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RCT · 2014 · n=399

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

Promisingcounts toward this tier

The longest and most ambitious trial in this topic, 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). The pre-specified secondary analysis of 'progressors' — those losing at least 0.5 mm — did separate, 40% versus 50% (p = 0.040). No difference on any clinical outcome. Safety excellent.

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
The primary outcome failed. A responder-threshold secondary reaching p = 0.040 after a null continuous primary is the weakest form of a positive structural claim, and 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. No clinical benefit at 3 years.

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