| In their study, Indrio et al1 argued that prophylactic use of L reuteri during the first 3 months of life reduced not only the onset of functional gastrointestinal disorders but also the associated private and public management costs. Their study was a placebo-controlled trial. They used oil as placebo; however, the type of the oil used was not mentioned. Oils can change gut behavior and result in enhanced or decreased colic frequency based on their constituents. Furthermore, maternal diet has also been known as an influential factor in changing colic frequency.2-4 One might wonder if this was considered throughout the Indrio et al study. Moreover, to promote uniform documentation by parents and confirm that the infants were correctly given the study products, 1 investigator at each center was always available by telephone to help parents. In most studies, medical records are used as the source of information for many purposes including evaluation of the quality of care provided. In the study by Indrio et al, however, despite their reliance on the medical records, there were no reports to validate recorded content against the interaction between patient and physician, questioning the accuracy and validity of the information provided by parents, especially on some subjective measurements for variables such as regurgitation. Improvement in patient care crucially depends on the availability of high-quality, validated health information in clinical practice. |