Physicians who ignore the growing demand for information about phytomedicines risk being left behind as patients take it upon themselves to self-medicate or seek out alternative practitioners.
  “Not a week goes by without someone asking me about some herbal medicine or another cancer cure and we need good information so that we can help patients with their decisions,” Dr. Brain Hardy, Pharm.D., Coordinator, Clinical Programs, Pharmacy, Sunnybrook Health Sciences Centre, told participants here at a special phytopharmacology meeting. In fact, solid information already exists. However, because much of it is published in languages other than English–often German–North American physicians are not aware of it, noted Dr. Edzard Ernst, Chair, Department of Complementary Medicine, Postgraduate Medical School, University of Exeter, U.K.
  In fact, as Dr. Ernst stressed, randomized, double-blind, placebo-controlled clinical trials assessing botanical medicines do exist, and he suggested that this is the data that we should be considering. Citing a number of examples, Dr. Ernst noted that there are already at least 16 well-conducted trials in which hypercholesterolemic subjects were treated with standardized garlic tablets.
  Results have consistently shown that garlic tablets lower cholesterol levels by about 12% more than placebo; that side effects are rare (unless the dosage taken is excessive), and that, indeed, garlic is often prescribed–and reimbursed– for precisely that indication in Germany.
  A recent double-blind, placebo-controlled trial reported in the peer-reviewed journal, Circulation, also found that

A meta-analysis of 15 randomized, placebo-controlled trials published in the British Medical Journal also determined that mild-to-moderately depressed patients who take St. John’s Wort (Hypericum) are 2.7 times more likely to improve than those on placebo.
  “Again, side effects are typically rare,” noted Dr. Ernst. Indeed, in Germany, St. John’s Wort is the leading prescription medication for the treatment of mild-to-moderate depression– well ahead of its chemical counterparts.
  Good clinical data also exist for gingko biloba for the treatment of both intermittent claudication, where significantly greater improvement in pain-free walking distance relative to placebo has been demonstrated, as well as in Alzheimer’s and multi-infarct dementia.
  According to results published in a recent JAMA report, improvement in cognitive function seen in gingko biloba-treated patients was clinically meaningful and clearly better than that seen in placebo controls. Good placebo or otherwise drugcontrolled studies also support the use of Hawthorne for earlier stage congestive heart failure, kava kava for anxiety, Dwarf palm for benign prostatic hypertrophy, peppermint for irritable

bowel syndrome and ginseng for both quality of life and erectile dysfunction.

With good evidence supporting the use of many of the more commonly used botanicals, other issues such as quality control still require urgent resolution. Unlike Germany where ethical botanical companies, including Lichtwer Pharma, apply the same manufacturing standards to their products as do brandname pharmaceutical companies, botanical medicines are almost totally unregulated here in Canada. (A noteworthy exception to this is a New Brunswick-based phytomedicine company, Planta Dei Pharma, which not only applies rigorous manufacturing standards to its products but, as does Lichtwer Pharma, makes only those products for which there is solid clinical evidence for their indications as per their labeling).
  This means that the same products which are often prescribed by physicians in Germany (and for which they are often reimbursed by the healthcare system) are sold over-the counter here, typically as food supplements.
  Most do not even have a DIN number, according to Dr. Frank Chandler, Ph.D., Director and Professor, College of Pharmacy, Dalhousie University, Halifax. (A DIN number on an OTC label is a signal to the public that at least the indication stated on the label is supported by reputable sources in the literature. If there are side effects or contraindications, DIN-numbered products will alert the public to them as well).
  Hence, if practitioners are looking to recommend herbal products to their patients–or if the public is considering taking a herbal product on their own–“if it does not have a DIN number, you should be asking why,” said Dr. Chandler.

“One of the first problems we have is, how do you control a food that can act as a drug,” continued Dr. Chandler. Although herbal remedies are not commonly associated with serious toxicity, “consumers often think herbs can’t harm, which is clearly not true,” he added. Comfrey, for example, can cause liver damage if not taken appropriately.
  Complicating the issue of potential toxicity, quality control of herbal medicines sold in Canada is, in a nutshell, “a sham,” according to Dr. Chandler.
  Depending on where the plant is grown, and what part of the plant goes into the final product, products may contain either little or none of the purported botanical highlighted on

the label. “Herbal medicines can also be mislabeled, adulterated, contaminated or have residue radioactivity [among other contaminants],” noted Dr. Chandler. An example was cited during the meeting where no detectable active ingredient was found in certain brands of Echinacea, some of the brands considered reputable, during one spot-check of various botanicals. (Spot-checking occurs in such a small percentage of shipments that it is grossly inadequate to ensure quality control).
  It was also pointed out that the manufacturing process itself can change the quality of the botanical. Even if the manufacturer starts out with high-quality raw material, it may lose some of that quality through the processing unless the company follows rigorous criteria. It is also important to recognize that in addition to the main pharmacologically active ingredient in a botanical, there are other complementary constituents within all herbal remedies. These constituents may interact synergistically with each other and enhance the botanical’s therapeutic effect. “Thus, you need to look at the therapeutic outcome from the whole herb, and not isolated constituents,” Dr. Chandler told delegates.
  Although in theory, no health claims can be made for botanicals when they are sold as food supplements, the literature that is often available to the public is at best promotional and at times outright fraudulent, added Dr. Chandler.
  In light of all this, the public needs good counsel from a reliable source–a role, speakers agreed, for which physicians are aptly suited.

“The problem is not that herbal products are not biologically active, because they are,” said Mr. Kenneth Keirstead, Corporate Director of Planta Dei Pharma. Rather, the industry itself needs to conform to high-quality manufacturing practices for cleanliness, purity and consistency, he stressed. “We also want Health Canada to bring in standardization of herbal products so that they can be reliably integrated into medical practice.” To this end, a Health Canada advisory committee on herbal medicines, chaired by Dr. Chandler, is working towards doing just that.
  Although the hurdles are legion, “right now we are concentrating on the quality and safety of herbal products, and while every herb may have a contraindication for some individual in the population, if we can provide quality products to the public, we will have moved the whole field of herbal medicine forward megafold,” concluded Dr. Chandler.