Excerpts taken from the article: German Kava Ban Lifted by Court: The Alleged Hepatotoxicity of Kava (Piper methysticum) as a Case of Ill-Defined Herbal Drug Identity, Lacking Quality Control, and Misguided Regulatory Politics
Until the year 2002, extracts of the rhizome and roots of the Melanesian plant kava [Piper methys- ticum G. Forst. (Piperaceae)] were marketed in Germany and other countries in the form of me- dicinal products licensed for the treatment of situational anxiety. After receiving a series of case reports concerning alleged liver toxicity, the German regulatory authority BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte; Federal Institute for Drugs and Medical Devices) decided in the summer of 2002 to cancel all drug registrations for all medicinal products containing kava by a simple administration decision, with the exception of homeopathic dilutions of 4D (1 : 10 000) or higher. Formally, the benefit-risk ratio was declared negative. Other regulators outside Germany soon followed this decision. The consequences of this ban were felt worldwide and led to an economic disaster in many South Pacific states. Within Europe, the kava ban deprived physicians of an effective and comparatively safe medication, creating a “therapeutic gap nobody wished for” .
– A ban that has been contested because of the poor evidence of risks related to kava. Only recently, two German administrative courts decided that the decision of the regulatory authority to ban kava as a measure to ensure consumer safety was inappropriate and even associated with an increased risk due to the higher risk inherent to the therapeutic alternatives. This ruling can be considered as final for at least the German market, as no further appeal has been pursued by the regulatory authorities. However, in order to prevent further misunderstandings, especially in other markets, the current situation calls for a comprehensive presentation of the cardinal facts and misconceptions concerning kava and related drug quality issues.
Possible Theories Concerning the Perceived Liver Damage
The analysis of the case reports by Teschke had revealed only very few case reports with a relatively high probability of having been caused by kava, among them one report with a proven allergic reaction to the product , and thus a type of reaction which must be assessed apart from the issue of typically dose-de- pendent toxic reactions. Although the number of cases seems in- significant when compared with the known exposure data (450 million daily doses in ten years according to IMS data), the ob- served cases still demand a pharmacological explanation. Thus, over the past twelve years, several theories have been published, which, all in all, can be summed up in five major lines of thought:
” The “human genetic variability theory”: According to this school of thought, kava preparations are completely harmless to the general population. However, there is a small subgroup of the European Caucasian population lacking the metabolizing liver enzyme cytochrome P450 subtype 2D6 (CYP 2D6), as ob- served in one case report . This mutation might lead to an unusual metabolic pattern in these patients, resulting in the transformation of the normally harmless constituents of kava into toxic metabolites in the liver. This theory suffers from the fact that this would be a typical dose-dependent toxicity. With approximately 7–9% of Caucasians being CYP 2D6-deficient, a much higher number of case reports would be expected not only in Germany, but in all Caucasian populations. This was quite obviously not the case; the observations were almost exclusively restricted to Germany and Switzerland, with the latter country using kava products of German origin.
In Western Herbal Medicine Chamomile is utilized more for stress, anxiety, insomnia and to increase digestion through its bitter principles. It is also used topically in balms and salves primarily for skin irritations, rashes and swellings. Balms would contain the infused oil or essential oil or both. Uncommonly, it is used for arthritis alone and may be part of a larger herbal topical formula but it is not thought of as a strong topical anti-inflammatory for musculo-skeletal issues.
A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. (using Traditionally prepared Persian Chamomile oil)
The Journal Phytomedicine published the study Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial earlier this year. In the trial it was found that for mild to moderate depression Rhodiola was slightly less effective than sertraline and both were not that different from placebo. In addition, there was a much higher rate of adverse effects with sertraline (63.2%) over Rhodiola (30.0%). Read a full analysis of the study at Natural Medicine Journal, Rhodiola Rosea vs Sertraline for Major Depression.
