Evaluation of efficacy and safety of a herbal formulation Cystone in the management of urolithiasis: Meta-analysis of 50 clinical studies

摘要

Systematic reviews form a potential method for overcoming the barriers faced by clinicians when trying to access and interpret evidence to help in their practice. Clinical trials give the evidence regarding efficacy/safety or otherwise about a treatment model or medication. These studies need to be looked at with a perspective of creating evidence-based healthcare. Meta-analysis is a process of combining study results that can be used to draw conclusions about therapeutic effectiveness or otherwise. The aim of the study is to carry out the meta-analysis of 50 clinical trials for identifying the efficacy and safety of Cystone in urolithiasis. In all, 50 clinical studies done at various centers between 1954 -and 2004 have been taken into account, which involved 3037 patients (Cystone: 1837 and others: 1200 of either sex). From each study, the demographic data of patients on entry was tabulated. The duration of treatment has varied from 2 weeks to 2 years and in most of the studies, except in pediatric patients, Cystone was used in the dose of 2 tablets thrice daily. Parameters such as size of renal calculi, clearance of calculi with reference to location of calculi, symptomatic relief and urinary excretion of stone forming constituents were evaluated. Statistical analysis was done using Fisher’s exact test, paired ‘t’ test or repeated measures of ANOVA followed by Dunnett’s multiple comparison test. The minimum level of significance was fixed at 95% confidence limit and a 2-sided p value of <0.05 was considered significant. Statistical analysis was performed using GraphPad Prism software (Version 4.01). Cystone is efficacious in management of urolithiasis especially when the site of urinary stone is ureter. This study indicated a significant symptomatic relief in Cystone group. Cystone treatment revealed a significant reduction in 24-hour urinary excretion of oxalate (p<0.01), uric acid (p<0.01), calcium (p<0.01), magnesium, and phosphorus with a significant increase in urine volume (p<0.01). This analysis also indicates the safety profile of Cystone. The adverse effects have been dyspepsia, flatulence and gastric irritation, which did not necessitate the withdrawal of the drug. There have been no reports of any serious adverse effects. Similarly, there is no report of mortality due to Cystone. The outcome of 50 clinical studies indicated that Cystone is useful in the management of urolithiasis as revealed by the clearance of calculi , symptomatic relief, increased urine volume, and reduction in the stone forming constituents in urine with negligible adverse effects. Introduction Systematic reviews form a potential method for overcoming the barriers faced by clinicians when trying to access and interpret evidence to help in their practice. Evidence-based healthcare is the integration of best research evidence with clinical expertise and patient values. Using evidence from a reliable research to inform healthcare decisions has the potential to ensure best practice and reduce variation in healthcare deliveries. However, incorporating research into practice is time consuming and so methods that can facilitate easy access to evidence for a busy clinician is required.1 Clinical trials give the evidence regarding efficacy/safety or otherwise about a treatment model or medication. These studies need to be looked at with a perspective of creating evidence-based healthcare. Meta-analysis is a process of combining study results that can be used to draw conclusions about therapeutic effectiveness or otherwise.2 Meta-analysis can be performed when the studies are similar with respect to population outcome and intervention.1 Meta-analysis (quantitative synthesis or overview analysis) is a term used to describe quantitative methods for combining information across different studies.2 A meta-analysis is a two-stage process; the first stage is the extraction of data from each study and the calculation of the result for each study. The second st