Structural effect of avocado/soybean unsaponifiables on joint space loss in osteoarthritis of the hip

Abstract

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 > 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) > 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 < median) was significantly greater in the placebo group than in the ASU group: from 1.69 ؎ 0.58 to 0.84 ؎ 0.77 mm (؊0.86 ؎ 0.62 mm) and from 1.66 ؎ 0.42 to 1.22 ؎ 0.7 mm (؊0.43 ؎ 0.51 mm), respectively (P < 0.01). The JSW decrease was identical, with no difference in ASU and placebo groups, in the less severely affected subgroup of patients (baseline JSW > median). Clinical parameters in the 2 groups did not differ significantly throughout the study. Conclusion. This pilot randomized, double-blind, placebo-controlled trial failed to demonstrate a structural effect of ASU in hip OA. However, in a post-hoc analysis, ASU significantly reduced the progression of joint space loss as compared with placebo in the subgroup of patients with advanced joint space narrowing. These results suggest that ASU could have a structural effect but require confirmation in a larger placebo-controlled study in hip OA.

The potential for dietary factors to prevent or treat osteoarthritis

“…There was no difference in clinical outcomes including pain or analgesic/non-steroidal antiinflammatory drug use (145) . This was somewhat similar to an earlier smaller study examining structural modification (146) , but very different from other earlier trials, where ASU demonstrated reductions in pain, functional disability or non-steroidal anti-inflammatory drug use in patients with hip or knee OA over 3-6 months (147)(148)(149) . In a dog anterior cruciate ligament transection model of OA, ASU reduced disease severity and decreased MMP13 production (150) , although in an ovine model of post-meniscectomy OA, ASU was described to have a 'subtle, but statistically significant' effect on cartilage (151) .…”

Targeting subchondral bone for treating osteoarthritis: what is the evidence?

“…In humans, ASU showed significant symptomatic efficacy in the treatment of OA [164]. Furthermore, one study evaluating the effect of ASU in hip OA patients over 2 years demonstrated a significant reduction in joint space loss in the most severe cases [165]. With regard to glucosamine, the hydrochloride formula administered to the cruciate transection rabbit OA model reduced the high subchondral trabecular bone turnover [166].…”

Treatment with Unsaponifiable Extracts of Avocado and Soybean Increases TGF-.BETA.1 and TGF-.BETA.2 Levels in Canine Joint Fluid

“…ASU have been used in the management of OA as a nutraceutical agent. The symptomatic efficacy of ASU has been demonstrated recently in double-blind, placebo-controlled prospective clinical trials in patients with OA (Blotman et al 1997;Maheu et al 1998;Appelboom et al 2001), with an evidence of reduced joint space narrowing (Lequesne et al 2002). Its ability to protect the articular cartilage of osteoarthritic joints in vivo remains to be established.…”

“…They are manufactured in France, as Piascledine, and to our knowledge are distributed only in that country. ASU have a symptomatic effect on knee and hip OA and slow down joint space narrowing in severe hip OA (Maheu et al 1998;Appelboom et al 2001;Lequesne et al 2002;Ernst 2003). Two recent in vitro studies explored more extensively the potential mechanism of action of ASU in OA.…”