OVERVIEW OF CLINICAL-TRIALS OF HYDERGINE IN DEMENTIA

Objective: To assess the overall effect of Hydergine (a combination dr ug called ergoloid mesylates) on patients with possible dementia and t o investigate potential moderators of an effect. Data Sources: MEDLINE , EMBASE, and two proprietary databases were searched for reports of c linical trials. Study Selection: Included were randomized, placebo-con trolled, double-blind, parallel-group trials in subjects with symptoms consistent with dementia performed with specified outcome instruments and sufficient statistical information to calculate effect sizes. For ty-seven (31%) of 151 trials reviewed met selection criteria. Data Ext raction: Potential moderating variables were extracted from each trial : sample size, inpatient-outpatient status, trial duration, age, gende r, meditation dose, publication year, and diagnostic grouping. Outcome measures were extracted with their associated statistics. Data Synthe sis: The overall combined treatment ef-fects (''adjusted d'') for thre e types of outcome measures were calculated. Overall, Hydergine was mo re effective than placebo as assessed by comprehensive ratings (d=0.47 ; 95% confidence interval [CI], 0.38 to 0.56; P=.0001), clinical globa l ratings (d=0.56; 95% CI, 0.44 to 0.68; P=.0001), and combined neurop sychological measures (d=0.27; 95% CI, 0.22 to 0.32; P=.0001). Inpatie nt status, daily doses of 4 mg or more, and vascular dementia were gen erally associated with larger effects. The effect in patients with pos sible Alzheimer's dementia was significant only for combined neuropsyc hological measures in five trials (d=0.30; 95% CI, 0.16 to 0.44; P=.00 01; and with a dose-response, P=.001). Conclusions: Overall, ergoloid mesylates were more effective than placebo. However, the effect in pat ients with possible Alzheimer's dementia was very modest at best. The dose-response relation suggests that potentially effective doses may b e higher than that currently approved. The circumstances of the effica cy of Hydergine remain inadequately defined.