J Endocrinol Metab

Journal of Endocrinology and Metabolism, ISSN 1923-2861 print, 1923-287X online, Open Access

Article copyright, the authors; Journal compilation copyright, J Endocrinol Metab and Elmer Press Inc

Journal website http://www.jofem.org

Original Article

Volume 10, Number 2, April 2020, pages 36-44

Effects of Policosanol in Patients With Metabolic Syndrome: A Six-Month Study

**Table 1.** Main Baseline Characteristics of Study Patients
	Policosanol (n = 50)	Placebo (n = 50)	Total (n = 100)
The table included concomitant medications consumed by ≥ 2 patients. All comparisons were not significant (Student’s t-test, χ² test). SD: standard deviation; ACEI: angiotensin-converting enzyme inhibitor.
Age (years) (mean ± SD)	51 ± 8	50 ± 9	51 ± 9
Body mass index (kg/m²) (mean ± SD)	30.8 ± 4.8	30.0 ± 4.7	30.4 ± 4.7
Waist/hip index (cm) (mean ± SD)	0.98 ± 0.1	0.98 ± 0.1	0.98 ± 0.1
Gender (n, %)
Male	41 (82.0)	40 (80.0)	81 (81.0)
Female	9 (18.0)	10 (20.0)	19 (19.0)
Personal history (n, (%))
Dyslipidemia	48 (96.0)	50 (100.0)	98 (98.0)
Arterial hypertension	47 (94.0)	48 (96.0)	95 (95.0)
Obesity (kg/m² ≥ 30)	24 (48.0)	26 (52.0)	50 (50.0)
Overweight (kg/m² ≥ 25, < 30)	24 (48.0)	19 (38.0)	43 (43.0)
Smoking	11 (22.0)	12 (24.0)	23 (23.0)
Diabetes mellitus	7 (14.0)	10 (20.0)	17 (17.0)
Thyroid disorder	3 (6.0)	3 (6.0)	6 (6.0)
Family history (n, (%))
Coronary disease	32 (64.0)	28 (56.0)	60 (60.0)
Diabetes mellitus	21 (42.0)	24 (48.0)	45 (45.0)
Cerebrovascular disease	15 (30.0)	19 (38.0)	34 (34.0)
Peripheral disease	2 (4.0)	5 (10.0)	7 (7.0)
Concomitant medications (CM) (n, (%))
Patients consuming CM	47 (94.0)	47 (94.0)	94 (94.0)
ACEI	36 (72.0)	31 (62.0)	67 (67.0)
Diuretics	16 (32.0)	16 (32.0)	32 (32.0)
Oral hypoglycemic drugs	8 (16.0)	7 (14.0)	15 (15.0)
Calcium antagonists	4 (8.0)	11 (22.0)	15 (15.0)
β-blockers	4 (8.0)	6 (12.0)	10 (10.0)
Anti-platelets	5 (10.0)	3 (6.0)	8 (8.0)
Anti-gout	5 (10.0)	3 (6.0)	8 (8.0)
Analgesics	5 (10.0)	3 (6.0)	8 (8.0)
Thyroid hormones	3 (6.0)	1 (2.0)	4 (4.0)
Anti-ulcer	1 (2.0)	1 (2.0)	2 (2.0)

Table 1. Main Baseline Characteristics of Study Patients

Policosanol (n = 50)

Placebo (n = 50)

Total (n = 100)

The table included concomitant medications consumed by ≥ 2 patients. All comparisons were not significant (Student’s t-test, χ² test). SD: standard deviation; ACEI: angiotensin-converting enzyme inhibitor.

Age (years) (mean ± SD)

51 ± 8

50 ± 9

51 ± 9

Body mass index (kg/m²) (mean ± SD)

30.8 ± 4.8

30.0 ± 4.7

30.4 ± 4.7

Waist/hip index (cm) (mean ± SD)

0.98 ± 0.1

Gender (n, %)

Male

41 (82.0)

40 (80.0)

81 (81.0)

Female

9 (18.0)

10 (20.0)

19 (19.0)

Personal history (n, (%))

Dyslipidemia

48 (96.0)

50 (100.0)

98 (98.0)

Arterial hypertension

47 (94.0)

48 (96.0)

95 (95.0)

Obesity (kg/m² ≥ 30)

24 (48.0)

26 (52.0)

50 (50.0)

Overweight (kg/m² ≥ 25, < 30)

24 (48.0)

19 (38.0)

43 (43.0)

Smoking

11 (22.0)

12 (24.0)

23 (23.0)

