Clinical Improvement and in Quality of Life-Functional Dyspepsia-

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-12-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Psychogenic Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Psychological support

Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson

Group Type EXPERIMENTAL

Psychological support

Intervention Type BEHAVIORAL

No psychological support

Patients of this group only received the conventional medical treatment, not receiving any psychological support

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

Interventions

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Psychological support

Intervention Type BEHAVIORAL

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* to have chronic upper abdominal symptoms consistent with ROME III criteria for functional dyspepsia
* to have an endoscopy to exclude structural organic causes at the time of the recruitment

Exclusion Criteria

* to have any organic pathology that could explain the dyspeptic symptoms
* to be using non-steroidal anti-inflammatory drugs (NSAIDs)
* to suffer physical or psychological impairments preventing them from properly completing the questionnaires

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No