The Status and Use of HpContaining Products

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In Germany and some other European countries, Hp-containing products are fully-licensed drugs on the basis of their well-established use. Such products have, in general, been authorised for the supportive treatment of painful degenerative joint and muscle conditions. The UK drug authorities issued in January 2007 a traditional-use registration for a proprietary drug containing, as sole active ingredient, an aqueous extract of Hp. This over-the-counter product was issued the therapeutic indication of "A traditional herbal medicinal product used for the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints, based on evidence of traditional use only". The licensing and registration of Hp products requires that the extracts of the herb be "standardised". This a basic principle in herbal medicine and aims to ensure the quality of herbal products, and to ensure that a single medicinal plant exists in the market in the form of one or more extracts that are essentially chemically similar and based on traditional processes. Hp extracts are standardised to a content of 1 to 3% of the iridoid glycoside, harpagoside, which is an active pharmaceutical marker but is considered not to be the sole active ingredient.

The recommendations for the standardisation of herbal extracts such as those set out by the German Commission E are unfortunately not universally followed by manufacturers of herbal medicinal preparations. This has led to much confusion and has undermined the image of herbal medicine. In the USA, Hp-containing products have been less stringently categorised, as are all other plant-derived medicinal products, as foods and are considered food supplements or so-called nutraceuti-cals [6]. Pharmacological treatments of osteoarthritis are exclusively aimed at relieving symptoms and not modifying the disease process, and alternative treatments of this chronic condition are frequently sought. There is a rate of self-medication in osteoarthritis is high, and Hp products belong to a variety of herbal preparations and food supplements that are widely used by such patients [7].

The traditional medicinal use of herbal extracts cannot be patented, but Hp extracts are found in patent applications describing Hp extracts in combination with other extracts or vitamins [8]. A novel medicinal use of a defined aqueous ethanol extract of Hp is the topic of an interesting patent application. The patent application [9], made by a German small-to-medium enterprise, describes the use of the Hp extract in the treatment of endometriosis, which is a painful inflammatory disorder.

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