INTRODUCTION

The explosive growth of the cosmeceutical industry has resulted in the introduction of many new ‘active’ ingredients. Most are derived from nature for unique marketing stories and to reduce the risk of federal oversight. About 100 different ingredients derived from plant sources are being incorporated into cosmeceutical and skin care products. It behooves all physicians and skincare providers recommending cosmeceuticals to have a working knowledge of botanicals so the best recommendations can be made to patients and clients.

Botanicals used for medicinals, flavorings, or fragrances are known as herbs. These are the historic foundation of pharmacologic medicine. An understanding of the significant science underlying the function of the botanical base is usually lacking. Specific issues include:

The methods of topical application of botanicals include: (1) water-based cream and lotion; (2) oil- and wax-based ointment; (3) powder and paste; (4) poultice of freshly cut herb; (5) fomentation or compress of warmed moistened herb; and (6) juice, tea, tincture, elixir, decoction, and infusion.

In the United States, botanical remedies are considered dietary supplements of food additives by federal regulators so there are no standards for potency of the components and efficacy of the products. In 2003, the Food and Drug Administration removed Ma huang (Ephedra sinica) from the market due to 155 deaths. Thirteen additional herbs including St John’s wort, gingko, ginseng, birthwort, arnica, cayenne, comfrey, henna, kava kava, mistletoe, rue, senna and yohimbine have induced fatalities. Severe mucocutaneous reactions induced by herbal formulations include anaphylaxis angioedema/urticaria, exfoliative erythroderma, linear IgA bullous dermatosis, lupus erythematosus, malignancies, pemphigus, Stevens–Johnson syndrome, Sweet’s syndrome, ulcerative stomatitis, and vasculitis.

The German Commission E regulates botanical products based on usage, clinical efficacy, and the quality of this evidence. It developed standardization of botanical products and now is the standard throughout the developed world. The US equivalent—PhytoPharm U.S. Institute of Phytopharmaceuticals—also evaluates clinical evidence and adverse reactions to identify ‘reasonable uses’ for hundreds of herbs. This information is very important with botanicals because the time of harvest, growing conditions, processing of the herb and ingredient mixes can substantially alter solubility, stability, pharmacokinetics, pharmacologic activity, and toxicity of the finished product.

These multiple variables indicate the need for certain efficacy and safety data. Quality healthcare demands evidence-based decisions. Only finished products tested in controlled double-blind clinical trials compared to placebo or a positive control of a prescription product and conducted by independent researchers using a statistically significant number of panelists is acceptable evidence based effectiveness.

A basic safety study of contact irritation and sensitization with a topical application of 50 or more patients should be a routine safety study for herbal products because these are far the most common adverse reactions. These studies also demonstrate to patients, clients, and media that healthcare providers of skin treatments and products put quality of care ahead of profits made from products based on dubious science and poor, if any, credible data.

Herbs with mucocutaneous therapeutic indications as determined by Commission E and PhytoPharm are listed in Table 12.1. The first group of herbs discussed below consists of most of the top 12 largest selling herbs in the US based on dollar volume. Of all the herbs listed with mucocutaneous applications, only 27 have been supported by reliable double-blind or open label clinical trials as listed in Table 12.2. The second group consists of most of the 21 herbs formulated into products tested in blinded clinical trials for treatment of photoaging as listed in Table 12.3.

Table 12.2 Herbs with clinical trials for treatment of mucocutaneous diseases/conditions

Table 12.3 Herbs with clinical trials for photoaging therapy

LARGEST SELLING HERBS

• Echinacea (Fig 12.1)

Echinacea angustifolia was originally used by the Sioux Native Americans not only for the treatment of snake bites and war wounds because of its antiseptic and analgesic properties, but also for insect bites, gonorrhea, measles, abscesses, and ulcers. The other two species are E. purpurea and E. pallida.

Fig. 12.1 Topical and oral Echinacea is an antioxidant. Echinacea is rich in caffeic and ferulic acids

E. purpurea contains the immunostimulating polysaccharides and glycoproteins, flavonoids, caffeic and ferulic acid derivatives, volatile oils, alkamides, polyenes, and pyrrolizidine alkaloids. E. pallida and E. angustifolia

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