PMID- 25791668 OWN - NLM STAT- MEDLINE DCOM- 20151007 LR - 20181202 IS - 1879-1360 (Electronic) IS - 0022-3999 (Linking) VI - 78 IP - 6 DP - 2015 Jun TI - A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia. PG - 563-8 LID - S0022-3999(15)00057-4 [pii] LID - 10.1016/j.jpsychores.2015.03.003 [doi] AB - OBJECTIVE: Epidemiological evidence suggests an association between psychological factors and functional dyspepsia (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 psychotherapy consisted in 8 group and 2 individual sessions focused on teaching techniques for coping with FD (intensive 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=<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. CI - Copyright (c) 2015 Elsevier Inc. All rights reserved. FAU - Orive, M AU - Orive M AD - Research Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain. Electronic address: miren.orivecalzada@osakidetza.net. FAU - Barrio, I AU - Barrio I AD - Department of Applied Mathematics, Statistics and Operational Research, University of the Basque Country UPV/EHU, Leioa, Spain. Electronic address: irantzu.barrio@ehu.es. FAU - Orive, V M AU - Orive VM AD - Digestive Service, Basurto University Hospital, Bilbao, Bizkaia, Spain. Electronic address: victormanuel.orivecura@osakidetza.net. FAU - Matellanes, B AU - Matellanes B AD - Psychology Department of Personality, Assessment and Treatment, University of Deusto, Bilbao, Bizkaia, Spain. Electronic address: b.matella@fice.deusto.es. FAU - Padierna, J A AU - Padierna JA AD - Department of Psychiatry, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain. Electronic address: jesusangel.padiernaacero@osakidetza.net. FAU - Cabriada, J AU - Cabriada J AD - Digestive Service, Galdakao-Usansolo Hospital, Bilbao, Bizkaia, Spain. Electronic address: joseluis.cabriadanuno@osakidetza.net. FAU - Orive, A AU - Orive A AD - Digestive Service, Galdakao-Usansolo Hospital, Bilbao, Bizkaia, Spain. Electronic address: aitor.orivecalzada@osakidetza.net. FAU - Escobar, A AU - Escobar A AD - Research Unit, Basurto University Hospital, Bilbao, Bizkaia, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain. Electronic address: antonio.escobarmartinez@osakidetza.net. FAU - Quintana, J M AU - Quintana JM AD - Research Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia, Spain; Health Services Research on Chronic Patients Network (REDISSEC), Bilbao, Bizkaia, Spain. Electronic address: josemaria.quintanalopez@osakidetza.net. LA - eng SI - ClinicalTrials.gov/NCT01802710 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150311 PL - England TA - J Psychosom Res JT - Journal of psychosomatic research JID - 0376333 SB - IM MH - *Adaptation, Psychological MH - Combined Modality Therapy/methods MH - Dyspepsia/physiopathology/*psychology/*therapy MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Psychotherapy/methods MH - Psychotherapy, Group MH - *Quality of Life MH - Self Report MH - Severity of Illness Index MH - Surveys and Questionnaires MH - Treatment Outcome OTO - NOTNLM OT - Dyspepsia related quality of life OT - Functional dyspepsia OT - Psychotherapy OT - Randomized clinical trial OT - Responsiveness EDAT- 2015/03/21 06:00 MHDA- 2015/10/08 06:00 CRDT- 2015/03/21 06:00 PHST- 2014/07/04 00:00 [received] PHST- 2015/02/27 00:00 [revised] PHST- 2015/03/03 00:00 [accepted] PHST- 2015/03/21 06:00 [entrez] PHST- 2015/03/21 06:00 [pubmed] PHST- 2015/10/08 06:00 [medline] AID - S0022-3999(15)00057-4 [pii] AID - 10.1016/j.jpsychores.2015.03.003 [doi] PST - ppublish SO - J Psychosom Res. 2015 Jun;78(6):563-8. doi: 10.1016/j.jpsychores.2015.03.003. Epub 2015 Mar 11.