N/A N=158 Randomized Supportive Care

Clinical Improvement and in Quality of Life-Functional Dyspepsia-

Psychogenic Dyspepsia

Bottom Line

View on ClinicalTrials.gov: NCT01802710 ↗

Enrolled (actual)

158

Serious AEs

—

Results posted

Jun 2019

Primary outcome: Primary: Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS) — 73.72; 65.31; 71.85; 64.89 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Psychological support (Behavioral); No intervention (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital Galdakao-Usansolo
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)	73.72; 65.31; 71.85; 64.89	—
SECONDARY Subjective Clinical Improvement	37; 17; 36; 26	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01802710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.