World Congress of Gastroenterology

WCOG 2019

Efficacy of combined treatment using Helicobacter pylori eradication therapy with anxiolytic in comparison with eradication therapy in patients with postprandial distress syndrome: a randomized trial


Currently the problem of efficacious treatment of functional dyspepsia is not fully solved. Postprandial distress syndrome (PDS) occurs nearly twice more frequent that epigastric pain syndrome, in 50% these two syndromes are overlap. Most of the previous trials recommended prokinetics and eradication therapy for PDS treatment, however it was effective only in 15-30% of cases. Anxiolitics seems to increase the efficacy of treatment as they reduce signs of anxiety, which aggravate the symptoms of postprandial distress syndrome in patients. In previous trials Buspirone (5-hydroxytryptamine 1A receptor agonist) showed the possibility to relax the proximal stomach in healthy individuals. Aim of the study: to assess the superiority of combined treatment using Helicobacter pylori eradication therapy with anxiolytic (Buspirone) in comparison with eradication therapy (ET) in patients with postprandial distress syndrome (PDS).

Materials and Methods:

It was a randomized trial. Adult patients (18-45 years old) with confirmed diagnosis of PDS were eligible to participate after the informed consent was signed. Diagnosis of PDS was set according to Rome IV criteria. Exclusion criteria were: presence of “red flag” symptoms or comorbidities that could explain the symptoms. All patients were tested for Helicobacter pylori using rapid one-step immunochromatographic assay for detection of monoclonal Helicobacter pylori antigen in stool samples or in PCR for Helicobacter pylori DNA, or due to morphological method. We used Hamilton Anxiety and depression Scales (HADS) to assess the presence of anxiety. We used the SF-36 questionnaire to allocate the quality of life. To allocate patients randomly a numbered series of sealed envelopes containing the number of the group assignments were used. Patients from the first group received ET according to the Maastricht 5 (2017) with Buspirone 10 mg, 3 times daily. The second group received ET treatment only. Duration of therapy was 14 days. Patients were assessed on the 15th and 30th day after the treatment started. The superiority was qualified if there was more lasting decrease in symptoms severity, reduced level of anxiety, improved quality of life.


Of 63 randomized patients 34 were allocated to the first group and 29 to the second one. The groups were statistically comparable in age, sex, prolongation of symptoms and their severity. All 63 patients had H. pylori positive tests. Treatment led to the reduction of postprandial heaviness on the 15th day in both groups (group 1 – 85,2%; group 2 – 34,5%). Symptoms recurrence till 30th day occurred significantly more often in group 2 patients (13,8% of those patients in the group 1 and 80% in the group 2, who did not have any symptoms at the previous assessment, p ˂ 0,001). Mean anxiety scores before the treatment were: at group 1 - 7,9 (29,4% of the patients did not have anxiety, 29,4% had covered anxiety, 41,2% had clinically significant anxiety); at group 2 - 7,7 (31% of the patients did not have anxiety, 31% had covered anxiety, 38% had clinically significant anxiety). Both groups were statistically comparable in anxiety level before the treatment (p=0,92). Comparing the anxiety levels before and after the treatment, there was a significant decrease shown in group 1 (82,3%), and only in 20,6% in group 2 (p = 0,001). The analysis of SF-36 questionnaire before the treatment demonstrated that patients from both groups had decreased scores at in Physical functioning, Physical role limitation, Body Pain, General health, Vitality, Social functioning. The mean scores of quality of life domains for the group 1 before the treatment were: Physical functioning (PF) - 74,7; Physical role limitation (RP) - 67,1; Body Pain (BP) - 58,8; General health (GH) - 57,4; Vitality (VT) - 56,8; Social functioning (SF) - 81,1; Emotional role limitation (RE) - 76,7; Mental health (MH) - 76,2. The results for group 2 were: PF - 75,4; RP - 69,0; BP - 58,5; GH - 56,2; VT - 57,7; SF - 80,5; RE - 75,3; MH - 78,6 (p for all domains > 0,05). The mean SF-36 scores for group 1 after the treatment were: PF - 84,1; RP - 78,3; BP - 73,9; GH - 69,7; VT - 70,4; SF - 89,3; RE - 81,9; MH - 83,8. For group 2: PF - 82,1 (p=0,91); RP - 77,9 (p=0,95); BP - 63,9 (p=0,006); GH - 60,7 (p=0,012); VT - 58,4 (p=0,003); SF - 81,3 (p=0,089); RE - 78,9 (p=0,87); MH - 79,8 (p=0,07).


The combination of ET with anxiolytic (Buspirone) demonstrates clinical and statistical superiority to ET only showing more lasting regression of symptoms, statistically significant decrease of anxiety level and improvement of quality of life in Body pain, General health, and Vitality domains.


 Postprandial distress syndrome, anxiety, quality of life