Prevalence of Non-Celiac Gluten Sensitivity in Patients with Refractory Functional Dyspepsia: a Randomized Double-blind Placebo Controlled Trial.
Study Goal
The researchers aimed to determine if a gluten-free diet (GFD) could improve symptoms in patients with refractory functional dyspepsia (RFD) and identify cases of non-celiac gluten sensitivity (NCGS).
Results Summary
Among 77 RFD patients, 35% showed symptom improvement on GFD, with 6.4% (18% of responders) experiencing symptom recurrence after gluten challenge, suggesting NCGS. Extra-intestinal symptoms like fatigue, pain, and headache also improved in NCGS patients on GFD.
Population
Patients with refractory functional dyspepsia (RFD) excluding celiac disease, wheat allergy, and H. pylori infection.
Effective Dosage
Not specified
Duration
6 weeks (GFD), followed by 3 months of follow-up
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
gluten-free diet (GFD) | decrease | gastrointestinal symptoms | patients with refractory functional dyspepsia (RFD) | ≥30% improvement in at least one of the reported symptoms | showed gastrointestinal symptoms improvement | #1 |
gluten-free diet (GFD) | decrease | fatigue and weakness | NCGS patients | P = 0.000 | improved | #2 |
gluten-free diet (GFD) | decrease | musculo-skeletal pain | NCGS patients | P = 0.000 | improved | #3 |
gluten-free diet (GFD) | decrease | headache | NCGS patients | P = 0.002 | improved | #4 |
gluten challenge | increase | gastrointestinal symptoms | GFD responders | 6.4% of patients with RFD, 18% of GFD responders | symptoms recurred | #5 |
Refractory functional dyspepsia (RFD) is characterized by symptoms persistence in spite of medical treatment or H. pylori eradication. No study has yet investigated the presence of gluten-dependent RFD as a clinical presentation of Non-Celiac Gluten Sensitivity (NCGS). Patients with RFD, in whom celiac disease, wheat allergy and H. pylori infection had been ruled out, followed a six weeks long gluten-free diet (GFD). Symptoms were evaluated by means of visual analogue scales; patients with ≥30% improvement in at least one of the reported symptoms after GFD underwent a double-blind placebo controlled gluten challenge. Subjects were randomly divided in two groups and symptoms were evaluated after the gluten/placebo challenge. GFD responders were further followed on for 3 months to evaluate the relationship between symptoms and gluten consumption. Out of 77 patients with RFD, 50 (65%) did not respond to GFD; 27 (35%) cases showed gastrointestinal symptoms improvement while on GFD; after blind gluten ingestion, symptoms recurred in 5 cases (6.4% of patients with RFD, 18% of GFD responders) suggesting the presence of NCGS. Furthermore, such extra-intestinal symptoms as fatigue and weakness (P = 0.000), musculo-skeletal pain (P = 0.000) and headache (P = 0.002) improved in NCGS patients on GFD. Because of the high prevalence of NCGS among patients with RFD, a diagnostic/therapeutic roadmap evaluating the effect of GFD in patients with RFD seems a reasonable (and simple) approach.