Structural effect of avocado/soybean unsaponifiables on joint space loss in osteoarthritis of the hip.
Arthritis Rheum. 2002 Feb;47(1):50-8. PMID: 11932878
OBJECTIVE: To evaluate the structural effect of avocado/soybean unsaponifiables (ASU) in the treatment of patients with symptomatic osteoarthritis (OA) of the hip. METHODS: Patients with regular painful primary OA of the hip (European League Against Rheumatism 1980 criteria) and a joint space still>or = 1 mm (Kellgren grade 1 to 3, assessed by an independent observer prior to inclusion) entered a prospective, multicenter, randomized, parallel group, double-blind, placebo-controlled trial of 2 years duration. Patients had at least a 6-month history of regular pain and an algofunctional index (AFI)>or = 4. The primary assessment criterion was a decrease of the joint space width (JSW) on plain anteroposterior radiographs of the pelvis performed in standing position, measured at the narrowest points by 2 independent readers, previously tested and selected and blinded to both the treatment and the time sequence. Secondary criteria were standard clinical outcome measurements (AFI, pain on a visual analog scale, consumption of nonsteroidal antiinflammatory drugs and patient's and investigator's global assessments). RESULTS: One hundred sixty-three patients were included: 102 men and 61 women (mean age 63.2 +/- 8.7 years). A total of 108 patients (72 men and 36 women; mean age 64 +/- 7.9 years) were radiologically evaluable at 23.7 +/- 2.6 months (ASU group; n = 55) and 23.7 +/- 3.2 months (placebo group; n = 53). Overall comparison of the evolution of JSW showed no difference between the ASU and placebo groups, from 2.35 +/- 0.93 to 1.87 +/- 1.10 mm and from 2.5 +/- 0.94 to 1.9 +/- 1.33 mm, respectively (intergroup P value at end point = 0.9). When patients were divided into 2 subgroups according to the median value of the baseline JSW (2.45 mm), the joint space loss in the most severely affected subgroup of patients (baseline JSW