Clinical role of a fixed combination of standardized Berberis aristata and Silybum marianum extracts in diabetic and hypercholesterolemic patients intolerant to statins

Figures & data

Figure 1 Scheme of the study.

Table 1 Features of participants on enrollment

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
Sex (male/female)	9/6	10/5	8/7
Age (years)	65.9±6.7	65.0±6.6	63.5±7.7
Weight (kg)	87.5±13.1	79.0±15.7	80.8±15.9
BMI	30.5±1.5	29.7±2.3	28.7±3.8

Notes: All values are expressed as median ± standard deviation. Values between groups were not statistically significantly different.

Table 2 Plasma total cholesterol at different times in the enrolled patients

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
T=0	210.7±28.8*	227.9±27.8	231.8±23.0
T=6 M	193.5±32.0	197.2±18.0	206.6±16.0
T=12 M	176.5±16.9**	183.5±12.0	191.9±16.0
% Δ 6 M vs T=0	−8.2	−13.5	−10.9
% Δ 12 M vs T=0	−16.2	−19.5	−17.2
P 6 M vs T=0	<0.01	<0.05	<0.01
P 12 M vs T=0	<0.01	<0.01	<0.01
P 12 M vs T=6 M	<0.05	<0.01	<0.01

Notes: All values (mg/dL) are expressed as median ± standard deviation. Δ = variation.

* P<0.05 versus Berberol^® alone and versus Ezetimibe + Berberol^®

** P<0.05 versus Berberol^® alone.

Abbreviations: M, months; T, time.

Table 3 Plasma low-density lipoprotein cholesterol at different times in the enrolled patients

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
T=0	146.3±25.6	166.8±15.7*	146.1±32.2
T=6 M	125±32.8	132.7±22.7	120.9±21.4
T=12 M	104.6±14.5	111.5±14.8	108.9±12.7
% Δ 6 M vs T=0	−14.6	−20.4	−17.2
% Δ 12 M vs T=0	−28.5	−33.2	−25.4
P 6 M vs T=0	<0.01	<0.01	<0.01
P 12 M vs T=0	<0.01	<0.01	<0.01
P 12 M vs T=6 M	<0.01	<0.01	<0.05

Notes: All values (mg/dL) are expressed as median ± standard deviation. Δ, variation;

* P<0.01 versus Berberol^® alone and versus Statin + Berberol^®.

Abbreviations: M, months; T, time.

Table 4 Plasma high-density lipoprotein cholesterol at different times in the enrolled patients

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
T=0	42.0±11.5	40.7±10.2	42.2±9.2
T=6 M	42.8±11.3	44.1±10.4	42.8±8.4
T=12 M	44.4±10.6	44.6±8.6	40.8±7.7
% Δ 6 M vs T=0	+1.9	+8.4	+1.4
% Δ 12 M vs T=0	+5.7	+9.6	−3.3
P 6 M vs T=0	NS	<0.01	NS
P 12 M vs T=0	NS	<0.01	NS
P 12 M vs T=6 M	NS	NS	NS

Notes: All values (mg/dL) are expressed as median ± standard deviation. Δ, variation.

Abbreviations: M, months; NS, not significant; T, time.

Table 5 Plasma triglycerides at different times in the enrolled patients

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
T=0	126.9±35.2	136.2±58.0	139.1±35.9
T=6 M	128.3±18.8	142.1±11.7	138.5±11.3
T=12 M	137.8±27.9	133.4±33.9	139.5±21.2
% Δ 6 M vs T=0	−1.1	+4.3	−0.4
% Δ 12 M vs T=0	+8.5	−2.1	+0.3
P 6 M vs T=0	NS	NS	NS
P 12 M vs T=0	NS	NS	NS
P 12 M vs T=6 M	NS	NS	NS

Notes: All values (mg/dL) are expressed as median ± standard deviation. Δ, variation.

Abbreviations: M, months; NS, not significant; T, time.

Table 6 Plasma fasting glucose in the enrolled patients

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
T=0	139.7±26.8	146.9±21.6	141.6±21.2
T=6 M	128.3±18.0*	142.1±11.7	128.5±11.3*
T=12 M	125.2±20.6	133.8±17.9	127.2±9.4
% Δ 6 M vs T=0	−8.2	−3.3	−9.3
% Δ 12 M vs T=0	−10.3	−8.9	−10.2
P 6 M vs T=0	NS	NS	<0.05
P 12 M vs T=0	<0.05	<0.05	<0.05
P 12 M vs T=6 M	NS	NS	NS

Notes: All values (mg/dL) are expressed as median ± standard deviation. Δ, variation.

* P<0.05 versus Ezetimibe + Berberol^®.

Abbreviations: M, months; NS, not significant; T, time.

Table 7 Plasma HbA_1c in the enrolled patients

	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
T=0	7.7±0.4	7.7±0.5	7.6±0.6
T=6 M	7.5±0.3	7.5±0.4	7.2±0.5
T=12 M	7.3±0.2	7.5±0.4	7.2±0.3
% Δ 6 M vs T=0	−2.9	−2.9	−5.3
% Δ 12 M vs T=0	−5.4	−2.9	−5.3
P 6 M vs T=0	<0.05	<0.05	<0.05
P 12 M vs T=0	<0.01	<0.05	<0.05
P 12 M vs T=6 M	<0.05	NS	NS

Notes: All values (%) are expressed as median ± standard deviation. Δ, variation.

Abbreviations: M, months; NS, not significant; T, time; HbA_1c, glycosylated hemoglobin.

Table 8 Tolerability assessment (N=15/group)

Tolerability	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
Very poor	0	0	0
Poor	4*	1**	1***
Fair	0	0	0
Good	11	14	14
Excellent	0	0	0

Notes: N: number of individuals per group.

* cramps (2), constipation (1), headache (1)

** asthenia

*** headache.

Table 9 Compliance assessment (N=15/group)

Compliance	Statins + Berberol^®	Ezetimibe + Berberol^®	Berberol^®
Very poor	0	0	0
Poor	7	7	0
Fair	6	6	5
Good	2	2	10
Excellent	0	0	0

Note: N: number of individuals per group.