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Research and Articles

Topic Study Result / Article Topic
Joint Patch Effectiveness "...The study also revealed that the level of glucosamine passing through the skin increased gradually over a period of 24 hours – there was no tailing off as might be expected and as is often seen with oral administration. This observation suggests that the activity of glucosamine is likely to be consistent over the 24 hour period of wear, so giving continued effect...."

REF: Dr. Annette Hudson and Cardiff University, "Joint Patch Skin Permeation and Effectiveness Study." May 2005

Review Abstract

General Patch Effectiveness "4 Myths About Transdermal Drug Delivery." Facts about patches.

REF: Ryan D. Gordon, PhD, and Tim A. Peterson, MS. 4 Myths About Transdermal Drug Delivery. Drug Delivery Technology, Vol. 3 No. 4 · June 2003

Full Article Text

Pill Effectiveness "...This maximum concentration of 11.5 micromol/l has previously been shown to contribute less than 2% of the galactosamine incorporated into chondroitin sulphate in incubations of glucosamine with cultured human chondrocytes, and is a much lower concentration than the glucosamine concentrations claimed by other investigators to have various significant in vitro effects. This raises questions about current biological rationales for glucosamine use that were based on in vitro effects of glucosamine at much higher concentrations.

REF: Beth Anne Biggee, Christina M Blinn, Timothy E McAlindon, Melynn Nuite  and Jeremiah E Silbert. Low levels of human serum glucosamine after ingestion of glucosamine sulphate relative to capability for peripheral effectiveness. Ann Rheum Dis. 2006; February 2006, 65:222-226.

Review Abstract

Topical Use "...Topical application of glucosamine and chondroitin sulfate is effective in relieving the pain from OA of the knee and improvement is evident within 4 weeks."

REF: Cohen M, Wolfe R, Mai T, Lewis D. A randomized, double blind, placebo controlled trial of a topical cream containing glucosamine sulfate, chondroitin sulfate, and camphor for osteoarthritis of the knee. J Rheumatol. 2003 Mar;30(3):523-8.

Review Abstract

Glucosamine "...Long-term treatment with glucosamine sulfate retarded the progression of knee osteoarthritis..."

REF: Pavelká K, Gatterová J, Olejarová M, Machacek S, Giacovelli G, Rovati LC. Glucosamine sulfate use and delay of progression of knee osteoarthritis: a 3-year, randomized, placebo-controlled, double-blind study. Arch Intern Med. 2002 Oct 14;162(18):2113-23.

Review Abstract

Chondroitin "...This study provides evidences that oral CS decreased pain and improved knee function... "

REF: Uebelhart, D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76.

Review Abstract

CMO "...The results of this study lead to several conclusions regarding its five principal objectives:

1) Optimum dosage levels appears to be equal for all three types of arthritis investigated: osteoarthritis, rheumatoid arthritis and reactive psoriatic arthritis. This is evidenced by the gradual return of minor arthritis symptoms in several of those treated with only 16 to 24 capsules, and no regression in those treated with 50 capsules in two series separated by one week without treatment.

2) Dosage level requirements appear to be equal irrespective of the severity of the subjects condition.

3) Initial response time for minor improvement appears to vary from two to seven days, irrespective of the severity of the subject's condition.

4) The time for maximum attainable response appears to vary from seven to twenty one days, resulting in 70% to 100% overall improvement. (Apart from this study, three of the most severely afflicted subjects were treated again after a five week interval, resulting in an additional 10% to 20% overall improvement.)

5) The two non-responding subjects both proved to have suffered previous damage to the liver from steroid or alcohol abuse, indicating that impaired liver function may preclude success with this protocol.

In addition, it was evident that for many subjects, the relief of inflammation resulted in marked improvement in joint deformation..."

REF: San Diego Clinic Immunological Center. Clinical Study On Cetylmyristoleate (CMO) vs Arthritis.

Review Abstract


Glucosamine Joint Patch Skin Permeation and Effectiveness Study.

