Treatment of type 2 diabetes and dyslipidemia with the natural plant alkaloid berberine

[Celebration]

http://www.ncbi.nlm.nih.gov/pubmed/18397984?ordinalpos=7&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

J Clin Endocrinol Metab. 2008 Jul;93(7):2559-65.

Treatment of type 2 diabetes and dyslipidemia with the natural plant alkaloid berberine.Zhang Y, Li X, Zou D, Liu W, Yang J, Zhu N, Huo L, Wang M, Hong J, Wu P, Ren G, Ning G.
Shanghai Clinical Center for Endocrine and Metabolic Diseases, Shanghai Institute of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, 197 RuiJin 2nd Road, Shanghai, People's Republic of China.

CONTEXT: Berberine, a natural plant alkaloid, is usually used as an antibiotic drug. The potential glucose-lowering effect of berberine was noted when it was used for diarrhea in diabetic patients. In vitro and in vivo studies have then showed its effects on hyperglycemia and dyslipidemia. OBJECTIVE: The objective of the study was to evaluate the efficacy and safety of berberine in the treatment of type 2 diabetic patients with dyslipidemia. DESIGN: One hundred sixteen patients with type 2 diabetes and dyslipidemia were randomly allocated to receive berberine (1.0 g daily) and the placebo for 3 months. The primary outcomes were changes in plasma glucose and serum lipid concentrations. Glucose disposal rate (GDR) was measured using a hyperinsulinemic euglycemic clamp to assess insulin sensitivity. RESULTS: In the berberine group, fasting and postload plasma glucose decreased from 7.0 +/- 0.8 to 5.6 +/- 0.9 and from 12.0 +/- 2.7 to 8.9 +/- 2.8 mm/liter, HbA1c from 7.5 +/- 1.0% to 6.6 +/- 0.7%, triglyceride from 2.51 +/- 2.04 to 1.61 +/- 1.10 mm/liter, total cholesterol from 5.31 +/- 0.98 to 4.35 +/- 0.96 mm/liter, and low-density lipoprotein-cholesterol from 3.23 +/- 0.81 to 2.55 +/- 0.77 mm/liter, with all parameters differing from placebo significantly (P < 0.0001, P < 0.0001, P < 0.0001, P = 0.001, P < 0.0001, and P <0.0001, respectively). The glucose disposal rate was increased after berberine treatment (P = 0.037), although no significant change was found between berberine and placebo groups (P = 0.063). Mild to moderate constipation was observed in five participants in the berberine group. CONCLUSIONS: Berberine is effective and safe in the treatment of type 2 diabetes and dyslipidemia.

PMID: 18397984

[Schema Thing]

1. So lick your berbers, folks

[Avalux]

2. Goldenseal. Also has antibiotic/antifungal properties.

Good stuff, apparently. :thumbsup:

[HannibalBarca]

3. Funny I did a few experiments with berberine

in pharma school, 2nd year I believe, though it mostly concentrated on its parasympatholytic effects on rat ileum tissue, inhibited calcium channels if memory serves. I love science!

[trotsky]

4. How drugs are found!

Evidence-based medicine in action. It's a beautiful thing.

[Celebration]

7. too bad it wouldn't be profitable for big pharma

Of course, that means it is cheap and available now.

[trotsky]

8. Are you saying the supplement biz doesn't rake in money?

:rofl:

[Celebration]

9. I'm saying the supplement biz

cannot afford to go the FDA testing route, since this is in no way patentable.

[trotsky]

11. So there's no money in it at all?

They make supplements and sell them at cost?
:rofl:

[Celebration]

12. Please, use your brain

There is no incentive for anyone to take this through FDA testing, because there would be no temporary monoply on marketing it through patent rights. If one person/entity gets is "approved", they could sell it, with approval, but so could others who had not gone to that extreme expense, and undercutting the price.

Give yourself a hard smack on the head and try to understand the concept.

[trotsky]

13. You won't even answer the simple question:

Do companies make money selling supplements?

I understand the answer to that question undercuts what you're trying to say, so I can't blame you for avoiding it.

[Celebration]

14. A little bit

But there is a lot of competition, because there is not any exclusivity. Their profit margins and the competitive atmosphere make it impossible for any single company to take an herb through the FDA testing procedure.

[varkam]

15. If by "a little bit" you mean "billions"

I know - chump change.

