Complications and Risks Botanical medicines are being used by an increasing number of patients, and they often do not advise their clinicians of this use. Certain patients are at risk for drug– botanical interactions or adverse reactions, and patients should be questioned about them (Tables 13.4 and 13.5). Mega doses of vitamins and supplements have associated risks and complications, and their use is increasing.
Because botanicals are regulated as dietary supplements, quality control is challenging.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) was enacted (10). This act makes it legal to refer to the supplement’s effect on the body’s structure or function or to
Table 13.2 Training and Licensure in Complementary and Alternative Medicine
Hypnotherapy The International Medical and Dental Hypnotherapy Association will certify hypnotherapists if they meet the minimum eligibility requirements and provide referrals.
Clinical hypnosis Basic certification requires a minimum of 40 hours of ASCH approved workshop training, 20 hours of individualized training, and a minimum of 2 years of independent practice using clinical hypnosis. The advanced level, called approved consultant, requires a minimum of 60 additional hours of ASCH-approved workshop training and 5 years of independent practice using clinical hypnosis.
American Society of Clinical Hypnosis (ASCH) Certification in clinical hypnosis ensures that the certified individual is a bona fide health care professional who is licensed in that state to provide medical, dental, or psychotherapeutic services.
Acupuncture Schools provide 3-or 4-year training programs in oriental In most states, the practitioner must provide medicine that consist of about 2,500 to 3,200 hours. proof that he/she has attended and graduated from an accredited school or from a school that is in the process of being accredited by the Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM).
Forty states either license or register acupuncturists as Doctors of Oriental Medicine or Acupuncture Physicians, and about two-thirds of these states grant licenses.
Table 13.3 Top-Selling Herbal Dietary Supplements in the Food, Drug, and Mass Market Retail Channels in 2009 (for 52 Weeks Ending December 27, 2009)
From Cavaliere C, Rea P, Lynch ME, et al. Herbal supplement sales rise in all channels in 2009. American Botanical Council. Herbalgram 2010;86:62. Available online at: http://cms.herbalgram.org/ herbalgram/issue86/article3530.html?Issue=86.
a person’s well-being. Products within the jurisdiction of DSHEA are easily recognized by the following statement on their labels: “This product is not intended to diagnose, treat, cure, or prevent any disease.” Because the FDA does not regulate these products, the potential for lack of standardization of products, as well as adulteration or mislabeling, exists. Pharmacokinetic evaluation is lacking.
Botanicals can cause toxicity in one of three ways: (i) the products can be adulterated; (ii) the labels can recommend dosages that exceed appropriate use and cause toxicity even when the product is safe in appropriate dosages; and (iii) even when they are of good quality and taken in the correct dosage, these products can interact with other supplements and pharmaceutical agents. The Institute of Medicine recommended the following measures: seed-to-shelf quality control, accuracy and comprehensiveness in labeling and other disclosure, enforcement against inaccurate and misleading claims, research into consumer use, incentives for privately funded research, and consumer protection against all potential hazards.