Lessons learned from the development of the diabetic supplement Gymnemosupium. Part 2
As we learned in Part 1 there have been copious amounts of clinical studies clearly demonstrating the astounding benefits of supplement therapy, however, the few studies that fail seem to receive most of the attention. It would appear that these few studies have helped to hindered wider acceptance of these truly remarkable substances.
We continue looking at the lessons I learned while developing a new supplement. Hopefully the information presented here will give you the knowledge to help your clients select a well-made supplement
Pterocarpus marsupium also demonstrates some very unique features, which include beta cell protective and regenerative properties as well as blood glucose lowering activity. These effects have been reproduced in numerous animal and human trials for over half a century. The majority of the animal studies use several different types of test species that have been make diabetic by the use of selected toxins and then given various extracts of Pterocarpus marsupium. In all of these studies Pterocarpus marsupium was able to reverse the damage to the beta cells and actually repopulate the islets.[i], [ii], [iii], [iv], [v], [vi] This also caused the almost complete restoration of normal insulin secretion. Almost all of those that did not receive any type of treatment remained severely hyperglycemic or did not survive during the testing period. Again, as compared to the control groups, the Pterocarpus marsupium groups had a significant percentage of subjects that did not become diabetic or hyperglycemic.12, 17 So, it appears that the uses of Pterocarpus marsupium will not only repair or regenerate beta cells in animals, but it may also act in a protective manner preventing beta cells from destruction by nullifying the effects of a toxic exposure. This ability to offer protection to beta cells in this fashion may be of particular benefit to newly diagnosed Type I diabetics that are still experiencing an autoimmune activity. Another property displayed by Pterocarpus marsupium is an insulin like activity.[vii], [viii] This is completely separate from the stimulation of insulin production from the repair of beta cells. Pterocarpus marsupium may lower blood sugar through an unrelated pathway of that of insulin. It seems that there are different cellular binding sites for insulin and Pterocarpus marsupium, which means that glucose lowering can occur regardless of the presence of insulin. This characteristic of Pterocarpus marsupium would be beneficial to both types of diabetics. In Type II diabetics, that suffer from primarily insulin resistance, it would completely bypass the normally ineffective insulin pathway allowing for glucose uptake, while in Type I diabetics it could supplement in part for the absence of insulin. One study even demonstrated that Pterocarpus marsupium may also lower blood lipid levels. The uses of an extract produced a reduction in serum triglycerides, total cholesterol and, low density lipoproteins (LDL) and very low density lipoproteins (VLDL) cholesterol.[ix]
Now, in the human trials Pterocarpus marsupium performed amazingly, especially given the testing criteria. In these two clinical trials diabetics were given no other treatment, except an extract of Pterocarpus marsupium. The first study evaluated both newly diagnosed and untreated Type II diabetics. In this study 97 patients were given varying doses of an extract of Pterocarpus marsupium ranging from 2 to 4 grams a day in attempts to achieve blood sugar control.[x] The trial continued for 12 weeks before evaluation of all monitored parameters. The results showed that 67% of all those tested were able to reduce and maintain glucose levels by using various amounts of Pterocarpus marsupium extract. The dose required for control for 73% of the patients was 2 grams a day, 16% of the patients needed 3 grams a day and 10% required 4 grams a day. There was significant decrease in both fasting and postprandial glucose levels. The average fasting blood sugar fell from 151mg/dl to 119mg/dl and postprandial glucose dropped from 216mg/dl to 171mg/dl. There was also a reduction of mean hemoglobin A1c from 9.8% to 9.4%. There were improvements noted in common diabetic symptoms without any adverse side effects reported during the treatment period. In the second study 22 diabetics, mostly Type II, with ages ranging from 29 to 70 years old were given a decoction of either 2 or 4 ounces three times daily made from 36 or 72 grams of dry bark of Pterocarpus marsupium respectively for 7 days.[xi] There were four parameters that were monitored during this study including fasting blood sugar, glucose tolerance, urine sugar content and diabetic symptoms. They were divided into two groups, Group A with 10 participants and Group B with 12. Group A received a decoction of 2 ounces three times a day while Group B received 4 ounces three times a day. In Group A only 3 out of
10 diabetics showed improvement in any of the areas of testing, which was glucose tolerance. While in Group B, 9 of the 12 patients experienced benefits in all testing areas. There was significant improvement in glucose tolerance and glucose uremia and also a decrease in fasting blood sugar and amelioration of some symptoms. During the study there were no unwanted side effects.
