| Methods |
RCT to compare two conditions. Randomisation biased towards more patients in experimental group. Assessments on three occasions: baseline, 2 and 6 months. |
| Participants |
50 patients (aged 30‐60) with somatisation disorder (unexplained somatic symptoms and 1 or more symptoms meeting ICHPPC criteria for specific functional disorders) recruited from GPs and other physicians in an out‐patient clinic. Therapist: 1 research GP. |
| Interventions |
T (n:33) = group cognitive behavioural therapy (focus on reducing dread, physical examination, patient education, cognitive restructuring, relaxation training), 8 3‐hr sessions in 2 months.
C (n:17) = waiting list.
Therapist received training in stress relaxation. Supervision of therapist unknown. |
| Outcomes |
6 month follow‐up: T superior to C on illness behaviour (IBQ), hypochondriasis (Whitley index), and medication use. No sign. differences on social problems (SPQ), anxiety (HAD), depression (HAD), sleep (SDI). |
| Notes |
non‐compliance: T=1/32.
withdrawal:
T=1/32,C=unknown.
no integrity check. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
