Antibiotics for the treatment of leptospirosis: systematic review and meta-analysis of controlled trials

Leptospirosis is a zoonotic disease prevalent mainly in developing countries and is associated with high case fatality. Antibiotics especially penicillin are the mainstay of treatment for a suspected or confirm case of leptospirosis but role of Penicillin has not been evaluated systematically in the light of current evidence. The present systematic review and meta-analysis is done to evaluate the role of antibiotics in the treatment of leptospirosis. Parallel group clinical trials involving use of penicillin in treatment of leptospirosis were searched from all available sources. Ten clinical trials were found suitable as per laid inclusion criteria eligible for present systematic review and five clinical trials were included in meta analysis. Clinical trials included for meta-analysis were compared on the basis of mortality, fever days, numbers of patients presenting with oliguria, and number of patients undergoing need based dialysis. Analysis was done by comprehensive meta analysis software 2. Qualitative outcomes are summarized as odds ratio and quantitative outcomes are summarized as standard mean difference with 95% confidence interval. Random and fixed models are used for analysis. There was no significant difference between penicillin group and controlled group for mortality [Odds ratio 1.59 [95% CI 0.59-4.29], P = 0.35], fever days [std difference in mean = -0.223 [95% CI 0.394-0.995], P = 0.358], number of patients presenting with oliguria [Odds ratio 1.795 [95% CI 0.325-9.929], P = 0.502], and number of patients who underwent need based dialysis [Odds ratio 1.587 [95% CI 0.919-2.731], P = 0.098]. Role of various antibiotics in treatment of leptospirosis is uncertain, and can be attributed to nonavailability of adequate clinical trials. Role of penicillin in the treatment of leptospirosis can be debated

Reporting statistics in clinical trials published in Indian journals: a survey

Clinical trials are having very important place in the hierarchy of evidence based medicine. It has been observed that current methods of use and reporting of statistics of clinical trials are responsible for errors in the interpretation of results. We decided to evaluate clinical trials published during 2007 and 2008 in four Indian journals to analyses statistical issues which may affect the interpretation of results. We analyzed all the clinical trials [46] published in Indian Pediatrics, Indian Journal of Pharmacology, Journal of Postgraduate Medicine and Indian Journal of Dermatology, Vanereology and Leprology in 2007-2008. Median number of end points reported in clinical trials as well as median number of end points which were used for testing of significance was four. Twenty one [45%] of trials reported repeated measurement. Eighteen [39%] trials had three or more than three treatment groups. median number of test of significance was 15. post hoc subgroup analysis was done in 19% [9] of trials. P value was the sole criteria for interpretation of results in most of the trials; confidence interval was calculated in 11 [23%] trials. Baseline comparison between the study groups was done in 41 [89%] trials. In all cases comparison was done by statistical tests. Exact sample size was calculated in 18 [39%] trials. There are great chances of committing error during the interpretation of results of these trials because of multiple treatment groups, repeated measurements of endpoints, multiple tests of significance, over reliability on P value and less use of confidence interval. Statistical methods available to reduce chances of errors should be used and result should be interpreted accordingly