OBJECTIVE: To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA). METHODS:Ninety patients with RA (disease duration < or = 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study. RESULTS: There were no significant difference between the 3 groups in terms of response to treatment. However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group. Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy. CONCLUSION: Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.
RCT Entities:
OBJECTIVE: To investigate the efficacy of oral type II collagen in the treatment of early rheumatoid arthritis (RA). METHODS: Ninety patients with RA (disease duration < or = 3 years) were treated for 12 weeks with oral bovine type II collagen at 1 mg/day (n = 30) or 10 mg/day (n = 30) or with placebo (n = 30), in a double-blind randomized study. RESULTS: There were no significant difference between the 3 groups in terms of response to treatment. However, we observed a higher prevalence of responders in the type II collagen-treated groups: 7 responders in the 10-mg type II collagen group and 6 in the 1-mg group, versus 4 in the placebo group. Furthermore, 3 patients in the 10-mg type II collagen group and 1 patient in the 1-mg type II group, but no patients in the placebo group, had very good response. A total of 14 patients had to be withdrawn from the study: 2 because of side effects (nausea) and 12 because of lack of efficacy. CONCLUSION: Only a minority of patients responded to treatment with oral type II collagen. These results justify further efforts to identify which patients will have good response to such therapy.
Authors: Arnold E Postlethwaite; Weng Kee Wong; Philip Clements; Soumya Chatterjee; Barri J Fessler; Andrew H Kang; Joseph Korn; Maureen Mayes; Peter A Merkel; Jerry A Molitor; Larry Moreland; Naomi Rothfield; Robert W Simms; Edwin A Smith; Robert Spiera; Virginia Steen; Kenneth Warrington; Barbara White; Frederick Wigley; Daniel E Furst Journal: Arthritis Rheum Date: 2008-06
Authors: L K Myers; D D Brand; X J Ye; M A Cremer; E F Rosloniec; M Bodo; J Myllyharju; T Helaakoski; M Nokelainen; T Pihlajaniemi; K Kivirikko; C L Yang; L Ala-Kokko; D J Prockop; H Notbohm; P Fietzek; J M Stuart; A H Kang Journal: Immunology Date: 1998-12 Impact factor: 7.397