Symptom-modifying effects of oral avocado/soybean unsaponifiables in routine treatment of knee osteoarthritis in Poland. An open, prospective observational study of patients adherent to a 6-month treatment

Abstract

ObjectivesObservational studies provide insights into real-life situations. Therefore, we assessed the effects of oral avocado/soybean unsaponifiable (ASU) capsules on pain relief and functional ability in patients, while they were receiving a routine treatment for knee osteoarthritis (OA).Material and methodsAn open, prospective, observational 6-month study was conducted in 99 centers in Poland in a group of 4822 patients with symptomatic knee OA receiving one 300 mg ASU capsule/day as a routine medication. The patients had no diagnoses of other rheumatic diseases and were not treated with other symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Data on OA symptoms and therapy were collected from the initiation of ASU treatment (visit 0) and during 3 consecutive control visits performed every 2 months (visits 1–3). Functional Lequesne index, severity of joint pain of one symptomatic knee (Laitinen index and VAS), use of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), adherence to treatment and adverse events were evaluated and recorded using electronic Case Report Forms.ResultsFour thousand one hundred and eighty-six patients (86.8%) attended all 4 visits. In 94.2% of patients (mean age 60.7 ±11.6 years SD, 73.4% female) at least one OA risk factor was identified. There was a significant improvement in functional ability between the last and baseline visits as evidenced by the median Lequesne index decreasing from 8 to 4 points (p < 0.001). Measures of pain intensity also fell significantly (p < 0.001) throughout the study: median Laitinen score decreased from 6 to 3 points, median pain at rest VAS – from 1.8 to 0 cm and median pain during walking VAS – from 5.6 to 1.9 cm. The significant differences were also noted between consecutive visits. The proportion of patients using analgesics and NSAIDs declined from 58.8% at the baseline visit to 24.9% at the last visit 3 (p < 0.001). Defined daily dose of NSAIDs decreased significantly from 1 at the baseline visit to 0.67 at the visit 3. Severe adverse events associated with ASU treatment were not observed.ConclusionsIt was the first observational study in Poland evaluating the effects of routine knee OA treatment with oral ASU. Only a small group of patients (13.2%) treated with ASU discontinued the study. The majority of patients adherent to the ASU treatment for 6 months showed gradual alleviation of joint pain, improvement in functional ability and a significant reduction in NSAIDs intake.

A Comparison between Avocado-Soybean Unsaponifiables and Celecoxib on Serum Levels of Cartilage Oligomeric Matrix Protein in Patients with Knee Osteoarthritis

“…Li et al reported significantly higher COMP levels associated with a higher Kellgren-Lawrence (K-L) grade. They suggested COMP as an appropriate diagnostic marker for subclinical knee OA but did not report the effect of celecoxib on COMP [21]; thus, their findings were not comparable to the current results.…”

“…However, ASU has been suggested as a useful treatment choice for symptomatic OA due to its anabolic, anticatabolic, chondroprotective, and anti-inflammatory effects [11]. At the clinical level, administration of ASU to OA patients significantly reduced patients' symptoms, improved their joint function, and resulted in reduced consumption of NSAIDs [11,21,22]. Although the usefulness of ASU for the treatment of OA has been reported by several studies, systematic reviews suggest better efficacy for knee OA compared with hip OA and conclude that its exact efficacy and safety, compared with routinely prescribed drugs, is still controversial [23].…”

Efficacy and safety of avocado‐soybean unsaponifiables for the treatment of hip and knee osteoarthritis: A systematic review and meta‐analysis of randomized placebo‐controlled trials

“…13,15 Some observational and clinical studies have shown a significant improvement in functional ability and joint pain accompanied by a reduction in the proportion of patients using analgesics and NSAIDs from 58.8% to 24.9%. [16][17][18] Previous systematic reviews and metaanalysis have evaluated ASU in the treatment of OA. However, these studies were focused on several nutraceuticals and dietary supplements including ASU.…”

Evaluation of the novel avocado/soybean unsaponifiable Arthrocen to alter joint pain and inflammation in a rat model of osteoarthritis

“…The effect of ASU on OA pain is somewhat unclear. In horses, ASU was found to have no effect on experimentally-induced lameness [ 8 ]; however, a mild improvement in symptoms has been observed in OA patients taking ASU for several months [ 9 , 10 ]. The aim of the current study was to evaluate the effect of a commonly used ASU, Arthrocen, on joint pain and inflammation using a rodent model of OA.…”