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What constitutes successful nutritional supplement therapy? PART 1

Lessons learned from the development of the diabetic supplement Gymnemosupium.

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. What is most interesting about these unsuccessful studies is not their failure, but rather why they failed. It appears that most failures are due to a lack of proper methods and materials used in the original study the work was based upon, not failure of the supplement itself to produce the desired effect.

There are numerous variables that must be taken into account when attempting any type of nutritional supplement therapy in the treatment of diabetes or any type of disease for that matter. While vitamin or mineral supplements come in several different individual forms that can be used, there are a plethora of variables attached to herbal therapy that must be elucidated before any treatment is begun. The first step in the selection process of an herb used to treat diabetes must be to determine how the herb lowers blood sugar. There are over 400 individual trees and plants that exhibit hypoglycemic properties.[i] [ii] [iii] They differ from prescription drugs in a number of ways. The first of which is that some herbs have ability to treat not just diabetic symptoms, but can actually address the primary cause of each type of diabetes. Also, the side effects or should I say benefits of these herbs are usually supportive and therapeutic unlike those associated with oral hypoglycemic therapy.

Now, in the effort to have the most efficacious treatment you must select, match and design each herbal treatment to the individual’s condition even within both types of diabetes. There are some herbs that are more beneficial to the condition of Type I diabetes than Type II, so they have to be categorized for proper usage. Taking a number of herbs indiscriminately can be just as ineffective as using drugs in the same matter. Even though there are a large number of herbs that exhibit hypoglycemic activity, the method in which they achieve this effect is of importance. Also, some of these herbs may have only been tested in animal trials and or have some innuendo to uses in traditional remedies, so it is not certain on how they will perform exactly in human studies.

Even if they pass this hurdle and lower blood sugar well in humans, the next question is it through a pancreatic or extrapancreatic process? For example, most Type II diabetics would benefit more from an extrapancreatic process that would lower blood sugar through a different pathway than the normal insulin route. While direct pancreatic stimulation in that same situation could be ineffective or just exacerbate the condition. So, knowing how blood sugar is lowered by a particular herb is essential for proper selection. This is why it is necessary to have both detailed animal and clinical trials clarifying the herb’s action. Also, you will find that some herbs have multiple characteristics that will treat several different conditions. While diabetes might be one of these conditions, it could be only incidental to a more predominant feature of the herb and this may require higher doses to achieve the hypoglycemic effect.

This brings us to another issue when selecting herbs; what dose size is required to reduce blood glucose in humans efficiently? This can vary widely depending on numerous factors including the specific type of herb used and the patient being treated. This is one of the considerations that should be used when choosing herbs for treatment aside from overall effectiveness. Even though some herbs lower blood sugar they may require a significantly large dose to do so and usually these same herbs do not have any additional therapeutic benefits. Once an herb has been properly selected there is another tier of scrutiny that must be addressed. Beyond the correct dosage what also must be known about the herb is if it was delivered in an extracted form and what was the percentage of the extract? Also, what component of the herb was the extract standardized to if any? There is also the matter of determining from what part of the herb did the extract come? This is a very important factor that must be examined closely. There are specific compounds found only in the leaves of some herbs, which are not found in the stems or roots. By using a different part of the plant than what was used in the clinical studies can produce little or no benefit to the user. Going even further, the materials used in the extraction process can make a significant difference in the action or potency of an herb. The two primary agents used in an extraction process are water and alcohol in the form ethanol. These agents can be used either singularly or in combination with each other in any ratio. Usually, the higher the ratio of ethanol used in an extraction process the more potent the extract. So, this information on the type of agents used must be taken into account when searching for optimum treatment benefit.

