Retrospective analysis of the effects of a highly standardized mixture of Berberis aristata, Silybum marianum, and monacolins K and KA in patients with dyslipidemia

Figures & data

Table 1 Characteristics of patients with dyslipidemia at T=0

Parameter	Untreated (N=72)	Lovastatin-treated (N=69)	BSM-treated (N=67)	BSM-treated (add-on) (N=18)	P-value
Sex (M/F)	32/40	29/40	31/36	11/7	–
Age (years)	53.6±6.7	57.1±9.2	55.8±7.4	51.6±10.3	ns
Weight (kg)	78.8±19.1 (N=45)	75.3±18.5 (N=41)	79.8±22.5 (N=49)	69.3±19.3 (N=12)	ns
BMI (kg/m^2)	33.4±7.1 (N=45)	32.5±6.2 (N=41)	34.9±7.2 (N=49)	30.5±4.2 (N=12)	ns
WL (cm)	100.8±14.2 (N=37)	102.5±16.6 (N=32)	104.2±16.3 (N=33)	97.6±11.5 (N=8)	ns
FG (mg/dL)	89.7±11.2 (N=68)	91.5±10.3 (N=58)	93.1±11.5 (N=63)	92.8±10.6 (N=9)	ns
HbA1c (%)	5.72±0.65 (N=45)	5.85±0.84 (N=40)	5.89±0.76 (N=52)	5.59±0.83 (N=5)	ns
BI (μU/mL)	11.2±7.9 (N=41)	10.7±11.3 (N=35)	11.5±4.9 (N=46)	9.9±12.5 (N=5)	ns
HOMA-R	2.67±3.2 (N=41)	2.69±3.4 (N=35)	2.70±3.3 (N=46)	2.70±2.9 (N=5)	ns
TC (mg/dL)	224.8±21.7 (N=72)	264.5±28.5 (N=69)	268.7±27.3 (N=67)	210.2±18.4 (N=18)	P<0.05*
HDL (mg/dL)	53.9±11.2 (N=69)	50.7±12.7 (N=66)	54.2±13.5 (N=64)	51.8±12.6 (N=18)	ns
LDL (mg/dL)	137.2±19.5 (N=69)	174.8±28.5 (N=66)	177.9±31.8 (N=64)	132.4±21.3 (N=18)	P<0.05*
TG (mg/dL)	117.3±32.1 (N=69)	153.2±42.5 (N=66)	159.5±38.7 (N=64)	175.2±49.8 (N=18)	P<0.05#
CPK (U/L)	140.9±75.1 (N=39)	136.5±75.1 (N=36)	148.3±91.8 (N=34)	132.7±58.4 (N=14)	ns
Creatinine (mg/dL)	0.89±0.4 (N=39)	0.96±0.7 (N=36)	1.01±0.9 (N=34)	0.95±0.7 (N=14)	ns
TSH (mU/L)	2.31±0.9 (N=39)	2.45±1.1 (N=36)	2.43±0.9 (N=34)	2.12±1.2 (N=14)	ns
AST (U/L)	23.8±9.5 (N=39)	21.5±12.3 (N=36)	23.6±12.8 (N=34)	28.8±17.4 (N=14)	ns
ALT (U/L)	37.2±19.3 (N=39)	33.4±21.2 (N=36)	36.6±24.5 (N=34)	39.2±26.5 (N=14)	ns

Notes: All parameters are expressed as median ± standard deviation.

* Untreated group versus lovastatin-treated and versus BSM-treated, and BSM-treated (add-on) versus lovastatin-treated and versus BSM-treated;

# untreated group versus lovastatin-treated, BSM-treated and BSM-treated (add-on).

Abbreviations: ALT, alanine transferase; AST, aspartate transferase; BI, basal insulin; BMI, body mass index; BSM, berberine, silymarin, and Monakopure™-K20; CPK, creatine phosphokinase; F, females; FG, fasting glucose; HbA1c, glycated hemoglobin; HDL, high density lipoprotein; HOMA-R, homeostatic model assessment of insulin resistance; LDL, low density lipoprotein; M, males; N, number of subjects; ns, not significant; TC, total cholesterol; TG, triglycerides; TSH, thyroid-stimulating hormone; WL, waistline.

