ProBetix

Description

PROBETIX® - The natural African traditional herbal aid for managing diabetes

ProBetix® is a natural, herbal supplement made from the extract of a traditional African herb, the indigenous Sutherlandia plant, which can assist diabetics in managing blood sugar levels.
 ProBetix® contains pinosundia, a unique extract from the Sutherlandia frutescens plant (subspecies microphylla), which in animal studies has been shown to reduce blood sugar levels, decrease intestinal glucose uptake and reverse insulin resistance.
 The extract is manufactured in the Western Cape with a unique patented extraction process for the exclusive use in ProBetix®.
 Sutherlandia, also known as “cancer bush”, is a hardy herbal plant that has for over a century been used by local peoples of southern Africa as a medicinal plant for treating a variety of ailments, including diabetes. 
 ProBetix® also contains alpha-lipoic acid, a powerful antioxidant that is widely used in the prevention of various diseases. Doctors in Germany have for well over 30 years been treating diabetics with alpha-lipoic acid to prevent cell damage caused by high free-radical levels.
 When diabetes develops, free radicals levels increase significantly and when complications develop the rate increases dramatically. These free radicals begin to damage cells and tissues, resulting in the numerous complications associated with the disease. Alpha-lipoic acid also increases the production of glutathione, which helps to
dissolve toxic substances in the liver.

Research breakthrough
Research conducted at the Nelson Mandela Metropolitan University (NMMU) in Port Elizabeth over a period of six years, showed Sutherlandia frutescens extract to reduce blood sugar levels of diabetic rats within days of been given the extract.
 The aim of the study was to verify the claims made for diabetes treatment and to investigate the safety aspect of the plant’s usage. Rats were used since the changes associated with the development of diabetes in these animals are very similar to those occurring in humans.  
 The results of the findings were published in the Journal of Ethnopharmacology (109 (2007) 121–127). The research has been peer reviewed and found scientifically sound. Scientists in other parts of the world have also independently verified it. The University of the Western Cape in 1997 undertook clinical toxicity studies on the plant and declared it safe for human use.
 The researchers at the NMMU also investigated the interaction with a generally used type-2 diabetes medication to establish whether there might be a negative drug interaction. They found that Sutherlandia decreased intestinal glucose uptake more significantly than the medication. No drug interactions or unwanted side effects were evident when both were administered simultaneously. 
They further studied the effects of Sutherlandia frutescens on blood sugar when insulin was administered simultaneously, and found that the blood sugar remained at stable, normal levels and neither compound was affected by the other.
 The study also showed Sutherlandia to restore a pre-diabetic state (the various stages before full-blown diabetes develops) over time to a state of normal levels of blood glucose and insulin. It further established that Sutherlandia could reverse insulin resistance by increasing glucose uptake by muscle and fat tissue.
 The researchers stressed that the extraction process was key to obtaining the specific combination of compounds from the Sutherlandia plant. It is known that the content and efficiency of herbal medicine made from the same plant varies. Since the studies at NMMU were done with a specific Sutherlandia extract, it cannot be taken for granted that all products made from Sutherlandia will have the same effects.
 The same extract used for the research is used in ProBetix®.
 
The compounds
Scientifically identified compounds contributing to the efficacy of Sutherlandia frutescens are L-canavanine, a non-protein amino acid; pinitol, a type of sugar that occurs naturally in certain plants; GABA, an amino acid and important neuro-transmitter (brain messenger); and asparagine, a non-essential amino acid.
 It is thought that the anti-diabetic action of Sutherlandia is caused by the combination of the various phytochemicals present in the plant.
 To further enhance the efficacy of ProBetix®, alpha-lipoic acid, an extremely versatile antioxidant, is added. It has been widely used in the treatment of diabetics and has also been well researched.
 Alpha-lipoic acid has also been found to be effective in restoring diabetic nerve function. Nerve damage, or neuropathy, affects over 50% of diabetics and is one of its most damaging complications. 
 A study conducted at the Heinrich Heine University in Dusseldorf, Germany, found that treatment with lipoic acid actually stimulated the regeneration of nerve fibres in diabetics in less that three weeks of treatment. The patients also experienced a significant reduction in pain and numbness associated with neuropathy. In Germany, alpha-lipoic acid has been approved for the treatment of polyneuropathy (when many peripheral nerves throughout the body malfunction simultaneously).
 A collaborative study between the Mayo Clinic and a medical centre in Russia found that alpha-lipoic acid significantly and rapidly reduced the frequency and severity of symptoms of the most common kind of diabetic neuropathy (burning, prickling sensations and numbness). The findings appeared in the March 2003 issue of Diabetes Care.

Specification 

PROBETIX capsules
Grading status:
C0  Prediagnosed Adjuvant
Proprietary Name (and dosage form):
PROBETIX capsules
Composition : Each capsule contains:
Sutherlandia frutescens extract   90mg
Alpha-Lipoic acid                         75mg
Inactive:
Microcrystalline cellulose
Magnesium stearate
Pharmacological Classification:
Complementary Medicine: African traditional
Pharmacological Action:
ProBetix contains Sutherlandia frutescens extract from the aerial parts of plant and Alpha-Lipoic acid.

