Napryeyenko, 2007, [21] [91] | Mild to moderate dementia with neuropsychiatric features | Multicenter, randomized, placebo- controlled | 395 (198 GBE treatment group and 197 placebo group); i.d. | ≥50 years (no upper limit); mean age = 65 ± 8 years for GBE treatment group and 63 ± 8 years for placebo group | 2 × 120 mg = 240 mg EGb 761/day (vs. placebo) for 22 weeks, no information on follow-up | Secondary outcome variable: change in patient self-ratings of presence and severity of dizziness and tinnitus using 11-point box scales. | Dizziness: Change from baseline at week 22 for the dizziness 11-point box scale was −1.7 for the GBE group and −0.3 for the placebo group; p < 0.001; mean reduction difference in dizziness severity in favor of GBE treated patients compared to placebo was statistically meaningful (−1.93 [95% CI: −2.24, −1.62]) Tinnitus: Change from baseline at week 22 for the tinnitus 11-point box scale was −1.1 for the GBE group and −0.0 for the placebo group; p < 0.001; mean reduction difference in tinnitus severity in favor of GBE treated patients compared to placebo was statistically meaningful (−1.96 [95% CI: −2.35, −1.57]). |
Nikolova, 2013, [21] [92] [article in Russian] | Mild to moderate dementia | Randomized, placebo- controlled, double-blind | 408 (203 received GBE treatment and 205 received placebo); i.d. | Not specified | 240 mg EGb 761/ day (vs. placebo) for 22 weeks, no information on follow-up | Secondary outcomes variable: change in 11-point box scales for the rating of presence and severity of dizziness and tinnitus from baseline. | Dizziness: Mean reduction difference in tinnitus severity in favor of GBE treated patients compared to placebo was statistically meaningful (−0.29 [95% CI: −0.88, −0.30]) Tinnitus: Mean reduction difference in tinnitus severity in favor of GBE treated patients compared to placebo was statistically meaningful (−0.66 [95% CI: −1.23, −0.09]). |