Hamilton 2000.
| Methods | RCT with 2 parallel treatment conditions | |
| Participants | 71 participants fulfilling criteria for functional dyspepsia, having continuous symptoms for 6 months, had been unresponsive to at least 2 medical treatments | |
| Interventions | Intervention: psychodynamic‐interpersonal therapy, based on Hobson 1985, manualised, 1 x 3‐hr session and 6 x 50‐min sessions Control: supportive therapy, with session length and number identical to psychodynamic‐interpersonal therapy Adherence to therapy by therapists was measured through SPRS rating of audiotapes |
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| Outcomes | Entry, end of 12‐week intervention, 12‐month follow‐up. Self rating of dyspeptic symptoms, gastroenterological rating of dyspeptic symptoms, SCL‐90‐R and GSI, healthcare use (gastroenterology clinic visits, medications, inpatient stays, procedures) | |
| Notes | Participants with reflux were included in the study, but a subanalysis was performed excluding them Data used for somatic symptoms and SCL‐90 scores at end of treatment. More than 20% of participants were lost to follow‐up, so 1‐year follow‐up data were not used | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed using a computer‐generated series of random numbers supplied by the trial statistician" |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information provided |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The gastroenterologists remained blind to the treatment groups" Comment: physician were blinded to treatment, therefore, scores on somatic symptoms at termination: low risk of bias Participants could not be blinded to treatment allocation Self report data on the SCL‐90: low risk |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: at end of treatment, 37/37 in the experimental group completed outcome data and 31/36 in the control group. Treatment drop‐out was similar across groups but none of the participants in the control group provided outcome data: this would suggest attrition bias. At follow‐up, these figures were 31/37 in the experimental group and 27/36 in the control group. In total, data were available for 79.5% of participants at 1‐year follow‐up. ITT analysis performed |
| Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information provided to permit judgement. No published report on pre‐specified outcomes |
| Other bias | Unclear risk | Comment: insufficient information to permit judgement |