Other factors that could effect the potency of an herb include harvest time, time to processing and time to actual uses. Depending on if the herb was harvested at its time of full maturity may effect its overall content and this could alter its characteristics. A long length of time from harvest to processing could have deleterious effects on herbs as well as a similar period of time from extraction to usage. These extended duration’s can cause a decrease in herb potency. Ideally, most herbs should be processed and utilized as soon as possible for maximum effect. One last consideration about the source of the herbs you select is where they are grown. It is best to use herbs that have been grown in their original point of origin. For example, if a herb is native to India then it should be harvested from that location, not just brought from there and transplanted into a different environment. The premise is that a particular herb grows where it is due to the climate and soil content. Moving it to and growing it in a different location may alter its function and characteristics. While an herb might thrive 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. 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.

Taking all this information into account brings us now to the actual herb selection process. While there are certainly plenty to choose from, there are two herbs that have proven themselves in both animal and clinical studies continually. They are Gymnema sylvestre and Pterocarpus marsupium.
Gymnema Sylvestre

Let’s begin by exploring some of the characteristics of Gymnema sylvestre. One very interesting property, but by far not the most, that Gymnema demonstrated was the ability to temporary suppress the taste sense of sweetness when chewed. Some studies suggest that Gymnema’s presence would block the absorption of sugar thus preventing it from raising blood sugar, but there are other studies contradicting this absorption theory. But the most extraordinary characteristic of Gymnema sylvestre is its ability to lower blood sugar by increasing insulin output by apparently regenerating beta cells.[iv] This has been demonstrated in a considerable number of both animal and human studies. In the animal studies a toxic agent was used to chemically destroy the insulin producing beta cells in their pancreas causing diabetes. Compared to the control groups, which didn’t receive any treatment, those receiving Gymnema leaves in any form, whole or extracted, had a very significant rate of remission.4, [v], [vi], [vii], [viii] Almost all of the other animals that didn’t receive any type of treatment did not survive. One animal study illustrated that the more potent the extract, the quicker the recovery took place.4 Now, what works well in test animals may not work similarly or at all in human subjects, but this is not the case with Gymnema sylvestre. There have been numerous human clinical trials that have all had positive results, but none more comprehensive than the two Gymnema studies published in 1990. One study investigated Type I diabetics, while the other Type II. In the first study 27 Type I diabetics with ages from 10 to 50 years and varying disease duration were given a total of 400mg a day in two divided doses of an extract of Gymnema sylvestre for up to 30 months.[ix] All were using daily insulin injections and were free from any complications. Almost all participants within the first monitoring period between 6 to 8 months had both declining blood glucose values and a very significant reduction in hemoglobin A1c. This was also accompanied by a decrease in dosage and uses of insulin. In fact, one patient with a disease duration of 10 years and another one with a duration two who were both using a total of twenty units of insulin a day each were able to discontinue insulin uses completely at this point in the study. This trend of these types of improvements continued through out the trial till its completion. Also, there were no reports of any type of adverse side effects or reactions.

The conclusions were that the uses of the Gymnema extract dramatically reduced fasting blood glucose, hemoglobin A1c and insulin requirements. The average fasting glucose dropped from 232mg/dl to 152mg/dl. Hemoglobin A1c mean of 12.8% at the beginning of the study fell to 8.2% at the end. Total insulin usage was cut in half as compared to the original doses. There were also significant decreases in glycosylated plasma proteins, total cholesterol and triglycerides. These results are in considerable contrast to those compared to the matched diabetic group receiving insulin alone for a year. Their insulin requirements either remained the same or increased and their average insulin usage was almost double to that of the Gymnema group. Their fasting blood glucose dropped only from 233mg/dl to 224mg/dl which is statistically insignificant. Also, hemoglobin A1c was only reduced from 12.7% to 11.8% at the end of the monitoring period. Now, on to the most remarkable part of this study. While there are herbs that will lower blood sugar effectively, Gymnema sylvestre demonstrates in this trial strong evidence that it accomplishes this through increased insulin production through beta cell repair or regeneration. It has always been assumed that after beta cells have been destroyed due to an autoimmune attack, characteristic of Type I diabetes, that only transplantation could restore insulin secretion. But through the monitoring of C-peptides, which are released in an equal ratio with insulin, the actual cause of blood sugar reduction can be concluded. The C-peptide levels in the Gymnema supplemented group were nearly twice as high as that compared to those on insulin treatment alone. There is no other explanation for the broad spectrum improvements in glucose control and the increased C-peptide production other than more insulin production from the beta cells. Nevertheless, all 27 Type I diabetic patients, which all suffer from insulin deficiency due to beta cell destruction, benefited from Gymnema treatment. This is another incredible aspect of this study. That disease duration didn’t have any bearing whatsoever on glucose improvement. Patients with diabetes for 25 years responded equally as well as those who have been diagnosed for only one year. So, there appears to be no time limitation on Gymnema uses to still receive benefits.

