Alternative medicine products

Discusses the potential interactions of alternative medicine products with prescription medications... 

Amber off-cuts and dust ate still used for varnish, and for alternative medicine products, where it is turned into creams to ease aching... 

A major contention of the herbal medicine advocacy is the notion that because these entities are natural products, they are somehow safer and better for human consumption. However, the vast majority of alternative medicine products are essentially unregulated and not yet required to demonstrate efficacy, safety, or quality before becoming commercially available. Currently, in the United States, there exists continued debate on what role the FDA should have in regulating and approving alternative medicines. ... 

Alternative medicine therapies have become increasingly popular, and it has been estimated that one-third of all Americans use herbal products. In 1997, herbal medicine sales increased nearly 59%, reaching an estimated total of 3.24 billion. One particular safety concern is potential interactions of alternative medicine products with prescription medications. This issue is especially important with respect to drugs with narrow therapeutic indexes, such as warfarin. More food and drug interactions have been... 

Medicinal products exist in a variety of forms, to be used for different routes of administration, aiming at either a systemic or a local effect. To obtain a systemic effect, the oral and parenteral routes are the most frequently used. Alternatively, medicinal products can be given through rectal, transdermal, nasal or pulmonary administration to achieve a systemic effect. Rectal and pulmonary administration may also be applied for a local effect. Medicinal products administered to the eye, nose and ear are mostly used for a local effect. 

BUSHKIN G, BUSHKIN E (2002) Ancient alternative medicine Time-honored native natural healthcare system. Health Products Business, January, 8-13. 

Complementary and alternative medicines A group of practices and products that are not presently considered to be part of conventional medicine, including alternative medical systems (e.g., homeopathic medicine and naturopathic medicine), mind-body interventions (e.g., meditation and mental healing), biologically-based therapies (e.g., dietary supplements, vitamins, herbs, and other natural products), manipulative body-based methods (e.g., acupuncture and massage), and energy therapies (e.g., therapeutic touch and bioelectromagnetic-based therapies). 

In the same period, vendors of proprietary medicines took advantage of our love of the natural to peddle a variety of plant-derived products. These were advertised as safer and more pleasant than those typically employed by physicians. For example, Mrs. Winslow s Soothing Syrup and Kopp s Baby Friend had morphine sulfate as their basic ingredient. Hostetter s Bitters was a 78 proof (39% ethanol) cocktail. This theme is being replayed currently as alternative medicine. This time around, controlled clinical trials are being carried out, slowly, to establish what works and... 

Recent guidelines entitled Non-clinical Local Tolerance Testing of Medicinal Product from the CPMP refer to the murine local l)unph node assay as a method for the assessment of the induction phase of skin sensitisation. This method measures the ability of compoimds to induce proliferative responses in skin-draining lymph nodes. This method uses fewer animals than alternative in vivo methods and reduces the trauma to which animals are potentially subjected. ... 

Complementary medicines (also known as traditional or alternative medicines) include vitamin, mineral, herbal, aromatherapy and homoeopathic products. They maybe registered or listed on the ARTG, depending on their ingredients and the claims made. Most complementary medicines are listed. 

With respect to pharmaceuticals, the mouse is cited as an alternative species in the ICH S5(R2) guideline for the detection of toxicity to reproduction for medicinal products and toxicity to male fertility (2). Since the ICH guideline is also cited in other guidance documents (3, 4), it is clear that the mouse should be considered for teratology type (see Note 1) studies. In addition, although not specifically mentioned in other guidelines (OECD, FDA, EPA, etc.), the mouse may be an appropriate rodent model for products from the food and chemical industries if the choice is justified based on the available pharmacokinetic or metabolic information etc. (5-8). 

There is an evolving variety of alternative healthcare practices and products to choose from. (See Terminology sidebar.) Adults and adolescents alike are asking themselves questions such as, Should I take a pill for my headache, or drink chamomile herbal tea There are several scientific counterparts to this seemingly simple question, for example Are these both remedies Are they equally effective Is one healthier or less toxic than the other Can they be used together At this time, there is no comparative information on codeine versus alternative medicine (e.g., acupuncture) as effective treatments for pain, cough, and diarrhea. 

