Study claim: A combination of glucosamine HCl and chondroitin sulfate was safe and effective for treating acute knee pain from osteoarthritis.
Published: Clegg DO, et al. Glucosamine, chondroitin sulfate and the two in combination for painful knee osteoarthritis. New Engl J Med 2006 Feb 23;354 (8):795-808.
Abstract: Glucosamine and chondroitin sulfate are used to treat osteoarthritis. The multicentre, double-blind, placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis.
We randomly assigned 1,583 patients with symptomatic knee osteoarthritis to receive 1,500mg of glucosamine daily, 1,200mg of chondroitin sulfate daily, both glucosamine and chondroitin sulfate, 200mg of celecoxib daily, or placebo for 24 weeks. Up to 4,000mg of acetaminophen daily was allowed as rescue analgesia. Assignment was stratified according to the severity of knee pain (mild [n=1229] vs moderate to severe [n=354]). The primary outcome measure was a 20 per cent decrease in knee pain from baseline to week 24.
The mean age of the patients was 59 years, and 64 per cent were women. Overall, glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 per cent. As compared with the rate of response to placebo (60.1 per cent), the rate of response to glucosamine was 3.9 percentage points higher, the rate of response to chondroitin sulfate was 5.3 percentage points higher, and the rate of response to combined treatment was 6.5 percentage points higher. The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group.
For patients with moderate-to-severe pain at baseline, the rate of response was significantly higher with combined therapy than with placebo (79.2 per cent vs 54.3 per cent). The response rate for this subgroup with celecoxib was 69.4 per cent. Adverse events were mild, infrequent and evenly distributed among the groups.
Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain.
The glucosamine HCl was donated by Ferro Pfanstiehl Laboratories in Illinois, through Wilke Resources. Ferro no longer manufactures glucosamine. Chondroitin sulfate was supplied by Bioiberica in Spain.
Potential Applications: Glucosamine and chondroitin are the best-studied dietary supplements for osteoarthritis.
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Study claim: Coenzyme Q10 is safe at a range of doses.
Published: Ikematsu H, et al. Safety assessment of coenzyme Q10 (Kaneka Q10) in healthy subjects: a double-blind, randomised, placebo-controlled trial. Regul Toxicol Pharmacol 2006 Jan 20; [Epub ahead of print].
Abstract: The safety profile of Coenzyme Q10 (Kaneka Q10) at high doses for healthy subjects was assessed in a double-blind, randomised, placebo-controlled study. Kaneka Q10 in capsule form was taken for four weeks at doses of 300, 600 and 900mg/day by a total of 88 adult volunteers. No serious adverse events were observed in any group.
Adverse events were reported in 16 volunteers with placebo, in 12 volunteers with the 300mg dose, in 20 volunteers with the 600mg dose and in 16 volunteers with the 900mg dose. The most commonly reported events included common cold symptoms and gastrointestinal effects such as abdominal pain and soft feces. These events exhibited no dose-dependency and were judged to have no relationship to Kaneka Q10.
Changes observed in hematology, blood biochemistry and urinalysis were not dose-related and were judged not to be clinically significant. The plasma CoQ10 concentration after eight-month withdrawal was almost the same as that before administration. These findings showed that Kaneka Q10 was well tolerated and safe for healthy adults at an intake of up to 900mg/day.
Potential applications: Coenzyme Q10 has demonstrated value for heart disease, high blood pressure, cancer, ageing, muscular dystrophy, multiple sclerosis, Parkinson's disease, Huntington's disease and periodontal disease.
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