Abstract: Astudy recently conducted at Cardiff University confirmed the ability of glucosamine (delivered via a patch) to enter the small blood vessels which lie beneath the skin surface. This finding indicates that this is a viable method of administration. Moreover, it allows a patch to be placed discreetly at some distance from the joint of concern. For example the patch might be placed on the arm despite the fact that the knee may be the actual problem area. This has obvious practical advantages: by their very nature joints are a point of movement, as such it is relatively difficult to apply and maintain a self-adhesive object (a sticking plaster or patch) and secondly it may not be suitable for the user to be seen to be wearing such an item. The ability therefore to be able to locate the patch away from the site of the problem is a strong practical benefit.

The study also revealed that the level of glucosamine passing through the skin increased gradually over a period of 24 hours – there was no tailing off as might be expected and as is often seen with oral administration. This observation suggests that the activity of glucosamine is likely to be consistent over the 24 hour period of wear, so giving continued effect, which is the desired administration for joint support formulas.

Glucosamine: There are numerous health benefits of which can be derived from the use of supplemental glucosamine. For example, glucosamine has been seen to help to prevent and alleviate atherosclerosis by stimulating the production of a protective substance (glycosaminoglycan) by the cells which that line the blood vessels. Glucosamine may also support the immune system by helping to suppress inflammation, however, the most typical use of glucosamine is in relation to the musculoskeletal system (bones, joints and muscles).

Glucosamine may also help to accelerate the healing rate of fractures - reports from doctors have stated that oral glucosamine supplementation has in some cases accelerated the healing of fractures by up to threefold.

Glucosamine can "instruct" chondroclasts (the destructive joint cells) to stop breaking down cartilage and can reactivate chondroblasts (the constructive joint cells) to recommence "building" new cartilage. This activity is particularly important as we get older or with individuals who exercise. Glucosamine is also an excellent treatment for osteoarthritis.

CONCLUSION: The Joint Patch provides a novel approach to administration that gives the consumer a viable, realistic alternative to pills. This route of administration may also be attractive to vegetarians and vegans who generally do not have the opportunity to consume supplemental glucosamine.

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Glucosamine sulfate use and delay of progression of knee osteoarthritis: a 3-year, randomized, placebo-controlled, double-blind study.

Abstract: Conventional symptomatic treatments for osteoarthritis do not favorably affect disease progression. The aim of this randomized, placebo-controlled trial was to determine whether long-term (3-year) treatment with glucosamine sulfate can modify the progression of joint structure and symptom changes in knee osteoarthritis, as previously suggested. METHODS: Two hundred two patients with knee osteoarthritis (using American College of Rheumatology criteria) were randomized to receive oral glucosamine sulfate, 1500 mg once a day, or placebo. Changes in radiographic minimum joint space width were measured in the medial compartment of the tibiofemoral joint, and symptoms were assessed using the algo-functional indexes of Lequesne and WOMAC (Western Ontario and McMaster Universities). RESULTS: Osteoarthritis was of mild to moderate severity at enrollment, with average joint space widths of slightly less than 4 mm and a Lequesne index score of less than 9 points. Progressive joint space narrowing with placebo use was -0.19 mm (95% confidence interval, -0.29 to -0.09 mm) after 3 years. Conversely, there was no average change with glucosamine sulfate use (0.04 mm; 95% confidence interval, -0.06 to 0.14 mm), with a significant difference between groups (P =.001). Fewer patients treated with glucosamine sulfate experienced predefined severe narrowings (>0.5 mm): 5% vs 14% (P =.05). Symptoms improved modestly with placebo use but as much as 20% to 25% with glucosamine sulfate use, with significant final differences on the Lequesne index and the WOMAC total index and pain, function, and stiffness subscales. Safety was good and without differences between groups. CONCLUSION: Long-term treatment with glucosamine sulfate retarded the progression of knee osteoarthritis, possibly determining disease modification.

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Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo.

