SYMPTOMATIC EFFICACY OF AVOCADO SOYBEAN UNSAPONIFIABLES IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE AND HIP - A PROSPECTIVE, RANDOMIZED,DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER CLINICAL-TRIAL WITH A 6-MONTH TREATMENT PERIOD AND A 2-MONTH FOLLOW-UP DEMONSTRATING A PERSISTENT EFFECT/

Objective. To assess the efficacy and safety of avocado/soybean unsapo nifiables (ASU) in the treatment of patients with symptomatic osteoart hritis (OA) of the knee or hip, as well as the potential residual effe cts of ASU after stopping treatment, to determine whether ASU might be a symptomatic slow-acting drug for the treatment of OA. Methods. One hundred sixty-four patients with regular, painful, primary OA of the k nee (n = 114) or hip (n = 50) entered a prospective, randomized, doubl e-blind, placebo-controlled, parallel-group, multicenter trial with a 6-month treatment period and a 2-month posttreatment followup. A 15-da y washout period for nonsteroidal antiinflammatory drugs (NSAIDs) prec eded the study. Efficacy was judged according to 1) Lequesne's functio nal index (LFI) and 2) pain on Huskisson's visual analog scale (VAS; 1 00-mm scale), intake of NSAIDs/analgesics, and overall disability scor e (by 100-mm VAS). Results. Eighty-five patients received ASU; 79 rece ived placebo. One hundred forty-four patients were evaluable at month 6 (75 taking ASU; 69 taking placebo). The mean +/- SEM LFI score decre ased from 9.7 +/- 0.3 to 6.8 +/- 0.4 in the ASU group and from 9.4 +/- 0.3 to 8.9 +/- 0.4 in the placebo group (P < 0.001 for intergroup dif ference at month 6). Pain decreased from 56.1 +/- 1.6 mm to 35.3 +/- 2 .3 in the ASU group and from 56.1 +/- 1.8 mm to 45.7 +/- 2.6 in the pl acebo group (P = 0.003 at month 6), NSAID consumption was slightly low er in the ASU group. Fewer patients in the ASU group required NSAIDs ( 48%, versus 63% in the placebo group; P = 0.054). The success rate was 39% in the ASU group and 18% in the placebo group, Overall functional disability was significantly reduced in the ASU group. Improvement ap peared more marked in patients,vith hip OA. A residual effect was obse rved at month 8, Tolerance was good to excellent for most patients. Co nclusion. ASU treatment showed significant symptomatic efficacy over p lacebo in the treatment of OA, acting from month 2 and showing a persi stent effect after the end of treatment.