Effects of Phyllanthus emblica extract on endothelial dysfunction and biomarkers of oxidative stress in patients with type 2 diabetes mellitus: a randomized, double-blind, controlled study

Figures & data

Table 1 Demographic characteristics of patients in all treatment groups

Parameter	P. emblica 250 mg	P. emblica 500 mg	Atorvastatin	Placebo
Total, n	20	20	20	20
Age, years	57.60±9.67	57.75±9.86	56.95±8.04	56.90±9.17
gender (M/F)	13/7	15/5	13/7	12/8
Body weight, kg	69.30±11.19	65.87±7.31	68.56±8.47	67.42±6.75
BMI, kg/m^2	24.88±2.76	25.22±2.67	26.02±3.12	24.75±2.41

Abbreviations: BMI, body mass index; P. emblica, Phyllanthus emblica.

Table 2 Effect of P. emblica 250 mg, P. emblica 500 mg, atorvastatin 10 mg, and placebo on RI

Parameter	P. emblica 250 mg twice daily (n=20)		P. emblica 500 mg twice daily (n=20)		Atorvastatin 10 mg + placebo, each once daily (n=20)		Placebo twice daily (n=20)
RI (%)	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
Mean	−2.25	−9.13*	−2.11	−10.04*	−2.68	−11.03*	−2.32	−0.90
SD	±1.37	±2.56	±0.98	±0.92	±1.13	±3.93	±1.21	±2.83

Notes:

* P<0.001 with all treatments compared to baseline and placebo; nonsignificant in placebo group versus baseline.

Abbreviations: SD, standard deviation; P. emblica, Phyllanthus emblica; RI, reflection index.

Figure 1 Absolute change in RI after 12 weeks of treatment.

Notes:P<0.001 when compared between A and D, B and D, C and D. Nonsignificant when compared between A and B, A and C, B and C.
Abbreviations: RI, reflection index; P. emblica, Phyllathus emblica.

Table 3 Effect of P. emblica 250 mg, P. emblica 500 mg, atorvastatin 10 mg, and placebo on biomarkers of oxidative stress and inflammation

Parameter	P. emblica 250 mg twice daily (n = 20)		P. emblica 500 mg twice daily (n = 20)		Atorvastatin 10 mg + placebo each once daily (n = 20)		Placebo twice daily (n = 20)
	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
	A	B	C	D	E	F	G	H
NO (μM/L)	32.02±14.81	43.31 ±16.99	33.27±11.07	49.03±11.22	35.24±9.71	63.69±15.04	39.29±8.15	37.88±9.22
MDA (nM/mL)	3.23±1.34	2.35±1.00	3.35±1.00	2.29±0.78	3.54±0.85	2.37±0.59	3.47±0.65	3.56±0.52
GSH (μM/L)	437.71 ±143.2	560.2± 169.4	405.7± 107.1	626.7±143.1	418.8± 166.7	641.8± 150.2	431.8±136.1	435.9±128.1
hsCRP (mg/L)	2.91±1.53	1.59±0.98	3.50±1.05	1.25±0.42	3.08± 1.38	0.97±0.78	3.09±1.44	2.94± 1.47

Notes: NO, P<0.001 for B versus A, D versus C, and F versus E; GSH, P<0.001 for B versus A, D versus C, and F versus E; MDA, P<0.001 for B versus A, D versus C, and F versus E; hsCRP, P<0.001 for B versus A, D versus C, and F versus E; in the placebo group, no changes in any of the parameters were statistically significant for G versus H.

Abbreviations: NO, nitric oxide; GSH, glutathione; hsCRP, highly sensitivity C-reactive protein; MDA, malondialdehyde; P. emblica, Phyllathus emblica.

Figure 2 Mean percent change in NO after 12 weeks of treatment.

Notes:P<0.01 between A and C and P<0.001 between A and D, B and D, and C and D. Nonsignificant when compared between A and B, P<0.005 B and C.
Abbreviations:P. emblica; Phyllathus emblica; NO, nitric oxide.

Figure 3 Mean percent change in MDA after 12 weeks of treatment.