In the second trial the same extract of Gymnema sylvestre is given to 22 Type II diabetics.[x] These participates received a total of 400mg a day in a divided dose for 18 to 20 months. They also continued their normal uses of sulfonylurea oral hypoglycemics. Ages ranged from 40 to 62 years and disease duration from 1 to 12 years. The results were a significant decrease in both fasting blood glucose and hemoglobin A1c, but not as dramatic as with the study using Type I diabetics. Average fasting glucose dropped from 174mg/dl to 124mg/dl and mean hemoglobin A1c fell from 11.91% to 8.48%. Oral hypoglycemic amounts were decreased in 21 of the 22 patients and 5 were able to discontinue uses completely. Also there was notable declines in several of the other blood testing parameters. This again is in sharp contrast to matched diabetics on drugs alone. Both fasting glucose and hemoglobin A1c had elevated slightly in a one year period. Drug doses either stayed the same or rose in that time. All other tested values had deteriorated. Also, the Gymnema supplemented group showed increased serum insulin levels as compared to those on drugs alone.

Dr. Brian P. Jakes, Jr., N.D., C.N.C. is a Board Certified Doctor of Naturopathy as well as a Certified Nutritional Consultant. In his practice, in Mandeville, LA, Dr. Jakes works with physicians to treat a large number of diabetes patients.

[i] Atta-Ur-Rahman, Khurshid Zaman. Medicinal plants with hypoglycemic activity. Journal of Ethnopharmacology, 26 (1989) 1-55

[ii] Yaniv, Z., Danfi, A., Friedman, J., Palevitch, D.. Plants used for the treatment of diabetes in Israel. Journal of Ethnopharmaocology. 1987 Mar-Apr; 19(2): 145-151

[iii] Karunanayake, EH., Welihinda, J., Sirimanne, SH., Sinnadorai, G.. Oral hypoglycemic activity of some medicinal plants of Sri Lanka. Journal of Ethnopharmacology. Jul:11(2): 223-31

[iv][iv] ERB Shanmugasundaram, K. Leela Gopinath, K. Radha Shanmugasundaram and VM Rajendran. Possible regeneration of the islets of langerhans in streptozotocin-diabetic rats given Gymnema Sylvestre leaf extracts. Journal of Ethnopharmacology, 30 (1990) 265-279.

[v] Shanmugasundaram KR, Panneerselvam C. Samudram P, Shanmugasundaram ER. Enzyme changes and glucose utilization in diabetic rabbits: the effect of Gymnema sylvestre, R.Br. J Ethnopharmacol 1983 Mar;7 (2): 205-34.

[vi] Okabayashi Y, Tani S. Fujisawa T, Koide M, Hasegawa H, Nakamura T, Fujii M, Otsuki M. Effect of Gymnema sylvestre, R.Br. on glucose homeostasis in rats. Diabetes Res Clin Pract 1990 May-Jun;9(2):143-8.

[vii] Venkatakrishna-Bhatt H, Srivastava Y, Jhala CI, et al. Effect of Gymnema sylvestre , R.Br. leaves on blood sugar and longevity of alloxan diabetic rats. Indian J Pharmacol 1981;13:99.

