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Objective: Nimesulide has been evaluated in numerous clinical studies in the management of a variety of acute painful conditions. However, there is limited Indian data available on the nimesulide/paracetamol fixed drug combination (FDC). Hence, an open-label prospective multicentric study was conducted to evaluate the safety and efficacy of this FDC in the management of acute painful conditions in real-world settings. Materials and methods: A prospective, open-label, and multicenter study conducted at 24 centers across Indian patients with acute painful conditions due to trauma, tendinitis, myalgia, low backache, sprains, pulled muscle, soft tissue injury, dental pain, and dental procedure/surgery. Nimesulide/paracetamol FDC was prescribed by clinicians as a part of routine practice. The effectiveness was evaluated on the numerical rating scale (NRS), that is, pain intensity at rest and movement, and the physician/patient global assessment scale (GAS) among the subgroups of acute painful conditions like myalgia, dental pain, low backache, etc. Hepatic safety was also evaluated among the subgroups at the end of treatment. Result: A total of 464 patients were included in the study. The reduction in NRS score at rest and movement during treatment duration across different types of pain was statistically significant (p < 0.001). Pain reduction was evident as per patient and physician GAS at the end of treatment in all indications. No clinically significant difference was found in liver parameters at the end of the study. Nimesulide/paracetamol (FDC) was well tolerated across all the subgroups. Conclusion: Nimesulide/paracetamol FDC was found to be well-tolerated and effective in pain management across all acute painful conditions in a real-world setting without any hepatic safety concerns.
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Background: Nimesulide shows preferential inhibition for the cyclooxygenase-2 (COX-2) enzyme, which blocks the formation of prostaglandins critical in pain and inflammatory pathways. Few studies in the past have reported rare and unpredictable hepatic effects with nimesulide. The present study aimed to evaluate the efficacy and safety of nimesulide/paracetamol (100 mg + 325 mg) fixed-dose combination twice a day for 2 weeks in the management of acute pain in Indian population. Materials and methods: This was a multicenter study, performed on 500 patients, by 24 experienced physicians across India. The primary outcome assessed clinical safety at 2 weeks for mild/serious adverse effects (AEs), change in liver function tests (LFTs), serum bilirubin and alkaline phosphatase levels. The secondary outcomes assessed the clinical effectiveness in reduction of pain at rest and at movement. Results: Analysis of LFT at 2 weeks showed a slight increase (mean change) in the aspartate transaminase {-0.73 [95% confidence interval (CI) -1.54, 0.09; p = 0.081]}, alanine transaminase [-1.73 (95% CI -2.82, -0.64; p = 0.002)], serum bilirubin [-0.02 (95% CI -0.04, -0.001; p = 0.018)] and alkaline phosphatase levels [-1.92 (95% CI -5.84, 2; p = 0.336), not exceeding the normal range. Only one in 500 patients reported AEs. The numerical rating scale (NRS) scores for intensity of pain at rest and at movement at 2 weeks, ?7 days and >7 days were 68.38%, 68.44% and 68.39%; and 65.43%, 64.60% and 66.02%, respectively. An improvement of 96.6% was observed in patient global assessment scale (GAS) and 97.2% in physician GAS. Conclusion: Nimesulide/paracetamol combination was safe, effective and well-tolerated in acute pain conditions and did not lead to clinically significant changes in liver parameters indicating hepatic safety.
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Introduction: Healthcare is probably the last frontier that Artificial Intelligence (AI) has not conquered. Cultural factors significantly impact the way healthcare is accessed and delivered. Affordability, educational and social status, physician training, lack of physician talent in difficult to serve areas all contribute to this. Cultural perspectives of clinicians and clinical habits during the human-computer interaction and inherent suspicion of lack of human to human interaction contribute to perceptions of inhibition in the adoption of AI in routine medical practice. In this paper we examine whether measurable cultural dimensions would impact the adoption of AI in routine clinical practice. Materials and Methods: Qualified Medical Professionals (n=206) were chosen randomly and an online secure survey was conducted consisting of 26 questions. 83% of respondents were from different parts of India, remaining 17 % from other countries like USA,Canada, UK, UAE, Oman, Zambia, Nigeria, Bangladesh, Vietnam and Japan. We defined four different cultural dimensions inspired by Hofstede’s cultural dimension theory and one dimension based on attitudes of clinicians towards technology in general. We measured the following: 1. Compliance distance (the degree of adherence to evidence based standards) 2. Collectivism vs Individualism (the sense of belonging to a group) 3. Long term vs Short term orientation (the idea of planning and thinking long term) 4. Uncertainty Avoidance (the degree of tolerance to uncertainty) 5. Technology Friendliness (the degree to which technology is perceived as being helpful) Results: We found that there were no differences in adoption of AI in clinical practices based on compliance, collectivism, and long term orientation. However, we found a correlation between the requirement for a face to face consultation (high uncertainty avoidance) and Non-adoption of AI. The results demonstrate that uncertainty avoidance hinder the acceptance of technology like telemedicine and AI alike. There were also no major differences in the adoption of AI based on any geographical variation, specialty or practice sector on the adoption of AI. Notably, tech savviness or technology friendliness did not affect the adoption of AI. We conclude that any useful AI technology which gives validated results could be adopted by clinicians in general and has potential to become a good screening measure in areas with poor healthcare access. Conclusion: Of the many cultural dimensions we studied, the only dimension that seemed to have an impact on the adoption of any technology including AI was the high uncertainty avoidance. Other dimensions did not impact the adoption of AI.
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"A Roadmap to Tackle the Challenge of Antimicrobial Resistance - A Joint meeting of Medical Societies in India" was organized as a pre-conference symposium of the 2 nd annual conference of the Clinical Infectious Disease Society (CIDSCON 2012) at Chennai on 24 th August. This was the first ever meeting of medical societies in India on issue of tackling resistance, with a plan to formulate a road map to tackle the global challenge of antimicrobial resistance from the Indian perspective. We had representatives from most medical societies in India, eminent policy makers from both central and state governments, representatives of World Health Organization, National Accreditation Board of Hospitals, Medical Council of India, Drug Controller General of India, and Indian Council of Medical Research along with well-known dignitaries in the Indian medical field. The meeting was attended by a large gathering of health care professionals. The meeting consisted of plenary and interactive discussion sessions designed to seek experience and views from a large range of health care professionals and included six international experts who shared action plans in their respective regions. The intention was to gain a broad consensus and range of opinions to guide formation of the road map. The ethos of the meeting was very much not to look back but rather to look forward and make joint efforts to tackle the menace of antibiotic resistance. The Chennai Declaration will be submitted to all stake holders.