title: Is there a benefit from intensified medical and psychological interventions in patients with functional dyspepsia not responding to conventional therapy?
abstract: OBJECTIVE
  In a prospective randomized, controlled trial, to compare the long-term outcome of intensive medical therapy (with or without cognitive-behavioural or muscle relaxation therapy) vs. standard medical therapy in patients with refractory functional dyspepsia (FD), referred to a tertiary referral medical center.
  
  
  METHODS
  A total of 100 consecutive FD patients were allocated to a standardized symptom-oriented 4 month therapy (SMT, n = 24), intensive medical therapy (IMT, medical therapy with testing-for and targeting-of abnormalities of motor-and-sensory function, n = 28) or IMT plus psychological interventions (either progressive-muscle relaxation (IMT-MR, n = 20) or cognitive-behavioural therapy (IMT-CBT, n = 28). The symptom intensity (SI) and health-related quality-of-life (HRQoL) after 12 months were prespecified primary outcome parameters.
  
  
  RESULTS
  After 12 months, significantly greater improvement of SI occurred in patients with IMT-all (with or without psychological interventions) compared with SMT (P < 0.025 vs. IMT-all). IMT, IMT-MR and IMT-CBT alone also resulted in significantly better improvement of the primary outcome parameters (P all < 0.025 vs. SMT). HRQoL significantly improved in all groups with intensive medical therapy but not standard medical therapy. Differences between intensive medical therapy-all and standard medical therapy were not significant. Concomitant anxiety and depression was improved significantly by IMT-CBT (vs. SMT) but not other treatments.
  
  
  CONCLUSIONS
  In FD patients with refractory symptoms, intensified medical management involving function testing and psychological intervention yields superior long-term-outcomes. Additional CBT may be effective for the control of concomitant anxiety and depression.
authors.affiliation: Department of Gastroenterology and Hepatology, and Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Essen, Essen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Haag
authors.forename: W
authors.initials: W
authors.lastname: Senf
authors.forename: S
authors.initials: S
authors.lastname: Tagay
authors.forename: M
authors.initials: M
authors.lastname: Langkafel
authors.forename: U
authors.initials: U
authors.lastname: Braun-Lang
authors.forename: A
authors.initials: A
authors.lastname: Pietsch
authors.forename: G
authors.initials: G
authors.lastname: Heuft
authors.forename: N J
authors.initials: NJ
authors.lastname: Talley
authors.forename: G
authors.initials: G
authors.lastname: Holtmann
mesh_terms: D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000209:etiology; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003866:Depressive Disorder / Q000209:etiology; D004415:Dyspepsia / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010352:Patient Dropouts; D011788:Quality of Life / Q000523:psychology; D012064:Relaxation Therapy; D016896:Treatment Outcome
chemical_list: D000897:Anti-Ulcer Agents; D000928:Antidepressive Agents