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Index

Comparison with Glucosamine & Painkillers.……………..2

Introduction ……………………………………………………………………… 3

Discovery of the Green Lipped Mussel ………………………… 3

Mode of Action ……………………………………………….………………… 3

Nutritional Table ………………………..…………………….…………….. 4

Frequently Asked Questions ………………………….……………… 5

About the Manufacturer ……….………………..……………………. 6

Clinical Trials ………………………….…….………………..………………. 7

Manufactured by:

For further information & inquiries please contact:

Email: seatone@permahealthcare.com � Web: www.permahealthcare.com

Delhi & NCR: G-14, Sector 18

Near Radisson Hotel Noida 201301 (U.P.) Ph: (120) 4242 444

Fax: (120) 4243 760

Mumbai: 100/101 Vatsalya Building

Vatsalya Co-op Society R.T.O. Road, Near R.T.O. Office 4 Bunglows, Andheri (West,

Mumbai 400 053 Ph: (22) 6518 5151 / 6161 / 7171

Bangalore: 4B Aisshwarya Lotus

Michael Palya 2nd Cross Indiranagar 1st Stage Bangalore 560 038

Ph: (80) 4173 2020

Western U.P. & Uttaranchal: 104-105 Arvind Puri

Meerut Cantt 250001 (U.P.) Ph: (121) 6546 534 / 35 /36

New Zealand’s Green Lipped Mussel Extract (GLME)

OF NEW ZEALAND LIMITED – ESTABLISHED 1904

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COMPARISON TABLE FOR TREATMENT OPTIONS FOR OSTEO & RHEUMATOID ARTHRITIS SEATONETM GLUCOSAMINE PAINKILLERS*

EFFICACY

Reduces pain � � � Reduces inflammation � Mild � Provides joint lubrication � � � Repairs damaged cartilage � � � Prevents cartilage deterioration � � � Gastro-protective � � � Effective for rheumatoid arthritis � � � Effective for osteo arthritis � � �

SIDE EFFECTS No adverse events with high dose � � � No adverse events with long-term use � � � Does not cause ulceration � � � Does not cause renal dysfunction � � � No adverse influence on platelets � � � Does not aggravate hypertension � � �

OTHER BENEFITS Contains omega fatty acid content � � � Contains therapeutic polysacharrides A range of

natural blends Only one �

Patient Profile: Any person suffering from Joint Problems

Seatone works best in patients with rheumatoid arthritis and grade I & II osteo arthritis

Expectations: Most people experience benefit 4-6 weeks after starting Seatone

First effect could be experienced within 1 week but may take as long as 3 months Treatment for joints is gradual, progressive & normally long-term

Thus, it is important to stay on the program until relief of symptoms occurs

Recommended Dosage: 1000mg (2 capsules) daily for 8-12 weeks, 500mg (1 capsule) daily for maintenance thereafter

For best result, take Seatone along with meals

* NSAIDs

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INTRODUCTION

Seatone contains purified extract of the unique New Zealand’s Green-Lipped Mussel (GLM) that has now been subjected to over 30 years of quality scientific research. It has been shown in laboratory and clinical trials, to be effective in treating both the rheumatoid and osteo forms of arthritis. How it does so is an interesting story and is an indication of the powers of nature, in particular that occurring in the seas, to provide remedies for some of the most debilitating diseases of our time.

DISCOVERY OF THE GREEN LIPPED MUSSEL The discovery was made when this mussel was involved in a research program looking at marine molluscs (shellfish) to see if any of them contained a possible treatment for cancer. The Green-Lipped Mussel (GLM) was included in this program because it is unique and is only found in New Zealand waters. Nothing was found in the mussel which would help with cancer but the trials indicated that the GLM demonstrated significant anti-inflammatory activity and anti-inflammatory drugs are used to treat arthritis. Thus it was thought that an extract of the Green-Lipped Mussel (GLME) might provide a valuable, natural anti-arthritic treatment for this very serious disease. We now have over 30 years of dedicated research, which together with the experience of arthritis sufferers worldwide, has proved GLME to be a highly successful treatment with the added bonus of not exhibiting the classical adverse side effects associated with anti-inflammatory drugs.