[viii] Shanmugasundaram, ERB, Venkatasubramanyam M, Vijendran M, and Shanmugasundara K.R. (1988) Effect of an isolate of Gymnema sylvestre R.Br. in the control of diabetes mellitus and the associated pathological changes. Ancient Science of Life 8, 183-194.

[ix] ERB Shanmugasundaram, G Rajeswari, K Baskaran, BR Rajesh Kumar, K Radha Shanmugasundaram and B. Kizar Ahmath. Use of Gymnema Sylvestre leaf extract in the control of blood glucose in insulin dependent diabetes mellitus. Journal of Ethnopharmacology, 30 (1990) 281-294.

[x] K. Baskaran, B. Kizar Ahamath, K. Radha Shanmugasundaram, and ERB Shanmugasundarm. Antidiabetic effect of a leaf extract from Gymnema sylvestre in non insulin-dependent diabetes mellitus patients. Journal of Ethnopharmacology 30 (1990) 295-305.

[1] Atta-Ur-Rahman, Khurshid Zaman. Medicinal plants with hypoglycemic activity. Journal of Ethnopharmacology, 26 (1989) 1-55

[1] Yaniv, Z., Danfi, A., Friedman, J., Palevitch, D.. Plants used for the treatment of diabetes in Israel. Journal of Ethnopharmaocology. 1987 Mar-Apr; 19(2): 145-151

[1] Karunanayake, EH., Welihinda, J., Sirimanne, SH., Sinnadorai, G.. Oral hypoglycemic activity of some medicinal plants of Sri Lanka. Journal of Ethnopharmacology. Jul:11(2): 223-31

[1][1] ERB Shanmugasundaram, K. Leela Gopinath, K. Radha Shanmugasundaram and VM Rajendran. Possible regeneration of the islets of langerhans in streptozotocin-diabetic rats given Gymnema Sylvestre leaf extracts. Journal of Ethnopharmacology, 30 (1990) 265-279.

[1] Shanmugasundaram KR, Panneerselvam C. Samudram P, Shanmugasundaram ER. Enzyme changes and glucose utilization in diabetic rabbits: the effect of Gymnema sylvestre, R.Br. J Ethnopharmacol 1983 Mar;7 (2): 205-34.

[1] Okabayashi Y, Tani S. Fujisawa T, Koide M, Hasegawa H, Nakamura T, Fujii M, Otsuki M. Effect of Gymnema sylvestre, R.Br. on glucose homeostasis in rats. Diabetes Res Clin Pract 1990 May-Jun;9(2):143-8.

[1] Venkatakrishna-Bhatt H, Srivastava Y, Jhala CI, et al. Effect of Gymnema sylvestre , R.Br. leaves on blood sugar and longevity of alloxan diabetic rats. Indian J Pharmacol 1981;13:99.

[1] Shanmugasundaram, ERB, Venkatasubramanyam M, Vijendran M, and Shanmugasundara K.R. (1988) Effect of an isolate of Gymnema sylvestre R.Br. in the control of diabetes mellitus and the associated pathological changes. Ancient Science of Life 8, 183-194.

[1] ERB Shanmugasundaram, G Rajeswari, K Baskaran, BR Rajesh Kumar, K Radha Shanmugasundaram and B. Kizar Ahmath. Use of Gymnema Sylvestre leaf extract in the control of blood glucose in insulin dependent diabetes mellitus. Journal of Ethnopharmacology, 30 (1990) 281-294.

[1] K. Baskaran, B. Kizar Ahamath, K. Radha Shanmugasundaram, and ERB Shanmugasundarm. Antidiabetic effect of a leaf extract from Gymnema sylvestre in non insulin-dependent diabetes mellitus patients. Journal of Ethnopharmacology 30 (1990) 295-305.