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What people say makes us excited::
As is true for any body of scientists evaluating the benefits and marketability of medi cines, Commission E was concerned about the safety of the herbs and phytomedicines it reviewed. According to Professor Varro E. Tyler, Dean and Distinguished Professor of Pharmacognosy Emeritus at Purdue University, the Commission reviewed safety data according to a "doctrine of absolute proof for safety ( Tyler, 1994). The Commission attempted to ensure that these medicines were reasonably safe when used according to the dosage, contraindications, and other warnings and provisions specified in the monographs.
Regarding efficacy, the Commission was guided by what Professor Tyler has termed the "doctrine of reasonable certainty." (Tyler, 1994.) That is, as long as the scientific data pro vided reasonable verification of particular historical use, the Commission would grant a positive evaluation. Accordingly, some of the early work of the Commission (1978 - 1989) was characterized by positive evaluations for some herbs for which a significant body of clinical studies did not exist. Most positively evaluated monographs are based on open clinical studies or data derived from field studies, patient case records, and pharmacologi cal research or proprietary data submitted by individual companies (Schilcher, 1997b). Numerous negative evaluations also were made during this period.
However, after 1990 the Commission began to focus more on good clinical practices (GCP) clinical studies to document the uses. In some cases, monographs for herbs that previously were granted approval for several uses were amended to a more restricted indi cation. A good example is the monograph for Hawthorn, originally published in 1984. The Hawthorn monograph initially contained a range of cardiovascular indications that included applications between stages I and II of the New York Heart Association's functional classification for heart disease. The approved indications formerly read as follows: "sensation of pressure and anxiety in the heart area," "geriatric heart condition that does not yet require digitalis," and "mild forms of bradycardia." However, in July 1994 the Commission published four separate monographs for various parts of the hawthorn plant. Only Hawthorn leaf with flower was approved for the more limited indication "for decreasing cardiac performance as described in functional Stage II of NYHA." This approval was based on clinical studies published for proprietary medicines made of both hawthorn parts and based on observations by physicians from clinical experience. Other hawthorn preparations made individually from berry (fruit), leaf, or flower were negatively evaluated due to the lack of evidence in clinical trials. However, they are still sold as "traditionally used Hawthorn preparations" only to support general heart function, according to provisions of Article 109a of the AMG (Schilcher, 1997b). (See Traditional Medicines above.)
This process of negative evaluations of the older dosage forms was challenged by the BAH. BAH suggested that because hawthorn preparations "form an important part of the German phytomedicines market with respect to self-medication," therefore, "when new clinical studies become available, it is important to check, and possibly amend, the older monographs, because the status of scientific knowledge represented by them may change owing to new research results. This, however, must under no circumstances auto matically mean that the older results published in a monograph are no longer valid, and, unless there is a direct conflict, those results must maintain their status as scientific docu mentation and be included in a monograph as before, perhaps with a slightly modified indication claim." Unfortunately, Commission E did not agree with this proposition, and the final monographs on Crataegus [Hawthorn] were published on 19 July 1994 without the same indications published in the 1984 monograph (Steinhoff, 1997). (For more on Hawthorn, please see pages 39 and 63.)
Negative assessments (i.e., Unapproved monographs) were made by Commission E in cases where "no plausible evidence of efficacy" was available or when safety concerns out weighed the potential benefits. The objective of the Commission was to "eliminate drugs with even minor risks, because these risks are not tolerable if they are not balanced by an acceptable benefit." (Keller, 1992.) Also, the Commission published negative monographs for medicinal plants which had no clinical or pharmacological studies or no plausible evi dence of efficacy reported in traditional medicine or empirical medicine (Schilcher, 1997b). Herbs that were evaluated negatively are published in the Unapproved Herbs sec tion of this book. Monographs on these herbal drugs and their phytomedicinal preparations are published without dosage recommendations. "Herbs which pose a risk have to be withdrawn immediately." (Busse, 1997c.) Unapproved Herbs that do not pose a health risk can be sold in the German market only until the year 2004.
According to Prof. Schilcher, the fact that by 1995 the Commission had negatively evaluated at least 115 herbal drugs is evidence that in Germany "scientifically oriented criteria for assessment apply for plant medicines." (Schilcher, 1997b.)
