Food elimination based on IgG antibodies in irritable bowel syndrome: a randomised controlled trial
- 1Department of Medicine, University Hospital of South Manchester, Manchester, UK
- 2Department of Health Sciences, University of York, York, UK
- Correspondence to:
Dr P J Whorwell
Department of Medicine, University Hospital of South Manchester, Manchester M20 2LR, UK;
- Received 13 April 2004
- Accepted 13 April 2004
Background: Patients with irritable bowel syndrome (IBS) often feel they have some form of dietary intolerance and frequently try exclusion diets. Tests attempting to predict food sensitivity in IBS have been disappointing but none has utilised IgG antibodies.
Aims: To assess the therapeutic potential of dietary elimination based on the presence of IgG antibodies to food.
Patients: A total of 150 outpatients with IBS were randomised to receive, for three months, either a diet excluding all foods to which they had raised IgG antibodies (enzyme linked immunosorbant assay test) or a sham diet excluding the same number of foods but not those to which they had antibodies.
Methods: Primary outcome measures were change in IBS symptom severity and global rating scores. Non-colonic symptomatology, quality of life, and anxiety/depression were secondary outcomes. Intention to treat analysis was undertaken using a generalised linear model.
Results: After 12 weeks, the true diet resulted in a 10% greater reduction in symptom score than the sham diet (mean difference 39 (95% confidence intervals (CI) 5–72); p = 0.024) with this value increasing to 26% in fully compliant patients (difference 98 (95% CI 52–144); p<0.001). Global rating also significantly improved in the true diet group as a whole (p = 0.048, NNT = 9) and even more in compliant patients (p = 0.006, NNT = 2.5). All other outcomes showed trends favouring the true diet. Relaxing the diet led to a 24% greater deterioration in symptoms in those on the true diet (difference 52 (95% CI 18–88); p = 0.003).
Conclusion: Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research.
- IBS, irritable bowel syndrome
- ELISA, enzyme linked immunosorbant assay
- AU, arbitrary unit
- HAD, hospital anxiety and depression scale
- QOL, quality of life
- NNT, number needed to treat