A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia M. Orive a,h, ⁎, I. Barrio b , V.M. Orive c , B. Matellanes d , J.A. Padierna e , J. Cabriada f , A. Orive f , A. Escobar g,h , J.M. Quintana a,h a Research Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain b Department of Applied Mathematics, Statistics and Operational Research, University of the Basque Country UPV/EHU, Leioa, Spain c Digestive Service, Basurto University Hospital, Bilbao, Bizkaia, Spain d Psychology Department of Personality, Assessment and Treatment, University of Deusto, Bilbao, Bizkaia, Spain e Department of Psychiatry, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain f Digestive Service, Galdakao-Usansolo Hospital, Bilbao, Bizkaia, Spain g Research Unit, Basurto University Hospital, Bilbao, Bizkaia, Spain h Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain abstract article info Article history: Received 4 July 2014 Received in revised form 27 February 2015 Accepted 3 March 2015 Available online xxxx Keywords: Functional dyspepsia Dyspepsia related quality of life Psychotherapy Randomized clinical trial Responsiveness Objective: Epidemiological evidence suggests an association between psychological factors and functional dys- pepsia (FD). Yet few randomized controlled trials (RCTs) of psychological interventions have been conducted for FD. We conducted an RCT to evaluate the efficacy of psychotherapy among chronic FD. Methods: One hundred fifty-eight consecutive patients with FD were randomized to medical therapy plus psy- chotherapy consisted in 8 group and 2 individual sessions focused on teaching techniques for coping with FD (in- tensive treatment (IT); n = 76) or medical therapy alone (conventional treatment (CT); n = 82). Patients completed validated self-reported questionnaires before and after the 10-week treatment and 6 months later. Linear mixed-effects models were used, in intention-to-treat analysis. Results: At the end of treatment period, statistically significant improvements were observed for IT compared with CT for dyspepsia-related quality of life (DRQoL). DRQoL mean changes of 6.09 and 3.54 were obtained in IT and CT patients, respectively (p = b 0.0001); and SS mean changes of 11.55 and 4.57 were obtained in IT and CT patients, respectively (p = 0.0013). Those improvements, measured by minimum clinically important difference (MCID), were clinically significant (DRQoL: 77% of the IT patients exceeded the MCID vs the 45% of the CT; SS: 75% vs 48%). Six months after treatment, those statistically significant improvements persisted for DRQoL (p = 0.0067) and for SS (p = 0.0405). Clinical improvements persisted for SS (63% vs 41%). Conclusions: These findings suggest that adding psychotherapy to standard medical therapy improves short-term outcomes in patients with FD and may have long-term effects as well. The cost-effectiveness of intensive therapy needs to be evaluated. Registration number and name of trial registry: NCT01802710 © 2015 Elsevier Inc. All rights reserved. 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 met- abolic disease likely to explain the symptoms. FD is the most common gastrointestinal problem seen in primary care settings [2], with a prev- alence of 12–15% [3]. Common symptoms include epigastric pain or dis- comfort, 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 Journal of Psychosomatic Research xxx (2015) xxx–xxx ⁎ Corresponding author at: Research Unit, Hospital Galdakao-Usansolo, Bo. Labeaga s/n, Bizkaia 48960, Spain. Tel.: +34 94 4007105; fax: +34 94 4007132. E-mail addresses: miren.orivecalzada@osakidetza.net (M. Orive), irantzu.barrio@ehu.es (I. Barrio), victormanuel.orivecura@osakidetza.net (V.M. Orive), b.matella@fice.deusto.es (B. Matellanes), jesusangel.padiernaacero@osakidetza.net (J.A. Padierna), joseluis.cabriadanuno@osakidetza.net (J. Cabriada), aitor.orivecalzada@osakidetza.net (A. Orive), antonio.escobarmartinez@osakidetza.net (A. Escobar), josemaria.quintanalopez@osakidetza.net (J.M. Quintana). PSR-08988; No of Pages 6 http://dx.doi.org/10.1016/j.jpsychores.2015.03.003 0022-3999/© 2015 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Journal of Psychosomatic Research Please cite this article as: Orive M, et al, A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia, J Psychosom Res (2015), http://dx.doi.org/10.1016/j.jpsychores.2015.03.003