Table 2 Outcomes after 6 months of treatment in patients with dyslipidemia

Parameter	Untreated (N=72)	Lovastatin-treated (N=69)	BSM-treated (N=67)	BSM-treated (add-on) (N=18)	P-value
Weight (kg)	79.3±18.8 (N=45)	75.8±19.1 (N=41)	78.4±24.5 (N=49)	68.9±20.5 (N=12)	ns
BMI (kg/m^2)	33.6±7.4 (N=45)	32.7±6.9 (N=41)	34.1±6.9 (N=49)	30.3±5.1 (N=12)	ns
WL (cm)	101.4±14.8 (N=37)	102.9±15.9 (N=32)	103.3±15.5 (N=33)	97.3±12.3 (N=8)	ns
FG (mg/dL)	91.3±13.8 (N=68)	93.8±14.6 (N=58)	87.5±13.2 (N=63)	89.9±12.9 (N=9)	ns
HbA1c (%)	5.80±0.80 (N=45)	5.91±0.66 (N=40)	5.25±0.94 (N=52)	5.12±0.87 (N=5)	ns
BI (μU/mL)	11.8±9.5 (N=41)	11.2±12.6 (N=35)	10.6±5.9 (N=46)	9.2±6.8 (N=5)	ns
HOMA-R	2.81±2.4 (N=41)	2.85±3.1 (N=35)	2.25±2.9 (N=46)	2.32±1.8 (N=5)	ns
TC (mg/dL)	219.3±27.5 (N=72)	208.9±24.2 (N=69)	191.3±25.8 (N=67)	158.4±15.1 (N=18)	P<0.05*
HDL (mg/dL)	54.3±12.5 (N=69)	53.7±11.9 (N=66)	55.9±11.2 (N=64)	54.5±11.8 (N=18)	ns
LDL (mg/dL)	135.2±19.5 (N=69)	129.4±22.3 (N=66)	122.1±24.4 (N=64)	101.7±21.5 (N=18)	P<0.05°
TG (mg/dL)	110.7±45.6 (N=69)	140.7±39.5 (N=66)	129.1±47.4 (N=64)	149.2±51.8 (N=18)	P<0.05§
CPK (U/L)	135.5±83.4 (N=39)	182.5±95.9 (N=36)	167.2±88.0 (N=34)	149.4±79.7 (N=14)	P<0.05ç
Creatinine (mg/dL)	0.82±0.3 (N=39)	0.91±0.9 (N=36)	0.94±0.8 (N=34)	0.89±0.4 (N=14)	ns
TSH (mU/L)	2.35±0.5 (N=39)	2.51±0.9 (N=36)	2.47±0.7 (N=34)	2.13±1.4 (N=14)	ns
AST (U/L)	25.5±11.5 (N=39)	28.4±17.4 (N=36)	26.5±14.7 (N=34)	31.4±15.4 (N=14)	ns
ALT (U/L)	39.2±22.4 (N=39)	39.4±27.5 (N=36)	39.8±28.2 (N=34)	41.3±29.7 (N=14)	ns

Notes: All parameters are expressed as median ± standard deviation.

* Untreated group versus BSM-treated and BSM-treated (add-on); lovastatin-treated versus BSM-treated and BSM-treated (add-on);

° BSM-treated (add-on) versus untreated group, lovastatin-treated and BSM-treated; untreated group versus lovastatin-treated and BSM-treated (add-on); untreated group versus lovastatin-treated.

§ Lovastatin-treated versus untreated.

ç Lovastatin-treated versus untreated.

Abbreviations: ALT, alanine transferase; AST, aspartate transferase; BI, basal insulin; BMI, body mass index; BSM, berberine, silymarin, and Monakopure™-K20; CPK, creatine phosphokinase; FG, fasting glucose; HbA1c, glycated hemoglobin; HDL, high density lipoprotein; HOMA-R, homeostatic model assessment of insulin resistance; LDL, low density lipoprotein; ns, not significant; TC, total cholesterol; TG, triglycerides; TSH, thyroid-stimulating hormone; WL, waistline.

Table 3 Percentage variation and statistical significance of outcomes after 180 days of treatment (versus T=0) in patients with dyslipidemia

Parameter	Untreated (%)	P-value	Lovastatin (%)	P-value	BSM (%)	P-value	BSM (add-on) (%)	P-value
Weight (kg)	+0.63	ns	+0.66	ns	−1.86	ns	−0.58	ns
BMI (kg/m^2)	+0.59	ns	+0.62	ns	−2.30	ns	−0.65	ns
WL (cm)	+0.60	ns	+0.39	ns	−0.86	ns	−0.31	ns
FG (mg/dL)	+1.78	ns	+2.51	ns	−6.02	ns	−3.13	ns
HbA1c (%)*	+1.40	ns	+1.03	ns	−9.87	P<0.05	−8.41	P<0.05
BI (μU/mL)	+5.38	ns	+4.67	ns	−7.83	ns	−8.08	ns
HOMA-R*	+5.24	ns	+5.95	ns	−16.77	P<0.05	−14.08	P<0.05
TC (mg/dL)°	−2.45	ns	−21.03	P<0.01	−24.65	P<0.01	−24.65	P<0.01
HDL (mg/dL)	+0.74	ns	+5.91	ns	+3.14	ns	+5.21	ns
LDL (mg/dL)°	−1.46	ns	−25.97	P<0.01	−31.37	P<0.01	−25.19	P<0.01
TG (mg/dL)°	−5.63	ns	−8.16	P<0.05	−19.06	P<0.05	−14.84	P<0.05
CPK (U/L)^	−3.83	ns	+33.70	P<0.05	+12.74	ns	+12.58	ns
Creatinine	−7.87	ns	−5.21	ns	−6.93	ns	−6.32	ns
TSH (mU/L)	+1.73	ns	+2.45	ns	+1.65	ns	+0.47	ns
AST (U/L)	+7.14	ns	+32.09	ns	+12.29	ns	+9.03	ns
ALT (U/L)	+5.38	ns	+17.96	ns	+8.74	ns	+5.36	ns

Note: All parameters are expressed as median ± standard deviation.

* P-values of each of the two groups are significant versus both untreated and Lovastatin group.

° P-values of each of the three groups are significant only versus untreated group.

^ P-value is of the Lovastatin group is significant versus all the other three groups.

Abbreviations: ALT, alanine transferase; AST, aspartate transferase; BI, basal insulin; BMI, body mass index; BSM, berberine, silymarin, and Monakopure™-K20; CPK, creatine phosphokinase; FG, fasting glucose; HbA1c, glycated hemoglobin; HDL, high density lipoprotein; HOMA-R, homeostatic model assessment of insulin resistance; LDL, low density lipoprotein; ns, not significant; TC, total cholesterol; TG, triglycerides; TSH, thyroid-stimulating hormone; WL, waistline.