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Mar 12

Food elimination diet is a viable alternative therapy for eosinophilic … – BMC Gastroenterology

Participants

We identified 405 EoE patients using the ICD-10 code K20.0 for EoE. From 405 patients, 126 patients were excluded as they were diagnosed and started on a treatment plan elsewhere. From the remaining 279 patients, 176 patients had trialed PPI monotherapy, of which 107 patients had EoE that was not histologically responsive to PPI monotherapy, and 69 patients had EoEPPI+. Out of these 69 patients, 22 patients trialed FED monotherapy after cessation of PPI monotherapy and were therefore entered into our retrospective cohort (Fig.1). The median age of these 22 patients was 34years (IQR 29.239.7, Table 1), and 13 were male (59.09%; Table 1, Table S1).

Flowchart of patients included in our retrospective cohort based on our inclusion criteria and in our prospective cohort based on voluntary enrollment

In Phase 1 of our study, all 22 patients were diagnosed with histologically confirmed EoE (median peak eosinophil count 47.5 eos/hpf, IQR 26.2583.75; Table 2). All patients were symptomatic with most patients suffering from dysphagia (81.82%, Table 2). All 22 patients were histologically responsive to PPI monotherapy, although dosages and frequencies varied between patients. The most popular PPI monotherapy was omeprazole 40mg twice daily (63.64%, Table 1). While on PPI monotherapy, most patients were asymptomatic (63.64%, Table 2). However, reported symptoms included dysphagia (22.73%, Table 2), heartburn (13.64%, Table 2), vomiting (4.55%, Table 2), abdominal pain (4.55%, Table 2), and regurgitation (4.55%, Table 2). EGD while patients were on PPI monotherapy revealed a median peak eosinophil count of 2.5 eos/hpf (IQR 06, Table 2), significantly less than at baseline (median 47.5, IQR 26.2583.75; Fig.2, Table S1).

Comparison of median peak eosinophils per high-power field in baseline, post-PPI monotherapy, and post-FED monotherapy in (A) all 22 patients with EoE responsive to PPI monotherapy who trialed FED monotherapy in the retrospective phase of our study, and (B) the 13 patients who had EoE that was histologically responsive to PPI monotherapy and FED monotherapy. A Peak eosinophils per high-power field in baseline (median 47.5, IQR 26.2583.75) versus post-PPI monotherapy (median 2.5, IQR 06), post-FED monotherapy (median 10, IQR 2.2530). B Peak eosinophils per high-power field in baseline (median 38, IQR 2085) versus post-PPI monotherapy (median 1, IQR 04), post-FED monotherapy (median 6, IQR 110). Error bars represent the interquartile range. Paired comparisons were made using the Wilcoxon Signed Rank Test. *** indicates p<0.001

All 22 patients trialed FED monotherapy after cessation of PPI monotherapy. Patients were on a variety of FEDs, with the most popular being dairy and wheat FED (two-food elimination diet, 2FED; 68.18%; Table 1). Most patients on FED monotherapy reported being asymptomatic (68.18%, Table 2). Symptomatic patients reported heartburn (22.73%, Table 2) and dysphagia (18.18%, Table 2). While on FED monotherapy, these 22 patients had a median peak eosinophil count of 10 eos/hpf (IQR 2.2530; Table 2, Table S1).

Out of 22 EoEPPI+ patients who trialed FED monotherapy, 13 patients (59.09%; Fig.1) were determined to have EoEPPI+, FED+, while 9 patients (40.91%; Fig.1) did not achieve histologic remission of EoE with FED monotherapy (EoE with histologic remission to PPI monotherapy but not FED monotherapy, EoEPPI+, FED). Thirteen EoEPPI+, FED+ patients had a median peak eosinophil count of 6 eos/hpf (IQR 110, Table 2) while on FED monotherapy, which was significantly less than they had at baseline (median 38, IQR 2085; Fig.2, Table S1).

Following trial of FED monotherapy, 15 patients out of 22 total patients were voluntarily enrolled in a prospective cohort for observation in Phase 2 of our study. Of these 15 participants, 9 were EoEPPI+, FED+ and 6 were EoEPPI+, FED (Fig.1). During this observation period, patients with EoEPPI+, FED resumed PPI monotherapy, while EoEPPI+, FED+ patients were given the option to revert to PPI monotherapy, continue FED monotherapy, or start FED monotherapy with PPI on an as needed basis. Median follow up duration for EoEPPI+, FED+ patients was 2.25years (IQR 1.512.48, Table 3), and median follow up duration for EoEPPI+, FED patients was 1.08years (IQR 0.732.38; Table 3, Table S2).

During the observation period, we recorded patient health-care utilization due to exacerbation while on maintenance treatment or trial of other treatment plans for EoE. Health-care utilization was similar between EoEPPI+, FED+ and EoEPPI+, FED patients. No patients had food impactions warranting urgent EGD or symptom exacerbation requiring urgent follow up visit (Table 3). One patient with EoEPPI+, FED+ (11.11%, Table 3) and two EoEPPI+, FED patients (33.33%, Table 3) underwent repeat EGD while on maintenance treatment plan for histologic re-evaluation. None of these patients had histologic reactivation of EoE while on maintenance treatment plan (Table 3). Four EoEPPI+, FED+ patients (44.44%, Table 3) and four EoEPPI+, FED patients (66.67%; Table 3, Table S2) had a repeat EGD for histologic evaluation of other treatment plans. These EGDs showed histologically reactivated EoE, so patients restarted their maintenance treatment plan following these empirical trials.

After the observation period, all 15 patients in the prospective cohort answered a three-item survey. When asked about why they pursued trial of FED monotherapy after knowing that their EoE was responsive to PPI therapy, a majority of patients (60%, Table 4) were concerned about long-term medication usage. Other patients cited that they suspected having side effects due to PPI monotherapy (13.33%), wanted to discover their food triggers (20%), or wanted options for future treatment (6.67%). When considering a FED monotherapy trial after having histologic remission with PPI monotherapy, a majority of patients answered that they would recommend this process for someone else with EoE (93.33%) and that they would personally go through this process again (80%).

The 9 patients who had EoEPPI+, FED+ answered an additional survey. Given that they had histologic remission to PPI monotherapy and FED monotherapy, patients had options for their maintenance treatment plan. A majority of patients decided to continue FED monotherapy (55.56%, Table 5), some chose to switch to FED monotherapy with PPI on an as needed basis (33.33%, Table 5), and others reverted to PPI monotherapy (11.11%, Table 5). When asked why they were following their particular maintenance treatment plan over other options, 66.67% answered that their treatment plan was more sustainable for them, and 33.33% answered they perceived that their current treatment plan had better symptom benefits (Table 5). A majority of patients also strongly agreed (55.56%, Table 5) that undergoing a FED monotherapy trial after knowing that PPI monotherapy induced histologic remission of their EoE had increased their overall quality of life and helped them identify a treatment plan that aligned with their lifestyle and beliefs.

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Food elimination diet is a viable alternative therapy for eosinophilic ... - BMC Gastroenterology

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