BMJ corrects column on MHRA's "traditional herbal registration" (BMJ)

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BMJ corrects column on MHRA’s "traditional herbal registration" (BMJ)

Published: Wednesday, July 2, 2014

Editor's note: BMJ has corrected a No Holds Barred column that criticized the Medicines and Healthcare Products Regulatory Agency (MHRA) for endorsing the efficacy of certain herbs. The correction clarifies that MHRA granted these herbs "traditional herbal registration," which since 2005 enables endorsement without any evidence of efficaciousness from clinical trials, but the MHRA says that long term uses "indicate that efficacy is at least plausible." Michael McIntyre, the chair of the European Herbal and Traditional Medicine Practitioners Association, highlights several corrections to the article and further clarifies that, "By authorising traditional herbal registrations, the MHRA is enabling the provision of quality controlled herbal medicines that have an established history of at least thirty years of safe use. Given the widespread use of these herbal remedies it would be irresponsible for them not to do this."

BMJ

 How the UK drug regulator became the herbalists' marketeer

Devil's claw, arnica flower, palmetto fruit, and feverfew are among herbs recently endorsed as meeting standards of "safety, quality, and efficacy" by the Medicines and Healthcare Products Regulatory Agency (MHRA). Yes: the supposedly serious governmental regulator of drugs and devices in the United Kingdom has approved the use of a bunch of non-evidence based interventions.

But devil's claw (harpagoside) has not been shown to be effective or safe for long term use. Evidence is insufficient to back the use of arnica, and if it does work it is likely to have more side effects than topical ibuprofen. Palmetto does not improve the urinary symptoms for which the agency allows it to be used. And there is not enough evidence that feverfew can improve migraine.

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Correction to How the UK drug regulator became the herbalists' marketeer

In this No Holds Barred column by Margaret McCartney, she suggested in the first paragraph that the Medicines and Healthcare Products Regulatory Agency (MHRA) had approved devil's claw, arnica flower, palmetto fruit, and feverfew for efficacy (BMJ2014;348:g3194, doi:10.1136/bmj.g3194).

To clarify, the MHRA has granted these herbs "traditional herbal registration," which since 2005 has enabled endorsement without any evidence of efficaciousness from clinical trials, but the MHRA says that long term uses "indicate that efficacy is at least plausible.

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Re: How the UK drug regulator became the herbalists' marketeer

The MHRA and Directive 2004/24/EC - AKA the Traditional Herbal Medicinal Products Directive (THMPD) which rules how traditional herbal medicines may be marketed, do not, as Margaret McCartney suggests, promote herbal medicines or mislead potential consumers. Instead the THMPD guarantees quality control and safety. It does not guarantee efficacy or even effectiveness but just describes traditional use. People have the right to access these traditional remedies if they so choose (and are prepared to pay for them). There may or not be benefits from them : in many cases it is as yet unknown whether these OTC herbal remedies actually work better than placebo bearing in mind that the major effect size for OTC and prescribed medicines (both conventional and herbal) is to be found in the placebo arm. By authorising traditional herbal registrations, the MHRA is enabling the provision of quality controlled herbal medicines that have an established history of at least thirty years of safe use. 

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