The 2 therapies, a 1-food and a 6-food elimination diet both used for eosinophilic esophagitis (EoE), were compared for outcomes after 6 weeks.
A 1-food elimination diet (1FED) and a 6-food elimination diet (6FED) led to similar levels of remission and improvement of histological and endoscopic markers among 129 adults patients who have eosinophilic esophagitis (EoE), according to study findings published online this week in The Lancet Gastroenterology & Hepatology.
The study investigators also highlighted that starting with eliminating just animal milk, which was the 1FED for this analysis, “is an acceptable initial dietary therapy for EoE.”
“Empirical elimination diets are effective for achieving histological remission in EoE,” they wrote, “but randomized trials comparing diet therapies are lacking.”
Patients in the United States receiving care at 10 sites of the Consortium of Eosinophilic Gastrointestinal Disease Researchers were recruited for the multicenter open-label trial and randomized 1:1 to the 1FED regimen (n = 67) or the 6FED regimen (n = 62; animal milk, wheat, egg, soy, fish and shellfish, and peanut and tree nuts), each for 6 weeks; the study period was May 23, 2016, to March 6, 2019. Fifty-four percent of the participants were men, the overall mean (SD) patient age was 37.0 (10.3) years, and concomitant proton pump inhibitor use was seen in 61% of the 1FED cohort and 69% of the 6FED cohort.
At the 6-week mark, an overall 6-percentage-point difference in histological remission rate separated the groups: Among the 1FED group, the remission rate was 34% vs 40% in the 6FED group (95% CI, –11% to 23%). For this analysis, histological remission was defined as a peak eosinophil count of less than 15 eosinophils per high-power filed (eos/hpf) and was the primary end point; secondary end points included scores on the Eosinophilic Esophagitis Histology Scoring System (EoEHSS), Eosinophilic Esophagitis Endoscopic Reference Score (EREFS), Eosinophilic Esophagitis Activity Index (EEsAI), and quality of life.
A significant difference was not seen for partial remission, which was measured at 10 eos/hpf or less and 6 eos/hpf or less. For the 1FED vs 6FED groups, 30% (95% CI, 19%-41%) and 37% (95% CI, 25%-49%) (P = .58), respectively, achieved 10 eos/hpf or less and 18% (95% CI, 9%-27%) and 32% (95% CI, 21%-44%) (P = .069) achieved 6 eos/hpf or less.
For complete remission, or 1 eos/hpf or less, the results were deemed significant. Six percent (95% CI, 0%-12%) of the 1FED cohort compared with 19% (95% CI, 10%-29%) of the 6FED cohort saw this milestone (P = .031).
Further, although peak eosinophils decreased in both patient groups (geometric mean ratio, 0.72; 95% CI, 0.43-1.20; P = 0.21), the changes seen from baseline for EoEHSS, EREFS, and EEsAI were not considered significantly different:
Crossover was permitted, and for the individuals who lacked histological response to 1FED and crossed to 6FED (n = 21), 43% achieved histological remission. For those in 6FED who lacked a response, their next treatment step was oral swallowed topical fluticasone propionate 880 mcg twice daily (n = 11); 82% achieved histological remission.
Drawing on their findings, the study authors note that among those who want to consider initiating empirical diet therapy, it’s okay to start with 1FED vs the more restrictive 6FED. In addition, a separate analysis of milk-specific immunoglobulin G4 (IgG4) showed that “baseline serum concentrations were associated with response to 1FED [and that] levels of IgG4 could potentially serve as a marker of milk reactivity in at least some patients.”
Kliewer KL, Gonsalves N, Dellon ES, et al. One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial. Lancet Gastroenterol Hepatol. Published online February 27, 2023. doi:10.1016/S2468-1253(23)00012-2