Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial

Figures & data

Figure 1 Study flow chart.

Table 1 Characteristics of subjects receiving either Ginkgo biloba extract or placebo who completed the study and discontinued the study

Characteristics	Subjects who (N=90)		P-value*
	Completed the study (n=58)	Discontinued the study (n=32)
Gender (women), n (%)	37 (63.8)	22 (68.8)	0.636
Age (years), mean ± SD	66.7±7.7	68.0±8.6	0.343
Height (cm), mean ± SD	167.0±8.6	168.0±7.8	0.566
Weight (kg), mean ± SD	76.8±14.9	71.6±11.0	0.095
Smoking, n (%)	6 (10.3)	2 (6.5)	0.541
Arterial hypertension, n (%)	45 (77.6)	24 (75.0)	0.781
Diabetes mellitus, n (%)	10 (17.2)	8 (25.0)	0.378
Previous stroke, n (%)	6 (10.9)	4 (12.5)	0.824
Previous transient ischemic attack, n (%)	12 (20.7)	5 (15.6)	0.557
Previous myocardial infarction, n (%)	1 (1.7)	0 (0)	0.356
Mood disorder, n (%)	3 (5.2)	4 (12.5)	0.241
Parkinson’s disease, n (%)	1 (1.7)	0 (0)	0.356
Chronic obstructive pulmonary disease, n (%)	3 (5.2)	2 (6.3)	0.652
Tinitus, n (%)	25 (43.19)	13 (40.6)	0.820
Headache, n (%)	21 (36.8)	13 (40.6)	0.725
Laboratory findings, mean ± SD
Sedimentation rate (mm/h)	14.6±13.1	15.5±19.7	0.794
White blood cell count (×10^9/L)	7.2±0.4	6.7±0.5	0.391
Red blood cell count (×10^12/L)	4.5±2.5	4.3±2.0	0.032
Platelet count (×10^9/L)	248.4±51.4	229.5±36.4	0.050
Hemoglobin (g/L)	138.8±10.2	139.6±13.1	0.752
Hematocrit (L/L)	0.4±0.03	0.4±0.04	0.306
Glucose (mmol/L)	6.2±1.9	6.7±3.5	0.850
Total bilirubin (μmol/L)	17.1±13.3	14.7±7.7	0.412
Aspartate transaminase (IU/L)	21.0±10.7	21.5±7.0	0.805
Alanine transaminase (IU/L)	21.1±8.0	20.4±12.4	0.801
Urea (mmol/L)	6.3±1.7	6.9±3.7	0.567
Creatinine (μmol/L)	84.8±23.8	82.9±18.2	0.701
Potassium (mmol/L)	4.3±0.4	4.3±0.4	0.958
Sodium (mmol/L)	140.2±4.3	138.5±4.7	0.089
Chlorides (mmol/L)	106.7±6.7	105.7±4.4	0.481
Cholesterol – high-density lipoprotein (mmol/L)	1.6±0.7	1.6±0.4	0.981
Cholesterol – low-density lipoprotein (mmol/L)	3.6±1.0	3.4±1.2	0.267
Triglycerides (mmol/L)	1.8±0.8	1.5±0.5	0.076
Prothrombin time (s)	1.2±0.1	1.29±0.1	0.570
Activated partial thromboplastin time (s)	30.5±11.2	27.8±6.4	0.260
Transcranial doppler – mean (±SD) flow velocity (cm/s)
Left carotid siphon	50.9±11.7	49.9±15.4	0.780
Right carotid siphon	50.3±9.9	52.4±14.1	0.533
Left middle cerebral artery	52.1±12.4	52.1±15.1	0.992
Right middle cerebral artery	51.9±10.8	54.4±13.6	0.482
Left anterior cerebral artery	−47.8±9.6	−33.9±35.8	0.003
Right anterior cerebral artery	−43.5±18.2	−35.3±36.9	0.622
Left posterior cerebral artery	28.1±14.6	33.5±18.7	0.252
Right posterior cerebral artery	28.3±12.6	33.9±18.9	0.216
Left vertebral artery	−27.6±11.5	−21.5±19.5	0.089
Right vertebral artery	−27.0±11.4	−22.3±17.1	0.158
Basilar artery	−30.3±13.8	−14.0±27.0	0.004
Neuropsychological assessment, mean ± SD
Sandoz Clinical Assessment Geriatric Scale	45.7±10.6	45.2±11.1	0.889
Folstein Mini-Mental State Examination	25.8±2.4	25.5±2.2	0.478
Mattis Dementia Rating Scale	126.8±13.4	124.1±12.4	0.354
Clinical Global Impression	2.86±0.8	2.9±0.7	0.255

Notes: Bold figures represent as statistically significant different values.

* Two-sided P-value of Student’s t-test for continuous variables and chi-square test for categorical variables.

Abbreviation: SD, standard deviation.

Table 2 Neuropsychological test results of subjects receiving Ginkgo biloba extract and placebo during the 6-month study period

Scale/visit No	Study groups, mean ± SD			F	P-value
	G. biloba 120 mg (n=20)	G. biloba 60 mg (n=19)	Placebo (n=19)
Sandoz Clinical Assessment Geriatric Scale				0.39454	0.676
V1	48.3±12.8	44.9±9.1	43.3±9.2
V4	45.7±12.7	40.7±8.2	39.1±6.9
V7	43.6±14.7	39.1±6.9	36.7±6.1
Folstein Mini-Mental State Exam				0.26780	0.766
V1	26.0±2.6	25.1±2.3	26.4 ±2.3
V4	27.4±2.1	26.9±2.4	27.8±2.3
V7	27.9±2.5	26.7±2.9	28.1±2.8
Mattis Dementia Rating Scale				0.29030	0.749
V1	128.8±10.0	123.9±14.4	127.6±15.6
V4	126.2±14.1	125.1±14.7	125.9±12.7
V7	128.4±13.7	124.9±16.5	127.2±12.4
Clinical Global Impression				3.4714	0.038
V1	2.6±0.8	3.1±0.7	2.6±0.8
V4	2.6±0.8	3.1±0.7	2.7±0.7
V7	2.6±0.8	3.1±0.7	2.8±0.7

Notes: F represents as a value calculated by ANOVA test to verify the statistical significance of difference between groups. Bold figure represents as statistically significant different value.

Abbreviations: V1, V4, V7, study visit number; ANOVA, analysis of variance.

Table 3 ARs reported by subjects taking Ginkgo biloba and placebo during the 6-month study period

AR	No of subjects (N=58)			Total
	G. biloba 120 mg (n=20)	G. biloba 60 mg (n=19)	Placebo (n=19)
Rash	1	0	2	3
Arterial hypertension	1	0	0	1
Varicose veins on legs	2	0	0	2
Headache	2	1	0	3
Tinnitus	1	1	0	2
Abdominal pain	0	1	0	1
Retching	0	1	0	1
Vertigo	1	1	3	5
Nausea	0	2	4	6
Vomiting	0	2	3	5
Tachycardia	0	0	1	1
Concentration impairment	0	0	1	1
Insomnia	0	0	1	1
Feeling generally unwell	0	0	1	1
Total (severe AR)	8 (0)	9 (3)	16 (9)	33 (12)

Abbreviation: AR, adverse reaction.