Rheumatology international
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of PG201 (Layla(®)) and celecoxib in the treatment of symptomatic knee osteoarthritis: a double-blinded, randomized, multi-center, active drug comparative, parallel-group, non-inferiority, phase III study.
The objectives of the study are to demonstrate the non-inferiority of PG201 (Layla(®)) 600 mg in comparison with celecoxib 200 mg for the treatment of symptomatic knee osteoarthritis (OA). In total, 309 patients were randomly assigned to receive either the test drug, PG201 600 mg (n = 154) or celecoxib 200 mg (n = 155). The primary efficacy variable was improvement in mean 100-mm pain VAS score from baseline to the final visit (week 8), and this value was compared between the 2 treatment groups. ⋯ These results met pre-specified criteria for non-inferiority for both the intent-to-treat and per-protocol populations. PG201 600 mg and celecoxib 200 mg were both well tolerated and no statistically significant differences in the tolerability profile between the groups. PG201 600 mg was as effective and safe as celecoxib 200 mg in the treatment of symptomatic knee OA and might be a useful new medication for the treatment of symptomatic knee OA.
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Greater trochanteric pain syndrome (GTPS) is a pathology that can involve the trochanteric bursa or the tendons which attach to the greater trochanter. To clarify the potential importance of bursa versus tendon pathology and of substance P (SP) in contributing to pain in this condition tendon and bursa tissue biopsies were obtained from 34 patients with GTPS and 29 control subjects. ⋯ There was a significantly greater presence of SP in the bursa (frequency: 9/12 vs. 6/16, p = 0.047), but not in the tendon (8/12 vs. 8/15, p = 0.484) of subjects with GTPS compared to controls. An increased presence of SP in the trochanteric bursa may be related to the pain associated with GTPS.
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The aims of this study were to investigate the effect of exercise therapy on the oxidative stress in fibromyalgia patients and relationship between oxidative stress and fibromyalgia symptoms. Thirty women diagnosed with fibromyalgia according to the American College of Rheumatology preliminary criteria, and 23 healthy women whose age- and weight-matched women were enrolled the study. Pain intensity with visual analog scale (VAS), the number of tender points, the fibromyalgia impact questionnaire (FIQ), the Beck depression inventory (BDI) were evaluated. ⋯ The exercise improved all parameters of oxidative stress and antioxidant parameters. Also, all clinical parameters were improved with exercise. We should focus on oxidative stress in the treatment for fibromyalgia with the main objective of reducing oxidative load.