Abstract: To investigate the efficacy and tolerability of a 3-month duration, twice a-year, intermittent treatment with oral chondroitin sulfate (CS) in knee osteoarthritis (OA) patients. DESIGN: A total of 120 patients with symptomatic knee OA were randomized into two groups receiving either 800mg CS or placebo (PBO) per day for two periods of 3 months during 1 year. Primary efficacy outcome was Lequesne's algo-functional index (AFI); secondary outcome parameters included VAS, walking time, global judgment, and paracetamol consumption. Radiological progression was assessed by automatic measurement of medial femoro-tibial joint space width on weight-bearing X-rays of both knees. Clinical and biological tolerability was assessed. RESULTS: One hundred and ten of 120 patients were included in the ITT analysis. AFI decreased significantly by 36% in the CS group after 1 year as compared to 23% in the PBO group. Similar results were found for the secondary outcomes parameters. Radiological progression at month 12 showed significantly decreased joint space width in the PBO group with no change in the CS group. Tolerability was good with only minor adverse events identically observed in both groups. CONCLUSION: This study provides evidences that oral CS decreased pain and improved knee function. The 3-month intermittent administration of 800mg/day of oral CS twice a year does support the prolonged effect known with symptom-modifying agents for OA. The inhibitory effect of CS on the radiological progression of the medial femoro-tibial joint space narrowing could suggest further evidence of its structure-modifying properties in knee OA.

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Clinical Study On Cetylmyristoleate (CMO) vs Arthritis.

Abstract:

The Purpose:

Having previously established the effectiveness and nontoxicity of CMO tm (cerasomal-cis-9-cetylmyristoleate) for arthritis symptoms of pain, inflammation, and impaired mobility, the purpose of the study was:

A) To determine optimum dosage levels for various types of arthritis,
B) To determine if different dosage levels would be required relative to the severity of each type of arthritis,
C) To observe response time required for initial and partial relief of symptoms,
D) To observe response time required for complete relief of symptoms, and
E) To determine factors influencing subjects who may not respond to the protocol.

The Subjects

Subjects were volunteers treated as outpatients. They presented with osteoarthritis, rheumatoid arthritis and other forms of reactive arthritis.

The Study

The study involved 48 subjects. Female subjects (28) ranged from 33 to 83 years of age. Male subjects (20) ranged from 29 to 74 years of age. All races and many ethnic backgrounds were represented. Age, gender, race, and ethnological background appeared to be irrelevant to patient response in this study.

The Protocol

CMOtm was administered orally in the form of 75mg capsules each morning and evening. The number of capsules and duration of treatment varied for each group of subjects. Subjects were advised to take capsules on an empty stomach with water only; and to avoid tea, chocolate, alcohol, coffee, cola, and other caffeinated drinks for five hours after taking the capsules.

Subjects were advised to completely avoid chocolate and alcohol during the entire trial period of two to three weeks duration. With a few exceptions for subjects who could not function without them, steroids were also prohibited. Otherwise diet was not controlled in any way. Subjects were permitted to continue taking their customary pain and nonsteroidal anti-inflammatory medications until they were no longer needed. Subjects were asked to visit or call in to report progress at least twice weekly.

The Results

Only two subjects failed to show marked or complete relief of all symptoms of pain and limited mobility normally associated with arthritis. Both of these nonresponding subjects had suffered prior hepatic problems: one from alcohol abuse resulting in cirrhoses of the liver; the other, a former professional athlete, presented with considerable liver damage from steroid abuse. Further studies are necessary to determine the role of liver function capacity with respect to this protocol. Liver damage resulting from steroids previously prescribed for arthritis may also prove to be a factor affecting patient response.

Group #1

Mild to moderately severe osteoarthritis & and reactive psoriatic arthritis.

In Group #1, eleven (11) subjects presented with mild to moderately severe osteoarthritis and one with reactive psoriatic arthritis were supplied with 16 capsules, two 75mg capsules to be taken each morning and evening for four days.

Nine reported about 20% to 30% improvement in articulation and inflammation and about 40% to 50% relief of arthritic pain within 36 hours. In these nine subjects, improvement continued rapidly for the next 60 hours, reaching a 70% to 80% improvement by the end of the four days. Two of the subjects continued to improve over the following week despite the fact they were no longer taking any capsules. However about half of this group experienced the return of some mild arthritic symptoms after about three to five weeks. (Although not included as part of this study, all the subjects in this group were treated again and their symptoms have not returned.) The patient with reactive psoriatic arthritis also experienced an almost complete reversal of his associated very severe psoriatic skin condition affecting about 20% of his total skin area.

