Evaluation of the efficacy of an antioxidant combination for the modulation of metabolic, endocrine, and clinical parameters in patients with polycystic ovary syndrome

Figures & data

Table 1. Comparison of metabolic parameters at baseline and after 6 months of treatment.

Parameter	MN (n = 33)				OC (n = 26)				MN + OC (n = 25)
	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p
Insulin (mg/dl)	31	8.5 ± 5.5	8.0 ± 3.9	0.555	25	9.3 (6.8-11.8)	7.7 (6.0-10.5)	0.667^a	24	10.7 ± 6.3	10.1 ± 5.7	0.380
Glucose (mg/dl)	32	85.0 (76.0-92.0)	82.5 (76.5-88.5)	0.856^b	26	84.2 ± 8.4	82.4 ± 8.4	0.15	23	78.1 ± 10.5	79.4 ± 12.2	0.605
HOMA-IR	31	1.60 (1.27-2.59)	1.50 (1.30-1.87)	< 0.05^b	24	2.11 ± 1.10	2.13 ± 1.29	0.912	22	1.43 (1.05-2.86)	1.53 (1.19-2.64)	1^b
TG (mg/dl)	30	64.5 (49.0-93.0)	63.5 (51.0-80.0)	0.585^b	26	65.9 ± 23.2	62.1 ± 21.9	0.233	22	73.4 ± 33.5	83.4 ± 35.9	< 0.05
TC (mg/dl)	32	175.5 (162.5-199.0)	177.5 (165.5-199.0)	0.473^b	26	170.7 ± 32.7	163.6 ± 32.7	0.089	22	171.3 ± 32.0	173.6 ± 29.8	0.636
HDL (mg/dl)	27	64.6 ± 17.0	67.2 ± 15.8	0.228	22	66.0 (70.0-79.0)	68.5 (60.0-81.0)	0.189^b	16	65.3 ± 15.9	62.1 ± 14.1	0.150
LDL (mg/dl)	27	108.0 (90.5-129.0)	98.0 (88.5-121.5)	0.248^b	22	93.0 ± 27.2	93.1 ± 23.2	0.962	16	98.6 ± 23.1	99.9 ± 19.9	0.761
AST (U/l)	31	18.0 (14.0-22.0)	19.0 (14.5-24.0)	0.200^b	26	19.2 ± 7.6	17.6 ± 6.9	0.158	22	20.5 ± 6.3	18.5 ± 5.3	< 0.05
ALT (U/l)	31	16.0 (12.5-22.0)	14.0 (11.0-19.5)	1^b	26	12.5 (10.0-18.0)	14.5 (12.0-21.0)	0.210^b	22	17.7 ± 10.4	17.5 ± 8.9	0.895
GGT (U/l)	30	15.0 (12.0-16.0)	15.5 (10.0-19.0)	1^b	24	13.5 (10.5-17.0)	16.0 (12.0-21.0)	0.057^a	22	15.5 (11.0-19.0)	15.0 (11.0-21.0)	0.824^b
UB	17	2.0 (1.0-2.0)	3.0 (2.0-4.0)	0.253^a	7	0.2 (0.1-0.2)	0.2 (0.2-0.3)	0.062^b	7	0.2 ± 0.2	0.3 ± 0.3	0.736
TB	28	0.7 ± 0.5	0.7 ± 0.4	0.762	26	0.7 ± 0.4	0.7 ± 0.4	0.263	19	0.5 (0.4-0.7)	0.4 (0.3-0.7)	0.424^b

^a Paired samples Wilcoxon test.

^b Non-parametric Sign test.

Quantitative variables were described by mean and standard deviation if they followed a Gaussian curve or by median and interquartile range if they did not follow a Gaussian curve (Shapiro-Wilks test).

ALT: alanine aminotransferase; AST: aspartate aminotransferase; GGT: γ-glutamyltransferase; HDL: high-density lipoprotein; HOMA-IR: homeostasis model assessment-estimated insulin resistance; IR: interquartile range; LDL: low-density lipoprotein; MN: MetioNac^® (α-lipoic acid + N-acetylcysteine + vitamin B₆ + S-adenosyl-L-methionine); OC: oral contraceptives; SD: standard deviation; TB: total bilirubin; TC: total cholesterol; TG: triglycerides; UB: unconjugated bilirubin.

