Jul 16, 2008
Unnatural Approach to Diabetes
As regular readers will be aware, I’m very skeptical of crank claims. Usually, these will claim to cure everything from premenstrual cramps to cancer by way of motor neurone disease and ingrowing toenails, all of them, with one pill. Forgive my flippancy, but the claims of many of those touting such panaceas usually beggars belief.
But some offer quite convincing claims for treating, but not necessarily curing, a specific illness with something novel. One such email arrived recently from a public relations company representing a company selling a herbal supplement. The release discusses the potential of an extract of mulberry leaf to prevent concentration spikes in the blood sugar of patients with Type 2 diabetes mellitus.
This disorder, which is on the increase in the developed world as obesity incidence rises, is characterised by insulin resistance, relative insulin deficiency and hyperglycemia (raised blood sugar levels). Changes in diet and more exercise can often ameliorate the effects in the early stages, but medication and insulin are usually needed in the long term. The main problem is the sharp rises and falls in the concentration of glucose in the blood, which puts a severe strain on the organs, in particular the heart.
The email I received, had the subject line “Type 2 diabetes: a look at natural alternatives to prescription drugs” and seemed innocuous enough. It mentioned the FDA’s pronouncements on diabetes drugs and the need to tighten up on their safety and then went on to highlight mulberry, a natural product that is now being marketed as Glucocil, which can purportedly help prevent those hazardous blood sugar spikes.
According to the press release, mulberry has been used for generations in Chinese medicine and some Indian foods, is showing great promise for Type 2 diabetes sufferers. After seven years of research and development, a medical researcher and scientist from China, Lee Zhong, has discovered a proprietary mulberry leaf extract that has been shown in numerous clinical trials to markedly lower blood sugar levels in Type 2 diabetics, helping them achieve a healthier diet and lifestyle. I asked Zhong for a few details about his work, the efficacy of this food supplement and possible medical issues associated with its use. You can read more about the study in the latest issue of Reactive Reports.
Zhong explains that, “Mulberry leaf
is
a natural
α-glucosidase inhibitorMulberry leaf is a natural α-glucosidase inhibitor. α-glucosidase
inhibitors do not lower blood sugar levels, they reduce and delay the abrupt elevation of blood sugars after meal, therefore stabilize blood sugar levels. π-glucosidase inhibitor drugs, such as Acarbose, are found to 1) reduce diabetic cardiovascular risks 2) be good for weight management 3)
prevent pre-diabetics to become type 2 diabetics.” Zhong and colleagues have published positive results on pure mulberry extract in the journal Diabetes Care, see reference.
It all sounds reasonable so far. But, what is not clearly mentioned in the press release is that Glucocil is not simply mulberry extract. Rather it is a blend of different ingredients:
- Mulberry leaf extract
- Cissus sicyoides (Insulina) leaf extract
- α-lipoic acid
- C. quadrangularis extract
- Banaba leaf extract
- Chromium polynicotinate
- vitamin B1, B6, B9 (folic acid), and B12
I asked Zhong about the presence of that chromium salt, as chromium deficiency has long been suggested to be a factor in the development of diabetes. “Chromium was not included in the extracts that used in our published clinical studies (or the efficacy tests),” he told me, “The ingredients used in the final Glucocil formula have records of many years’ safe human usage.” He adds that, “Glucocil was not developed overnight. We had thousands of tests and have plenty scientific evidence to support the product.”
That’s as maybe, but, I think he missed my point, it’s not the safety of the formulation that concerns me, although chromium picolinate has been linked to liver toxicity (Eur J Intern Med. 2002, 13, 518-520), it’s how it can be marketed as a natural product when it so obviously contains a rather non-natural ingredient in the form of that chromium salt. It seems especially odd given that chromium itself is thought to have an effect on diabetes, although that’s as yet unproven.
Aside from the clinical trials and tests carried out with mulberry in isolation, as far as I know, no double-blind placebo-controlled trials have been carried out on the mixed formulation that includes the chromium salt, which has variously been used as a “natural” slimming aid without serious proof of efficacy. Chris Leonard, Director, Translational Research and Technology at Memory Pharmaceuticals, points Sciencebase readers to what he describes as a “thoughtful and well-referenced discussion on chromium and diabetes.
