Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial.

BACKGROUND: Aggressive challenging behaviour is frequently reported in adults with intellectual disability and it is often treated with antipsychotic drugs. However, no adequate evidence base for this practice exists. We compared flexible doses of haloperidol (a typical, first-generation antipsychotic drug), risperidone (an atypical, second-generation antipsychotic), and placebo, in the treatment of this behaviour. METHODS: 86 non-psychotic patients presenting with aggressive challenging behaviour from ten centres in England and Wales, and one in Queensland, Australia, were randomly assigned to haloperidol (n=28), risperidone (n=29), or placebo (n=29). Clinical assessments of aggression, aberrant behaviour, quality of life, adverse drug effects, and carer uplift (positive feelings about the care of the disabled person) and burden, together with total costs, were recorded at 4, 12, and 26 weeks. The primary outcome was change in aggression after 4 weeks' treatment, which was recorded with the modified overt aggression scale (MOAS). Analysis was by intention to treat. This study is registered as ISRCTN 11736448. FINDINGS: 80 patients had adherence of 80% or more to prescribed drug. Aggression decreased substantially with all three treatments by 4 weeks, with the placebo group showing the greatest change (median decrease in MOAS score after 4 weeks=9 [95% CI 5-14] for placebo, 79% from baseline; 7 [4-14] for risperidone, 58% from baseline; 6.5 [5-14] for haloperidol, 65% from baseline; p=0.06). Furthermore, although no important differences between the treatments were recorded, including adverse effects, patients given placebo showed no evidence at any time points of worse response than did patients assigned to either of the antipsychotic drugs. INTERPRETATION: Antipsychotic drugs should no longer be regarded as an acceptable routine treatment for aggressive challenging behaviour in people with intellectual disability.

Screening and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial.

BACKGROUND: Alcohol misuse is highly prevalent among people attending emergency departments, but the effect of intervention by staff working in these departments is unclear. We investigated the effect of screening and referral of patients found to be misusing alcohol while attending an emergency department. METHODS: We undertook a single-blind pragmatic randomised controlled trial. Patients received either an information leaflet or an information leaflet plus an appointment with an alcohol health worker. Outcome data were collected by patient interview and examination of hospital records at 6 and 12 months. FINDINGS: 599 patients were randomised over a 12-month period. At 6 months, those referred to an alcohol health worker were consuming a mean of 59.7 units of alcohol per week compared with 83.1 units in the control group (t -2.4, p=0.02). At 12 months those referred were drinking 57.2 units per week compared with 70.8 in controls (t -1.7, p=0.09). Those referred to the alcohol health worker had a mean of 0.5 fewer visits to the emergency department over the following 12 months (1.2 compared with 1.7, t -2.0, p=0.046). Differences in quality of life were not found. INTERPRETATION: Opportunistic identification and referral for alcohol misuse in an emergency department is feasible, associated with lower levels of alcohol consumption over the following 6 months, and reduces reattendance at the department. Short-term reductions in alcohol consumption associated with referral for brief intervention for alcohol misuse benefit patients and reduce demand for accident and emergency department services.