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Analysis 1.3. Comparison 1 Celecoxib versus placebo, Outcome 3 Number withdrawn due to adverse events.. .. Analysis 1.4. Comparison 1 Celecoxib versus placebo, Outcome 4 Number experiencing any serious adverse events.. Analysis 1.5. Comparison 1 Celecoxib versus placebo, Outcome 5 Number experiencing gastro-intestinal events
Analysis 1.3. Comparison 1 Celecoxib versus placebo, Outcome 3 Number withdrawn due to adverse events.. .. Analysis 1.4. Comparison 1 Celecoxib versus placebo, Outcome 4 Number experiencing any serious adverse events.. Analysis 1.5. Comparison 1 Celecoxib versus placebo, Outcome 5 Number experiencing gastro-intestinal events
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:To assess the benefits and harms of oral strontium ranelate to treat osteoarthritis. B A C K G R O U N D Description of the conditionOsteoarthritis is a common, age-related, heterogeneous group of disorders characterised by focal areas of loss of articular cartilage in synovial joints, and structural changes such as subchondral bone remodelling and osteophytic formations (Dieppe 2005; Sarmanova 2016). Although osteoarthritis can affect any joint, the most commonly affected are the knees, hips, spine, and hands (Van der Kraan 2016). Osteoarthritis is classified as either primary/idiopathic (cartilage degeneration with no underlying abnormality) or secondary (as a result of repetitive motion, trauma, inflammatory arthritis, or congenital abnormalities) (OARSI 2015). Clinical manifestations of osteoarthritis include impaired mobility, as well as joint pain, inflammation, tenderness, stiffness, and crepitation (Van der Kraan 2016). Osteoarthritis is frequently associated with physical impairment and poor quality of life. In 2010, the estimated worldwide prevalence of radiographically confirmed and symptomatic knee and hip osteoarthritis was 3.8% and 0.85%, respectively (Cross 2014). The progressive and disabling nature of this disorder contributes significantly to the burden of disease for the individual person as well as for the health system. Among 291 clinical conditions included in the Global Disease Burden 2010 study, hip and knee osteoarthritis ranked 11th in terms of years lived with disability (YLDs) and 38th in terms of overall burden measured by disability-adjusted life years (DALYs) (Cross 2014).
Background: Osteoarthritis (OA) is one of the most common forms of arthritis which is caused by the degeneration of joint cartilage. It is often associated with disability and leads to impairment of quality of life. The clinical picture is similar to the disease Sandhigatavata described in Ayurveda (one among the Vatavyadhi) and is characterized by symptoms such as Sandhi Shoola (joint pain), Sandhishopha (swelling of joint), and Prasarana-Akunchana-Ashakti (difficulty in movements of the joint). The safety of 10 Ayurvedic classical formulations most commonly used in OA was clinically evaluated and the findings are provided in this article. Aim and objective: Critical analysis of clinical safety outcomes of classical Ayurvedic formulations, viz. Vatari Guggulu, Yogaraj Guggulu, Punarnava Guggulu, Maharasnadi Kwatha, Dashmoola Ghrita, Narayan Taila, Kottamchukkadi Taila, Gandharvahasta Taila, Dhanwantara Taila, and Ksheerbala Taila in patients of OA, generated through studies at different Institutes of Central Council for Research in Ayurvedic Sciences (CCRAS). Materials and methods: Data collected from four different clinical studies completed in multiple centers of CCRAS were retrospectively evaluated to assess the safety profile of 10 formulations that are commonly used in OA. Evaluation of safety was done by analyzing liver function tests (LFT) and renal function tests (RFT) before and after the trial period. Paired sample t-test was used to compare mean change from baseline to the 84th day. A p value of <0.05 was considered significant. Conclusion: The findings in four different clinical studies reveal that all ten formulations are clinically safe in patients belonging to various age groups, gender, geographical area, and Prakriti.
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