Table 2. Comparison of endocrine parameters at baseline and after 6 months of treatment.

Parameter	MN (n = 33)				OC (n = 26)				MN + OC (n = 25)
	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p
17β-estradiol (pg/ml)	32	56.5 (41.5-98.5)	55.8 (35.0-107.4)	1^b	25	49.0 (24.0-176.0)	30.9 (2.03-41.9)	< 0.05^b	24	84.0 (40.3-152.0)	31.0 (19.5-46.9)	< 0.01^a
17-OHP	28	0.98 (0.57-1.68)	1.18 (0.58-2.08)	0.701^b	24	1.18 (0.44-1.88)	1.10 (0.50-1.86)	1^b	23	1.22 (0.80-1.66)	1.20 (0.40-1.58)	0.490^a
LH (mIU/ml)	32	8.58 (4.25-11.35)	7.65 (4.93-11.95)	0.860^b	25	7.81 ± 3.71	5.16 ± 3.15	< 0.01	25	6.93 ± 5.33	3.78 ± 2.26	< 0.05
FSH (mIU/ml)	32	5.89 (4.19-6.68)	5.76 (4.20-7.27)	0.860^b	25	5.11 ± 2.24	4.10 ± 2.58	0.092	25	4.60 (2.13-5.46)	4.26 (2.70-6.46)	1^b
LH/FSH (mIU/ml)	32	1.39 (0.92-2.63)	1.32 (0.87-2.43)	0.210^a	25	1.55 (0.99-2.01)	1.12 (0.84-1.67)	< 0.05^a	25	1.38 (0.94-2.24)	0.94 (0.53-1.22)	< 0.01^b
T (nmol/l)	30	0.56 (0.34-1.64)	0.45 (0.33-0.93)	0.320^a	25	1.15 (0.26-1.54))	0.80 (0.25-1.53)	0.093^b	23	0.44 (0.36-0.89)	0.45 (0.24-1.26)	0.286^b
Andro (nmol/l)	29	4.50 (1.88-8.60)	2.63 (1.75-4.30)	< 0.05^b	25	3.14 (1.69-4.21)	2.27 (1.70-3.00)	< 0.05^b	21	3.68 (2.78-4.89)	2.11 (1.25-2.70)	< 0.05^a
SHBG	29	59.0 (42.8-91.1)	59.0 (46.0-85.1)	1^b	25	76.0 (53.7-97.3)	67.0 (45.0-120.0)	< 0.01^a	21	59.5 (46.2-75.0)	65.0 (36.5-180.0)	0.503^b
SDHEA (nmol/l)	27	3.49 (2.24-6.35)	3.56 (2.44-6.24)	0.684^a	24	5.29 ± 2.88	4.63 ± 2.91	0.059	23	4.33 (2.90-7.42)	3.17 (2.64-4.89)	< 0.01^b
TSH (µU/ml)	31	2.08 ± 1.03	1.97 ± 1.04	0.460	26	2.40 (1.12-2.91)	2.24 (1.60-2.91)	0.690^b	23	2.11 ± 1.17	2.10 ± 1.05	0.914
HC	29	10.60 (7.80-14.30)	10.22 (8.30-13.47)	0.094^a	23	11.20 (9.24-13.50)	10.80 (8.95-12.40)	0.664^b	22	11.34 ± 5.72	11.08 ± 4.36	0.788
HbA1c (%)	27	5.07 ± 0.37	5.10 ± 0.37	0.743	25	5.15 ± 0.33	5.06 ± 0.39	0.267	22	5.14 ± 0.28	5.10 ± 0.26	0.606

^a Paired samples Wilcoxon test;.

^b Non-parametric Sign test.

Quantitative variables were described by mean and standard deviation if they followed a Gaussian curve or by median and interquartile range if they did not follow a Gaussian curve (Shapiro-Wilks test).