MODE OF ACTION

Seatone naturally contains several active ingredients and the therapeutic effect results from the complementary effects of a number of compounds working together.

Glycogen complex :

Principal anti-inflammatory

PUFA’s : Secondary anti-inflammatory

Glycosaminoglycans : Joint lubrication, shock absorption and cartilage maintenance

Lipids : Gastro-protective Minerals & Vitamins : Nutritional benefit

Principal anti-inflammatory Seatone performs two distinct anti-inflammatory activities. The principal anti-inflammatory activity is due to a glycogen complex that has the ability to inhibit the emigration of neutrophils from the blood vessels. What this means is that soldier cells (neutrophils) are inhibited from attacking our own cells when an inflammatory stimulus is present. Preventing inflammation with its associated pain and reduced mobility symptoms is a primary requirement for an arthritis treatment. Joint lubrication & shock absorption

Seatone also has a natural content of glycosaminoglycans. This is the name for a group of polysaccharides which includes chondroitin sulphate, dermatan sulphate, hyaluronic acid etc. These glycosaminoglycans are used by the body for the biosynthesis of compounds called proteoglycans. The proteoglycans have a very strong affinity for water molecules in the joints, to which they bind, and form very large, slippery, space filling molecules. The function of these large combination molecules is to act as shock absorbers and also lubricants in the joints.

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Prevents cartilage deterioration Seatone also helps in prevention of joint degradation. In young people and those not affected by arthritis, the rate of cartilage degeneration in the joints is equaled by that of regeneration. In older people and in arthritic disease states this balance is upset leading to a reduction in the padding and lubrication of the joints. Certain cytokine induced enzyme activity is known to accelerate the breakdown of cartilage process and the inhibition of this enzymic activity is thus very desirable. Seatone has been shown in laboratory studies to inhibit the cytokine activity that would lead to the production of cells responsible for this process. Protects stomach lining

Another valuable feature of the product is that it has been found to have natural gastro-protective properties. This means that, not only does it not damage the delicate stomach lining; it actually provides a protective function for it. Thus, the product is able to relieve the inflammatory symptoms associated with arthritic diseases whilst protecting the stomach from the damaging effect of some painkillers should a person need to be taking these at the same time.

Summary To summarize, we have in Seatone a marine natural product that contains the components that the body requires to effectively relieve the symptoms of arthritic diseases without inducing the classical adverse side effects associated with many drug therapies – An excellent example of the therapeutic potential of the seas!

NUTRITIONAL TABLE Table 1 : Seatone GLME – Average Composition Composition Unit Minerals Sodium 5 g / 100g Potassium 1 g / 100g Magnesium 350 Mg / 100g Calcium 500 Mg / 100g Iron 30 Mg / 100g Zinc 5 Mg / 100g Manganese 1 Mg / 100g Copper 1 Mg / 100g Nickel 0.4 Mg / 100g Cadmium 0.4 Mg / 100g Lead 0.4 Mg / 100g Mercury 0.01 Mg / 100g Vitamins B1 0 – 0.2 mg / 100g B2 0 – 0.2 mg / 100g B3 0 – 0.4 mg / 100g B6 0 – 0.2 mg / 100g B12 0 – 0.2 mg / 100g C 0 – 0.2 mg / 100g D3 0 – 0.3 mg / 100g E 0 – 0.2 mg / 100g Amino Acids Cysteic Acid 2.3 g / 100g Aspartic Acid 3.2 g / 100g Threonine 1.4 g / 100g Serine 1.5 g / 100g Glutamic Acid 4.0 g / 100g Proline 1.2 g / 100g Glycine 4.0 g / 100g Alanine 1.7 g / 100g Cysteine 0.2 g / 100g Valine 1.5 g / 100g Methionine 0.8 g / 100g Iso-leucine 1.4 g / 100g Leucine 2.1 g / 100g Tyrosine 1.2 g / 100g Phenylalanine 1.3 g / 100g Lysine 2.7 g / 100g Histidine 0.7 g / 100g Arginine 2.5 g / 100g Other Components Protein (N x 6.25) 40 - 50 g / 100g Lipids 10 - 20 g / 100g Cholesterol 0.1 - 0.2 g / 100g Carbohydrate (by diff) 10 - 30 g / 100g Mineral Ash 10 - 20 g / 100g Moisture < 5 g / 100g Calorie Value approx. 400 calories / 100g

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FREQUENTLY ASKED QUESTIONS Does Green Lipped Mussel Extract (GLME)

work for everyone?

