Herbal medication safety

The reiuctance of many physicians to prescribe herbai medications is in many ways understandabie. Much research needs to be done to ensure the efficacy and safety of many herbs. Few authoritative texts are avaiiabie that summarize the avaiiabie ciinicai research (see Tyier 1994). Because physicians naturaiiy want to provide their patients with the best avaiiabie care, herbal medications do not always present an attractive option due to the uncertainty that surrounds them. 

One danger is that because herbal medications are not regulated, few if any clinical trials are performed even for safety or efficacy. One example is bilberry. Bilberry fruit is used to treat diabetes and diabetic retinopathy. Although animal models support the antioxidant role in vasoprotection, no well-designed and conducted clinical trials exist.The antioxidant effect may have benefit in AMD, as well. The antioxidant efficacy in bilberry is likely due to the tannin content, which is also found in grapes. 

There is inadequate documentation about herbal medicine in the cormtry. The plant remedies have not been scientifically validated for safety and efficacy for them to be included in list of essential drugs for natiorral health systems (JJ). Herbal medical practice is also still shrouded in secrecy and perceptions of metaphysical powers. It is essential that research should explode the myths and superstitions associated with herbal remedies by establishing the real basis of the therapeutic properties of the medicirral plants used in herbal remedies (J 2). 

The use of botanical or herbal medications has increased markedly in the past decade. Popular botanical products in the USA include echinacea, garlic, ginseng, gingko, Ma-huang, psyllium, St. John s wort, and saw palmetto. These natural medicinals are available without prescription and, unlike over-the-counter medications, are considered to be nutritional supplements rather than drugs. As such, these substances are marketed without FDA review of efficacy or safety and there are no mandated require-... 

The approach is quite similar to that for a well-established medical product, in that the applicant must submit bibliographic data supporting the safety, efficacy and duration of the traditional use of the herbal remedy (see Table 8.2). 

Because of the interest in and popularity of alternative and complementary medicines and healing practices, the scientific method is being applied to a wide variety of these remedies. Different types of studies seek to establish if and how individual, alternative medicines exert their effect. Clinical trials are being conducted to compare a specific alternative medicines with the accepted conventional medical standard of care for a specific condition thus, for example, an herbal extract may be compared with a pharmaceutical-grade drug to demonstrate unequivocally the safety and effectiveness of a product or practice. However, complementary and alternative medicine has only recently been deemed worthy of scientific scrutiny (for decades many natural remedies and practices were dismissed outright as being obviously inferior to Western science-based medicine), and many alternative therapies have not yet been... 

As noted above, all available information on the historical use of botanical preparations will be accepted for safety consideration. But for FDA clinical reviewers, such experiences are often poorly documented and difficult to interpret or correlate with the paradigm of conventional (Western) medicine. In the alternative medical system, almost all the diagnoses to be treated with herbal medicine are defined in imprecise and foreign terms. Typically, one herbal medicine is indicated for numerous seemingly unrelated conditions, most of which are symptomatic relief without clear mechanisms. Furthermore, many botanicals are combinations of multiple herbs, but few references are available for the rationale of combining so many ingredients. 

Bent S Herbal medicine in the United States Review of efficacy, safety, and regulation Grand rounds at University of California, San Francisco Medical Center. J Gen Intern Med 2008 23 854. [PMID 18415652]... 

The Med Check Program will help patients to improve the safety and effectiveness of their drug therapy, including prescription medications, OTC medications, and herbal products. Patients will receive a comprehensive review of all their medications, with a written report and patient education about each of their drug-related problems. A pharmacist will work with the patients and their physicians to develop a plan to address these problems. 

Recent reports from European health authorities have linked kava to at least 25 cases of liver toxicity, including hepatitis, cirrhosis, and liver failure. The FDA is currently (2002) investigating the health risks of the herbal supplement. Under review are 38 Americans, including a liver transplant recipient, with medical problems associated with kava use. As of February 2002, sales have been halted in Switzerland and are suspended in Britain, Germany is acting to make kava a prescription product and the FDA recommends avoiding kava until safety questions are answered. 

Herbal medicines are becoming more and more popular, and indeed some herbal products may be considered to benefit people with liver disease, e.g. Silybum marianum (milk thistle), Picrorhiza kurroa, Phyllanthus, etc. Herbal hepatotoxicity is increasingly being recognised, for example, with kava kava, black cohosh, and many traditional Chinese remedies. The range of liver injury includes minor transaminase elevations, acute and chronic hepatitis, steatosis, cholestasis, zonal or diffuse hepatic necrosis, veno-occlusive disease and acute liver failure. In addition to the potential for hepatotoxicity, herb-drug interactions may affect the safety and efficacy of concurrent medical therapy [15]. 

In a 5-year toxicological study of traditional remedies and food supplements carried out by the Medical Toxicology Unit at Guy s and St. Thomas Hospital, London, 1297 symptomatic enquiries by medical professionals were evaluated (28). Of these, an association was considered to have been confirmed, probable, or possible in 12, 35, and 738 cases respectively. Ten of the confirmed cases were related to Chinese or Indian herbal remedies. As a result of these findings, in October 1996 the UK Committee on Safety of Medicines extended its yellow card scheme for adverse drug reaction reporting to include unhcensed herbal remedies, which are marketed mostly as food supplements in the UK (the scheme had always apphed to hcensed herbal medicines) (29,30). This was an important milestone in herbal pharmacovigilance. 

There are 4 specialized commissions at the MOH Phcirmaceuticals (9 members) Biologicals (6 members) Herbal and Homeopathic Preparations (5 members) and Medical Devices (6 members). Each commission gives a scientific statement on the assessment of the cliniccil safety and efficacy of the products under registration. They also comment on the scientific reasons for performing clinical trials in Bulgaria. All commissions fall under the responsibility of the NDI. 

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