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Table 1 Epidemiological and clinical characteristics at baseline, according to the treatment group, values are given as the mean (SD) or frequency (n=63)

From: Melatonin analgesia is associated with improvement of the descending endogenous pain-modulating system in fibromyalgia: a phase II, randomized, double-dummy, controlled trial

 

Amitriptyline (n = 21)

Melatonin (n = 21)

Amitriptyline + melatonin (n = 21)

P value

Age (years)

49.80 ± (8.91)

47.40 ± (7.84)

49.72 ± (7.24)

0.59

Body index

27.65 ± (3.91)

27.18 ± (4.04)

27.58 ± (4.62)

0.60

Education (years)

10.95 ± (5.09)

11.30 ± (3.76)

8.22 + (5.6)

0.39

Smoking (n/%)

2 (9,5)

2 (9,5)

1 (5)

0.83

Clinical Comorbidity Yes/No

10 (47,6)

9 (42,9)

13 (65)

0.33

Hypertension (n/%)

5 (23,8)

5 (23,8)

8 (40)

 

Hypothyroidism (n/%)

3 (14,3)

1 (4,8)

7 (35)

 

Asthma (n/%)

1 (4,8)

1 (4,8)

2 (10)

 

Other (n/%)

3 (15)

0 (0)

1 (4,8)

 

Global pain on visual analogue scale†

62.88 ± (14.26)a

64.90 ± (15.44)a

69.57 ± (10.94)b

0.03

FIQ†

53.78 ± (12.83 )a

64.87 ± (12.83)b

65.15 ± (9.94)b

0.005

Pain catastrophizing scale for the Brazilian population (B-PCS)†

  
 

25.90 ± (10.38)

32.90 ± (12.28)

25.90 ± (10.38)

0.07

Pittsburgh Sleep Questionnaire

19.31 ± (6.58)

22.67 ± (7.69)

24.28 ± (7.79)

0.16

Hamilton Depression Scale†

17.61 ± (6.37)

21.70 ± (5.88)

17.61 ± (6.33)

0.05

Pain pressure threshold†

2.17 ± (0.21)a

1.99 ± (0.16)b

2.05 ± (0.24)a

0.04

Brain-derived neurotrophic factor (BDNF)€

   

Mean (SD)

48.28 ± (24.00)

52.54 ± (23.87)

48.28 ± (27.34)

 

Median [interquartile (IQ) 25;75]

45.51 (12.8;101.51)

54.78 (20.66;97.85

37.51 (18.75;92.3)

0.79

Psychiatric disease (SCID-I)

6 (76%)

15 (71%)

13 (65)

0.45

Depression

8 (38%)

1 (62%)

11 (55%)

 

Anxiety

11(52%)

12 (57%)

5 (25%)

 

Analgesic used weekly in last 3 months

    

Median (Q25-75)€

6 (3;28)

7 (2;26)

7 (3;29

0.91

Analgesic use: days/week in last 3 months¥

  

(<4 = no, ≥4 = times)

20 (95%)

20 (95%)

17 (85%)

0.43

A e aminophen/Dipirone

19 (90,5%)

16 (76,2%)

15 (75%)

 

NSAID

7 (33,3%)

10 (47,6%)

9 (45%)

 

Opioid

1 (4,8%)

0

0

 

Active use of central nervous system active medication¥

  

Yes/No

14 (66,7%)

16 (76%)

14 (70%)

0.16

Antidepressant (n/%)

14 (66,7%)

15 (71%)

13 (65%)

 

Anticonvulsant (n/%)

2 (9,5%)

2 (9,5%)

1 (5)

 

Benzodiazepine (n/%)

0

5 (23,8%)

2 (10%)

 
  1. Different superscripts (a and b) indicate significant differences among treatment groups according to the Bonferroni test.
  2. Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
  3. €Kruskal-Wallis Test.
  4. ¥Chi-Square or Fisher’s test.
  5. †ANOVA.
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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