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Functional dyspepsia (FD)is defined as the presence of symptoms thought to originate in the gastroduodenal region with no evidence of structural disease that is likely to explain the symptoms. The cause of this condition is unclear, not being a recognized treatment for it. The conventional treatments for those patients are symptom based. Unfortunately, these medications are not very effective. Patients with FD report poorer health status, mental health, and social functioning than patients with structural gastrointestinal pathology. Our aim is to compare a combined intervention (medical plus psychological intervention) versus conventional intervention (medical intervention)in regard to the health related quality of life, symptomatology, anxiety and depression of those patients. The investigators hypothesized that compared with conventional intervention a combined intervention would yield significantly better short (after treatment) and medium term (six months after treatment) improvement of health related quality of life and symptoms.
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Patients were recruited from the digestive services of Galdakao-Usansolo and Basurto hospitals. They were randomly allocated to the control or experimental group. 82 patients were included in the control group and 76 in the experimental group.
Regarding the intervention, the treatment of the control group was a conventional (medical) intervention. It was focused on the most bothersome symptom. Prokinetic (for example cinitapride) or antisecretory agent (for example omeprazole) was prescribed in standard dose. Experimental group received the combined intervention (medical plus psychological intervention). The psychological support consisted of ten weekly sessions, which the first 8 were in group and the last 2 were individuals. In those sessions the patients received a) an information session to increase the patients' knowledge of functional dyspepsia; b) a Beck's cognitive-behavioural therapy focused on modifying the influence of some cognitive issues to gastrointestinal symptoms; c) and progressive-muscle relaxation according to Jacobson, with the aim to provide the ability to relax in certain stress situations. This technique was created for reducing anxiety by alternately tensing and relaxing the muscles.
All the patients completed all the self questionnaires at baseline (t0), at the end of the treatment (T1) and at six months follow up (T2). The health related quality of life was assessed by the Dyspepsia Related Health Scale (DRHS), and anxiety and depression were assessed by the Hospital Anxiety and Depression Scale (HADS). Finally, the subjective clinical improvement was also considered and it was measured by a question about how they feel in regard to the functional dyspepsia, with five alternatively responses (a) Much better, b) quite a lot better, c) somewhat better, d) about the same, e) somewhat worse, f) quite a lot worse, g) much worse).
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158 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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