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BACKGROUND: A sufficient number of randomised controlled clinical trials (RCTs) with high methodological reliability are required to allow a critical assessment of therapeutic interventions. The aim of this study was to evaluate the final reports of the Institute for Quality and Efficiency in Health Care (IQWiG) addressing non-medical interventions. These reports were analysed in order to determine how many endpoint-related comparisons were evaluated by clinical studies, how many by RCTs and how many by methodologically reliable RCTs. METHODS: Seventeen out of eighteen final reports of the IQWiG department of non-medical interventions were critically analysed. The final reports had been generated from 2006 till 2009. Comparison of therapeutic procedures and patient relevant endpoints were taken from the final reports. Additional patient relevant endpoints were considered whenever these had been included in the result section. RCTs considered essential for the assessment were identified. RCTs obtaining the biometric rating no shortcomings, moderate shortcomings or low bias were considered to be of methodological reliability. RESULTS: A total of 537 comparisons addressing single endpoints were identified. Clinical studies were available for 50% of these comparisons (n=272). For 38% of the comparisons (n=205) RCTs could be included, but in only 18% these RCTs had reliable methods. The number of reports containing zero, one, and more than one RCT was 6, 4, and 7, respectively. Methodologically reliable RCTs were included in only 8 out of 17 final reports. DISCUSSION: The analysis of evidence showed that both the number and the quality of studies were insufficient. This is why better standards for the evaluation of non-medical interventions need to be established. This may be achieved by raising the regulatory requirements and by intensifying research from independent institutions.

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OBJECTIVE: Although the treatment of schizophrenia with many second generation antipsychotics is known to be associated with metabolic changes, such as hyperglycemia or hypercholesterolemia, the underlying mechanisms of these adverse reactions remain unclear. In light of the recent focus on the involvement of semicarbazide-sensitive amine oxidase (SSAO) in glucose metabolism, we investigated SSAO serum activity in schizophrenic patients treated with antipsychotics with the objective of determining a possible link between SSAO and impaired glucose metabolism. METHODS: Blood samples were drawn from 44 schizophrenic patients (24 receiving second generation antipsychotics known to disturb glucose metabolism) on day 1 and day 5 of inpatient treatment. Forty-one healthy adults with no medical condition known to influence SSAO served as controls. RESULTS: Of the 44 schizophrenic patients, the 24 treated with second generation antipsychotics known to disturb glucose metabolism showed significantly lower SSAO serum activity [day 1 (mean +/- SD): 477 +/- 105 mU/L; day 5: 438 +/- 86 mU/L] than the 20 patients treated with other antipsychotics not known to influence glucose metabolism (day 1: 513 +/- 124 mU/L, p = 0.359; day 5: 542 +/- 204 mU/L, p = 0.021) only after 5 days of treatment and compared to healthy controls (526 +/- 142 mU/L, p = 0.021). No differences were observed between schizophrenic patients treated with first generation antipsychotics and the controls. CONCLUSION: We found decreased SSAO serum activity exclusively in schizophrenic patients treated with second generation antipsychotics known to disturb glucose metabolism. In terms of the role of SSAO in glucose metabolism, the observed decrease in SSAO serum activity may be linked to metabolic changes that are known to occur in schizophrenic patients being treated with many second generation antipsychotics.

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Semicarbazide sensitive aminooxidase (SSAO) is known to interplay with monoamine oxidases (MAO) and several antidepressants. Taking into account the monoamine hypothesis concerning the pathophysiology of depression, the aim of the present pilot study was to evaluate serum SSAO activity in depressed patients. A total of 21 inpatients with major depression and 41 healthy controls were studied. Serum SSAO activity was determined by HPLC on days 1, 5 and 10 of inpatient treatment. At baseline without medication including antidepressants, highly depressed patients (MADRS score>or=30) had significantly decreased serum SSAO activity (mean 385+/-161 mU/l) when compared to healthy controls (mean 526+/-141 mU/l; p=0.003). This SSAO decrease was less pronounced at day 5 and day 10 under an antidepressive drug regime. Decreased serum SSAO activity was observed in patients with major depression, especially in those with high MADRS scores. The present results support the hypothesis of dysfunctional monoaminergic metabolism in the pathogenesis of depressive disorders. The disputable association between depression and monoamine metabolism requires further investigation, particularly with regard to SSAO activity and medication status.

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Consumption of pizza, salad and iced tea was assessed in four separate tests at a central location. Three aspects of context were added in successive tests-social interaction during consumption, the physical environment in which the food was consumed and choice among foods-so that the fourth test had all effects present. The proportion consumed averaged from 79 to 82% of the food presented and increased significantly in the presence of one or more of the context manipulations. Salad consumption was higher when there was a choice of dressings in an enhanced environment. Pizza and tea consumption were higher in an enhanced restaurant-like environment. Social interaction alone has no detectable impact on food consumption. It is concluded that people eat more in enhanced contexts and careful consideration should be given to the environment in studies of food consumption.

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