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The UK Medicines and Healthcare products Regulatory Agency (MHRA), the government agency responsible for ensuring the safety of medicines and medical devices in the United Kingdom, granted its first product registration under the European Directive on Traditional Herbal Medicinal Products in November of 2006.1 The first product registered under the new scheme was A.VogelŪ Atrogel (aka Atrosan Gel) Arnica Gel (Bioforce UK Ltd), an arnica (Arnica montana) herb-based gel traditionally used for the symptomatic relief of muscular aches and pains, stiffness, sprains, bruises, and swelling from contusions. The product is marketed in the United States as Arnica Rub from Bioforce USA of New York.
“This first product registration is an important landmark,” said Kent Woods, chief executive of the MHRA in an MHRA press release.1 “We hope that Atrogel Arnica Gel will be the first of many products to receive a traditional herbal registration. Our aim is to enable those consumers who wish to take herbal medicines to make an informed choice from a wide range of products which have been made to assured standards of safety, quality, and patient information. The MHRA will continue to work closely with the herbal sector to enable them to understand and meet the requirements of the new scheme.”
Under the UK’s Traditional Herbal Medicines Registration Scheme, established in 2005 and required by the European Directive on Traditional Herbal Medicinal Products, all manufactured traditional herbal medicines placed on the UK market will now have to meet certain safety and quality requirements outlined in the scheme.2,3 There is transitional protection until 2011 for products that were legally on the UK market before April 2004. Companies have to submit a dossier to the MHRA demonstrating that their product meets the requirements of the scheme in order to obtain the new registration. MHRA expects a progressive build in the number of registered products as 2011 approaches.
A recent randomized, double-blind clinical trial tested the efficacy of A.Vogel Atrogel Arnica Gel in treating symptoms of multiple osteoarthritis in the fingers, and the gel was judged more effective than the pharmaceutical 5% Ibuprofen gel by patients and their doctors.4 In this study, which was conducted in Switzerland from May of 2003 to March of 2004, 174 patients applied either the proprietary arnica gel or the nonsteroidal anti-inflammatory drug ibuprofen to their affected finger joints 3 times a day for 21 days. Patients filled out questionnaires at the beginning and end of the trial, regarding their hand function and pain. The results indicated that both treatments were equally effective in reducing pain and in reducing the severity and duration of morning joint stiffness. More patients and medical investigators expressed satisfaction with the efficacy of Arnica Gel than with Ibuprofen. The study will soon be published in the journal Rheumatology International (E. Sheets, e-mail, January 30, 2007).
Atrogel Arnica Gel is composed of Arnica montana extract, ethanol, purified water, glycerin, and hydroxpropyl methylcellulose.
-Courtney Cavaliere
References
1. MHRA grants landmark registration for traditional herbal medicine [press release]. London: Medicines and Healthcare products Regulatory Agency; November 8, 2006.
2. Brinckmann J. MHRA publishes guidance on acceptable sources of evidence for traditional use under the future EU directive on traditional herbal medicinal products. HerbalGram. 2004;64:54-55.
3. Brinckmann J, McIntyre M. Proposed quality control guidelines for the EU directive on traditional herbal medicinal products: implications for small- to medium-sized enterprises. HerbalGram. 2006;70:62-66.
4. Arnical gel study report: multiple osteoarthritis study with arnica and Ibuprofen gel. Roggwil, Switzerland: Bioforce AG; November 2004.
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