C.A. Pruneti, F. Petraglia, S. Rossi, S. Rota, M. Stomati, M. Luisi, A.R. Genazzani - Vol. 5, Marzo1999, num.1
Testo Tabelle Immagini Bibliografia Summary Riassunto Indice
Studio, in doppio cieco, degli effetti
a livello comportamentale, psicofisiologico ed endocrinologico in pazienti
con amenorrea ipotalamica, di un trattamento farmacologico a breve termine
con Pivagabina (PVG)
A double-blind study of the behavioural,
psychophysiological and endocrine effects of a short-term drug treatment with
Pivagabine (PVG) in patients with hypothalamic amenorrhoea
Objective: the aim of this study was to determine the behavioural, psychophysiological and endocrine effects of pivagabine, a modulator of CRF release, in patients with hypothalamic amenorrhoea with no significant weight loss, receiving the drug to relieve anxious and depressive symptoms that are frequently associated with this disorder.
Methods: twenty women with hypothalamic amenorrhoea received 900 mg oral pivagabine for seven consecutive days or placebo according to a double-blind, randomised design. Patients were assessed psychologically with three questionnaires, the Symptom Questionnaire (SQ), a 92-item questionnaire consisting in four scales assessing anxiety, depression, physical symptoms, and hostility, the Crown & Crisp Experiential Index (CCEI), a 48-item, six-scale questionnaire investigating free and phobic anxiety, depressive and hysteroid behaviour, obsessive traits, and somatic complaints, and the Pisa Stress Questionnaire (PSQ), a 32-item, six-scale questionnaire investigating sense of responsibility, vigour, stress disorders, precision, free-time, and hyperactivity. Patients were assessed at baseline and at the end of the treatment period for their psychophysiological profile, comprising the simultaneous recording of frontal muscle electromyographic activity (EMG), Galvanic skin response (GSR), body temperature (T), heart rate (HR) and respiratory rate (RR) during a 6-min stressful mental task and another 6-min period of recovery. The endocrine assessment comprised salivary and plasma cortisol, plasma luteinising hormone, follicle stimulating hormone, growth hormone (GH), adrenocorticotropin (ACTH), prolactin, insulin-like growth factor-1, and beta-endorphin levels at baseline and after the end of treatment.
Results: pivagabine treatment induced significant decreases in the levels of cortisol and ACTH and increases in GH levels. Baseline-end-point differences were found in psychophysiological and psychometric data both in the placebo-treated and the pivagabine-treated groups, but are difficult to interpret. However, pivagabine induced improvement, as evidentiated by the scores of the SQ (somatic items) and the CCEI (free anxiety, obsessive traits, and total scores).
Conclusions: the administration of pivagabine in patients with hypothalamic amenorrhoea induced reduction of perceived stress and its endocrine correlates. Since the study was carried out on a small sample, it needs replication.