Sutherlandia frutescens extract consists of L-canavanine, pinnitol, GABA and asparagine as it’s main active constituents. It has been shown to normalise insulin levels and glucose uptake in peripheral tissues, suppress intestinal glucose uptake and increase the diabetic index to normal levels. Not much is known about the pharmacokinetics of this plant.

Alpha-lipoic acid (LA), also known as Thiotic acid, is a naturally occurring compound that is synthesized in small amounts by plants and animals. It is a potent biological anti-oxidant, and a cofactor in vital energy-producing reactions in the body. Due to these activities is it used for the treatment of diabetic neuropathies and for the prevention of glaucoma.
Absorption after oral ingestion is from the small intestine and distribution to the liver via the portal circulation and to various tissues in the body via the systemic circulation. It is metabolised to its reduced form, dihydrolipoic acid (DHLA), by mitochondrial lipoamide dehydrogenase. It readily crosses the blood-brain barrier.
30-40% of an oral dose of racemic LA is absorbed. Peak plasma concentrations of the natural R-LA form is found to be 40-50% higher than S-LA form, suggesting R-LA is better absorbed than S-LA and is the more active form. Peak plasma concentration of LA is reached after one hour or less and declines rapidly.

Indications:
ProBetix is indicated to assist in the normalisation of blood glucose levels and to prevent and treat diabetic peripheral neuropathies and glaucoma in people suffering from diabetes.
Mode of Action:
The precise mechanism by which Sutherlandia Frutescens exerts its action is not quite clear yet but it is thought to be due to a synergic working of the phytochemicals therein. There is now strong evidence that the interaction of these bio-active compounds is responsible for its remarkable properties. In a recent animal study using a unique extract the blood sugar of diabetic rats was shown to stabilize to normal levels within a few days of being given the extract. There was also a significant increase in glucose uptake into muscle and adipose tissue, and a significant decrease in intestinal glucose uptake with no weight gain noted. It was found that Sutherlandia when taken with other antidiabetic medications presented no drug interactions and unwanted side effects were evident when given together.

It has been shown that supplementing with LA can partly restore diabetic nerve function after only four months of high-dose oral treatment. It is thought that this is due to its role in the oxidation of pyruvate and alpha-ketoglutarate in the mitochondria. Ultimately enhancing energy production and possibly its antioxidant activity may account for its possible benefit in diabetic polyneuropathy.
The Mayo Clinic recently conducted a study with a Russian medical center to test LA’s ability to help specifically with diabetic neuropathy. They reported that LA seemed to actually change the metabolism of the nerve or blood supply to the nerve with noted relief in symptoms.
Another study conducted at the Heinrich Heine University in Dusselfdorf found that treatment with LA actually stimulated the regeneration of nerve fibers in diabetics in less than three weeks of treatments and patients experienced a significant reduction in pain and numbness associated with neuropathy.

Contra – Indications:
Hypersensitivity to any of the ingredients in ProBetix, including excipient.

Do not use ProBetix during pregnancy or when breastfeeding.

Warnings:
Keep out of reach of children and uninformed persons as in the case of all medicines and supplements.

It is not recommended that any diabetic persons attempts to self-medicate for this condition. Type-1 diabetics who are well controlled are advised to maintain their existing insulin regimen. Type-2 diabetics who are interested in supplementing their management with ProBetix should discuss this with their health care professional.

Interactions:
Supplementation with ProBetix lowers blood glucose levels and patients on antihypertensive or diabetic medication may need the dose of these medications to be reduced while taking ProBetix to avoid possible hypoglycemia, and should be monitored by a physician.
Pregnancy and Lactation:
Use of ProBetix is not recommended during pregnancy and lactation.

Dosage and Directions for use :
Before taking this supplement, please ensure that the condition has been diagnosed by a practitioner.

Take two capsules in the morning after breakfast.

Not recommended for children less than 12 years old.

Do not discontinue any prescribed medication without first discussing it with your healthcare practitioner

Side-effects and Special Precautions:
Known side-effects include occasional reports of: dry mouth, mild diuretic effect, abdominal pain, nausea and vomiting, loose stool or constipation. Slight dizziness has occasionally been noted in very weak patients who take ProBetix without eating a meal first.
Known Symptoms of overdosage and particulars of its treatment:
At larger than recommended doses concomitant use with anti-coagulants or antiplatelet drugs may increase the risk of bleeding.
Treatment is symptomatic and supportive.

Identification:
A size 2 hard gelatine capsule with a Lime green cap and a yellow body containing a grey-white powder with a characteristic taste. No imprinting on the capsule.
Presentation:
White container with a green screw-on cap containing 60 capsules.

Storage Instructions:
Store in a cool dry place below room temperature (25°C).
Keep out of reach of children.
Name and Address of  applicant:
Ferlot Manufacturing & Packaging (Pty) Ltd.
PO Box 1662, Jeffreys Bay, 6330
Tel: 042 293 1278   Fax: 042 293 3351

Date of Publication of this Package Insert:
January 2008
FMPPPM55/01