Purpose: To examine clinical practice effectiveness of a medical food containing serum-derived bovine immunoglobulin (SBI) for the management of symptoms in irritable bowel syndrome with diarrhea (IBS-D) patients.
Methods: From 165 IBS-D patient medical charts [mean age=59.6 years (range: 19-98), female (n=109), Caucasian (n=144)], recorded daily stools/consistency, abdominal pain, and patient/ physician reported quality of life (QoL) scores were retrospectively collected on those prescribed SBI for a minimum of 8 weeks. A generalized estimating equations model was used to analyze and compare changes for scores of symptoms and QoL.
Results: Where data existed in charts, 46% of patients on SBI had a combined mean score reduction in daily stools, improvement in stool consistency (Bristol Stool Scale from >5 to <5) and decrease in abdominal pain (?30%). Significant improvements (p<0.001) in individual symptom and QoL scores with a high response were also reported for daily stools (76%), consistency (78%), abdominal pain (69%), as well as patient (79%) and physician QoL (73%). Eleven patients experienced 13 adverse events (AEs) while receiving SBI with nausea (n=6) most prevalent. No serious AEs were reported, but 4 patients discontinued SBI.
Conclusion: In this retrospective chart analysis of IBS-D patients who took a medical food containing SBI for 8 weeks, there were statistical improvements in daily stool number, stool consistency, abdominal pain and QoL scores supporting its use IBS-D.