. Many like the Asian and European systems go back thousands of years, appear in pharmacopeia, and with such a tradition of use are better understood than those of indigenous origins that are often only orally or secondarily recorded (DeSmet et al., 1992a, DeSmet, 1992b).

Indigenous herbalism

Indigenous medicinal systems are the most diverse and are still practiced where such cultures are intact, but are continuously

Asia

Overall, the incidence of serious adverse reactions is significantly lower with most of these therapeutic remedies when compared to pharmaceutically derived drugs. However, the need still exists to more closely monitor practitioners and formulators of any traditional medicine, including those of Asian origin, so that medicinal irregularities and unethical practices are reduced. Also, Chinese herbal prescriptions are individualized and when dispensed are not usually labeled, and should adverse

Surveillance of adverse effects through databases

Regardless of the type of herbalism being practiced some adverse reactions are more easily recognizable than others. Postulates have been proposed by Hughes (1995) to define if adverse effects are linked to a drug use. According to Stewart, 1990, DeSmet, 1995b, events that are pharmacologically predictable are often dose-dependant and thus preventable by dose reduction, or if allergenic, by elimination. However, in spite of the mode of application, individual differences in physiology may

Bridging the gap between herbalism and allopathy

Most importantly, it is now recognized that allopathic clinicians have little training in understanding how various forms of herbalism and self-medications are impacting on the health of their patients, who are often, also under prescriptive medication. However, as awareness of potential interactions with allopathic treatments and herbal remedies increases, many clinicians and hospitals are eliciting this information on admission questionnaires (Murphy, 1999). To ensure that patients will be

Pharmacokinetic behavior of plant-derived drugs

Studies on plant-derived drugs primarily with quinine and sparteine have provided a better understanding of factors affecting the pharmacokinetic behavior of drugs within human populations. It has been recognized, for instance, that age effects storage and clearance rates just as the ability to metabolically oxidize certain compounds can be genetically determined and racially focused. Diseases affecting the kidney and liver can alter the clearance rates of certain compounds or exacerbate

Herbal drug transmission in utero or through mother's milk

It is well known that transmission of particular drugs in utero to the fetus or through breast milk to an infant can take place. Evidence is accumulating that this is also true should mothers use certain herbal remedies during pregnancy or while nursing their babies. Effects may be transient, grave, or fatal. The fetus is in particular jeopardy should herbs with teratogenic, carcinogenic, toxic or abortifacient properties be employed. For example, constituents like salicylates are potentially

Allergic reactions

Allergic reactions that can occur with herbal use are manifested in a variety of forms (Rieder, 1994). Both Type I immediate hypersensitivity reactions leading to rhinitis, headache, dermatitis (hives), and/or anaphylactic shock are commonly induced by cross-reactions among Asteraceous (daisy family) plants taken internally, whereas delayed Type IV, contact dermatitis is more prevalent when topical applications are used (Gordon, 1999). Within this family, wide cross-reactions are known and a

Dental products

Adverse effects of dental products containing plant components are rare, but are worthwhile considering (Ocasio et al., 1999). These formulations often include natural sources of calcium carbonate that can vary in abrasivity, and when derived from seashells may contain high amounts of mercury. It is not unusual for Asian herbal dentifrices to be packaged in lead tubing and it is unclear how many are still being sold in this way.

Aside from hypersensitivity reactions to flavoring agents that are

Problems associated with long-term use

Today, many herbal remedies are being used prophylactically to maintain or enhance good health or prevent certain conditions from occurring. Since many of these herbal medications are popular and promoted as both safe and efficacious, it is not always possible for the long-term user to understand why this practice could be harmful. Symptoms can vary from trivial to severe and are particularly disconcerting when they effect the heart, blood pressure, liver, gastrointestinal tract and nervous or

Effects on internal organs

Detoxification and clearance of poisonous substances from the body are primarily a function of the liver and kidneys and they are often the first to be affected by toxic herbs (Larrey, 1994, DeSmet et al., 1996, Kaplowitz, 1997, Nortier et al., 1999, Stickel et al., 2000). Sometimes the causes are more obtuse, as when kava user developed a necrotizing hepatitis (Strahl et al., 1998), but not the usual ‘kava dermatology’ of yellow and scaling skin associated with long-term use (Ruze, 1990).

Effects under predisposing conditions

Patients taking herbs for various purposes may also predispose themselves to unwanted conditions prior to surgery, when pregnant, if atopic, or under treatment for other conditions, including those that require psychoactive medications. Deaths due to medication of generally recognized ‘as safe’ herbs are extremely rare. These events are more likely due to adulterants in the formulations, to unknown interactions in complex mixtures, as a result of undisclosed pharmaceutical interactions, to

Effects of slimming agents

Natural slimming agents can also be problematical as has been found for guar gum that has elicited severe adverse obstructions of the bowel and esophagus, particularly among those with esophageal abnormalities (Opper et al., 1990, Seidner et al., 1990) that in one instance was fatal (Lewis, 1992a). The presence of sparteine in a variety of herbal remedies used for slimming and diabetes has been reported to cause circulatory collapse, respiratory arrest (Galloway et al., 1992) and classic

Drug and herbal interactions

Numerous examples exist of drug and herbal interactions. These effects may potentiate or antagonize drug absorption or metabolism, the patient's metabolism, or cause unwanted side-reactions such as hypersensitivity (Brinker, 1997, Cupp, 1999, Blumenthal, 2000). Such effects may also impinge on pharmaceutical product interactions occurring concurrently with those elicited by herbal use (Aslam and Stockley, 1979, Jankel and Speedie, 1990). Care should be taken to understand effects of foods (

Adulterations

Adulterations in herbal remedies are particularly disconcerting since they occur so unexpectedly. Usually they remain undetected unless they can be linked to an outbreak or epidemic. In this respect veno-occlusive disease due to pyrrolizidine alkaloids, discussed elsewhere, can be life-threatening or fatal (Chauvin et al., 1994, Drew and Myers, 1997). While adulterations related to Asian medicines have already been reviewed, it is noteworthy that misidentification of plants has resulted in a

Conclusion

Overall, when compounded and prescribed appropriately the safety of traditional herbal medications is high. It is generally recognized that life-threatening events are rare, compared to the hundreds of thousands reported for pharmaceutical products each year. This is due, in part, to the moderate bioreactivity that is imparted by most herbal preparations and the knowledge that is known regarding parameters of use. Although linkage to some adverse effects may not be discovered, since problems

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