[Celebration]

16. ya gotta be kidding, LOL

What are you adding up--every single herb and vitamin, acupuncture visit, reiki visit, chiropractor visit, all into one lump sum??? Do you think they are all going to chip in and try to get berberine tested? Only to have any other person/entity who feels like marketing the product undercut the price, making the initial investment in FDA testing virtually worthless? I hope you have someone competent hired to invest your personal money.

[varkam]

17. What personal money? I'm a law student.

And as I wrote in my post a few weeks back, the sum total of CAM expenditure in the US was around 30 billion or so. I don't think it is unreasonable to say that at least a couple of those benjamins belong to the whole of the vitamin and herb supplement market (seeing as how they tend to be the most popular mechanisms of CAM).

[Celebration]

18. It isn't the net worth of the company that is the issue in any case

A company could have the net worth of Exxon Mobil, Merck, and Monsanto combined and they would not make an investment into FDA approval for a drug or supplement that was already freely available as a supplement, If they made decisions like that, they would soon drive their businesses into bankruptcy. It would be an extremely poor business decision. That should be obvious to anyone.

[varkam]

28. I'm not sure what that has to do with what I wrote.

Maybe I'm missing something.

[trotsky]

19. "A little bit"?!?!?

:rofl:
http://www.nutraceuticalsworld.com/articles/2008/04/dietary-supplements-the-latest-trends-issues

The growth of the top performing products in the estimated $24-25 billion U.S. dietary supplement market is rising at double-digit rates thanks to increased consumer focus on health, better industry regulation, and trends geared to­ward greater globalization and financing, industry sources suggest.

“The U.S. dietary supplement sector is highly fragmented in terms of growth. Overall growth during the next year or so is probably in the 4.5% to 6% range, but there are some vast variations,” said Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT. “The A-to-Z nutrients, like multivitamins, will stay in the big box stores as low-growth-rate commodities. And some botanicals are down in sales if not negative. But there is tremendous consumer interest in probiotics, certified organic cosmetics, home care and pet care; some of these are easily showing double-digit growth, and some are growing in the 20% to 40% range,” he estimates.

These advances are taking place despite a confluence of market forces pressuring manufacturers, including consolidation, rising costs, new regulations and questions about the integrity of raw and manufactured materials from China and elsewhere.

Sales in the global nutraceuticals in­dustry is projected to reach $187 billion by 2010, buoyed by rising sales in traditional markets like the U.S. and the European Union (EU), and by rising sales in emerging markets like China and India, according to Global Industry Analysts, San Jose, CA. Last year, the U.S. represented 32%—or about $21 billion—of total sales in the global market, the analysts indicated. Together, the U.S., the EU and Japan represented about 86% of the global market in 2007.

$25 BILLION (that's with a "B") in the United States. $187 BILLION (again another "B") globally.

That's what you call "a little bit"?
:rofl:

With $25 BILLION up for grabs in the US alone, you don't think the supplement makers roll in the dough? They're not paying up the wazoo for FDA testing & approval, so they basically have production and distribution costs, and that's it. Please, join us here in reality and acknowledge that the profit motive drives not only "big pharma" but your sacred cow of supplement makers too.

[Celebration]

20. But that really isn't the point is it?

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x41130#41398

Do you even know how businesses make decisions? In the broad sense, it is called cost benefit analysis. For something like this, there is a project appraisal.

The proposed project-getting berberine approved by the FDA-- has nothing to do with the size of the industry, Vitamin C sales, or garlic sales, oregano oil sales, or chiropractic adjustments. Since I assumed everyone knew the basics of the goal of running a business--that is, making a profit, my answers have been directed at those people. When asked about the whether the businesses make a profit, I would hope that they would, or they would go out of business. The "little bit" refers to the likely net profit margin of BERBERINE, which is the project appraisal.

The net projected profit margin of berberine is not enough to support the cost of FDA testing, given that any other company could undercut their price. The net projected profit margin of berberine is enough to support marketing the product, but not with the added front end load of getting the approval.

Comprende? Logic 101, or so I thought.

[trotsky]

21. You are changing the subject again.

Nobody brought up getting berberine approved by the FDA. That's your red herring. (Logic 101, indeed!) There is nothing, nothing at all, from stopping a supplement maker from isolating that and selling it in pill form or whatever. Of course there are no guarantees that what they sell you contains "enough" of the substance, or hasn't lost potency, or even does what is claimed. But that's beside the point. There's tons of money to make in the supplement biz, it's JUST as tainted as big pharma in that regard, and possibly even moreso since there's only a fraction of the oversight and regulation. I fully understand why you don't like discussing that.

