Kaloba Cold Cure: How the MHRA condones quackery
Wednesday, October 01, 2008
The newspapers today were delighting in reporting that a new cold treatment was being made available to us in Britian. Kaloba is an extract of the geranium Pelargonium sidoides, and has been "used by Zulus for hundreds of years".The Telegraph tells us that "extracts are particularly good at reducing the amount of phlegm." Remarkably, the paper tells us that,
Research by the Cochrane Review showed it to be "effective in resolving all symptoms including headaches and nasal discharge in adults when taken for an extended time period.The Daily Mail tells us that,
To the Daily Mail's credit they do point out that licensing the pills in the UK does not require the manufacturers to produce evidence of efficacy. They say,A herbal medicine used by African tribes to counter colds and flu has been given the go-ahead for use in Britain.
For hundreds of years, Zulus have taken extracts from the geranium plant to stop coughs and sneezes.
They say it is particularly effective at cutting phlegm.
However, because it is a herbal remedy the manufacturers, who claim it can activate the body's anti-viral defences, do not have to prove it is effective.
Indeed, the MHRA have issued their own assessment and say that,
This registration is based exclusively upon the longstanding use of the extract from the roots of Pelargonium sidoides as a traditional herbal medicine and not upon data generated from clinical trials. There is no requirement under the Traditional Herbal Registration scheme to prove scientifically that the product works.There are a number of odd things here that are worth noting. Firstly, the MHRA does not look at the use of this stuff within Zulu tribes to assess whether there has been sufficient 'traditional use' to determine whether it should be granted a license. They actually looked at evidence of usage within the EU - not amongst Zulus, but principally amongst Germans where this herbal remedy has been on sale for some time.
The second is whether there is any evidence at all for the effectiveness of Kalabo. The Telegraph were remarkably selective in quoting the Cochrane review about this plant. Far from being "effective in resolving all symptoms" as reported, the Cochrane review actually concluded that "There is limited evidence for the effectiveness of P. sidoides in the treatment of ARIs. (acute respiratory tract infections)". From the trials reviewed, there was a lot of heterogeneity of outcomes (read 'confusion') and that the 'significant' results came from an unpublished trial. So, it may be effective. But the evidence is too confusing to draw firm conclusions.
But the manufacturers Schwabe Pharmaceuticals and their sales outlet Boots will undoubtedly be welcoming the MHRA's decision to let this stuff loose on us and the misleading and (mainly) uncritical reporting by the nations finest newspapers are undoubtedly providing a good sales launch.
Labels: MHRA
posted by Le Canard Noir at
12:16 AM
8 Comments:
I'm of the impression that the directive 2004/24/EC means that the MHRA don't have much choice in the matter. I may be wrong, but I thought that the Traditional Herbal Medicines Registration Scheme was basically an instrument to aid trade in the EU - i.e., the EU has 'legalised' unproven herbal remedies that have traditional use (again, I think it is a reqirement of the directive that the remedy must have traditional use in the EU rather than in the place of origin) in order that they may be sold in all EU countries. Good for industry. Good for consumer choice. Not so good for consumer protection. You can buy a greater number of products, but the trade-off is that you are considerably less certain of the benefits.
You are right to point out what a shit state of affairs it is, but possibly a bit harsh on the MHRA - as far as I can tell they are "only obeying orders". EU directives on herbal products and vitamin pills (not to mention homeopathics) are basically meant to 'harmonise' legislation in member states and assist trade. Everything else seems to be secondary to businesses being allowed to trade freely cross borders.
"A significant number of medicinal products, despite their long tradition, do not fulfil the requirements of a well-established medicinal use with recognised efficacy and an acceptable level of safety and are not eligible for
a marketing authorisation. To maintain these products on the market, the Member States have enacted differing procedures and provisions. The differences that currently exist between the provisions laid down in the Member States may hinder trade [etc...]"
From: Directive 2004/24/EC
PS - excuse the loser-length post, I just find EU directives very interesting.
PPS - you're right about the Telegraph and the Mail's pieces on Kaloba and having scanned Google News just now I can tell you that the Metro's coverage was pretty awful too. They are cherry picking from the same Cochrane review and their angle is that Pelargonium is going to "stem the overprescription of antibiotics", which are (apparently) "ineffective against viral versions [of colds and influenza]". Which is funny, because I'd never heard about these bacterial cold and influenza bugs. Presumably what they actually mean is that instead of prescribing one useless placebo, doctors are now free to prescribe another?
At least a placebo that doesn't do anything won't help spread resistance to antibiotics.
The operative point is that it 'works' if taken over a period of time. Snce colds are self limiting this obviously is going to happen regardless of what you do or take. IOW there is no evidence of its effectiveness if that is the measure of it.
Of the many scientists who have criticized homeopathy, is there not one who will sue for defamation for being called a pseudo-scientist?
Hmm, think you're a little negative here. Herbal remedies have been around a lot longer than drugs, in fact as far as I know all drugs are, in fact artifical copies of the active constituents of the herbs!
Amongst other trials:
Efficacy of a Pelargonium Sidoides Preparation in Patients With the Common Cold: A Randomized, Double Blind, Placebo-Controlled Clinical Trial .
EXPLORE: The Journal of Science and Healing , Volume 3 , Issue 6 , Pages 573 - 584
V . Lizogub , D . Riley , M . Heger
Conclusions:
EPs represents an effective treatment of the common cold. It significantly reduces the severity of symptoms and shortens the duration of the common cold compared with placebo. The herbal drug is well tolerated.
Anonymous - by posting this trial, you are doing what all quacks do - cherry pick studies. You pick the most favourable evidence and do not discuss it in its wider context. This trial was indeed reviewed in the Cochrane review I mentioned in my post, along with other less favourable reviews. To therefore, highlight this one trial is misleading as it ignores less favourable evidence.
You guys are embarassingly partisan and stupid. 'Consumer protection' - you make me throw up!
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