Propiedades Medicas Del Cartílago De Tiburón

Chondroitin for osteoarthritis [protocol]

Singh JA, Wilt TJ, Mcdonald R
This protocol should be cited as: Singh JA, Wilt TJ, Mcdonald R. Chondroitin for osteoarthritis (Protocol for a Cochrane Review). In: The Cochrane Library, Issue 1, 2006. Oxford: Update Software.

Background

Osteoarthritis is the most common of all joint disorders and is one of the leading causes of disability in theUSA (Gabriel 1995; Peyron 1992). Pathologically, osteoarthritis is characterized by softening and degeneration of articular cartilage and formation of new bone at joint margins and capsular fibrosis. Clinically, osteoarthritis manifests as joint pain, stiffness, deformity and loss of function. Clinical and radiographic surveys have found that the prevalence of osteoarthritis increases with agefrom 1% in people 18 years) with OA of any joint. Subgroup analysis for safety and efficacy will be done for age, race and gender.

Types of intervention

• Chondroitin arm:
• Use of oralchondroitin alone or in combination with glucosamine
• Comparator arm:
• Placebo or active medications including NSAID, analgesics (e.g. Acetaminophen), opioid pain-relieving, glucosamine orother "herbal" medication

Types of outcome measures

• Primary outcomes:
• 1. Mean change in Pain: Pain subscale of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) (Bellamy 1988), rest pain and pain on motion in chondroitin vs. control/comparator
• 2. Percent achieving Minimal Clinically Important Improvement (MCII) on WOMAC (Tubach 2005) in chondroitin vs.control/comparator
• Secondary Outcomes:
• 1. Clinical Efficacy outcomes:
• a. Pain on walking for index joint, pain in index joint during activities other than walking
• b. Physical function - Both performance-based (e.g., 50-foot walk) and patient-based (WOMAC (total and subscale scores))
• c. Patient and physician global assessment
• d. OMERACT-OARSI responsecriteria (Dougados 2000, Pham 2004)
• e. Need for use of concomitant medications
• f. Lequesne index (Lequesne 1997)
• g. Need for joint surgery or arthroscopy
• h. Quality of life as assessed by specific (Health Assessment Questionnaire (HAQ)) and generic questionnaires (Short-Form-36 (SF-36) and others)
• 2. Radiographic outcomes: Radiological changes in joint spacewidth/narrowing in mm, or other radiographic criteria
• 3. Safety will be measured by:
• a. Specific adverse effects (gastrointestinal, cardiac, renal, hematologic and other side-effects) and total number of adverse effects/events
• b. Total number of withdrawals and withdrawals judged to be due to adverse effects in each group
• c. Number of deaths.
We will search the Food and DrugAdministration(FDA) web site for obtaining the adverse effect data.
• Pharmacoeconomics:
• Wherever data is applicable, we will perform analyses comparing chondroitin to comparator regarding the cost of drugs per month and the number needed to treat (NNT) to prevent one patient from having an adverse event and NNT to have one patient achieve MCII on WOMAC. We will analyze direct medicaland nonmedical costs as well as indirect medical costs in the analysis and report indirect costs (productivity losses) separately (Gabriel 2003).

Search strategy for identification of studies

Electronic Searches: The trials search coordinator (TSC) will carry out the searches of The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS, CINAHL, AMED and CurrentControlled Trials. There will be no language or date restrictions in the search for trials and the databases will be searched from inception to present date. The search will be updated before the completion of the review to ensure inclusion of new trialsin the intervening period.
Manual Searches: The reference lists of the studies included in the review will be searched for further trials. Since...