The efficacy of intra-articularly administered MYC 2095, triamcinolone hexacetonide and placebo in gonarthritis. A combined double-blind clinical trial.
We report the results of a double-blind three-centre study, employing a cross-over design, set up to compare the efficacy of intra-articular injections of Myc 2095 (20 mg), triamcinolone hexacetonide (Lederspan) (20 mg) and placebo in 40 patients with synovitis of the knee joint. Each patient included in the study contributed data on 2 of the 3 treatment variables being compared. Seven clinical parameters were assessed every 6 weeks, while the doctor's and the patient's assessments were scored. Intra articular treatment both with Myc 2095 and triamcinolone hexacetonide proved to be effective. Placebo response was also very high. After the first Myc 2095 injection, improvement in "tenderness", "pain under load" and "swelling and hydrops" was significantly superior to that following placebo treatment. The evaluation of the second injections indicated a marked carry-over effect from the first course. This was also evident from the doctor's and patient's assessments. The importance of including a placebo in the evaluation of anti-phlogistic drugs in clinical trials, emerged from this study.
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000031:analogs & derivatives; D007270:Injections, Intra-Articular; D007719:Knee Joint; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011282:Pregnenediones / Q000008:administration & dosage / Q000627:therapeutic use*; D013585:Synovitis / Q000188:drug therapy*; D014222:Triamcinolone Acetonide / Q000008:administration & dosage / Q000627:therapeutic use*
C023030:MYC 2095; D010919:Placebos; D011282:Pregnenediones; D014222:Triamcinolone Acetonide; D006854:Hydrocortisone