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

Maheu E, Cadet C, Marty M, Moyse D, Kerloch I, Coste P, Dougados M, Mazières B, Spector TD, Halhol H, Grouin JM, Lequesne M · Annals of the Rheumatic Diseases

A three-year structural trial, and its primary endpoint is null: mean joint space width loss at 3 years was −0.638 mm on ASU and −0.672 mm on placebo (p = 0.72). A secondary analysis of 'progressors' — those losing at least 0.5 mm — did separate, 40.4% versus 50.3% (p = 0.040). The trial's other progressor definition, which counts a total hip replacement as progression, gave 42.2% versus 51.4% (p = 0.054), and hip replacement itself was numerically more common on ASU (23.3% versus 18.7%). No difference on any clinical outcome. Adverse events, serious adverse events and withdrawals for safety were alike in both groups.

Population

399 patients with symptomatic hip osteoarthritis, minimum joint space width 1-4 mm, randomised; 345 in the full analysis set

Intervention

300 mg/day ASU-Expanscience for 3 years

Comparator

Placebo

Limitations

A responder-threshold secondary reaching p = 0.040 after a null continuous primary is the weakest form of a positive structural claim, and that responder analysis was added by a protocol amendment several years into the trial, before unblinding, rather than planned from the start. The authors themselves say the effect is 'to be confirmed' and its clinical relevance 'requires further assessment'. Joint space measured manually with a graduated magnifying glass. Sponsored by Laboratoires Expanscience, which makes the preparation; three of the twelve authors are full-time employees of the company and the other nine all declare payments from it.