Diabetes mellitus

7 (14.0)

10 (20.0)

17 (17.0)

Thyroid disorder

3 (6.0)

6 (6.0)

Family history (n, (%))

Coronary disease

32 (64.0)

28 (56.0)

60 (60.0)

Diabetes mellitus

21 (42.0)

24 (48.0)

45 (45.0)

Cerebrovascular disease

15 (30.0)

19 (38.0)

34 (34.0)

Peripheral disease

2 (4.0)

5 (10.0)

7 (7.0)

Concomitant medications (CM) (n, (%))

Patients consuming CM

47 (94.0)

94 (94.0)

ACEI

36 (72.0)

31 (62.0)

67 (67.0)

Diuretics

16 (32.0)

32 (32.0)

Oral hypoglycemic drugs

8 (16.0)

7 (14.0)

15 (15.0)

Calcium antagonists

4 (8.0)

11 (22.0)

15 (15.0)

β-blockers

4 (8.0)

6 (12.0)

10 (10.0)

Anti-platelets

5 (10.0)

3 (6.0)

8 (8.0)

Anti-gout

5 (10.0)

3 (6.0)

8 (8.0)

Analgesics

5 (10.0)

3 (6.0)

8 (8.0)

Thyroid hormones

3 (6.0)

1 (2.0)

4 (4.0)

Anti-ulcer

1 (2.0)

2 (2.0)

**Table 2.** Effects on Oxidative Values (Mean ± SD)
Treatment	Baseline	3 months	6 months	Changes (%)
^aP < 0.05, comparison with placebo (Student’s t-test for independent samples). ^bP < 0.01, comparison with baseline (Student’s t-test for paired samples). SD: standard deviation.
Redox index
Policosanol	3.4 ± 0.7	3.2 ± 0.8	2.8 ± 0.9^a^{, b}	-17.6^a
Placebo	3.4 ± 0.8	3.3 ± 0.8	3.3 ± 0.8	- 2.9
Malondialdehyde (µM)
Policosanol	11.3 ± 5.5	10.6 ± 4.4	10.4 ± 5.1	-8.0
Placebo	11.8 ± 6.1	12.0 ± 5.2	11.7 ± 5.8	-0.8
Total organoperoxides (µM)
Policosanol	172.3 ± 55.6	161.7 ± 45.0	158.2 ± 44.4	-8.2
Placebo	172.0 ± 63.9	158.6 ± 31.0	157.4 ± 37.8	-8.4
Advanced protein oxidation products (µM chloramine)
Policosanol	29.5 ± 32.4	28.1 ± 32.3	28.9 ± 45.3	-2.0
Placebo	26.2 ± 17.4	24.5 ± 13.1	26.1 ± 16.9	-0.4
Superoxide dismutase (U/L/min)
Policosanol	6.2 ± 3.4	6.6 ± 3.1	6.4 ± 3.8	+3.2
Placebo	6.8 ± 2.9	6.7 ± 4.0	6.8 ± 3.7	0.0
Catalase (U/L/min)
Policosanol	169.3 ± 49.2	163.2 ± 53.1	173.8 ± 28.7	+2.7
Placebo	159.7 ± 39.3	160.3 ± 35.3	160.5 ± 30.7	+0.5

Table 2. Effects on Oxidative Values (Mean ± SD)

Treatment

Baseline

3 months

6 months

Changes (%)

^aP < 0.05, comparison with placebo (Student’s t-test for independent samples). ^bP < 0.01, comparison with baseline (Student’s t-test for paired samples). SD: standard deviation.

Redox index

Policosanol

3.4 ± 0.7

3.2 ± 0.8

2.8 ± 0.9^a^{, b}

-17.6^a

Placebo

3.4 ± 0.8

3.3 ± 0.8

- 2.9

Malondialdehyde (µM)

Policosanol

11.3 ± 5.5

10.6 ± 4.4

10.4 ± 5.1

-8.0

Placebo

11.8 ± 6.1

12.0 ± 5.2

11.7 ± 5.8

-0.8

Total organoperoxides (µM)

Policosanol

172.3 ± 55.6

161.7 ± 45.0

158.2 ± 44.4

-8.2

Placebo

172.0 ± 63.9

158.6 ± 31.0

157.4 ± 37.8

-8.4

Advanced protein oxidation products (µM chloramine)

Policosanol

29.5 ± 32.4

28.1 ± 32.3

28.9 ± 45.3

-2.0

Placebo

26.2 ± 17.4

24.5 ± 13.1

26.1 ± 16.9

-0.4

Superoxide dismutase (U/L/min)

