A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF INTRAVENOUS LOADING WITH S-ADENOSYLMETHIONINE (SAM) FOLLOWED BY ORAL SAM THERAPY INPATIENTS WITH KNEE OSTEOARTHRITIS

Objective. We evaluated the effectiveness and rapidity of onset of S-a denosylmethionine (SAM), administered as daily intravenous boluses of 400 mg for 5 days, followed by oral tablets, 200 mg thrice daily for 2 3 days, versus a matching placebo regimen, in the treatment of 81 pati ents with symptomatic knee osteoarthritis (OA). Methods. The study was bicentric, randomized, double blinded, and placebo controlled. Patien ts underwent a 7-day washout of arthritis medications prior to initiat ion of this study treatment. Major outcome measures were the Stanford Health Assessment Questionnaire disability and pain scales, and supple mental visual analog scales for rest and walking pain. Results. At one site, patients had milder OA, the baseline characteristics of the tre atment groups were well matched, and the SAM treated group showed sign ificantly greater reduction in overall pain and rest pain (p < 0.05) t han the placebo treated group. At the other site, the patients had mor e severe OA, randomization yielded markedly different treatment groups , and the response to treatment did not differ between groups. Onset o f SAM effect was seen as early as 14 days after the start of treatment . Conclusion. SAM may be an effective treatment for some patients with symptomatic knee OA, and merits further study. Intravenous loading be fore oral maintenance therapy may be advantageous.