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.
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
All four methods compared well with respect to reliabilities. However, the Verbruggen and Kallman methods performed better. The method most sensitive to change was the Kallman method, followed by Verbruggen and global scores. This study also suggests that structural changes could be detected in hand OA over a 1-year period.
Objective. To evaluate factors influencing orthopedic surgeons' decision in daily practice to recommend or not recommend total hip arthroplasty (THA) in patients with hip osteoarthritis (OA). Methods. General practitioners and rheumatologists were asked to prospectively include 1 patient with hip OA for whom a consultation with an orthopedic surgeon was planned to determine whether or not THA was indicated. The following variables were obtained: age, sex, occupational status, body mass index, comorbidities, duration of hip OA, patient's global assessment, Western Ontario and McMaster Universities Osteoarthritis Index pain and functioning subscale scores, New Zealand score, quality of life, and structural parameters on radiographs. The surgeon's decision was obtained by followup questionnaires. Statistical analysis evaluated potential predictors of the surgeon's decision (indication for THA within the next 6 months, yes or no) using univariate and multivariate analysis. Results. A total of 558 patients were included (249 men, 300 women, mean age 68.4 years, mean disease duration 4.9 years). The surgeon's decision, available for 486 patients, was to prescribe THA in 60.7% of patients. On multivariate analysis, the variables related to the surgeon's decision were the presence or absence of severe cardiovascular disease, Short Form 12 physical subscale score, and amount of joint space narrowing. Conclusion. While the amount of structural degradation is only slightly or not at all taken into account in numerous criteria and/or recommendations on indications for THA, it is an independent predictor of the surgeon's decision in daily practice. Such a discrepancy should be evaluated and understood in further studies.
ObjectiveTo determine whether cardiometabolic factors are associated with hand osteoarthritis (HOA) symptoms, radiographic severity and progression in a post hoc analysis of the phase III Strontium ranelate Efficacy in Knee OsteoarthrItis triAl (SEKOIA) trial, designed to determine the effect of strontium ranelate on knee osteoarthritis (OA).MethodsAmong the 1683 patients randomised in the SEKOIA study, 869 with radiographic HOA at baseline (rHOA≥2 joints with Kellgren-Lawrence grade ≥2) were included in a cross-sectional analysis. For longitudinal study, we included only the 307 patients with rHOA at baseline from the placebo group. We evaluated whether baseline symptomatic HOA, radiographic severity and clinical and rHOA progression were associated with coronary heart disease and/or metabolic diseases (obesity, diabetes and hypertension, dyslipidaemia) by multivariate regression analysis.ResultsAt baseline, 869 patients (72% women) were included in the cross-sectional analysis; 26% were symptomatic. On multivariate analysis, symptomatic HOA was associated with coronary heart disease (OR 3.59, 95% CI (1.78 to 7.26)) but not metabolic diseases. After a mean follow-up of 2.6 years, for the 307 participants in the placebo group, on multivariate analysis, worse clinical HOA outcome was associated with coronary heart disease (OR 2.91, 95% CI (1.02 to 8.26)). The slow radiographic progression did not allow for revealing any associated factors.ConclusionsSymptomatic HOA and worse HOA clinical course are associated with coronary heart disease. These results strengthen the systemic component of HOA and the association between OA pain and cardiac events.Trial registration numberISRCTN41323372.
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