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Life Sci ; 146: 139-47, 2016 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-26772822


AIMS: The objective of this study was to assess the efficacy profile of Nx4 (Neurexan ®) in an acute experimental stress setting. An acute stress reaction is a biopsychological condition arising in response to an event that is individually regarded as emotionally stressful. Medications can mitigate stress perception and stress reactions, but may also have side effects. MATERIALS AND METHODS: Sixty-four healthy male and female volunteers participated in this prospective two-arm two-site study following an explorative randomized placebo-controlled double-blind study design. Participants took six tablets of either Nx4 or placebo during a time period of 2.5h before exposure to an acute psychological stressor (Trier Social Stress Test), and were subsequently monitored for 1.5h. Subjective stress ratings as well as cardiovascular and neuroendocrine parameters were analyzed before and after stress exposure. KEY FINDINGS: All changes in primary and secondary efficacy parameters corresponded well with the experimental acute stress setting. Nx4 did not affect subjective stress ratings but significantly diminished stress-induced increases in salivary cortisol and plasma adrenaline. Nx4 was as safe as placebo and very well tolerated. SIGNIFICANCE: The results suggest an attenuated neuroendocrine stress response in healthy volunteers induced by Nx4. However, further investigations are needed to confirm these observations as well as to better understand why some parameters were affected while others were not. Future investigations should be extended to chronically stressed individuals with a greater disposition to experience stress in everyday life. Identifier: NCT01703819.

Extratos Vegetais/uso terapêutico , Estresse Psicológico/tratamento farmacológico , Estresse Psicológico/psicologia , Adulto , Doença Crônica , Método Duplo-Cego , Emoções , Epinefrina/sangue , Feminino , Hemodinâmica/efeitos dos fármacos , Humanos , Hidrocortisona/sangue , Masculino , Extratos Vegetais/efeitos adversos , Estudos Prospectivos , Caracteres Sexuais , Resultado do Tratamento
Neurosci Biobehav Rev ; 60: 51-64, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26616735


Emerging evidence indicates that treatment context profoundly affects psychopharmacological interventions. We review the evidence for the interaction between drug application and the context in which the drug is given both in human and animal research. We found evidence for this interaction in the placebo response in clinical trials, in our evolving knowledge of pharmacological and environmental effects on neural plasticity, and in animal studies analyzing environmental influences on psychotropic drug effects. Experimental placebo research has revealed neurobiological trajectories of mechanisms such as patients' treatment expectations and prior treatment experiences. Animal research confirmed that "enriched environments" support positive drug effects, while unfavorable environments (low sensory stimulation, low rates of social contacts) can even reverse the intended treatment outcome. Finally we provide recommendations for context conditions under which psychotropic drugs should be applied. Drug action should be steered by positive expectations, physical activity, and helpful social and physical environmental stimulation. Future drug trials should focus on fully controlling and optimizing such drug×environment interactions to improve trial sensitivity and treatment outcome.

Antidepressivos/administração & dosagem , Antipsicóticos/administração & dosagem , Encéfalo/efeitos dos fármacos , Meio Ambiente , Transtornos Mentais/tratamento farmacológico , Plasticidade Neuronal/efeitos dos fármacos , Animais , Encéfalo/fisiopatologia , Humanos , Transtornos Mentais/fisiopatologia , Plasticidade Neuronal/fisiologia
J Psychosom Res ; 79(6): 492-7, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26553385


OBJECTIVE: The study investigates the association between somatosensory amplification and the reporting of side effects. It establishes a German version of the Somatosensory Amplification Scale and examines its psychometric properties in a representative sample of the German population. METHODS: Sample size was 2.469, with 51% taking any medication. Participants answered the Somatosensory Amplification Scale, Generic Assessment of Side Effects Scale, and indicated whether they were taking any medication and the type of medication. Correlational analysis and binary logistic regression were performed. RESULTS: When examining a subsample reporting both medication intake and general bodily symptoms, participants higher in somatosensory amplification rated more of their general bodily symptoms as medication-attributed side effects. However, somatosensory amplification scores were not associated with the intake of any type of medication. In the overall sample, higher somatosensory amplification scores were associated with an increased report of bodily symptoms. Additionally, participants with higher somatosensory amplification reported intake of a greater number of different medications. The psychometric properties of the translated scale were good, and previously established associations of somatosensory amplification with demographic variables (age, sex) were replicated. CONCLUSION: Results suggest a possible attributional bias concomitant to somatosensory amplification which in turn may increase the reporting of side effects after medication intake.

Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/psicologia , Córtex Somatossensorial/fisiopatologia , Adulto , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Fatores de Risco