Interestingly, the 126 unapproved monographs, although they constitute only 33 per cent of the total monographs published, produce 97 of the total number of categories of adverse side effects. This is consistent with the fact that 45 herbs were negatively evaluated precisely due to documentation or reasonable suspicion of these types of risks. By comparison, the 254 positive monographs contain only 75 types of side effects (mostly adverse; not all side effects listed are adverse). This constitutes 29 percent more side effects noted for Unapproved herbs than for Approved herbs. (This data is found in Table 13.)
Table 13: Unapproved Monographs with Documented or Suspected Risk
The herbs in this table were evaluated negatively by Commission E due to the presence of actual risk or concern about potential risks. In some cases, documentation of benefit also may be inadequate. For complete information on some risks, the monograph should be consulted.
Herb |
Risk |
Angelica seed and herb Basil Bilberry leaf Bishop's Weed fruit Bladderwrack Borage Bryonia |
Photosensitivity caused by coumarins Mutagenic effect of estragole High or chronic dose can cause intoxication Allergic reactions; photosensitivity due to khellin Hyperthyroidism due to daily dose over 150 meg iodine (it should be OK in small amount for topical use for dryness effect ) Hepatotoxic pyrrolizidine alkaloids Numerous risks cited |
Celery |
Allergic skin reactions; can contain large amounts of phototoxic furanocoumarin |
Chamomile, Roman |
Rare allergic reactions |
Cinnamon flower Cocoa Colocynth |
Allergic reactions to skin and mucosa Allergic skin reactions and migraine headaches G.i. irritation and possible hemorrhagic diarrhea due to curcurbitacin; kidney damage, cystitis |
Coltsfoot Delphinium flower |
Hepatotoxic pyrrolizidine alkaloids Alkaloids can cause bradycardia, hypotension, cardiac arrest, central paralyzing and curare-like effect on respiratory system |
Elecampane |
Irritation of mucosa and allergic contact dermatitis due to alantolactone |
Ergot |
Wide spectrum of activity |
Goat's Rue |
Hypoglycemic effect of galegin |
Hound's Tongue Kelp Lemongrass, Citronella oil Liverwort herb Madder root Male Fern Marjoram Marsh Tea Monkshood Mugwort Nutmeg Nux Vomica Oleander leaf Papain Parsley seed Pasque flower Periwinkle |
Hepatotoxic pyrrolizidine alkaloids Hyperthyroidism due to daily dose over 150 meg iodine (it should be OK in small amount for topical use for dryness effect ) Toxic alveolitis associated with inhaling undetermined amount of oil Irritation of skin and mucous membranes associated with protoanemonin in fresh plants Mutagenic and carcinogenic potential of lucidin content Wide spectrum of adverse reactions Potential unclear risks of arbutin and hydroxyquinone content Poisoning associated with abusive dosing, e.g., abortions Serious, varied spectrum of effects possible within therapeutic dose Abortifacient action reported. Psychoactive, abortifacient effect of large doses Spastic CNS action of strychnine Poisoning, sometimes fatal, due to oleandrin Increased tendency to bleed for someone with clotting disorders Large doses of apiol in essential oil produce vascular congestion and contraction of smooth muscles in bladder, intestines, and uterus Fresh plants and preparations with protoanemonin produce severe irritation of skin and mucosa Suppressed immune system in animal experiments |
Petasites leaf Rhododendron, Rusty-leaved Rue Saffron Sarsaparilla root Scotch Broom flower Senecio herb Soapwort herb, Red Tansy flower and herb Walnut hull |
Hepatotoxic pyrrolizidine alkaloids Poisoning due to grayanotoxine content Phototoxic and mutagenic effects, liver and kidney damage associated with furanocoumarins Adverse effects noted in doses over 10 g used for abortion Gastric irritation and temporary kidney impairment suspected Contraindicated in MAOI therapy and hypertension Hepatotoxic pyrrolizidine alkaloids Mucous membrane irritation with high levels of saponins Poisoning due to abuse of large doses of herb with possible thujone content of oil Potential mutagenic effect of juglone |
| Yohimbe bark | Nervousness, tremor, sleeplessness, anxiety, hypertension, and tachycardia, nausea, vomiting associated with therapeutic administration of yohimbine; interaction with psychopharmacological herbs |
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