Pilot Study:
a) 21 Generalised Anxiety Disorder (GAD) patients were treated double-blind with either diazepam or placebo for 6 weeks. This active treatment period was preceded by one-week single-blind placebo ‘wash-in’, and followed by two-week single-blind ‘washout’. Results showed that diazepam used in moderate doses for 6
weeks produced anxiety recurrence and withdrawal symptoms.
b) 10 GAD patients were randomly allocated to Cognitive-Behaviour Therapy (CBT) and compared with the above diazepam and placebo groups. All treatments were balanced for degree of Psychologist/patient contact. At cessation of active treatment CBT superiority was indicated. Post-Study psychotropic prescription and
psychological treatment were assessed at 12 months follow-up. The CBT group had the lowest incidence of
subsequent treatment interventions.
Main Study :
101 GAD patients were randomly allocated to diazepam, placebo, CBT, CBT + diazepam, and CBT + placebo, and treated over 10 weeks. Outcome measures at end of treatment and at 6 months follow-up revealed the superiority of all CBT treatments; especially CBT alone, and CBT + diazepam. Diazepam was more effective than placebo. CBT + diazepam, and diazepam groups showed no anxiety recurrence during graded withdrawal.
Secondary Study :
205 long-term benzodiazepine users were matched for age and sex with controls. Inspection of medical case notes showed that benzodiazepine users had higher rates of previous physical illness, GP attendance, and non-psychotropic drug prescription. Differences emerged between anxiolytic, hypnotic, and anxiolytic + hypnotic benzodiazepine users in age, history of physical illness, and previously prescribed medication.
Tertiary Study :
44 long-term benzodiazepine users were interviewed. The incidence of psychological ill-health and social problems was lower than expected. Patients were dependent on medication, and reported concern if their medication were to be stopped. Nevertheless 40% considered stopping benzodiazepines.
Results from the above studies are discussed in relation to clinical management of GAD, and current concerns about benzodiazepine dependence and withdrawal.