Could EU herbal monographs contribute to Malta's treatment armamentarium?

Ten years have passed since Directive 2004/24/EC regulating herbal medicinal products across the EU were published. The directive created the Committee on Herbal Medicinal Products within the European Medicines Agency whose remit includes the creation and publishing of official EU monographs on herbal medicinal products. These monographs include the official uses of the products and their evidence for efficacy and safety. To this effect, we are interested in analysing the potential impact herbal product EU monographs could have on the therapeutic treatment options available for prescribers in Malta. Therefore our aim was two-fold. First, to rationalise the spread of indications of the herbal substances listed in the community herbal monograph inventory and subsequently determine if these herbal substances could potentially contribute to the treatment options available in our local scenario (Malta). 128 EU monographs were analysed resulting in a total of 230 indications which subsequently codified into 42 unique ATC codes. The Malta Medicines List contains 1456 unique ATC codes. Comparative analysis of the Malta Medicines List revealed that the 21 therapeutic areas had 4 or less pharmaceutically used substances (5th level ATC codes) registered and therefore in our opinion are areas with limited therapeutic choice. The following 4 therapeutic areas, A05 bile and liver therapy, A13 tonics, A15 appetite stimulants and D03 preparations for treatment of wounds and ulcers, could potentially benefit from the registration of herbal medicinal products according to the EU herbal monographs. If such registration is effected the aforementioned areas would no longer be considered limited because more than 4 therapeutic choices would be available to prescribers. This study is the first study across the EU to analyse the potential impact of published EU herbal monographs on therapeutic coverage in an EU member state and confirms the notion that herbal products could potentially increase the treatment options available in areas where few medical products have been registered due to Malta's small market size.

Neurotrophic effect of naturally occurring long-chain fatty alcohols on cultured CNS neurons.

A long-chain fatty alcohol,n-hexacosanol, that we have isolated from the Far-Eastern traditional medicinal plant, Hygrophila erecta, Hochr., is shown to promote the maturation of central neurons. Added at 500 nM to fetal rat brain neurons in culture, it increased both neurite outgrowth by a factor of 4-6 and the number of collaterals, especially in multipolar neurons. The biochemical differentiation of cultured neurons was also strikingly enhanced by this compound: it increased the protein content and almost doubled the activities of two neuron-specific enzymes, phosphate-activated glutaminase and neuron-specific enolase, by 92 and 78%, respectively. Extensive studies with several synthetic long-chain fatty alcohols showed that the neurotrophic activity was maximal for n-hexacosanol. It is suggested that some long-chain fatty alcohols with an appropriate length of hydrocarbon chain might play an important role in central neuron development.

Dose effects of smoked marihuana on human cognitive and motor functions.

Graded doses of marihuana were administered to five adults in a longitudinal repeated-measurements design. Speed of response was the basic parameter measured accross tests of increasing cognitive involvement. Marihuana produced significant dose-response effects of impaired performance in all test scores. However, single automatic motor abilities demonstrated greater sensitivity than tests of greater complexity. Evidence is presented for tolerance development.