New approaches to the evaluation of anti-rheumatic drugs

No effect of transfer factor in juvenile rheumatoid arthritis by double-blind trial.

“…These findings are in accordance with a double-blind 12-week crossover trial in 6 adults with rheumatoid arthritis (Maini et al, 1976), and with an open trial of 8 patients with JRA (Gr0hn et al, 1976). In rheumatic diseases with a natural fluctuating course, a longer period (6 months) and a parallel group study are considered more convenient for documenting toxicity and for demonstrating possible specific activity (Hill, 1969;Amor et al, 1974;Fr0land et al, 1974;Gr0hn et al, 1976;Maini et al, 1976).…”

“…As there are still no uniformly accepted diagnostic criteria of JRA and no simple ways of estimating disease activity (Hill, 1969;McCarty, 1972;Amor et al, 1974;Levy and Dick, 1975), a panel of subjective and objective criteria was used. Extensive planning before the trial, the help of statisticians, and regular discussions by the team of investigators during the trial were valuable.…”

“…We therefore decided to carry out a controlled clinical trial. Because of the relatively large fluctuations in disease activity with time, a parallel rather than a cross-over trial was conducted, with one group treated with transfer factor and one group treated with placebo (Hill, 1969;Amor et al, 1974).…”