J Rheumatol
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Randomized Controlled Trial
An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia.
To evaluate the efficacy and safety of pregabalin monotherapy versus placebo for symptomatic pain relief and improvement of patient global assessment in patients with fibromyalgia (FM) enrolled from countries outside the United States. ⋯ Pregabalin demonstrated modest efficacy in pain, global assessment, and function in FM at 450 mg/day, and improved sleep across all dose levels, but it did not provide consistent evidence of benefit at 300 and 600 mg/day in this study. Pregabalin was generally well tolerated for the treatment of FM. (Clinical trial registry NCT00333866).
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Randomized Controlled Trial
Effects of bedtime very low dose cyclobenzaprine on symptoms and sleep physiology in patients with fibromyalgia syndrome: a double-blind randomized placebo-controlled study.
To determine the effects of bedtime very low dose (VLD) cyclobenzaprine (CBP) on symptoms and sleep physiology of patients with fibromyalgia (FM), unrefreshing sleep, and the α-nonREM sleep electroencephalographic (EEG) anomaly at screening. ⋯ Bedtime VLD CBP treatment improved core FM symptoms. Nights with CAP(A2+A3(Norm)) ≤ 33% may provide a biomarker for assessing treatment effects on nonrestorative sleep and associated fatigue and mood symptoms in persons with FM.
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Multicenter Study
Measuring pain in systemic sclerosis: comparison of the short-form McGill Pain Questionnaire versus a single-item measure of pain.
Studies of pain in systemic sclerosis (SSc) have used a variety of measures, including single-item measures and the 15-item short-form McGill Pain Questionnaire (MPQ-SF). The objective of our study was to compare the performance of the MPQ-SF to a single-item pain numerical rating scale (NRS) and determine whether the MPQ-SF effectively differentiates between sensory and affective components of pain in SSc. ⋯ The substantial overlap between sensory and affective subscales of the MPQ-SF and the similarity of the MPQ-SF and NRS pain measures compared to other patient-reported outcomes suggest that the 15-item MPQ-SF does not provide tangible advantages compared to the single-item pain NRS. These findings support recommendations to use a single-item NRS pain measure in SSc as it is less burdensome to patients than the MPQ-SF.
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Comparative Study Clinical Trial
Adalimumab or cyclosporine as monotherapy and in combination in severe psoriatic arthritis: results from a prospective 12-month nonrandomized unblinded clinical trial.
To assess the efficacy and safety of adalimumab or cyclosporine (CYC) as monotherapy or combination therapy for patients with active psoriatic arthritis (PsA), despite methotrexate (MTX) therapy. ⋯ The combination of adalimumab and CYC is safe and seemed to produce major improvement in both clinical and serological variables in patients with severely active PsA and inadequate response to MTX.