Policosanol

6.2 ± 3.4

6.6 ± 3.1

6.4 ± 3.8

+3.2

Placebo

6.8 ± 2.9

6.7 ± 4.0

6.8 ± 3.7

0.0

Catalase (U/L/min)

Policosanol

169.3 ± 49.2

163.2 ± 53.1

173.8 ± 28.7

+2.7

Placebo

159.7 ± 39.3

160.3 ± 35.3

160.5 ± 30.7

+0.5

**Table 3.** Effects on Lipid Profile (Mean ± SD)
Treatment	Baseline	3 months	6 months	Changes (%)
^aP < 0.05, comparison with baseline (Student’s t-test for paired samples); ^bP < 0.05, comparison with placebo (Student’s t-test for independent samples). LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; SD: standard deviation.
Total cholesterol (mmol/L)
Policosanol	5.86 ± 0.9	5.26 ± 0.9^a	5.24 ± 0.8^{a, b}	-10.6^b
Placebo	5.99 ± 1.3	5.67 ± 1.1	5.82 ± 1.2	- 2.8
LDL-C (mmol/L)
Policosanol	4.27 ± 1.2	4.12 ± 1.1	3.68 ± 1.2^{a, b}	-13.8^b
Placebo	4.35 ± 1.5	4.28 ± 1.3	4.24 ± 1.2	- 2.5
HDL-C (mmol/L)
Policosanol	1.03 ± 0.3	1.08 ± 0.2	1.12 ± 0.5^{a, b}	+8.7^b
Placebo	1.10 ± 0.5	1.11 ± 0.5	1.05 ± 0.3	-4.5
Triglycerides (mmol/L)
Policosanol	3.06 ± 1.6	2.89 ± 1.4	3.00 ± 1.5	-2.0
Placebo	3.01 ± 1.8	3.02 ± 1.6	3.02 ± 1.9	+0.3

Table 3. Effects on Lipid Profile (Mean ± SD)

Treatment

Baseline

3 months

6 months

Changes (%)

^aP < 0.05, comparison with baseline (Student’s t-test for paired samples); ^bP < 0.05, comparison with placebo (Student’s t-test for independent samples). LDL-C: low-density lipoprotein cholesterol; HDL-C: high-density lipoprotein cholesterol; SD: standard deviation.

Total cholesterol (mmol/L)

Policosanol

5.86 ± 0.9

5.26 ± 0.9^a

5.24 ± 0.8^{a, b}

-10.6^b

Placebo

5.99 ± 1.3

5.67 ± 1.1

5.82 ± 1.2

- 2.8

LDL-C (mmol/L)

Policosanol

4.27 ± 1.2

4.12 ± 1.1

3.68 ± 1.2^{a, b}

-13.8^b

Placebo

4.35 ± 1.5

4.28 ± 1.3

4.24 ± 1.2

- 2.5

HDL-C (mmol/L)

Policosanol

1.03 ± 0.3

1.08 ± 0.2

1.12 ± 0.5^{a, b}

+8.7^b

Placebo

1.10 ± 0.5

1.11 ± 0.5

1.05 ± 0.3

-4.5

Triglycerides (mmol/L)

