A randomized controlled trial of a 10 week group psychotherapeutic treatment added to standard medical treatment in patients with functional dyspepsia.

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.

Impact of interdisciplinary treatment on physical and psychosocial parameters in patients with fibromyalgia: results of a randomised trial.

AIM: Fibromyalgia (FM) is a persistent disorder that can have a devastating effect on patients' lives. The purpose of the study was to assess the effects of an interdisciplinary treatment for FM on patients' physical and psychosocial parameters. METHODS: A randomised controlled clinical trial carried out among 153 patients. The control group (CG) received standard pharmacological therapy. The experimental group (EG) received an interdisciplinary treatment. At baseline and 6 months after the intervention, participants completed assessment for impact of FM in the quality of life, anxiety, depression, coping with pain, social support and satisfaction with the treatment. RESULTS: A total of 110 participants completed the trial. Six months after the intervention, statistically significant improvements in quality of life (p = 0.04), pain (p = 0.03), self-assertiveness (p = 0.01), mental self-control (p = 0.05), social support (p = 0.02) and satisfaction (p = 0.0001) were observed in the EG. Randomisation to the EG was identified as a predictor for improvement. CONCLUSION: An interdisciplinary intervention may be appropriate for patients referred to a hospital pain management unit.