17-OHP: 17-hydroxyprogesterone; Andro: androstenedione; FSH: follicle-stimulating hormone; HbA1c: glycated hemoglobin; HC: homocysteine; IR: interquartile range; LH: luteinizing hormone; MN: MetioNac^® (α-lipoic acid + N-acetylcysteine + vitamin B₆ + S-adenosyl-L-methionine); OC: oral contraceptives; SD: standard deviation; SDHEA: dehypdroepiandrosterone sulfate; SHBG: sex hormone-binding globulin; T: testosterone; TSH: thyroid-stimulating hormone.

Table 3. Comparison of clinical parameters at baseline and after 6 months of treatment.

Parameter	MN (n = 33)				OC (n = 26)				MN + OC (n = 25)
	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p	N	Basal Mean ± SD or Median (IR)	6 months Mean ± SD or Median (IR)	p
Quantitative parameters, Median ± SD or Median (IR)
Hirsutism	28	10.5 (5-18)	9 (4-12)	< 0.05^a	25	10 (9-12)	6 (4-9)	< 0.001^a	19	12.3 ± 6.7	8.4 ± 5.8	< 0.01
Alopecia	29	2 (1-3)	1 (1-2)	< 0.01^a	25	1 (1-1)	1 (0-1)	0.267^b	21	1 (1-2)	1 (1-1)	0.122^a
Migraine	29	2 (0-10)	0 (0-4)	0.189^b	26	0 (0-13)	0 (0-9)	0.255^a	21	3 (0-26)	2 (0-8)	0.140^a
Acne, face	24	2 (1-3)	1 (1-2)	< 0.05^b	20	2.6 ± 1.1	1.6 ± 0.7	< 0.001	15	2.6 ± 1.2	1.9 ± 1.1	< 0.05
Acne, neck*	10	1.5 (1-3)	1 (1-2)	< 0.05^a	4	1.3 ± 0.5	1 ± 0	–	2	2 ± 1.4	1 ± 0	–
Acne, back	13	2.2 ± 1.3	1.6 ± 0.8	< 0.05	10	2.2 ± 0.9	1.5 ± 0.9	< 0.001	9	2.9 ± 1.1	1.6 ± 0.9	< 0.01
BMI, kg/m^2	21	24.8 ± 5.9	24.2 ± 5.9	0.454^b	20	22.6 ± 3.9	22.5 ± 3.4	0.767	18	26.9 ± 11.4	26.3 ± 9.7	1^b
Qualitative parameters, frequency of positive response (%)
Acne, face	30	26 (86.7)	24 (80.0)	0.500	26	23 (88.5)	21 (80.8)	0.625	22	20 (90.9)	18 (81.8)	0.687
Acne, neck	30	14 (46.7)	11 (36.7)	0.250	26	9 (34.6)	4 (15.4)	0.063	22	8 (36.4)	2 (9.1)	< 0.05
Acne, back	29	16 (55.2)	15 (51.7)	1.000	26	15 (57.7)	12 (46.2)	0.543	22	16 (72.7)	9 (40.9)	< 0.05
Irregular menstruation	29	29 (100)	16 (55.2)	< 0.001^c	26	23 (88.5)	6 (23.1)	< 0.001	19	17 (89.5)	7 (36.8)	< 0.01

^a Paired samples Wilcoxon test.

^b Non-parametric Sign test.

^cBinomial test.

* The probability value was not considered for the OC and MN + OC groups, given their small sample sizes.

Quantitative variables were described by mean and standard deviation if they followed a Gaussian curve or by median and interquartile range if they did not follow a Gaussian curve (Shapiro-Wilks test). Qualitative variables were described by absolute and relative percentage frequencies.

BMI: body mass index; IR: interquartile range; MN: MetioNac^® (α-lipoic acid + N-acetylcysteine + vitamin B₆ + S-adenosyl-L-methionine); OC: oral contraceptives; SD: standard deviation.

Data availability statement

Data sharing is not applicable to this article as no new data were created or analyzed in this study.