Rhodiola is known to affect several body systems including the cardiovascular, central nervous and reproductive and has adaptogenic, anti-stress, neuroendocrine and antioxidant effects. Read Rhodiola rosea: A Phytomedicinal Overview by The American Botanical Council for an in depth look at it. It is an excellent article.
David Winston mentions it is useful in cardiovascular-based depression in his article Differential Treatment of Depression and Anxiety with Botanical and Nutritional Medicines and for deficiency insomnia in his article Botanical/Nutritional Protocols For Insomnia and Other Sleep Disorders.
I think the next trending herb will be turmeric (Curcuma longa) or curcumin the principal curcuminoid derived from the spice turmeric. In fact, I rarely hear about turmeric and more often hear about curcumin. Just look at #curcumin and see how many tweets there are! It seems to be popping up everywhere these days from golden milk recipes to studies looking at a diverse group of diseases. Below there are three studies highlighting curcumin and PMS, cardiovascular disease and depression. The main action of turmeric is anti-inflammatory, and as many diseases have inflammation at their core, it has many possible applications. As seen in this review inflammation is part of all these diseases.
These diseases include Alzheimer’s disease (AD), Parkinson’s disease, multiple sclerosis, epilepsy, cerebral injury, CVDs, cancer, allergy, asthma, bronchitis, colitis, rheumatoid arthritis, renal ischemia, psoriasis, diabetes, obesity, depression, fatigue, and AIDS.
Depression has been linked recently in article and studies to inflammation. A recent study Curcumin for the treatment of major depression: a randomised, double-blind, placebo controlled study. looked at the effects of curcumin (500 mg twice daily) or placebo for 8 weeks on individuals with major depressive disorder. There was some positive results in favour of curcumin, enough to warrant further investigation. Another study Curcumin and major depression: a randomised, double-blind, placebo-controlled trial investigating the potential of peripheral biomarkers to predict treatment response and antidepressant mechanisms of change looked at the same dosage of curcumin and found ‘ that curcumin supplementation influences several biomarkers that may be associated with its antidepressant mechanisms of action.’ Could curcumin in conjunction with an anti-inflammatory diet produce a better effect? Dr Weil thinks that is a convincing idea. It is also intersting to me that St. John’s Wort which has shown some effect on mild depression but is vastly over marketed for it, has always been thought of as a nerve anti-inflammatory, healing to heal nerve injury and reduce pain. Jim McDonald talks about it in treatment of back pain and nerves…
Spring seems to have arrived after a shaky start! The last 2 posts on seasonal allergies covered supplements, herbs, probiotics, and nutraceuticals.
In addition to trying supplements either herbal or nutraceutical you could also try nasal irrigation for your allergies. Several studies have shown that nasal irrigation can reduce the symptoms of seasonal rhinitis.
Echinacea is an amazing herb and after being touted as THE herb for the common cold was found on every health food store and pharmacy shelf. The problem is the quality of these products is widely variable and the recommended dosages are broad, some of them being ineffectual. The Cochrane Review Echinacea for preventing and treating the common cold says,
Most consumers and physicians are not aware that products available under the term Echinacea differ appreciably in their composition, mainly due to the use of variable plant material, extraction methods and the addition of other components.
- Use Echinacea purpurea alone or in combination with Echiniacea augustifolia
- Liquid may be preferable as there is come evidence that actual contact with the oral mucosa is more effective
- Francis Brinker noted that Echinacea trials that used liquid extracts showed positive outcomes in upper respiratory infections
- Start the dosing regime at the very -first- signs of sickness
- Use a loading dose of 5 mL (capsule 1500 mg), followed by 2.5 mL (500-750 mg) every 1-2 hours for the first day
- The liquid dose is based on a 1:2 fresh root extract
- For the next 2 days use 5 mL (1500mg) three times a day
- For children use Clark’s rule to calculate the dose
Stay up-to-date with studies that have an impact on your practice. Subscribe to Galen’s Watch: Journal Watch for Complementary Health Practitioners.