[Controlled study of the effect of dihydroergocristine on organic brain psychosyndrome].

The aim of this study was to verify long-term therapeutic efficacy and tolerance of dihydroergocristine (DHEC, CAS 17479-19-5) in a double blind placebo controlled study, in elderly patients with psychosyndrome characterized by memory and behaviour impairment. Two hundred patients, aged more than 65 years, were randomly divided into two groups of one hundred each. The first group received one 6-mg DHEC tablet daily for four months and the other group received placebo. The evaluation parameter for efficacy was the neuropsychological test SCAG (Scale of Clinical Assessment for Geriatrics), administered before and after 30, 60 and 120 days. The results showed a significant difference between DHEC and placebo with regard to total and partial scores of SCAG as well as to single items (mental alertness, recent memory, disorientation, anxiety, mood depression, emotional lability, motivation, uncooperativeness, fatigue, headache, tinnitus). After as few as thirty days of DHEC treatment the severity of mental and psychological symptoms was markedly decreased (p vs placebo < 0.01), as documented by significant positive changes of SCAG items. The four-month double blind period was followed by a two-month single blind period, during which patients of both groups received placebo. At the end of these two months, SCAG total score was unfavourably increased in patients previously administered DHEC, although scores were still significantly lower both versus baseline and versus previous placebo patients. Safety was good (placebo: one case of diarrhea; DHEC: one case of gastralgia and dizziness). Nine patients dropped out for reasons unrelated to treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes