A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia
Introduction
According to the ROME III Diagnostic Criteria [1], functional dyspepsia (FD) is defined as symptoms thought to originate in the gastroduodenal region in the absence of any organic, systemic, or metabolic disease likely to explain the symptoms. FD is the most common gastrointestinal problem seen in primary care settings [2], with a prevalence of 12–15% [3]. Common symptoms include epigastric pain or discomfort, belching, heartburn, bloating, post-prandial nausea, pressure or fullness, and/or early satiety [3].
Although the cause of FD is unclear, it is likely to be multifactorial [4], [5]. Because there is no standard recognized treatment, FD is a difficult condition for both clinicians and patients. Current treatment generally focuses on medical therapy, emphasizing pharmacological interventions and dietary changes [6], [7]. However, most patients do not fully respond to this approach [5]. Psychological interventions [5], [7] have been proposed as alternative or additional management options.
Epidemiological evidence suggests an association between psychological factors and FD [5]. Psychotherapy has proven to have beneficial effects for similar indications, such as irritable bowel syndrome [8], unexplained physical symptoms, chronic fatigue syndrome, and peptic ulcer disease [5]. Psychotherapy has also been shown to reduce health-care costs in patients with functional gastrointestinal disorders [5], [8]. These successes have encouraged the use of psychological intervention in patients with FD. However, the benefits of such interventions remain unclear in this population [5].
Few randomized controlled trials of psychological intervention have been conducted for FD [5], [9]. A recent well-established systematic review [5] identified only four eligible trials that demonstrated benefits of psychotherapy on dyspepsia symptoms, which persisted for 1 year. Those results should be interpreted with caution, as Soo et al. [9] suggested, because different methodologic problems limit the interpretation of these results.
We performed a parallel-group randomized controlled trial to evaluate the efficacy of psychotherapy among patients with FD. We also evaluated the magnitude of differences, evaluating patient reported outcomes that are easy to interpret clinically. Primary outcome variables included disease specific instruments and a global outcome measure. Psychological status measured by Hospital Anxiety and Depression Scale (HADS) [10], [11] was included as secondary outcome.
Section snippets
Participants
Patients from the digestive services of Galdakao-Usansolo and Basurto University Hospitals between the ages of 18 and 80 years with chronic upper abdominal symptoms consistent with ROME III criteria [1] for FD were recruited for this study. To be eligible for this parallel randomized controlled trial, all patients were required to have an endoscopy to exclude structural organic causes for their symptoms at the time of recruitment. Patients were excluded if they had any organic pathology that
Participant flow
Fig. 1 depicts the recruitment of patients and their flow through each stage of the study population, as recommended by the CONSORT statement [20].
Participants and non-participants
There were no significant differences between participants and non-participants in outcome scores at baseline. At T2, non-participants were more likely to be divorced (19% vs 3%), had less education (8% vs. 18% with university or postgraduate studies), and had worse baseline scores on the DRHS severity of common symptom scale (mean, 52.69 [SD, 18.04]
Discussion
In this parallel-group randomized clinical trial (RCT), 10 weeks of medical therapy plus psychotherapy yielded statistically and clinically significant improvements in global and disease specific outcomes compared with medical therapy alone. Six months after treatment, the benefits of intensive therapy on global and disease specific outcomes continued, however in a lesser extent, and there were continued improvements in the secondary measures of anxiety and depression in the intensive therapy
Acknowledgments
We gratefully thank all the members of the Department of Gastroenterology from Galdakao-Usansolo and Basurto University Hospitals, especially the endoscopy experts of Galdakao-Usansolo Hospital (Dra M. Lorenzo, Dr J. Aguirre, Dr J. Cabriada, Dra M. López, Dra M. González, Dra M. Durán, Dr A. Bernal, Dr J. Arevalo, Dra A. Hernández, Dr L. Bridet, Dr J. Hernández) and Dr San Salvador, a specialist of the Bilbao region's primary care, for their invaluable collaboration in patient recruitment. We
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