Botanical products

For any intervention intended to impact favorably upon human health, it is important to evaluate its safety and efficacy in order to demonstrate that it does not cause harm and it does provide the expected benefit. The gold standard method for evaluating any intervention, whether it be a botanical product, dietary supplement, drug, medical device or medical procedure, is the randomized, clinical trial (RCT). A clinical trial is a type of experiment conducted in human subjects where the effects of at least two interventions are compared. Often, the clinical trial takes the form of an active treatment compared to an inactive control or placebo. 

Brinker F. Variations in effective botanical products the case for diversity of forms for herbal preparations as supported by scientific studies. HerbalGram 46 36-50, 1999. 

Marker constituents of botanical products can be different types. 

In 2001, the FDA found that a number of botanical products brought to its attention contained aristolochic acid, a chemical that has been implicated in kidney disease. The agency advised consumers to discontinue the use of any supplement that contained this chemical. 

Although it may not always be possible to control the sources or extraction conditions to produce only a single component, they should be arranged so as to produce, as far as possible, a consistent mixture. Impurity profiles of botanical products are often monitored by a number of anal3hical procedures to ensure product quality. Minor components that have pharmacological activity should not necessarily be viewed as impurities. In some cases, the activity of a botanical or fermentation drug substance may be attributed to a number of components. 

Clearly, care must be exercised to ensure that dietary manipulation and supplementation do not produce oral loads able to swamp the body s defenses. For the reasons outlined above, a decision tree has been developed to assist in the risk assessment of botanical products. ... 

Liquid chromatography-electrospray ionization mass spectrometry (LC-ESTMS) for analysis of sildenafil has also been developed and applied to 40 botanical products. About half of the analyzed samples proved to contain undeclared additives of the three drugs sildenafil, vardenafil, and tadalafil <2004JPBA525>. A similar electrokinetic capillary chromatography method to that proposed for the determination of sildenafil 82 has been reported for vardenafil 98 and tadalafile 99. Statistical evaluation of the electrophoretic results was achieved. The described method is thought to be rapid and sensitive <2004JCH231>. 

The SSN estimated U.S. botanical sales in 1999 to be 4 billion. The network further quantified where consumers buy their botanical products. Forty-seven percent are sold in retail stores, 30% are sold in multilevel distribution systems, 8% are sold by mail order or practitioners, 6% was sold by Asian herbal shops, and only 1% was purchased on the Internet (13). Notwithstanding these findings, it is important to note that the Internet was the fastest growing sales market for botanical products, at 150% per year (45). 

In 1997, Landmark Healthcare Inc. commissioned a report entitled The Landmark Report on Public Perceptions of Alternative Care. They conducted 1500 telephone interviews in November 1997, using random digit selection. The survey included a representative sample of minority patients—85%o Caucasian, 8%o African-Americans, and 3% Hispanic. The survey found that 17%o of the U.S. population used botanical dietary supplements in the past year and even more striking, 75 /o of the U.S. population was most likely to use botanical products. Eighty-five percent of those reported to have taken a botanical supplement self-prescribed and self-administered the products. Three-fourths of patients who used alternative forms of care did so in conjunction with conventional medicine, yet 15% of patients replaced their conventional treatment with alternative care (16). 

The NMI surveyed by mail 2002 households, July through August 2001. Only 53%i of botanical supplement users were satisfied with botanical supplements. Despite the low satisfaction for botanical products, supplement users accounted for most of the increase in the previous year 46%i of botanical users increased utilization while only 10%i of the general population... 

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). 

FDA commissioned a study of dietary supplement sales in the United States in 1999. Samples of products were purchased from a representative sample of retail establishments, catalogs, and the Internet. The authors looked at the consistency of botanical products purchased. Forty percent to 46% of botanicals and botanical products were consistent with the ingredients listed on the label. Botanical extracts were even less consistent with the label, only 12%i to 24%i (depending on where purchased) were found to be consistent... 

Table 1 Estimates for Botanical Utilization, Sales Data in the United States, and Reasons for Patient Use of Botanical Products... 

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