Group #2

Severe to crippling rheumatoid arthritis

In Group #2, nine (9) subjects presenting with severe to crippling rheumatoid arthritis were supplied with 50 capsules to be taken in two series, two 75mg capsules each morning and evening for seven days, with a seven day interval before repeating the same dosage for 5 1/2 more days. Four of these subjects were unable to walk and were accustomed to being transported by wheelchairs. One, her femur being fused at the hip, was unable to achieve a sitting position for wheelchair transport. She could, however, move about slowly on crutches as long as she was accompanied by someone to aid her in maintaining her balance. Otherwise she could only stand or lie down. The remaining four could move about with canes or walkers. All nine subjects presented with pain, inflammation, and marked deformation of nearly all proximal interphalangeal and large joints. Five presented with limited lumbar flexion and pain in the vertebral column. All had difficulty grasping and manipulating common objects.

On the fourteenth day, at the end of the one week interval without treatment, six(6) subjects reported minor continuing improvement; two reported maintaining their improved status and one continued to show no improvement. Treatment was resume an the fifteenth day for 5 1/2 more days.

By the end of the treatment period, all but two subjects reported to be 90% free of pain with a return of 70% to 100% mobility. The fused hip joint remained fused, of course, but with a return of over 70% mobility in other joints, the subject felt hip surgery now to be worth consideration. The nonresponsive subject proved to have cirrhoses of the liver, which may have been the reason for her inability to respond to treatment. Further investigation is necessary to determine the role of liver function in this protocol.

Group #3

Mild to moderately severe rheumatoid arthritis

In Group #3, fourteen (14) subjects presenting with mild to moderately severe rheumatoid arthritis were supplied with 24 capsules, two 75mg capsules to be taken each morning and evening for 6 days. After three days of treatment, eleven reported about 20% to 30% improvement in articulation and inflammation, and about 40% to 50% relief of arthritic pain. In these eleven subjects, improvement continued rapidly over the next four days, approaching the 80% to 100% level. The remaining three subjects reported similar improvement by the end of the fourth day, with an overall improvement of 70% to 80% after seven days.

Most of the subjects continued to report minor additional improvement for one week or more, even though they were no longer under treatment. However, six in this group began to experience the return of some mild arthritic symptoms after about three to four weeks. (Although not included as part of this study, all subjects in this group were treated again and their level of improvement has subsequently stabilized.)

Group #4

Severe to crippling osteoarthritis

In Group #4, fourteen (14) subjects presenting with severe to crippling osteoarthritis were supplied with 50 capsules to be taken in two series, two 75mg capsules each morning and evening for seven days, with a seven day interval before repeating the same dosage for 5 1/2 more days. Three of these subject were unable to walk and were accustomed to being transported by wheelchairs. The other eleven could move with crutches, walkers and canes. All presented with pain, inflammation and marked deformation of nearly all interphalangeal and large joints. Four presented with limited lumbar flexion and pain in the vertebral column. Ten had difficulty grasping and manipulating common objects.

After four days of treatment, ten in this group reported 30% to 50% improvement in articulation and inflammation and about 40% to 60% relief of arthritic pain. In these ten subjects, improvement continued rapidly over the next three days, reaching 80% to 100% by the end of seven days. One reported no perceptible change.

On the fourteenth day, at the end of the one week interval with out treatment, nine subject reported continuing minor improvement, four reported maintaining their improved status and one continued to show no improvement. Treatment was resumed on the fifteenth day for 5 1/2 more days.

By the end of the treatment period, eleven subjects reported 80% to 100% relief of pain with a return of 80% to 100% mobility. Two subjects reported a 70% to 80% of articular mobility with a 70% to 90% reduction of arthritic pain. The one non-responsive subject proven to have previous liver damage as a result of sports related steroid abuse. Further studies are necessary to determine the role of liver function in this protocol.

