OZHEALTH ARTHRITIS CREAM CLINICAL STUDY
Published in the International Journal of Rheumatology, 2003 Click here to download full Clinical Study
Objective: 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 chon- droitin 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. (J Rheumatol 2003;30:523"8)
"…The finding that improvement in pain rating in the active group was evident after Day 1, with clinically significant improvement evident at both 4 and 8 weeks, suggests that the topical preparation has a rapid onset of action. The speed of onset of pain relief observed in this study was an unexpected finding. While one can only speculate about the mechanisms underlying the clinical observations, it is possible that the peppermint oil and camphor provided immediate analgesic activity and that repeated application of these agents contributed to the observed results over the 8 weeks…It is also possible that the apparent rapid onset of action may be due to absorption of the glucosamine and chondroitin sulfate into the bloodstream and/or direct uptake into local joint tissue in amounts comparable to those available from oral administration…"
Highlights of the Clinical Study
Results of a clinical study from Australia published in the March 2003 Journal of Rheumatology show benefits of controlling pain associated with osteoarthritis of the knee through use of a topical cream preparation containing camphor, glucosamine sulfate, chondroitin sulfate and peppermint oil. The study was conducted under the auspices of the Department of Complementary Medicine, Royal Melbourne Institute of Technology (RMIT), and the Centre for Complementary Medicine, Monash University, both in Melbourne, Australia.
A Randomized, Double-Blind, Placebo-Controlled Trial of a Topical Cream Containing Glucosamine Sulfate, Chondroitin Sulfate and Camphor for Osteoarthritis of the Knee
Marc Cohen, Rory Wolfe, Trudy Mai, Daniel Lewis
Journal of Rheumatology, March 2003
Study was single centred, randomized, double-blind, placebo-controlled 63 subjects were diagnosed with osteoarthritis of the knee based on the American College of Rheumatology definition Patients were randomly assigned to use either a topical preparation containing the active preparation, which was a water-soluble cream containing glucosamine, chondroitin sulfate, camphor (3.1%) and peppermint oil, or, a placebo, for eight weeks Nearly all of the patients using the active cream (available as OzHealth Arthritis Cream® in the Australia), obtained immediate pain relief The results also showed there was a greater mean sustained reduction in pain at both four weeks and eight weeks for the formula contained in OzHealth Arthritis Cream group compared to the placebo group A majority of the users experienced gradually and continually improving pain relief over the eight weeks Surprisingly, with continued use, one-third of the users group had their chronic osteoarthritis pain completely or nearly completely eliminated within eight weeks or less According to the study author, Marc Cohen, M.D., Ph.D., RMIT University, "It is my hypothesis that the observed gradual and continual improvement in pain scores is likely to be due to the glucosamine and chondroitin. The painresults were consistent with previous studies conducted with oral administration of these same nutrients. Additional studies need to be done." The formula contained in OzHealth Arthritis Cream utilizes a unique proprietary skin delivery technology, FUSOME
CLINICAL STUDY PRESS RELEASE
Clinical Study Shows Effectiveness of Short and Long Term use of Topical Cream for Osteoarthritis Knee Pain Evidence Clear Within Four Weeks in Randomized, Double-Blind, Placebo-Controlled Trial Using Topical Preparation NEW YORK, March 3, 2003 - Results of a clinical study published in the March 2003 Journal of Rheumatology show longterm benefits of topical application of a preparation containing camphor, glucosamine and chondroitin sulfate. The study, "A Randomised, Double-Blind, Placebo-Controlled Trial of a Topical Cream Containing Glucosamine Sulfate, Chondroitin Sulfate and Camphor for Osteoarthritis of the Knee," shows continuous reduction of pain due to osteoarthritis of the knee, with clinically significant results within four weeks. According to the study's principal investigator, the study also suggests that topical application of these agents, along with a unique proprietary technology, FUSOME®, is an effective route of administration. Under the auspices of the Department of Complimentary Medicine, RMIT University, and the Centre for Complimentary Medicine, Monash University, both in Melbourne, Australia, a single centered, randomized, double-blind, placebo-controlled trial was performed with 63 subjects chosen from the community after assessment for eligibility. Key to the assessment criteria was a diagnosis of osteoarthritis of the knee based on the American College of Rheumatology definition, which includes knee pain most days during the prior month, as well as morning stiffness of the knee for 30 minutes or less. Patients were randomly assigned to use either a topical preparation containing camphor, glucosamine, and chondroitin sulfate, or a placebo, for eight weeks. The two treatment groups were similar with respect to demographic composition and illness history.
Clinical Study Shows Reduction in Osteoarthritis Knee Pain…2
The active preparation was a water-soluble cream containing glucosamine sulfate, chondroitin sulfate and shark cartilage of which 10 to 30 percent is chondroitin sulfate, camphor (3.1%) and scented with peppermint oil. This exact preparation is a commercially available cream sold as OzHealth Arthritis Cream® that is formulated using a proprietary technique - FUSOME® - aimed at maximizing skin penetration of the beneficial ingredients. This unique system consists of high efficiency emulsifiers and skin emollients and micro-encapsulation of the beneficial ingredients. The placebo preparation was a simple cosmetic cream that used conventional skin emollients, petrolatum and mineral oil, and conventional emulsifiers; stearic acid and glycerol stearate , rather than the proprietary technology.
The primary outcome measure was an assessment of subjective pain using a Visual Analogue Scale (VAS). Secondary outcome measures included measures of pain, stiffness and physical function using the Western Ontario and the McMaster Universities Osteoarthritis Index (WOMAC) and quality of life using the SF-36 questionnaire.
The study showed a significant difference between the two groups existed after the first day of use of creams. Nearly all of the patients using OzHealth Arthritis Cream® obtained immediate pain relief. Additionally, the results showed there was a greater mean sustained reduction in pain at both four weeks and eight weeks for the OzHealth Arthritis Cream® group compared to the placebo group. A majority of the OzHealth Arthritis Cream® users experienced gradually and continually improving pain relief over the eight weeks. A surprising result was that with continued use, one-third of the OzHealth Arthritis Cream® group had their chronic osteoarthritis pain completely or nearly completely eliminated within eight weeks or less.
Clinical Study Shows Reduction in Osteoarthritis Knee Pain…3
According to Marc Cohen, MD, PhD, Department of Complementary Medicine, Faculty of Life Sciences, RMIT University, and principal investigator of this study, "The observed gradual and continual improvement in pain scores is likely to be due to the glucosamine and chondroitin content and this is consistent with previous studies."
Oral administration of glucosamine and chondroitin sulfate have been consistently shown in previous studies to relieve the pain and joint stiffness associated with osteoarthritis and long-term consumption of glucosamine may reduce the radiographic progression of osteoarthritis of the knee. Glucosamine, although it is rapidly absorbed from the gastrointestinal tract when taken orally, is subject to uptake and degradation by the liver and uptake into non-joint tissues. Therefore, when administered orally (typically 1500 mg of glucosamine and 1200 mg of chondroitin sulfate daily), only a small percentage is available to the joint.
Says Dr. Cohen, "Our results clearly show that the proprietary system in this product effectively targets osteoarthritic knee pain and provides immediate pain relief along with long term improvement of pain with continued use." Dr. Cohen adds, "The study shows promise, regardless of mode of action, for those osteoarthritis patients who have not had success with oral glucosamine/chondroitin, or, who prefer to apply a topical preparation over taking numerous pills several times a day." The Journal of Rheumatology is available online at www.jrheum.com.