Effect | None |
Trial Design | Double blind |
Trial Length | 1-6 months |
Number of Subjects | 228 |
Sex | Both Genders |
Age Range | 45-64 |
Supplementation of four doses of CII to rheumatic patients (20mcg, 100mcg, 500mcg, or 2.5mg) over 24 weeks noted that the lower doses were associated with higher response rates than the higher doses, with the 19% response seen in placebo being outperformed by a 39% response in the 20mcg group (25% response in 2.5mg was not statistically significant).
Response was determined by at least a 30% reduction in joint soreness with responses on ACR and the Paulus criteria, and when looking only at the 30% reduction in pain all treatment groups (excluding ACR and Paulus) performed somewhat equally.
IgA and IgG antibodies were detected only in a few subjects, and appeared to predict responsiveness to therapy at all doses despite their specificity to CII or overall amounts being affected.