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... 

The Division of Health Interview Statistics, National Center for Health Statistics, CDC conducted a survey entitled Utilization of Complementary and Alternative Medicine by United States Adults in 1999. The survey attempted to obtain a representative sample of minorities and also patients without telephones. This is important because these demographic groups tend to report lower utilization of botanicals products than Caucasians and those of higher socioeconomic status. The CDC found that 9.6% of the population took botanical medicines. Hispanics reported the lowest use of CAM followed by African-Americans, and then Caucasians 19.9%, 24.1%, and 30.8%i, respectively. The western part of the United States reported the highest use of CAM (15). 

The popularity of botanical products in the United States is reflected in a survey on complementary and alternative medicine that showed that American consumers had spent an estimated 5.1 billion on botanical products in 1997 (1). In the same year, the global market for botanical medicinal products was estimated to be approximately 20 billion (2,3). It has been estimated that currently more than 1500 botanical products are available in the U.S. market alone (4). This popularity has been fueled, in part, by the perception that botanicals are naturally derived products, and hence are safe and devoid of adverse effects. This perception appeared to be justified by a paper summarizing the fatality of pharmaceutical drugs and botanical products in the 1981-1993 period, in which statistics compiled by the National Center for Health Statistics, the American Association of Poison Control Centers, Centers for Disease Control and Prevention, the Journal of the American Medical Association, and the U.S. Consumer Product Safety Commission showed an annual mortality rate of 100,000 deaths... 

In the United States, the use of products, including botanicals, thought to fall within the realm of complementary and alternative medicine is very common. It is difficult to obtain reliable estimates of use or to compare many of the current publications in this area because of diverse definitions for categorizing these products (e.g., dietary supplement, food supplement, herbal medicine, natural remedy, traditional medicine, etc.) in both the United States and elsewhere. A recent report on the use of complementary and alternative medicine by U.S. adults in 2002 indicated that approximately 19% of the population used nonvitamin, nonmineral, and natural products, 19% used folk medicine, and 3% used megavitamin therapy in the past 12 months (1). 

The use of vertebrates to evaluate tolerability and absorption of drug administered via the vaginal route has been widely criticized on the basis of scientific and ethical considerations. Studies on animals can be substituted by validated in vitro tests as described in the guideline issued by Committee for Proprietary Medicinal Products (CPMP), now Committee for Medicinal Products for Human Use (CHMP) [112], Before an in vitro test can be considered valid, this test must undergo a procedure aimed at establishing its relevance and reliability. The relevance of the alternative test has to be compared with accepted in vivo standard methods. 

The medical use of botanicals in their natural and unprocessed form undoubtedly began when the first intelligent animals noticed that certain food plants altered particular body functions. Much information exists about the historical use and effectiveness of botanical products. Unfortunately, the quality of this information is extremely variable. One of the most complete compendiums of clinical recommendations regarding the use of botanicals is the Report of the German Commission E (a committee that sets standards for herbal medications in that country Blumenthal, 2000). Interest in the endocrine effects and possible nutritional benefits of certain purified chemicals such as dehydroepiandrosterone. melatonin, high-dose vitamins, and minerals has led to a parallel development of consumer demand for such substances. These substances, together with the botanicals, constitute a substantial source of profits for those who exploit the concept of "alternative medicine."... 

As the popularity of new botanical products increases, they are used in concurrence with modern and traditional medicine—a practice known as complementary and alternative medicine (CAM). A survey in the United States shows an increase of CAM use from 34% to 42% of the population in 1997 (Eisenberg et al 1998). The same report estimated Americans spent some 5.1 billion on herbal medicines (in a 20 billion global market) and another 27 billion on alternative medical treatments (Eisenberg et al 1998 Dev, 1997,1999). 

In summary, we examined extensively the SFE for the alternative replacement of the traditional LSE in pharmaceutical industry. We found that for many sample resources, the SFE is found to be advantageous over the LSE. Furthermore, by cooperating column chromatography with several types of bioassay tests, we demonstrated a sufficient economic feasibility of the implementation of the SFE for the selective separation of the total extracts and subsquently the high-purity prodrug substances from the natural medicinal products. 

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