ABSTRACT
BACKGROUND: Endoscopy scoring is a key component in the diagnosis of ulcerative colitis (UC) and Crohn's disease (CD). Variability in endoscopic scoring can impact patient trial eligibility and treatment effect measurement. In this study, we examine inter- and intraobserver variability of inflammatory bowel disease endoscopic scoring systems in a systematic review and meta-analysis. METHODS: We included observational studies that evaluated the inter- and intraobserver variability using UC (endoscopic Mayo Score [eMS], Ulcerative Colitis Endoscopic Index of Severity [UCEIS]) or CD (Crohn's Disease Endoscopic Index of Severity [CDEIS], Simple Endoscopic Score for Crohn's Disease [SES-CD]) systems among adults (≥18 years of age) and were published in English. The strength of agreement was categorized as fair, moderate, good, and very good. RESULTS: A total of 6003 records were identified. After screening, 13 studies were included in our analysis. The overall interobserver agreement rates were 0.58 for eMS, 0.66 for UCEIS, 0.80 for CDEIS, and 0.78 for SES-CD. The overall heterogeneity (I2) for these systems ranged from 93.2% to 99.2%. A few studies assessed the intraobserver agreement rate. The overall effect sizes were 0.75 for eMS, 0.87 for UCEIS, 0.89 for CDEIS, and 0.91 for SES-CD. CONCLUSIONS: The interobserver agreement rates for eMS, UCEIS, CDEIS, and SES-CD ranged from moderate to good. The intraobserver agreement rates for eMS, UCEIS, CDEIS, and SES-CD ranged from good to very good. Solutions to improve interobserver agreement could allow for more accurate patient assessment, leading to richer, more accurate clinical management and clinical trial data.
This study examined the inter- and intraobserver variability of inflammatory bowel disease endoscopic scoring systems (endoscopic Mayo Score, Ulcerative Colitis Endoscopic Index of Severity, Crohn's Disease Endoscopic Index of Severity, Simple Endoscopic Score for Crohn's Disease) in a systematic review and meta-analysis.
ABSTRACT
Moringa oleifera leaves were selected as a model due to their hundreds of health benefits. On the other hand, the powder of these leaves has exhibited poor flowability, low tensile strength, bitter taste, poor dissolution rate, and lack of information regarding dosage. These are the common hurdles and limitations in the adaptation of herbal-based medications. Therefore, a comprehensive study was planned to introduce herbal-based medicines into mainstream medicines by standardization according to the U.S. Food and Drug Administration (FDA) and international pharmaceutical standards. A Simplex Lattice Design (SLD) of Design Expert 8.0 software was used to formulate different concentrations of superdisintegrant, binder/diluent, and sweeteners. An Instron Universal Testing machine coupled with a 13 mm stainless cylindrical die was used to manufacture tablets by means of direct compression method at 20 kN applied force. Therefore, selection of excipients was made on the basis of their tensile strength, flowability, and taste-masking properties. Optimum formulation was tested on rabbits for toxicity and growth rate. All formulated tablets were evaluated on standard parameters for orally disintegrating tablets described by the Food and Drug Authority (U.S.). The optimum formulation fulfills all standard parameters such as hardness, disintegration time, friability, and dissolution rate. The present formulation showed no toxicity when tested on rabbits. The present study provides a fundamental understanding of the tableting characteristics of natural medicines. The present study provides information that will help to overcome the challenges.
