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Safety and Efficacy

Safety and Efficacy Data of the Constituent Ingredients of Motion Medicine
Prepared under contract by
Dustin L Johnson PhD (Medical Science)ExSAP Scientific Evaluator CAWD,
Healthy Environments and Consumer Safety Branch,
Health Canada


Research Evaluation:
Dustin L Johnson, PhD
ExSAP Scientific Evaluator
CAWD,
Healthy Environments and Consumer Safety Branch,
Health Canada
269 Laurier Ave. W., Room 4-035
Address Locator 4904D
Tel: 613-948-7765
dustin_johnson@hc-sc.qc.ca


Motion Medicine

Motion Medicine (MM) is a blend of ingredients recommended for topical application to areas of body soreness for the relief of pain due to inflammation, muscle strains and joint arthritis. Within the cream are known anti-inflammatory compounds (methyl salicylate and methylsulfonylmethane), analgesics (menthol, camphor, thymol, and lavender oil) and circulation enhancers, as well as ingredients that may facilitate tissue repair (glucosamine, condroitin, vitamin E, grape seed and sea cucumber extract). Specially formulated with skin permeants (eucalyptus oil and polysorbate 20) and hydrating ingredients (glycerol), MM is a very safe and highly efficacious topical therapy cream.

Indications for use: - for the management of pain and inflammation due to muscle strains and osteoarthritis - may facilitate healing of damaged muscle and cartilage tissue

Motion Medicine is appropriate for self-care because it relieves pain and inflammation associated with common ailments including muscle aches and strains and osteoarthritis, and may promote and improve the health of users.

The route of administration of MM is strictly limited to external application to areas of body soreness. It is not for application on mucous membranes. Motion Medicine has a restricted dose of 10 grams per day (divided into 4 applications) and should not be used on children or if pregnant or breast-feeding. It should NOT be used when on anticoagulant (blood thinning) medication such as Coumadin.

Motion Medicine has been sold in Canada for over 10 years under the trade names Embracecare Treatment Cream and Proflex. It has been distributed to participants at amateur golf tournaments and to chiropractors across the country. To date there have not been any reported adverse events associated with self-care use of Motion Medicine.


Safety

Evidence for Low Systemic Exposure of Topically Applied Motion Medicine™

In their undiluted form (i.e. concentrations approximating 100%), some of the ingredients found within Motion Medicine™ are of toxicological concern. These ingredients include camphor, methyl salicylate and thymol. However, when used diluted within MM, these compounds are no longer considered harmful. Other commonly used over-the-counter topical analgesics tend to have higher concentrations of these ingredients, suggesting MM is safer than other creams. A study was recently conducted that measured the systemic exposure to camphor, methyl salicylate and menthol through topical application of dermal patches; it was found that when a total of 300 mg menthol, 375 mg camphor and 600 mg methyl salicylate were applied to the skin for 8 hours, the resulting plasma concentrations of each compound reached only up to 40 nanograms/mL (representing less than 1/1000th of the amount of each compound originally applied to the skin) (Martin et al. 2004). In addition to low systemic exposure through dermal patches containing menthol/camphor/methyl salicylate, this research also revealed that removal of these compounds occurs relatively quickly within the human body (within hours of topical application), suggesting that camphor, methyl salicylate and menthol are unlikely to accumulate within the body with daily use of MM. Together the results suggest that daily topical application of MM is safe and is not likely to lead to any major adverse events.


Efficacy

Evidence for Pain Reduction Due to Osteoarthritis

A double-blind randomized control clinical study has been conducted to assess the level of pain reduction due to knee osteoarthritis after topical application of a cream containing 0.3% glucosamine sulfate, 0.72% condroitin sulfate, 1.4% shark cartilage (of which 10-30% is condroitin sulfate), 3.2 % camphor, 0.9% peppermint oil (which has a high menthol content), emulsifiers, and skin emollients (Cohen et al. 2003). The placebo cream contained less than 0.9% peppermint oil, emulsifiers, emollients as well as stearic acid and glycerol stearate. Subjects were told to generously apply the cream to their painful knees, and to repeat cream application as necessary (it was estimated that on average 30 mg glucosamine, 78 mg chondroitin and 320 mg camphor were applied each day). The study lasted eight weeks and fifty nine subjects (of 63) completed the study. Reduction of pain associated with knee osteoarthritis was statistically significant for the group receiving cream containing glucosamine/chondroitin/camphor (Cohen et al. 2003). Adverse events were minimal (above the placebo group, 1 subject reported fatigue, 1 subject reported nausea, 1 subject withdrew due to blurred vision while another withdrew due to gall stones), indicating that liberal use of this cream over a period of eight weeks was safe. The results suggest that daily application of a cream containing a glucosamine-chondroitin-camphor combination can significantly reduce the pain associated with knee osteoarthritis (Cohen et al. 2003).


Caveats

Motion Medicine™ as a formulation has not been studied in vitro or in vivo. Thus any safety and efficacy data must be extrapolated from studies using similar creams containing the ingredients found within Motion Medicine™. Invariably these compounds are present in different ratios and may occur in the presence of compounds not found within MM and/or in the absence of compounds found within Motion Medicine™.

The following is a list of ingredients found within Motion Medicine™ (the concentration of each compound within the cream is given) followed by scientific evidence of the safety and efficacy of each ingredient. Where available, a significant attempt has been made to focus on studies employing external rather than internal exposure to the ingredients, and to highlight studies carried out on humans rather than lab animals or in in vitro cell culture systems.


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Detailed ingredient safety - PDF