Randomised, controlled trial of avocado–soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study

Abstract

Objective To assess the ability of avocado–soybean unsaponifiable—Expanscience (ASU-E) to slow radiographic progression in symptomatic hip osteoarthritis (OA). Methods Prospective, randomised, double blind, parallel group, placebo controlled 3 year trial. Patients with symptomatic (painful ≥1 year, Lequesne Index between 3 and 10) hip OA (American College of Rheumatology criteria) and a minimum joint space width (JSW) of the target hip between 1 and 4 mm on a pelvic radiograph were randomly assigned to 300 mg/day ASU-E or placebo. Standing pelvis, target hip anteroposterior (AP) and oblique views were taken annually. The primary outcome was JSW change at year 3, measured at the narrowest point on pelvic or target hip AP view (manual measure using a 0.1 mm graduated magnifying glass). The full analysis dataset (FAS) included all patients having at least two successive radiographs. An analysis of covariance Mixed Model for Repeated Measurements with Missing at Random (for missing data) was performed to compare adjusted 3 year JSW changes (primary outcome) and the percentages of ‘progressors’ (JSW loss≥0.5 mm) between groups. Results 399 patients were randomised (345 kept in the FAS), aged 62 (35–84) years, 54% women, mean body mass index 27 (SD 4) kg/m 2 , mean symptom duration 4 (SD 5) years, 0–100 normalised Lequesne Index 30 (SD 9) and global pain visual analogue scale 37 (SD 23) mm. Mean baseline JSW was 2.8 (0.9) mm. There was no significant difference on mean JSW loss (−0.638 mm vs −0.672 mm, p=0.72, in the ASU-E and placebo groups, respectively) but there were 20% less progressors in the ASU-E than in the placebo group (40% vs 50%, respectively, p=0.040). No difference was observed on clinical outcomes. Safety was excellent. Conclusions 3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires further assessment. Trial registration number on ClinicalTrial.gov NCT01062737

Effects of avocado/soybean unsaponifiables (ASU) on the treatment of ligature-induced periodontitis in rats

“…It can be assumed that this effect must be due to anti-inflammatory and proliferative effects in the connective tissue that were induced by the ASU treatment. 13,14,15,17,20,21 However, these results were not maintained in the other periods or confirmed by the other analyses, such as the CEJ-CB and the volumetric % bone analysis performed by the micro-CT. The discrepancy between the data obtained from the analysis of the % bone in the furcation with the data of the distance between the CEJ-CB and CEJ-aJE at 7 days might be due to the different areas of assessment; while the first analysis was performed at the furcation, the other analyses were performed in the interproximal region.…”

“…Clinical studies have found that ASU reduce the intra-articular space and improve joint kinesiology function. 2,13,14,15 The effects of ASU on the protection and proliferation of intra-articular tissues were verified histologically in studies with sheep 14 and dogs. 13 In vitro studies have shown that ASU downregulates the expression of pro-inflammatory mediators, such as PGE2, TNFα, iNOS, IL1β, IL6, and IL8, 16,17,18 and matrix metalloproteinases, such as MMP2, MMP3, and MMP13; 18,19,20 ASU also promotes the upregulation of the expression of growth factors such as TGFβ1, TGFβ2, and BMP2 17,21,22 and the synthesis of proteins of the matrix of the connective tissue, such as collagen and agrecans.…”

“…11 This medication is considered to be a structural modifier of the joint tissues that were previously destroyed by the progression of arthritis/osteoarthritis. 12,13,14,15 The mechanism of action of this medication may make it applicable as a possible adjunctive agent for periodontal treatment. Clinical studies have found that ASU reduce the intra-articular space and improve joint kinesiology function.…”

Supplementary Methods in the Nonsurgical Treatment of Osteoarthritis

“…21 After 3 years, ASUs decreased joint space narrowing in the treated group, indicating a potential structure-modifying effect of ASUs on hip OA.…”

A Review of Nutraceuticals in Joint Arthritis

“…361 patients were enrolled and it was found that there was no difference between the two groups after a 6-month followup period. A study by Maheu, et al enrolled 399 patients with symptomatic hip OA [38]. There was no significant difference on mean joint space width in the ASU and placebo groups; however there was a rate of 20% less progression in the ASU group but this was not statistically significant.…”