[Non-hormonal therapy for menopausal disorders: results of a multicentric double-blind trial (author's transl)].
A multicentric trial was conducted under double-blind conditions to assess the efficacy of veralipride in the treatment of menopausal disorders, when compared with placebo. Excellent or good results were obtained in 32 of the 40 patients (80 p. cent) with sudden flushes, after veralipride treatment, and only 17 of the 35 patients (48,5 p. cent) after placebo. In spite of the remarkable sensitivity of these disorders to placebo administration, the results are highly significant (p < 0-01) in favor of veralipride. Successful results after veralipride were more frequently noted in cases of natural menopause (21 out of 23 cases = 91,3 p. cent) than those with an artificial menopause (11 out of 17 cases = 64,7 p. cent). In psycho-functional disorders (anxiety, irritability, depressive syndrome), veralipride gave excellent or good results in 17 out of 32 cases, placebo in 8 out of 31 cases, a significant difference in favor of veralipride (p < 0,05). No significant modifications in biological parameters studied were noted, and only 2 cases of mild galactorrhea and mammary congestion were observed, though not reported by the patients. One patient complained of vertigo. Veralipride appears, therefore, to be the first non-hormonal therapy effective against disorders of the climateric.
D000328:Adult; D002979:Climacteric / Q000187:drug effects; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D010919:Placebos; D011602:Psychophysiologic Disorders / Q000188:drug therapy; D013469:Sulpiride / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
D010919:Placebos; D013469:Sulpiride; C027429:veralipride
Traitement non hormonal des troubles de la ménopause. Etude multicentrique en double insu.