Table 2. RCTs eligible for inclusion in the dietary intervention in IBS systematic review.
Author | Design | Participants | Interventions | Methodology | Outcomes |
---|---|---|---|---|---|
Atkinson et al.10 | UK RCT, single center. | 150 Rome II IBS. Tested for food serum IgG assay. Recruited from secondary care; 83% female. | Diet avoiding foods that they were intolerant of, according to IgG assay or sham diet for 12 weeks. | Method of randomization and concealment of allocation not stated. Double-blind. Other IBS medications allowed. | Patients asked “Compared with your IBS before you started the food elimination diet, are you now: terrible, worse, slightly worse, no change, slightly better, better, or excellent?” Better or excellent was taken as significant improvement |
Biesiekierski et al.11 | Australian RCT, single | 39 Rome III IBS patients intolerant of gluten, but celiac excluded. Recruited from newspaper advertisement; 89% female. | Diet spiked with 16 g gluten per day vs. placebo for 4 weeks. | Adequate method of randomization and concealment of allocation. Double-blind. No other IBS medications allowed. | Patients answering “no” to the question “Over the last week were your symptoms adequately controlled?” |
Staudacher et al.12 | UK RCT, single center | 41 Rome III IBS. Recruited from secondary care. Bloating and/or diarrhea included, predominant constipation excluded. | FODMAPs diet vs. habitual diet for 4 weeks. | Method of randomization and concealment of allocation not stated. Open study—patients not blinded (unclear if researchers masked). | GI symptom rating scale. Patients asked “Were your symptoms adequately controlled over the previous week?” |
FODMAPs, Fermentable Oligo-Di-Monosaccharides and Polyols; GI, gastrointestinal; IBS, irritable bowel syndrome; IgG, immunoglobulin G; RCT, randomized controlled trial.