Clinical efficacy and safety of glucosamine, chondroitin sulphate, their combination, celecoxib or placebo taken to treat osteoarthritis of the knee: 2-year results from GAIT.

Background: Knee osteoarthritis (OA) is a major cause of pain and functional limitation in older adults, yet longer-term studies of medical treatment of OA are limited.

Objective: To evaluate the efficacy and safety of glucosamine and chondroitin sulphate (CS), alone or in combination, as well as celecoxib and placebo on painful knee OA over 2 years.

Methods: A 24-month, double-blind, placebo-controlled study, conducted at nine sites in the US ancillary to the Glucosamine/chondroitin Arthritis Intervention Trial, enrolled 662 patients with knee OA who satisfied radiographic criteria (Kellgren/Lawrence grade 2 or 3 changes and baseline joint space width of at least 2 mm).

The burden of osteoarthritis: clinical and quality-of-life issues.

Osteoarthritis (OA), the most common form of arthritis, is a potentially devastating joint disease, affecting 27 million US adults. Its pathophysiology is marked by a gradual degenerative process accompanied by low-grade inflammation, and, although there is a strong correlation between age and OA risk, the abnormal changes that occur in the articular cartilage of people with OA differ notably from the typical changes associated with joint aging in several important ways. Risk factors for OA are multiple and span a variety of risk domains, such as lifestyle issues (eg, obesity and engagement in manual labor), genetic predisposition, sex and ethnicity (risk is higher in women and African Americans), and comorbidities.

Assessing single joints in arthritis clinical trials.

The need to develop validated outcome measures to assess response to therapies in single joints has been recognized. In 2004, a task force was established to assess established and novel outcome measures in accordance with the OMERACT filter (truth, discrimination, and feasibility) for single joint assessment. This report describes the proceedings of the single joint assessment special interest group (SIG) at OMERACT 9, including an updated literature review of imaging of the knee joints, with a focus on the extent to which these modalities fulfill the OMERACT filter.

The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis: a report from the glucosamine/chondroitin arthritis intervention trial.

Objective: Osteoarthritis (OA) of the knee causes significant morbidity and current medical treatment is limited to symptom relief, while therapies able to slow structural damage remain elusive. This study was undertaken to evaluate the effect of glucosamine and chondroitin sulfate (CS), alone or in combination, as well as celecoxib and placebo on progressive loss of joint space width (JSW) in patients with knee OA.

Methods: A 24-month, double-blind, placebo-controlled study, conducted at 9 sites in the United States as part of the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), enrolled 572 patients with knee OA who satisfied radiographic criteria (Kellgren/Lawrence [K/L] grade 2 or grade 3 changes and JSW of at least 2 mm at baseline).

Open-label study of clarithromycin in patients with undifferentiated connective tissue disease.

Objective: The macrolide family of antibiotics (erythromycin, clarithromycin, and others), have both antimicrobial and immunomodulatory effects. This study explored the effect of clarithromycin on the clinical course of patients with undifferentiated connective tissue disease (UCTD) in a 12-week open-label study.

Methods: The diagnosis of UCTD was based on symptoms/signs of connective tissue disease, and the presence of 1 or more positive autoimmune disease tests, but with insufficient criteria to make a definitive diagnosis.

Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis.

Background: Glucosamine and chondroitin sulfate are used to treat osteoarthritis. The multicenter, double-blind, placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis.

Methods: We randomly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily, 1200 mg of chondroitin sulfate daily, both glucosamine and chondroitin sulfate, 200 mg of celecoxib daily, or placebo for 24 weeks.

An overview of treatment options for persistent shoulder pain.

Persistent shoulder pain (PSP) associated with rotator cuff disorders, glenohumeral osteoarthritis (OA), or adhesive capsulitis is a very common, often difficult-to-treat condition. The first step in nonoperative therapy for PSP in most patients is physical therapy, rest, and use of various heat modalities. Relief of pain from exercises aimed at improving strength and range of motion may be enhanced by administration of oral analgesics.

State-of-the-art disease-modifying osteoarthritis drugs.

Significant advances have occurred in the symptomatic management of osteoarthritis over the past several decades. However, the development of so called disease-modifying osteoarthritis drugs is in a more formative stage. Although increased knowledge of osteoarthritis pathophysiologic pathways provides more rational opportunity for targeting specific elements of the degenerative process, limitations in our ability to measure disease progression/regression hamper assessment.

Hyaluronan therapy: looking toward the future.

Hyaluronan therapy has numerous medical applications, including the treatment of joint arthropathies, wound healing, prevention of postsurgical adhesions, treatment of urinary incontinence, ophthalmic surgery, and tissue augmentation and engineering. Studies have been conducted and are ongoing to evaluate the efficacy of intra-articular hyaluronans in disease modification in osteoarthritis of the knee; efficacy in disease states other than osteoarthritis; as adjunct therapy after joint surgery; and in joints other than the knee--namely the shoulder, hand, hip, temporomandibular joint, spine, foot, and ankle. Preliminary results have been promising and parallel what has been found in treatment of osteoarthritis of the knee.

Intra-articular hyaluronans in knee osteoarthritis: rationale and practical considerations.

Intra-articular hyaluronans are used to treat pain associated with osteoarthritis of the knee. Many controlled clinical studies have demonstrated their efficacy for this indication. The rationale for the use of hyaluronans therapeutically is based on observations that hyaluronic acid is an important component of the synovial fluid acting as a cushion and lubricant for the joint and also serving as a major component of the extracellular matrix of the cartilage, helping to enhance the ability of cartilage to resist shear and maintain a resiliency to compression.

Nonsurgical approaches to pain management for osteoarthritis of the knee.

The effective management of pain in osteoarthritis of the knee is complex and subject to many treatment- and patient-related variables. This article reviews the broad range of nonsurgical options available to the clinician, which include pharmacologic and nonpharmacologic measures such as weight loss, physical and occupational therapy, exercises, and the use of assistive devices. Pharmacotherapeutic options for osteoarthritis of the knee include the use of oral agents, topical creams, and intra-articular injections of hyaluronans or glucocorticoids.

Understanding osteoarthritis of the knee--causes and effects.

Osteoarthritis of the knee is common, increasing with age in both women and men, but is generally more prevalent in women following the fourth decade. Osteoarthritis may be primary/idiopathic or secondary as a consequence of trauma, surgery, infection, or another disease process. Normal articular cartilage is composed of an extracellular matrix and chondrocytes.

Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee.

Nonprescription doses of naproxen sodium, acetaminophen, and placebo were compared to determine their efficacy and safety in osteoarthritis of the knee. In two identical multicenter, randomized, double-blind, placebo-controlled, multidose, parallel-design studies, patients with osteoarthritis aged (mean +/- SD) 60.6 +/- 12.

American pain society pain questionnaire and other pain measures in the assessment of osteoarthritis pain: a pooled analysis of three celecoxib pivotal studies.

The aim of this study was to evaluate the utility of the American Pain Society (APS) questionnaire in the assessment of osteoarthritis (OA) pain and to determine the onset of action of celecoxib in the treatment of acute flare pain in patients with OA of the knee or hip. Pooled data from three pivotal, randomized, double-blind, placebo-controlled, 12-week trials of patients with OA who exhibited a flare of disease activity after withdrawal of nonsteroidal anti-inflammatory drug or analgesic therapy were evaluated. Patients completed the APS Pain Measure Questionnaire, which evaluates pain intensity and quality of life, at baseline and daily for the first 7 days of therapy.