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We conclude that significantly more patients in novel combination drug group compared to tramadol/paracetamol only group had a superior analgesic effect with lesser adverse reactions.

Background: Chronic Kidney Disease (CKD) is one of the major health disorders associated with significant morbidity and mortality. This was a 6 week’s interventional study of orally administered, symbiotic supplement (probiotic with prebiotic) in stage 5D patients of chronic kidney disease (CKD) on twice a week hemodialysis. The objective was to look for safety of symbiotics (Nitrophage ForteTM) and for its anti-inflammatory effects measured by serum hsCRP (Highly specific C reactive protein), IL-6 (Interleukin- 6) and TNF-α (Tumour Necrosis Factor- α) levels. This translating to improvement in the Quality of life (QOL) assessed using SF-36 QOL questionnaire and Subjective Global Assessment (SGA) scoring. Methods: Subjects on twice a week dialysis for at least 3 months were included. Parameters at baseline (representing previous 3 months) were compared to that at the end of treatment. Oral supplementation of strain specific and unique composition of symbiotic sachet supplementation were administered twice daily containing Lactobacillus acidophilus 400mg, Bifidobacterium longumm 400mg, Streptococcus thermophilus with Fructooligosaccharide 100mg adding to 1 gram was given for 6 weeks.Results: 38 patients out of total 48 enrolled completed the study. Symbiotic therapy was found to be well tolerated with no significant adverse effects. 60.52%, 55.26%, 44.7% of the patients had a decrease in hsCRP, TNF-α and IL-6 respectively. Among responders hsCRP and TNF-α showed significant decrease in levels from the baseline (p <0.05). Modified SF-36 QOL questionnaire mean score revealed significant improvement in general health (p < 0.05). Among secondary parameters renal biomarkers like urea, BUN and sodium showed statistically significant decrease (p <0.05).Conclusions: This study establishes the safety and anti-inflammatory efficacy of this symbiotic supplement. To our knowledge this is the first study looking at anti-inflammatory role of symbiotic in CKD 5D Patients. A placebo controlled, double blinded study with a larger sample size is warranted in future to further establish these findings.

Objective: The primary objective of the study was to assess the awareness, knowledge, and practice of pharmacovigilance (PV) among the practicing doctors. The secondary objective was to ascertain the reason for underreporting of adverse drug reactions (ADRs) in India. Methods:A cross-sectional study was conducted using a pretested and validated questionnaire. The questionnaire was designed to assess these parameters of PV. These questionnaires were distributed among 90 doctors to ascertain the answers. In addition, the same parameters were reassessed (post-questionnaires) after sensitizing the doctors about PV. Results:Only 52 doctors took the posttest, a response rate of 57%. The mean awareness, knowledge, and practice of PV among doctors were 4.70, 3.60, and 2.90, respectively, which significantly increased in post-test questionnaire (p<0.05). The Pearson correlations revealed that the level of awareness among the respondents was significantly related to the knowledge and the practice of PV, linearly, and positively. In other words, higher the awareness more was the knowledge and better was the methods of application. The most common factor discouraging doctors from reporting ADRs was they found it difficult to decide whether ADR has occurred or not (32.69%). Conclusion:There was a significant positive correlation between awareness, knowledge, and practice of PV. In spite of these findings, the ADR reporting rate is negligible in India. To bring about a strong culture of reporting among doctors, it is mandatory to continuously expose doctors to the concepts of PV by continuous medical education, workshops, seminars and to make reporting mandatory in India.