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RCT · 2023 · n=120

The short-term effect of glucosamine-sulfate, nonanimal chondroitin-sulfate, and S-adenosylmethionine combination on ultrasonography findings, inflammation, pain, and functionality in patients with knee osteoarthritis: A pilot, double-blind, randomized, placebo-controlled clinical trial

Veličković Z, Pavlov Dolijanović S, Stojanović N, Janjić S, Kovačević L, Soldatović I · Archives of Rheumatology

Promisingcounts toward this tier

The only trial to take SAMe as far as a structural measurement in a human knee, and it is null between groups. Its abstract reports a minor rise in ultrasound cartilage thickness in the higher-dose arm at six months; the results section states that at baseline, three months and six months there was no statistically significant difference between groups in cartilage thickness at any measured site in either knee. The delta changes for pain, the Tegner Lysholm score, WOMAC and SF-36 did not differ between groups either, and pain fell in all three arms with the largest fall in the placebo group at three months. Superiority in reducing ultrasonographic osteoarthritis findings was not demonstrated. Intrarater reliability for the thickness measurement was good, at an intraclass correlation of 0.936.

Population
Adults with symptomatic knee osteoarthritis by American College of Rheumatology criteria, mean age 66.4, 92 of 120 female, one centre in Belgrade
Intervention
A fixed combination of glucosamine sulfate, non-animal chondroitin sulfate and SAMe at two strengths: 375/300/100 mg or 750/600/200 mg daily for six months
Comparator
Placebo
Limitations
A three-way combination, so nothing here can be attributed to SAMe, and its SAMe dose is 100 to 200 mg a day against the 600 to 1,200 mg used in the osteoarthritis trials. A pilot powered on pain rather than on cartilage thickness, for which the authors say they could find no comparable study to size against. Six months, one centre, and ultrasound rather than MRI. The study and the investigational product were sponsored by the manufacturer, which supplied drug and placebo; one investigator was paid a per-patient fee.

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