Assessment of serum-free cortisol levels in patients with adrenocortical carcinoma treated with mitotane: A pilot study

Objective Mitotane treatment in adrenocortical carcinoma (ACC) results in unreliable measurement of serum total cortisol (TC) levels because of an elevation in corticosteroid-binding globulin (CBG). Design The use of a newly-developed serum-free cortisol (FC) assay was assessed to investigate the characteristics of a more valid measure of cortisol status. Patients Sixty-two serum samples from patients with ACC treated with mitotane were studied. Different subgroups were studied according to mitotane levels (<14, 14-20 and >20 mg/dl), hydrocortisone replacement treatment, presence of Cushing's syndrome (CS) and adrenocorticotrophin (ACTH) levels. Measurements Serum FC was measured using a newly-developed assay, TC, CBG and plasma ACTH using conventional laboratory kits; TC-to-CBG (Free cortisol index, FCI, nmol/mg) and TC-to-FC (TFR) ratios were calculated. Results CBG levels were elevated and positively correlated to mitotane levels. FC was positively related to TC and FCI in nearly all subgroups studied. Plasma ACTH was negatively related to parameters of cortisol levels in the total samples studied. In the 'target' subgroup with normal ACTH levels and mitotane levels 14-20 mg/dl, no correlation of plasma ACTH with any parameter studied was seen, and FC suggested over-replacement with hydrocortisone treatment in the subgroup with CS. Conclusions FC measurement may offer additional information in the follow-up of patients on mitotane, especially when there is a history of CS which invalidates the use of acute changes in plasma ACTH as a parameter of hydrocortisone replacement. These preliminary data suggest that it may prove useful as a biochemical marker when TC or FCI are invalidated by mitotane treatment or plasma ACTH is suppressed by hypercortisolaemia. Larger studies are needed to substantiate the clinical utility of FC measurement in specific groups of patients. © 2010 Blackwell Publishing Ltd

Self-wise, Other-wise, Streetwise (SOS) training, an intervention to prevent victimization in dual-diagnosis patients: results from a randomized clinical trial

Background and Aims: Patients with co-occurring substance use and other mental disorders are vulnerable to crime victimization, yet no evidence-based preventive interventions exist. Our aim was to test the efficacy of a new intervention, Self-wise, Other-wise, Streetwise training (SOS training), to prevent victimization in these dual-diagnosis patients as an add-on to care as usual. Design: Multi-site single-blind parallel randomized controlled trial. Setting: Three sites within one psychiatric service in Amsterdam, the Netherlands. Participants: Adult in-patients and out-patients with dual diagnosis (n = 250), who were predominantly male (70.4%), aged on average 42.1 years, and diagnosed with 3.7 DSM-IV disorders. Intervention and comparator: Care as usual, consisting of pharmacotherapy combined with individual psychotherapy, group psychotherapy and/or supportive counselling (n = 125) was compared with care as usual plus SOS training: a 6-week, 12-session manualized group training focused on enhancing emotion regulation skills, conflict resolution skills and street skills (n = 125). Measurements: Victimization was assessed with the Safety Monitor, the Dutch equivalent of the International Crime Victims Survey, in a face-to-face assessment. The primary outcome measure was treatment response (yes/no), with ‘yes’ defined as reporting at least a 50% reduction in the number of past-year victimization incidents at the 14-month follow-up compared with baseline. Analyses were performed according to the intention-to-treat principle. Findings: The proportion of participants achieving treatment response for total victimization was 54.0% in the control group and 67.6% in the experimental group, a significant difference [odds ratio (OR) = 1.78, 95% confidence interval (CI) = 1.02–3.11, P = 0.042]. Treatment response for violent victimization was achieved by 68.7% of the control group and 79.3% of the experimental group (OR = 1.75, 95% CI = 0.91–3.34, P = 0.092). With a Bayes factor of 2.26, this result was inconclusive. Conclusions: Among dual-diagnosis patients, care as usual plus Self-wise, Other-wise, Streetwise training was more effective in preventing victimization than care as usual alone