1997 Volume 19 Issue 4 Pages 308-317
The clinical usefulness of so-called cerebral vasodilators and metabolic activators for patients in the chronic stage of CVD is now in question, and the regulatory authorities in Japan have requeasted further information. There have been many parallel-comparison, randomized, placebo-controlled trials of metabolic activators in Japan, and after an exhaustive search, 14 were selected. Most of them had adopted an 8-week treatment period. To quantify the average treatment effect, meta-analysis was conducted. The primary endopint was the clinical global outcome assessed at the end of 8 weeks of treatment by using a 5-point Likert scale. Secondary endpoints included the subjective, psychiatric, and neurological symptoms, and ADL, which were assessed in the same manner as the clinical glabal outcome. The upper two categories in each scale were considered as “effective” outcomes. The odds ratios in terms of the efficacy were 1.59 (p<0.0001) for the clinical global outcome, 1.77 for the subjective symptoms, and 1.85 for the psychiatric symptoms. However, the odde ratios for the nourological symptoms and ADL were relatively low. Efficacy appeared to be greater in patients with ischemic stroke than in those with cerebral hemorrhage. The pooled control efficacy rate in the placebo group was estimated to be 18.1%, with an absolute difference of 8.4% from active drugs. In conclusion, cerebral vasodilators and metabotic activators were shown to be 1.6 times more effective than a placebo in terms of the relative global efficacy, based on a meta-analysis of 14 selected, randomized, placebo-controlled drug trials conducted in Japan from 1972 to 1992.