No, clinical studies indicate a success rate of about 75 per cent for arthritis sufferers. The big advantage of GLME is that it doesn’t cause the classical adverse side effects of drug therapy. How soon can one expect results?

Most people see results within four to six weeks after starting the capsules, but this differs for everyone. Some people keep taking normal anti-inflammatories along with GLME in the early weeks and taper this off as GLME starts showing effect. What is the recommended daily usage

level for GLME?

The normal level is about 1 gram of GLME powder each day for the average adult. This equates to two Seatone 500mg capsules each day but there is no danger in doubling this level if desired. Long-term, continual use of GLME has been mentioned. Is it necessary to take

the product forever?

Not necessarily. Some people find that, once they are experiencing a satisfactory level of relief, they can stop taking the product altogether until another flare up occurs. However, the majority of people prefer to gradually reduce the daily usage by trial and error until they establish their minimum daily maintenance requirement - usually one Seatone 500mg capsule. Does GLME claim to have no side effects?

Certainly not! In fact we do not believe that there is anything which has pharmacological activity, which may not have some side effects.

The question is then, the nature and level of side effects which might be experienced. The side effects which might be experienced by people using GLME are based on the clinical trial reports plus those reported by customers during the 30 years of worldwide usage. There are no serious adverse side effects associated with use of GLME. However, because the product is a shellfish derivative, it may create an allergy reaction in people susceptible to shellfish allergy. If a person wishes to try the product but suspects that he may be allergic to shellfish, he can just take one capsule per day for a few days and if no allergy reaction occurs, he can then increase gradually to two capsules. If a person does experience an allergy reaction he should stop using the product and the symptoms will disappear. A reduction of the allergy symptoms can be accelerated by use of a suitable anti-histamine prescribed by a medical practitioner. In a few cases, there has been a temporary exacerbation of arthritic symptoms after commencing to use the capsules. This condition has only lasted for a few days and has almost always preceded excellent results. Some people have experienced mild indigestion and flatulence but the likelihood of these can be minimized by making sure that the product is consumed at the start of a meal. On the positive side, there is one beneficial side effect, which has been reported frequently. This is a significant enhancement of vitality, often described as ‘a feeling of well being’. This could, simply be due to the effect of relief from pain coupled with increased movement. Has the safety of long-term use of GLME

been tested?

Yes, even though GLME is derived from a widely consumed food, the product has been subjected to the standard, international tests for toxicity and also teratogenicity to ensure that it is perfectly safe to consume at many times the recommended usage level without causing toxic effects or adversely influencing a developing foetus in a pregnant person.

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Is GLME safe if taken along with other

medications?

There have been no reports of any contra-indications when GLME has been taken together with other anti-inflammatory products whether these have been drugs or natural preparations. It is unlikely that GLME would contra-indicate with other pharmaceuticals due to its basic food status. However, it would be preferable for it not to be used if a person was using monoamine oxidase inhibitory drugs (anti-depressants which are now not generally used). When should GLME not be taken?

It is important to note that GLME should not be used to treat gouty arthritis. The reason for this is that gout is caused by an excess of uric acid, which precipitates in the joints. In common with cheese and wine, shellfish contain a significant level of purine nitrogen which would act as a precursor for the biosynthesis of uric acid! Also, anyone with an allergy to seafood should avoid GLME. People on a completely salt-free diet may also want to avoid using GLME because it contains very small amounts of natural sea salts.

ABOUT THE MANUFACTURER

OF NEW ZEALAND LIMITED

100 years of history - established in 1904, Healtheries is an innovative and consumer-driven business, providing products around the world for people who want to enhance their good health and well-being.

