Introduction

This paper includes the results of a laboratory research into the mechanisms of action of the mussel extract and also those from a 4-year clinical study involving 120 patients suffering 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.

Sixty-four males and fifty-six females made up this group with most patients in the age group of 60-70. Several of them had been referred total knee replacement. All patients in the study were provided information on the use of Green Lipped Mussel (GLM) for degenerative joint disease. They were advised that GLM Extract had been shown to have an anti-inflammatory effect equal to that of Indocin but more importantly it had a nutritive metabolic effect. The importance of mucopolysacharrides (glycosaminoglycans) in the formation of basic proteoglycans cartilage was stressed.

Patients with a known allergy to seafood, shellfish and alfalfa were excluded from the study but patients who were taking some form of NSAIDs or pain medication were allowed to continue but were requested to keep a record of all medications required.

Pain Assessment

The Huskinson visual analogue pain scale was used to assess pain where the pain intensity ranged from " no pain" to "worst possible pain ". (Intensity Scale Fig. 1.)

Inflammatory Index

An estimate of overall inflammatory activity of the joints based upon clinical evidence of swelling, trauma, redness, heat and pain was made. A history of " minutes of morning stiffness" as well as daily activity, participation in sports etc. was recorded by the patients.

The patient's opinion of their condition in comparison to their initial state (same, a little better, a lot better, worse, much worse) was recorded. The physician's evaluation was also made at the time of each visit (excellent, good, no change).

Notes were made as to tolerance of GLM Extract and compliance. Notes were also made in reference to the use of NSAID's, pain medication, tropical cream and ointments.

The patients were prescribed 3 GLM Extract capsules (a total of 1500mg extract) per day taken with food and then 2 capsules daily as a permanent maintenance dose. The product used in the study contained 500mg GLM and 100mg alfalfa.

The study was designed to last one year and out of 120 patients, only eleven were eventually elected for total knee replacement.

X-RAY evaluation

X-Rays of the patients were graded on the basis of a scale of I to IV using the Kellgren and Lawrence system - degree of osteoarthritis progressing by grade from grade I (minimal, least, severe) to grade IV (bone on bone).

The response to management in these groups of patients studied became evident at the time of the first follow-up visit. Many grade I & II patients who had presented with an initial analogue of 7 reported a 0 - 2. These patients continued to remain comfortable and active during the rest of the study.

Evidence of pain, heat and swelling was noted to be significantly diminished or absent during the remaining visits.

The two patients who were using canes no longer required them. A significant number of patients were able to reduce their NSAID intake by 50% or more. Most patients reported that their condition was much improved. No patient complained that his condition was worse.

Patient's and Practitioner's Assessments

95 patients reported of much improvement and 16 reported of some improvement. 9 patients reported of no change.

According to the practitioner, 19 patients (27%) had shown no improvement, 38 patients (31%) had shown good improvement and 63 patients (52%) had made excellent progress.

11 patients did eventually come for joint replacement therapy but felt that GLM protocol had bought them some more time.