Notes:P<0.001 when compared between A and D, B and D, and C and D. Nonsignificant when compared between A and B, B and C, and A and C.
Abbreviations:P. emblica, Phyllathus emblica; MDA, malondialdehyde.

Figure 4 Mean percent change in gluthathione after 12 weeks of treatment.

Notes:P<0.01 when compared between A and B, and A and C. P<0.001 when compared between A and B, B and D, and C and D. Nonsignificant between B and C.
Abbreviation:P. emblica, Phyllathus emblica.

Figure 5 Mean percent change in hs-CRP after 12 weeks of treatment.

Notes:P<0.01 when compared between A and B. P<0.001 when compared between A and D, B and D, and C and D. P<0.05 between A and C. Nonsignificant between B and C.
Abbreviations: hs-CRP, highly sensitivity C-reactive protein; P. emblica, Phyllathus emblica.

Table 4 Effect of P. emblica 250 mg, P. emblica 500 mg, atorvastatin 10 mg, and placebo on lipid profile

Parameter	P. emblica 250 mg twice daily (n=20)		P. emblica 500 mg twice daily (n=20)		Atorvastatin 10 mg + placebo each once daily (n=20)		Placebo twice daily (n=20)
	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
	A	B	C	D	E	F	G	H
TC (mg/dL)	183.7±30.04	161.8±19.81	193.2±24.90	164.5±22.53	183.7±3741	135.6±26.94	188.9±35.20	192.2±32.73
HDL-C (mg/dL)	39.10±4.12	42.10±5.58	41.45±6.73	47.70±6.17	40.44±6.76	47.95±5.34	38.35±5.21	37.50±5.68
LDL-C (mg/dL)	116.9±28.24	95.90±19.43	124.3±27.49	92.60±25.35	126.00±34.90	78.50±16.71	126.2±39.45	135.5±45.27
Triglycerides (mg/dL)	150.8±42.50	132.0±39.82	164.5±70.54	123.8±41.52	155.0±56.51	106.5±30.79	164.3±21.70	169.0±19.85
VLDL-C (mg/dL)	27.25±7.12	24.20±5.86	31.35±10.58	24.45±5.73	25.20±6.57	19.90±3.64	26.40±5.17	25.6±4.98

Notes: TC, P<0.001 for B versus A, D versus C, and F versus E, P<0.01 for B versus H and D versus H, P<0.001 for F versus H; HDL-C, P<0.01 for B versus A and D versus C, P<0.001 for F versus E, P<0.05 for B versus H, and P<0.001 for D versus H and F versus H; LDL-C, P<0.01 for B versus A and D versus C, P<0.001 for F versus E, P<0.001 for B versus H and D versus H and F versus H; Tg, P<0.01 for B versus A, P<0.001 for D versus C, F versus E, B versus H, D versus H, and F versus H; VLDL-C, P<0.01 for B versus A and D versus C, P<0.001 for F versus E, nonsignificant for B versus H and D versus H, and P<0.001 for F versus H; in the placebo group, no changes in any of the parameters were statistically significant for G versus H.

Abbreviations:P. emblica, Phyllanthus emblica; TC, total cholesterol; HDL-C, high-density lipoprotein cholesterol; TG, triglycerides; VLDL-C, very low-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol.

Table 5 Effect of P. emblica 250 mg, P. emblica 500 mg, atorvastatin 10 mg, and placebo on HbA_1c levels

Parameter	P. emblica 250 mg twice daily (n=20)		P. emblica 500 mg twice daily (n=20)		Atorvastatin 10 mg + placebo each once daily (n=20)		Placebo twice daily (n=20)
	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
	A	B	C	D	E	F	G	H
HbA1c (%)	7.79±0.48	7.57±0.54	7.56±0.5	7.09±0.88	7.62±0.33	6.99±0.39	7.64±0.44	7.66±0.46

Notes:P<0.01 compared between B and A, D and C; P,0.001 between F and E and between F and H; P<0.05 between D and H; nonsignificant when compared between g and H and between B and H.

Abbreviations: HbA_1c, glycosylated hemoglobin; P. emblica, Phyllanthus emblica.