Terra Sigillata

This blog was established originally to discuss the promise of natural products in human therapeutics, particularly to identify those herbal medicines that might have some potential for utility as medicines. However, a quick review of my posts reveals a majority of reports of negative outcomes of efficacy or other problems with herbal medicines.

Well, as many of my readers and fellow bloggers down under are aware, the situation in the US is not unique. According to this news report out of Australia:

Popular folk remedies such as aloe vera and lavender oil may not possess healing properties that are often attributed to them, a study has found.

A Choice magazine survey of scientific literature found inconclusive evidence for the effectiveness of folk remedies in everyday use in Australia.

I thought our funding situation in the US was dire, with NIH’s NCCAM devoting about $120 million to alternative medicine research each year (with approx 50% devoted to dietary supplements):

Australian Integrative Medicines Association president Professor Marc Cohen said the government had announced $5 million for research into alternative remedies in November last year….”So the government is responding. But $5 million doesn’t buy us a lot of research.”

More insightfully, Prof Cohen cuts right to the heart of the issue and notes a key problem with the study of herbal medicines: a positive or negative result with one product derived from one herbal extract does not apply to all extracts made from the same plant:

Prof Cohen said a lack of product-specific research created confusion about folk remedies, as some products were much better than others. “The best comparison I can make is with red wine. There’s a big difference between Grange Hermitage and cask wine, and if you’ve done research on one you can’t really compare it to the other,” he said.

And so, yet another story concludes with one of my own central mantras:

Professor Cohen said requiring companies to conduct specific research before putting claims on their products would help regulate the market.

And the chances of that are????

Comments

  1. #1 Andrew Dodds
    January 11, 2007

    Have to admit, having read the title, that the post would be:

    Problem with herbal medicine in Australia: All of our plants are poisionous. So are the animals. And don’t even think of stepping in the sea..

  2. #2 Philip LaMarche
    January 11, 2007

    I don’t know about lavender oil, but I tried aloe vera on my irritated eye lids ( after trying many other things which didn’t work) and it healed the eye lids permanently after two hours. The same happened with a friend of mine.
    Another friend who was wounded in the Iraq war, was going to have his foot amputated. He rubbed aloe vera on it and his foot is now perfectly healthy.
    Some researchers are stupid.

  3. #3 kweiblen
    January 14, 2007

    So, as I see it, you are saying basic requirements for any regulation of herbal/ vitamin products would be:

    1. Make sure the product actually contains the natural product it cites on the label.

    2. Standardize the chemical entity and amount(i.e.the individual salt,amount of extract in milligrams or international units, etc.)which appear in various manufacturers’ products, so that their relative strengths can be acertained.

    3. Prove the safety and efficacy of the natural product by performing randomized controlled trials.

    I thought that numbers 1 and 2 were already done by a government agency in Oz for herbal products and vitamins. I understand that the FDA doesn’t have any control over vitamin and herbal manufacture in the US (except when they cause harm), but that self-policing was done by the American Botanical Council. I have no idea how thorough this scrutiny is.

    Number 3 always seems to be done marginally and with data sets which are way too small due to profitability issues.

    That we do not even have 1 or 2 as an assurance in the US is the first problem to be solved, and we are putting the cart before the horse in reporting adverse effects to herbal medications if we can’t be sure the product even contains the ingredients it cites on the label.

    Is this essentially correct?

  4. #4 Joseph j7uy5
    February 4, 2007

    Ms. Weiblen, that is correct. The first step in any empirical undertaking is to know what you are dealing with, and in what quantity.

    Another point: I’d imagine the rate of finding interesting compounds is actually higher amongst naturally-derived products than it is in the traditional pharmaceutical development cycle, but that is not saying much. The fact is, most compounds wash out, for some reason or another.

  5. #5 Abel Pharmboy
    February 17, 2007

    kweiblen, the American Botanical Council is an educational organization whose goal is “to promote the responsible use of herbal medicines.” However, they have no authority on herbal labeling or quality control. There are true trade organizations like the American Herbal Products Association and the Natural Products Association (formerly NNFA), but these only make recommendations for the industry – nothing is binding.

    Labeling now does have to include at least the plant name and nutrient, but there is no independent oversight to ensure product composition. In defense of some cases, though, the actual active principle(s) are not even known, so even regulated standardization is not likely to be effective. But even where the active compound is known, standardization is not enough – the preparation and excipients in each formulation can influence bioavailability, even if standardized for content. Hence, I’ve always been a big proponent of solid, Phase I pharmacokinetic studies before embarking on expensive RCTs. So, yes, the state of 1 and 2 are not so good.

    That makes clinical trials a big question – outside of some of the bigger European manufacturers, most recent efficacy trials are supported by NIH on budgets that seem big, but pale in comparison to what is need for adequate statistical power to detect small effects.

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