Although there are countless numbers of herbal supplements available today for diabetes, they are not all formulated equally. Just selecting herbs that have been proven successful in the treatment of diabetes for a supplement does in no way assure its effectiveness. In this section we will view the differences in extracts, herb cultivation and function, and the importance of supplement content and purity. Gymnemosupium has been specially manufactured to properly address all of these details and provide in all respects a superior supplement.
One of the very first considerations in examining a supplement is it potency. Are the herbs in a form and dosage similar to that used in the clinical studies? This is a very significant problem in the supplement industry today. Just because the term extract is employed does not guarantee it is the same extract ratio that was successful in the clinical studies. This is made very apparent in the studies with Gymnema sylvestre. It has been grossly overlooked that the extract ratio of the Gymnema used in the studies is much higher than those commercially available. To achieve similar results as in the studies the dosage of lesser extracts must be increased. This is again providing that the proper part of the plant was used. Gymnema sylvestre extracts are most effective when only leaves are used. Some manufactures use a combination of leaves, stems and roots or just stems and roots, which have not been proven effect. It is primarily the bark of the Pterocarpus marsupium that demonstrates the previously listed properties, not the more plentiful and less costly wood or roots of the plant. Also, the extraction process and the reagents used are of great concern. Again, the proper ethanol/aqueous combination used in the extraction process must be adhered to as well. Any deviation from these standards can compromise the product and ultimately the success of the therapy. To solve these problems, both the Gymnema sylvestre and Pterocarpus marsupium used in Gymnemosupium are standardized extracts taken from the most active component of each individual herb. They are also delivered in an appropriate dose adjusted to duplicate the clinical study environment. This factor is virtually never taken into account and as a result most people using supplements receive a sub-therapeutic dose, which can result in only nominal benefits if any at all.
Herb Characteristics and Sources
The herbs in Gymnemosupium appear to demonstrate both a pancreatic and extra-pancreatic effect in their clinical studies. This would make them equally effective in treating both Type I and Type II diabetes. In fact, there is even some evidence that Gymnema sylvestre and Pterocarpus marsupium might work synergistically when combined. Their individual differences may compliment each other by possibly addressing the problem through different mechanisms and produce a greater effect than their sum. Actually, these two herbs have performed so well in their clinical studies that the Mayo Clinic has even decided to investigate them further.[xii]
As mentioned before, even though there are a large number of herbs that exhibit hypoglycemic activity, the method in which they achieve this effect is of great importance. While pure symptomatic treatment, similar to that of insulin or oral hypoglycemics, can decrease blood glucose level, it does not elicit any extended metabolic improvements. For example, when either insulin or oral hypoglycemic therapy is removed for a short period of time there is an immediate increase in blood glucose levels. However, when specific herbs are used and then withdrawn, there is not a dramatic reversion as with drug treatment. This lends the premise that there may be something more than just symptomatic treatment taking place. This is exemplified by the noted increase in insulin production in both Type I and II diabetics when using just Gymnema sylvestre. What I am ultimately eluding to is that selected herbs might invoke natural healing, which is not seen in drug therapy uses. It is also suggested by the author of these studies that the continued uses of these same herbs might eventually cause reduction and elimination of conventional treatments. So, while some herbs will reduce blood sugar effectively, it is the herbs like Gymnema sylvestre and Pterocarpus marsupium that might create continuing metabolic improvements.
Another consideration is the source of the herbs selected for supplement uses. There is every reason to believe that it is best to use herbs that have been grown in their original country and location. While an herb can be replanted and grown in a foreign location, there is no assurance that it will be exactly as the one from its native area. This could be due to soil content alone. Much like how the exact same fruit will taste different when grown in different parts of the country. Variations in the presence and amount of specific minerals in the soil can be the greatest factors that could change the properties of an herb and render it virtually ineffective. So, with all these variables associated with herb usage it is very important to know if the manufacture of the herbs you select as a reputation of producing a quality product without the uses of pesticides. Nutraceutical Specialties only uses herbs grown in India, which both Gymnema sylvestre and Pterocarpus marsupium are native. There are processed by Sabinsa Corporation, a leader in botanical and pharmaceutical research and manufacturing, with facilities both here in the U.S. and India.
