Nelson’s homeopathic arnica: no evidence of efficacy but wins licence
Strange but true.. the UK’s medicines regulators have bent over backwards to help CAM remedies become licensed - so much so, however, that even CAM supporters are wondering if they’ve gone too far.
This month the MHRA has given Nelson’s the UK’s first ever licence for a homeopathic medicine.
It is the first licence to be awarded under a controversial new MHRA scheme which allows homeopathic remedies to side-step proof of efficacy required for other medicines.
Critics say the approval by the Medicines and Healthcare Products Regulatory Agency gives consumers the impression that the MHRA is saying that homeopathy is scientifically proven. And Ironically, arnica is one of the most contentious homeopathic remedies, as several clinical trials and a systemic review by Prof Edzard Ernst’s team at the University of Exeter have found no evidence that homeopathic arnica works any better than placebo.
The MHRA has granted Nelson’s Arnicare 30c pillules a licence for the relief of sprains or bruising, allowing the product label to state: “A homeopathic medicinal product used within the homeopathic tradition for symptomatic relief of sprains, muscular aches and bruising or swelling after contusions.” Robert Wilson, chair of Nelsons, said: “The fact that therapeutic indications may now be included on the packaging of licensed homeopathic medicines not only opens the practice of homeopathy up to new users but also gives it added credibility as a safe and natural complement to conventional medicine.”
And it is that added credibility that has roused the ire of scientists. Prof Ernst said that homeopathic arnica has been tested more often than any other homeopathic remedy and does not work: “There is no biological plausibility, so this is a cynical mockery of evidence-based medicine”, he said.
The licence has been awarded under the MHRA’s new Homeopathic National Rules Scheme, introduced in September 2006 to facilitate licencing of remedies. However, critics say the Scheme has made licencing too easy, as it explicity states that homeopathic remedies can be awarded licences without having to demonstrate that they work.
The MHRA says: “The purpose of the Scheme is to enable homoeopathic medicinal products to be registered with indications for the relief or treatment of minor symptoms and conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor)”. As long as the conditions or symptoms being treated are minor, says the MHRA, “the rules do not require rigorous clinical data”.
Amazingly, the MHRA accepts homeopathic provings in considering efficacy.
The rules for submission of a product for licencing say manufacturers must come up with evidence of quality and safety and “one or more” of the following:
• Study reports in relation to the product which is the subject of the application,
• Published scientific literature;
• Homoeopathic provings.
In an podcast interview with the British Medical Journal, Prof Ernst commented: “I’m sure the product by Nelson’s is of good quality and is entirely safe; it actually doesn’t contain any arnica because it is too highly dilute to contain any arnica, so it’s got to be safe. And proof of efficacy in the traditional way is not required, therefore it can obtain a licence. All this simply shows that the regulation for homeopathic products is barmy.”
* The Homeopathic National Rules Scheme, Brief Guidance for Manufacturers and Suppliers, September 2006 MHRA: www.mhra.gov.uk
* Evidence for, evidence against, BMJ Podcast, 15 May 2009, by Birte Twisselmann: www.bmj.com
