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Clinician’s Corner: Herbal Therapy

Herbal therapy is complicated. So often it is difficult to see any benefit from Herbal therapy, while side effects seem to appear rapidly.  Recommending these products can be particularly challenging, given the fact we seem to have better pharmacotherapeutic choices in the prescription department.

Best website I’ve found: National Center for Complementary and Integrative Health. https://nccih.nih.gov/health

Herbal Regulations

  • The FDA loosely regulates dietary supplements, under the Dietary Supplement Health and Education Act of 1994 (DSHEA ’94). They are not regulated like drugs, either prescription or over the counter.
  • Dietary supplementary are: vitamins, minerals, other botanicals, amino acids, enzymes, organ tissues, glandular, and metabolites.  These dietary supplements fall under the category of “foods” and not “drugs”.
  • The FDA doesn’t require proof that these products work. The burden of proof is on the FDA to prove they are dangerous or adulterated. Consumers should also note that rigid quality control standards are not required for nutraceuticals and substantial variability can occur in both the potency and the purity of these products.
  • Given the regulatory structure for herbal medicines, there is a lot of variation in the quality of commercially available products in the United States and elsewhere. Variability in product quality can impact the product’s efficacy, safety, and therefore clinical usefulness.  Therefore, it is best to buy the product at the same pharmacy.

What Germany does so well:

  • Commission-E is Germany’s equivalent to the FDA in the United States.
  • There are 380 monographs evaluating the safety and efficacy of herbs for licensed medical prescribing in Germany. Published in 1998.
  • official monographs that give the approved uses, contraindications, side effects, dosage, drug interactions and other therapeutic information essential for the responsible use of herbs.
  • 70% of German doctors prescribe herbs. Rarely do United States physicians recommend herbal products

SAFETY: a glaring example: Despite ephedra products comprising only 0.8 percent of all dietary supplement sales in 2001, they were responsible for 64 percent of all herb-related adverse events reported to United States Poison Control Centers during the same year. Fortunately, the FDA banned all products containing ephedra in April 2004.

Many herbal products interact with prescription medications.  Always consult your Thompson Pharmacist before using herbal therapy.