One last recommendation when selecting any type of supplement is its contents and amount of any additional additives. A major problem in the supplement industry is the practice of not delivering the advertised amount of active ingredient in each capsule. This can be the result of many factors, but it is likely that poor manufacturing practices can be to blame. There are capsule fill claim tolerances dictated by the FDA, but even when these are obeyed it can still dramatically effect total capsule content. This is why
Nutraceutical Specialties strives for an average fill tolerance of just 2% of advertised ingredients insuring capsule quality. Now, there is also the matter of receiving something other than what is advertised to be in your supplement. There are additives used for a number of purposes when manufacturing tablets and capsules. They are referred to as fillers, binders, coating and excipients. While these additives are generally inert, some can cause hyperglycemia in susceptible diabetics. This was reported in a study that gave diabetics a multivitamin, which caused their blood sugar to increase.[xiii] Usually, this is due to an allergic type of reaction with the only symptom being high blood sugar. Actually, this type of reaction takes place regularly in some diabetics due to specific foods. This can account for a number of unexplained high blood sugar readings. So, it is important to know what extra ingredients are in any supplement you consume and attempt to keep their amounts to a minimum. Understanding this problem, Nutraceutical Specialties has intentionally restricted the uses of additives to the least amount necessary to properly fill each capsule.
In conclusion, Gymnemosupium is the culmination of an exceptional amount of research, design and development of a supplement created to address the condition of diabetes. This effort was based not only on the surface issues of diabetes, but also on the subtleties that can often be overlooked. Regardless of how efficacious a substance is it can be made virtually inert, if it is not delivered under the proper methodology as delineated in its related studies. We believe that we have identified and compensated for a number of variables that can jeopardize successful therapy and in that process have created a superior supplement in Gymnemosupium.[i] BK Chakravarthy, Saroj Gupta and KD Gode. Functional Beta cell regeneration in the islets of pancreas in alloxan induced diabetic rats by (-)-Epicatechin. Life Sciences 1982 Volume 31, No. 24 pp. 2693-2697. [ii] Manickam M, Ramanathan M, Jahromi MA, Chansouria JP, Ray AB. Antihyperglycemic activity of phenolics from Pterocarpus marsupium. J Nat Prod 1997 Jun;60(6):609-10. [iii] Faiyaz Ahmad, Parwaiz Khalid, Mohammed Mubin Khan, Meena Chaaubey, Anil K Rastogi, and Jalil R. Kidwai. Hypoglycemic activity of Pterocarpus marsupium wood. Journal of Ethnopharmacology 35 (1991) 71-75. [iv] MC Pandey, Demonstrator, PV Sharma. Hypoglycaemic effect of bark of pterocarpus marsupium roxb. (Bijaka) on alloxan induced diabetes. The Medicine & Surgery 16 June 1976 p. 9-11 [v] BK Chakravarthy, Saroj Gupta, SS Gambhir, KD Gode. Pancreatic Beta-cell regeneration in rats by (-)-epicatechin. Lancet October 3, 1981. p. 759-760. [vi] BK Chakravarthy, Saroj Gupta, KD Gode. Antidiabetic Effect of (-)-Epicatechin. Lancet July 31, 1982. p.272-273. [vii] Ahmad F. Khalid P, Khan MM, Rastogi AK, Kidwai JR. Insulin like activity in (-) epicatechin. Acta Diabetol Lat 1989 Oct-Dec;26(4):291-300. [viii] Rizvi SI, Abu Zaid M, Suhail M. Insulin-mimetic effect of (-) epicatechin on osmotic fragility of human erythrocytes. Indian J. Exp Biol 1995 Oct;33(10):791-2. [ix] Jahromi MA, Ray AB. Antihyperlipidemic effect of flavonoids from pterocarpus marsupium. J Nat Prod 1993 Jul;56(7):989-94. [x] Indian Council of Medical Research. Flexible dose open trail of Vijayasar in cases of newly-diagnosed non insulin dependent diabetes mellitus. Indian J Med Res 1998 Jul;108:24-9. [xi] Dr. MC Pandey, Prof. PV Sharma. Hypoglycaemic effect of bark of pterocarpus marsupium roxb. The Medicine & Surgery 15 November 1975 p. 21-23. [xii] Hunt D. New discovery restores pancreas and balances blood sugar. Journal of Longevity Vol.6/No.7 p.6-9. [xiii] Sparks SP, Jovanovic-Peterson L, Peterson CM. Blood glucose rise following prenatal vitamins in gestational diabetes. J AM Coll Nutr 1993 Oct;12(5):543-546.