Pharmacologist and toxicologist Sanjeev Thohan, Research Director at drug discovery company Exelixis, adds that chromium picolinate is quite distinct from the hexavalent form of chromium made infamous by the Erin Brokovich issue. He points out that there have been some clinical trials conducted within the last year that use different derivatives of chromium picolinate and that these are close to finishing and will make their data available in the next year or two. He adds that one must, “Remember that the bioavailability of the picolinate derivative and its action on the beta cells is what will determine if there is a positive effect on insulin. Insulin sensitizer drugs, I believe in some of the clinical trials, are being used with the chromium compounds to see the possibility of synergy.” Thohan highlights an additional UK government PDF resource on chromium. The US government’s PDF document on dietary recommendations for vitamins and trace elements also includes a section on chromium.
Zhong adds that, “This product is being marketed as a dietary supplement (not a food or drug) and is designed to assist those who are trying to manage their condition primarily through changes in lifestyle, primarily diet and exercise.” But, to my mind, something with proven activity in such a potentially debilitating disease should not be marketed as a supplement. Consumers should be made aware of the dangers of diabetes and consult their doctor over possible treatments and outcomes.
Zhong tells me that the marketing does stress that potential users talk to their healthcare workers and that they should monitor their blood sugar carefully. However, one in ten, he concedes, don’t necessarily do so. With diabetes on the rise, one in ten could turn out to be quite large numbers of people using an apparently potent supplement without any clear knowledge of what it might be doing to their bodies and without strictly monitoring the progression of their disease.
“Generally speaking, those who are most interested in this product are those who are newly diagnosed and are not on multiple meds as is the case with those who are more seriously ill,” adds Zhong, “The typical Glucocil consumer is someone who is looking for more natural nutritional support.”
Yes, there are problems with pharmaceutical products. But, maybe its time physiologically active herbal remedies were
brought under
the pharma umbrellamaybe its time physiologically active herbal remedies were brought under the pharma umbrella rather than being sold disguised as food supplements. Indeed, there are calls for this to happen in Europe and elsewhere. This way, not only would they gain acceptance or rejection quickly, but those that are truly effective and worthy, and safe, would reach the patients who really need them and lose the downy feathers of alleged quackery.
UPDATE: There’ll be a post on the regulations debate on Sciencebase, July 23, so grab the site newsfeed to keep up to date or sign up here to get the item delivered by email.
Mudra, M., Ercan-Fang, N., Zhong, L., Furne, J., Levitt, M. (2007). Influence of Mulberry Leaf Extract on the Blood Glucose and Breath Hydrogen Response to Ingestion of 75 g Sucrose by Type 2 Diabetic and Control Subjects. Diabetes Care, 30(5), 1272-1274. DOI: 10.2337/dc06-2120
Thanks for sharing Greg, very interesting story. Of course, you could have picked the “wrong” herbal at some point and poisoned yourself, but then again, that can happen with a prescribed drug too…
I am firmly against bringing herbals and alternative medicines under any “pharma” umbrella where possible remedies languish unavailable pending definitive studies which wait to be made in spite of lack of funds.
Willow bark extract, the precursor of aspirin, is still marketed separately with the caveat that the claims made for it were not approved by the FDA. Gallega officinalis, or goat’s rue, is the herb from which the #1 Diabetes-2 medication, Metformin, has been developed, but no one can buy goat’s rue except from the very sites accused of quackery by promoting folk medicines. This is not to say that all promoted supplements have real worth, far from it — and there will always be those whose consumption is predicated on hearsay and the desire for quick, no-hassle remedies that require no deviation from the poor diets and excerise-poor lifestyles adopted by the majority. (And I daresay we all know some health-food addicts that wax eloquent on the benfits of this or that while looking no more healthy than the next person.)
When first diagnosed with Diabetes-2, I was put on Metformin 850 mg and Enalapril Maleate 2.5 mg and given a glucose-monitoring meter. I was told to avoid the usual: sweets, starches, certain fruits, etc. and to adopt an exercise program (no details – left up to me). I weighed 210 lbs.
For six months I lived with diarrhea and depression, though the restricted diet and the exercise took off 15 lbs. The doctor claimed he wasn’t happy with the blood sugar levels and increased the metformin to 1350 mg. A cholesterol-lowering medication was prescribed as well, but I never filled it.
To shorten the narrative, I threw out all the medications and started using the antidiabetic herbs and supplements I found on the Internet, very few of which are “FDA approved”.