Key facts

• New Zealand's leading manufacturer of dietary supplements, nutritional foods, health beverages and marine products.

• Most trusted natural healthcare brand in New Zealand (Readers Digest Survey - 2000, 2001,2002 & 2003).

• 4th most recognised of all NZ brands.

• Product portfolio of 750 products with annual sales exceeding $50 million.

• The business provides jobs for 230 staff in four offices and two state-of-art factories in NZ, Australia & UK.

• Healtheries has in place stringent quality control procedures.

• Only New Zealand manufacturer with MAF (Ministry of Agriculture & Fisheries), TGA Pharmaceutical and GMP (Good Manufacturing Practice) certification.

• Green Lipped Mussel Extract (GLME)

accounts for a third of Healtheries exports to more than 30 countries.

History

• Healtheries was established in 1904 as a

specialty flour-mill. • The business became very much a part of

the New Zealand way of life during the next 60 years providing staple products to a growing nation.

• In 1970 the company began exporting and

now exports to more than 30 countries worldwide.

• Healtheries was purchased by the Lanes

Capital group in 1990. Lanes also owns Hansels, Krispa, Natural Products and Aztec.

• In 2000, Healtheries bought Mcfarlane

Laboratories - renowned globally for its Green Lipped Mussel Extract and other unique marine products.

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CLINICAL TRIALS New Zealand’s Green Lipped Mussel Extract (GLME) has been studied in a number of clinical trials in patients with arthritis. The results of these studies have been very promising and demonstrated that GLME can significantly reduce the symptoms of arthritis. A USA Pilot Study done on Gonarthrosis (2000) Kendall R, Lawson J and Hurley LA. New research and a clinical report on the use of GLME in the management of arthritis. Townsend Letter for Doctors and Patients, 2000; 204:98-111 This paper includes the results of a laboratory research into the mechanisms of action of the green-lipped mussel extract and also those from a 4-year clinical study involving 120 patients suffering from osteo arthritis. The results, which originate from a university and also a clinical practice in the USA are once again excellent and fully support all the earlier positive data for the product. The research referenced above provides extensive evidence for the beneficial use of the Green-Lipped Mussel Extract (GLME) in the treatment of arthritic disorders in both human and animal subjects. The mechanisms of action involve anti-inflammatory, chondro-protective and gastro-protective functions and point to the product providing more than simply symptomatic relief. The paper also contains some valuable data confirming the potential for reducing cartilage degradation by inhibition of catabolic cytokine activity and the value of the naturally present glycosaminoglycans in the extract for joint health.

French Study involving Osteo Arthritis of the Knee (1986) Audeval, B., Bouchacourt, P., Double blind, placebo-controlled study of the mussel (New Zealand Green-Lipped Mussel) in Gonarthrosis (arthritis of the knee). La Gazette Medicale, 93 (38), 1986 : 111-115 This double blind, placebo-controlled clinical study was conducted to the full European protocol as detailed in The European Directive on Clinical Trials of New Drugs Against Rheumatism in 53 patients with arthritis of the knee showing that GLME was a very effective treatment for arthritis, when judged using both - objective (mobility measures) and subjective (patient perception of symptoms) means of assessment. The two most debilitating features of arthritis – pain and loss of function – both responded well to the treatment.

Glasgow Homeopathic Hospital Study (1980) Gibson, RG. Gibson. S.L.M, Conway, V., et al. GLME on the treatment of Arthritis. The Practitioner, 224, 1980 : 955-960 This was the first long-term double blind clinical study examining the effect of GLME on 66 patients with arthritis. The results showed that GLME was effective in treating patients with both osteo arthritis (OA) and rheumatoid arthritis (RA). The proportion of patients benefiting from treatment with GLME was higher in the RA than the OA group. The trial results indicated that 67.9% of the rheumatoid patients and 39.5% of the osteo patients benefited from the treatment. An interesting point relating to these figures is that they agreed with those compiled from unsolicited anecdotal reports originating from people in countries all around the world.