Policosanol

3.06 ± 1.6

2.89 ± 1.4

3.00 ± 1.5

-2.0

Placebo

3.01 ± 1.8

3.02 ± 1.6

3.02 ± 1.9

+0.3

**Table 4.** Effects on Laboratory Indicators (Mean ± SD)
Treatment	Baseline	3 months	6 months
^aP < 0.05, comparison with baseline (Student’s t-test for paired samples). ^bP = 0.052, ^cP < 0.01, comparison with placebo (Student’s t-test for independent samples). Apo: apolipoprotein; SD: standard deviation.
Alanine amino transferase (U/L)
Policosanol	32.3 ± 17.4	26.8 ± 10.9	27.2 ± 11.5
Placebo	30.6 ± 18.2	27.1 ± 14.5	26.7 ± 14.4
Aspartate amino transferase (U/L)
Policosanol	28.7 ± 12.1	26.3 ± 9.9	26.1 ± 10.1
Placebo	27.6 ± 10.0	25.11 ± 9.7	26.0 ± 10.9
Glucose (mmol/L)
Policosanol	5.5 ± 1.7	5.8 ± 1.5	5.7 ± 1.6
Placebo	5.9 ± 1.4	6.0 ± 1.4	5.8 ± 1.3
Creatinine (µmol/L)
Policosanol	102.7 ± 15.9	103.5 ± 19.9	102.0 ± 19.0
Placebo	102.4 ± 18.0	102.0 ± 15.8	103.2 ± 21.2
Alkaline phosphatase (U/L)
Policosanol	170.8 ± 36.8	177.3 ± 42.2	169.9 ± 40.5
Placebo	174.2 ± 40.7	173.1 ± 46.0	175.9 ± 44.8
Total proteins (g/L)
Policosanol	74.4 ± 6.6	72.3 ± 6.3	72.0 ± 7.3
Placebo	75.5 ± 5.4	74.1 ± 6.6	73.0 ± 7.0
Albumin (g/L)
Policosanol	47.1 ± 3.4	46.5 ± 3.4	46.1 ± 3.6
Placebo	48.5 ± 3.8	46.8 ± 3.7	46.8 ± 3.5
Uric acid (µmol/L)
Policosanol	442.1 ± 91.1	443.3 ± 105.3	443.4 ± 91.9
Placebo	441.7 ± 87.6	445.3 ± 93.9	461.0 ± 108.7
Urea (mmol/L)
Policosanol	5.1 ± 1.4	5.1 ± 1.3	5.0 ± 1.2
Placebo	4.8 ± 1.2	4.7 ± 1.3	4.8 ± 1.4
Apo A (g/L)
Policosanol	2.24 ± 0.6	1.89 ± 0.6	1.95 ± 0.5
Placebo	2.18 ± 0.7	1.93 ± 0.7	1.98 ± 0.7
Apo B (g/L)
Policosanol	1.63 ± 0.5	1.45 ± 0.5^b	1.40 ± 0.4^{a, c}
Placebo	1.73 ± 0.5	1.66 ± 0.6	1.72 ± 0.6

Table 4. Effects on Laboratory Indicators (Mean ± SD)

Treatment

Baseline

3 months

6 months

^aP < 0.05, comparison with baseline (Student’s t-test for paired samples). ^bP = 0.052, ^cP < 0.01, comparison with placebo (Student’s t-test for independent samples). Apo: apolipoprotein; SD: standard deviation.

Alanine amino transferase (U/L)

Policosanol

32.3 ± 17.4

26.8 ± 10.9

27.2 ± 11.5

Placebo

30.6 ± 18.2

27.1 ± 14.5

26.7 ± 14.4

Aspartate amino transferase (U/L)

Policosanol

28.7 ± 12.1

26.3 ± 9.9

26.1 ± 10.1

Placebo

27.6 ± 10.0

25.11 ± 9.7

26.0 ± 10.9

Glucose (mmol/L)

Policosanol

5.5 ± 1.7

5.8 ± 1.5

5.7 ± 1.6

Placebo

5.9 ± 1.4

6.0 ± 1.4

5.8 ± 1.3

Creatinine (µmol/L)

Policosanol

102.7 ± 15.9

103.5 ± 19.9

102.0 ± 19.0

Placebo

102.4 ± 18.0

102.0 ± 15.8

103.2 ± 21.2

Alkaline phosphatase (U/L)

Policosanol

170.8 ± 36.8

177.3 ± 42.2

169.9 ± 40.5

Placebo

174.2 ± 40.7

173.1 ± 46.0

175.9 ± 44.8

Total proteins (g/L)

Policosanol

74.4 ± 6.6

72.3 ± 6.3

72.0 ± 7.3

Placebo

75.5 ± 5.4

74.1 ± 6.6

73.0 ± 7.0

Albumin (g/L)

Policosanol

47.1 ± 3.4

46.5 ± 3.4

46.1 ± 3.6

Placebo

48.5 ± 3.8

46.8 ± 3.7

46.8 ± 3.5

Uric acid (µmol/L)

Policosanol

442.1 ± 91.1

443.3 ± 105.3

443.4 ± 91.9

Placebo

441.7 ± 87.6

445.3 ± 93.9

461.0 ± 108.7

Urea (mmol/L)

Policosanol

5.1 ± 1.4

5.1 ± 1.3

5.0 ± 1.2

Placebo

4.8 ± 1.2

4.7 ± 1.3

4.8 ± 1.4

Apo A (g/L)

Policosanol

2.24 ± 0.6

1.89 ± 0.6

1.95 ± 0.5

Placebo

2.18 ± 0.7

1.93 ± 0.7

1.98 ± 0.7

Apo B (g/L)

Policosanol

1.63 ± 0.5

1.45 ± 0.5^b

1.40 ± 0.4^{a, c}

Placebo

1.73 ± 0.5

1.66 ± 0.6

1.72 ± 0.6