Of course, cinnamon and fenugreek aren’t going to be condemned anytime soon by the FDA or anyone else, but the same isn’t true of some of the others.
Using my glucose monitor I was able to find out which ones worked and which ones didn’t, that simply. Now I weigh 20 lbs less (175) and the diarrhea and depression are over. The last blood test showed normal blood pressure, cholesterol, triglycerides, glyco-hemoglobin and blood glucose levels. The only downside was the cash outlay that made it possible – more expensive than the co-payments shelled out for the prescription meds.
I’ve also found that my body doesn’t give up when I accidentally leave the supplements at home; i.e., after regular use of the supplements, a “miss” every now and then did not cause blood sugar to spike after a meal – like it did when I forgot the Metformin. I’m grateful to the “Health Food” companies online that made it possible. The doctor initially did not approve, but now with three good blood tests in a row over the last nine months, he just says “keep doing whatever you’re doing”. And what I’m doing is what would not have been possible if some regulatory agency had interfered with my freedom to experiment with herbs and – yes – chemical supplements like chromium picolinate.
True, I haven’t been on this current regimen for years and years to know whether the good results have any preventative effect on diabetes complications like limb death, neuropathy, detached retina, heart or kidney failure, etc. On the other hand, many of those with amputated limbs and diabetes-indiced blindness or coronaries were faithfully taking their FDA-approved insulin or oral medications.right up to the sad events.
Ah, but what about those people taking a daily dose of some particular herbal to stop them getting one disease and repeatedly banging their organs (particularly liver and heart) with a compound that is not safe in its unmetabolised form. The case in point is related to your cranberry example and concerns grapefruit juice and an old antihistamine Triludan. Admittedly, one would have to have drunk an awful lot of grapefruit juice for the Triludan to remain unmetabolised long enough to cause heart damage. However, my point is that many herbals are concentrated versions of such products and so popping a daily pill might provide the equivalent of several glasses of the drink, which could quite easily interfere with a prescribed drug.
A person prescribed antidepressants might imagine that taking St John’s Wort alongside would be safe and helpful. It most likely wouldn’t be, especially if they also have thyroid problems. The fact that there is a serious disconnect between herbals and pharma products could be lethal in some cases, which is why I think there should be better controls.
No, I’ll go back to bladder infections as an example. This is a bit of a deviation from herbals but there is research suggesting that cranberries are useful for preventing bladder infections. Key word is prevention. Once an infection has taken root, no sane doctor is going to recommend cranberry extract or juice. Rather, antibiotics are standard treatment.
To reiterate, I’m not arguing that they should not be regulated. In fact, I’m a huge supporter of increased regulations AND training for anyone who provides information on these types of products. Right now, it’s far too relaxed and pardon my language but some of the ‘advice’ provided along with purchases is daft at best (speaking from personal experience on that one). What I am saying is that pharmaceuticals are far more potentially onerous as a comparative whole and that it seems excessive to subject herbals to the exact same scrutiny and testing. I think a separate category is realistic and would be effective, plus safer than the current wishy washy pseudo-regulations around most herbals.
Mina, but I guess that’s the point. If these herbals aren’t active then why are they being sold? If they’re inactive, then they’re nothing more than placebos, they’re like a crutch for someone with perfectly good legs.
“commonly used as preventative an supportive treatments alongside pharmaceuticals”, sorry but that really just sounds like an evidence-free proposition.
I’m not saying that all herbals are hogwash, some do have physiological effects and because they do, they should be regulated properly. Take St John’s Wort, anyone who feels a bit miserable can buy it OTC and start popping pills in the hope of making themselves better, totally unaware of its latent interactions with certain medications, often made by the same companies via their pharma wing:
http://www.intelihealth.com/IH/ihtIH/WSIHW000/8513/31402/348539.html
More to the point, herbal manufacturers are not allowed to make medical claims about herbal products, so consumers buy these things blindly or having read some anecdotal evidence in lifestyle magazines of non-controlled, non-blinded, quasi clinical trials.
Like I said before, if they have no effects, then they’re a waste of money, if they do have effects then these should be regulated because the effects could be hazardous when mixed with other diseases and pharma products.
Which mainstream herbals do you think are worthy? Echinacea? Ginseng? Maluka honey? None of those have any proven efficacy beyond acting as a poor source of some vitamins and minerals.