Abstract
Purpose: The diagnosis of cow's milk (CM) allergy is a challenge. The Cow's Milk-related-Symptom-Score ($CoMiSS^{TM}$) was developed to offer primary health care providers a reliable diagnostic tool for CM related symptoms. The predictive prospective value of the $CoMiSS^{TM}$ was evaluated in three clinical trials. Methods: Pooled analyses of the three studies were conducted based on regressing the results of the month-1 challenge test on the month-1 $CoMiSS^{TM}$, adjusting for baseline $CoMiSS^{TM}$ using a logistic regression model. In addition a logistic regression model was also fitted to the month-1 challenge test result with the change in $CoMiSS^{TM}$ from baseline as a predictor. Results: Results suggest that infants having a low $CoMiSS^{TM}$ (median, 5) after 1 month dietary treatment free from intact CM protein have a significant risk of having a positive challenge test (odds ratio, 0.83; 95% confidence interval, 0.75-0.93; p=0.002). Pooled data suggest that the change in $CoMiSS^{TM}$ from baseline to month-1 can predict CM related symptoms as a confirmed diagnosis according to the challenge test at month-1. However, in order to validate such a tool, infants without CM related symptoms would also need to be enrolled in a validation trial. A concern is that it may not be ethical to expose healthy infants to a therapeutic formula and a challenge test. Conclusion: Pooled data analysis emphasizes that the $CoMiSS^{TM}$ has the potential to be of interest in infants suspected to have CM-related-symptoms. A prospective validation trial is needed.