Test-based exclusion diets in gastro-esophageal reflux disease patients:A randomized controlled pilot trial

摘要

AIM:To investigate the clinical response of gastroesophageal reflux disease(GERD)symptoms to exclusion diets based on food intolerance tests.METHODS:A double blind,randomized,controlled pilot trial was performed in 38 GERD patients partially or completely non-responders to proton pump inhibitors(PPI)treatment.Fasting blood samples from each patients were obtained;leukocytotoxic test was performed by incubating the blood with a panel of 60food items to be tested.The reaction of leukocytes(rounding,vacuolization,lack of movement,flattening,fragmentation or disintegration of cell wall)was then evaluated by optical microscopy and rated as follows:level 0=negative,level 1=slightly positive,level 2=moderately positive,and level 3=highly positive.A"true"diet excluding food items inducing moderatesevere reactions,and a"control"diet including them was developed for each patient.Then,twenty patients received the"true"diet and 18 the"control"diet;after one month(T1)symptoms severity was scored by the GERD impact scale(GIS).Hence,patients in the"control"group were switched to the"true"diet,and symptom severity was re-assessed after three months(T2).RESULTS:At baseline(T0)the mean GIS global score was 6.68(range:5-12)with no difference between"true"and control group(6.6±1.19 vs 6.7±1.7).All patients reacted moderately/severely to at least 1 food(range:5-19),with a significantly greater number of food substances inducing reaction in controls compared with the"true"diet group(11.6 vs 7.0,P<0.001).Food items more frequently involved were milk,lettuce,brewer’s yeast,pork,coffee,rice,sole asparagus,and tuna,followed by eggs,tomato,grain,shrimps,and chemical yeast.At T1 both groups displayed a reduction of GIS score("true"group 3.3±1.7,-50%,P=0.001;control group 4.9±2.8,-26.9%,P=0.02),although the GIS score was significantly lower in"true"vs"control"group(P=0.04).At T2,after the diet switch,the"control"group showed a further reduction in GIS score(2.7±1.9,-44.9%,P=0.01),while the"true"group did not(2.6±1.8,-21.3%,P=0.19),so that the GIS scores didn’t differ between the two groups.CONCLUSION:Our results suggest that food intolerance may play a role in GERD symptoms development,and leucocytotoxic test-based exclusion diets may be a possible therapeutic approach when PPI are not effective or indicated.