Now where "big pharma" comes into play is isolating the active compound, perhaps enhancing it, refining it, testing the claims under FDA oversight, and then marketing/selling it with the backing that it will do what is claimed. That is what my initial response on this thread hinted at. Lots of new drugs are discovered in this very manner. You then spun things off into this subthread attacking "big pharma" and profitability.

[Celebration]

22. this is YOUR spin--

And big pharma won't do what you suggest because anyone can make and sell berberine. They can also get it independently assayed if they want. Big pharma is not going to do it, and the supplement industry is not going to do it. IT....WILL....NOT.....GET......DONE.

This has absolutely nothing to do with the size of the industry involved. It only has to do with the profit margin of that one product.

And, why is the size of the supplement industry even relevant to the OP, if it is not in context of getting berberine tested and approved? Changing the subject again? This is about berberine helping diabetes patients, berberine possibly getting marketed, etc. Vitamin C sales are not relevant to any of that. Nor are big pharma sales relevant to that, nor is vaccine safety relevant to that, and to top it all off, Vioxx is not relevant--in case anyone wants to go there.

All of my responses in this thread have been, and will remain, in the context of berberine. I am not going to be sidelined into some sort of what size is the supplement industry narrative that is clearly not relevant. You guys can keep talking about it if you want, and I will keep pointing out that it is irrelevant to the OP.

[trotsky]

23. You're missing the forest for the trees, is the problem.

First off, we have one limited study that shows potential for a modest effect on diabetes treatment. We don't even know how this will pan out in larger studies, and whether the effect will benefit the vast majority of diabetes patients. Can we agree on that?

What you're then skipping to is saying we get past that and now we know of a substance that will help diabetics. How do we get it to them? You claim there's no money in it for "big pharma." I say this is completely wrong. LOTS of drugs started as natural substances - the money for "big pharma" comes from, as I pointed out, refining, enhancing, mass producing, and guaranteeing dosage and results. IT...CAN...AND...WILL...GET...DONE. It's happened before and will happen again.

But even FAILING that, there is nothing stopping your beloved supplement makers from doing the same thing. There's PLENTY of money in that, and they don't have to prove a thing, even that they're putting "enough" active ingredient in the bottle. That's how the supplementers tie into this.

So what's the problem here?

[Celebration]

24. the difference is

This is already readily available as an herbal supplement. They could enhance it and refine it all they want but the product that was tested is already available, so they would be competing against something of a lower price which has been shown to work. So, the economics are just not there. If the product needed to be enhanced and refined to work you might have a point. It already works.

Supplement makers already market the product, so I am not sure what you are getting at. The product doesn't need any sort of "enhancement." There may be a specific type that has more of an active ingredient, etc. etc. but it is not rocket science and anyone could market an effective product. Could the Big Pharma change the formulation to make it patentable, get it tested through the FDA, and then mark up the price 1000 times? Sure. Do you think consumers would go for it, knowing they could get an herb that is basically the same and has also been shown to be effective?

[trotsky]

25. "It already works."

Umm, were you reading the above conversation at all?

[Celebration]

26. Works is as works does

Given a drug costing four hundred hundred bucks a month that has gone thru FDA testing, vs. an herb at twelve bucks a month that was shown in one good study to be effective, I think I would try the latter first and see if it worked.

This is pretty much a no brainer, because blood testing results and a good diary could allow for a person just to follow the numbers. An ineffective herb (or drug, for that matter) would be readily apparent.

[trotsky]

27. $400/month, huh?

And that number would have come from a market research study?

A detailed cost analysis?

Or did it maybe come straight outta your ass?

Does $12/mo. get you guaranteed amounts? Efficacy? Even accurate labeling? If you know anything about the supplement biz, you'll know the answer to all three of those is NO.

[Warpy]

5. A couple of things need to be pointed out.

First, diabetes is nothing to play with. This information is from preliminary research which could very well be negated by further research.

Second, the improvements were small. If this pans out, it could be an adjunctive treatment but no substitute for standard Type II diabetes treatment involving diet and exercise plus medication where necessary.

It is interesting, however, in light of so many newer antidiabetic drugs being shown to cause significant problems after general release.

[Celebration]

6. *one* good thing about diabetes

It lends itself well to self monitoring. If a person responds to berberine it should be readily apparent through frequent blood test monitoring and record keeping.

[LeftishBrit]

10. Interesting news!