Summary

The results of this study lead to several conclusions regarding its five principal objectives:

1) Optimum dosage levels appears to be equal for all three types of arthritis investigated: osteoarthritis, rheumatoid arthritis and reactive psoriatic arthritis. This is evidenced by the gradual return of minor arthritis symptoms in several of those treated with only 16 to 24 capsules, and no regression in those treated with 50 capsules in two series separated by one week without treatment.

2) Dosage level requirements appear to be equal irrespective of the severity of the subjects condition.

3) Initial response time for minor improvement appears to vary from two to seven days, irrespective of the severity of the subject's condition.

4) The time for maximum attainable response appears to vary from seven to twenty one days, resulting in 70% to 100% overall improvement. (Apart from this study, three of the most severely afflicted subjects were treated again after a five week interval, resulting in an additional 10% to 20% overall improvement.)

5) The two non-responding subjects both proved to have suffered previous damage to the liver from steroid or alcohol abuse, indicating that impaired liver function may preclude success with this protocol.

In addition, it was evident that for many subjects, the relief of inflammation resulted in marked improvement in joint deformation.

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A randomized, double blind, placebo controlled trial of a topical cream containing glucosamine sulfate, chondroitin sulfate, and camphor for osteoarthritis of the knee.

Abstract: To assess the ability of a topical preparation of glucosamine sulfate and chondroitin sulfate to reduce pain related to osteoarthritis (OA) of the knee. METHODS: Sixty-three patients were randomized to receive either a topical glucosamine and chondroitin preparation or placebo to be used as required over an 8 week period. Efficacy was assessed using a visual analog scale (VAS) for pain as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the SF-36 questionnaire. RESULTS: VAS scores indicated a greater mean reduction in pain for the glucosamine/chondroitin preparation group (mean change -3.4 cm, SD 2.6 cm) compared to the placebo group (mean change -1.6 cm, SD 2.7 cm) after 8 weeks. After 4 weeks the difference between active and placebo groups in their mean reduction from baseline was 1.2 (95% CI 0.1 to 2.4, p = 0.03) and after 8 weeks was 1.8 (95% CI for difference between groups, 0.6 to 2.9 cm; p = 0.002). CONCLUSION: Topical application of glucosamine and chondroitin sulfate is effective in relieving the pain from OA of the knee and improvement is evident within 4 weeks.


Low levels of human serum glucosamine after ingestion of glucosamine sulphate relative to capability for peripheral effectiveness.

Abstract: Oral glucosamine preparations are widely used as a treatment for osteoarthritis, purportedly functioning by a variety of mechanisms suggested by results of in vitro experiments, and generally using glucosamine concentrations well in excess of 100 micromol/l. OBJECTIVE: To use high performance liquid chromatography with a high sensitivity Metrohm-Peak instrument for pulsed amperometric measurement of human serum glucosamine; a detection limit of 0.5 micromol/l at 1:10 serum dilution allowed measurement of low levels of glucosamine in human serum, which previously has not been possible. METHODS: Eighteen subjects with osteoarthritis were given 1,500 mg of commercial glucosamine sulphate after an overnight fast, and serum was then obtained at baseline and every 15-30 minutes over 3 hours, and additionally, from two subjects at 5 and 8 hours. Urine samples were collected at baseline and 3 hours after ingestion from three subjects. RESULTS: Baseline glucosamine was below the detection limit of 0.5 mumol/l for all subjects, but after ingestion, glucosamine was detected in 17/18 subjects, beginning to rise at 30-45 minutes to a maximum at 90-180 minutes, with a range of 1.9-11.5 micromol/l (0.34-2 microg/ml). CONCLUSION: This maximum concentration of 11.5 micromol/l has previously been shown to contribute less than 2% of the galactosamine incorporated into chondroitin sulphate in incubations of glucosamine with cultured human chondrocytes, and is a much lower concentration than the glucosamine concentrations claimed by other investigators to have various significant in vitro effects. This raises questions about current biological rationales for glucosamine use that were based on in vitro effects of glucosamine at much higher concentrations.

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