Table 1 Demographic and baseline clinical characteristics of patients
Characteristic | Pregabalin | Usual care | p |
|---|---|---|---|
N = 486 | N = 239 | ||
Age (years), mean (SD) | 47.0 (12.6) | 45.2 (13.6) | 0.070 |
Sex (female), n (%) | 325 (72.9%) | 159 (69.1%) | 0.307 |
Body mass index (kg/m2), mean (SD) | 25.6 (4.0) | 26.1 (4.7) | 0.185 |
Marital status, n (%) | 0.625 | ||
Married or with couple | 307 (63.2%) | 154 (65.0%) | |
Single | 105 (21.6%) | 57 (24.1%) | |
Widow/er | 25 (5.1%) | 9 (3.8%) | |
Divorced/separated | 49 (10.1%) | 17 (7.2%) | |
Educational level, n (%) | 0.463 | ||
No education | 15 (3.1%) | 15 (6.3%) | |
Primary education | 183 (37.7%) | 85 (35.6%) | |
Secondary education | 106 (21.9%) | 48 (20.1%) | |
Intermediate educational level | 102 (21.0%) | 46 (19.3%) | |
Higher education (university) | 75 (15.5%) | 43 (18.0%) | |
Others | 4 (0.8%) | 2 (0.8%) | |
Work status, n (%) | 0.219 | ||
Active | 251 (51.8%) | 119 (49.8%) | |
Housewife | 127 (26.2%) | 58 (24.3%) | |
Sick leave | 47 (9.7%) | 11 (4.6%) | |
Unemployed | 32 (6.6%) | 18 (7.5%) | |
Retired | 19 (3.9%) | 20 (8.4%) | |
Does not work (students) | 4 (0.8%) | 7 (2.9%) | |
Others | 5 (1.0%) | 6 (2.5%) | |
Psychiatric comorbidities, n (%) | |||
Major depression | 89 (18.3%) | 41 (17.2%) | 0.780 |
Panic disorder | 67 (13.8%) | 22 (9.2%) | 0.100 |
Social anxiety | 48 (9.9%) | 16 (6.7%) | 0.200 |
Phobias | 38 (7.8%) | 15 (6.3%) | 0.550 |
Obsessive-compulsive disorder | 18 (3.7%) | 9 (3.8%) | 0.867 |
Others | 94 (19.3%) | 41 (17.2%) | 0.542 |
Medical comorbidities, n (%) | |||
Chronic pain | 230 (47.3%) | 78 (32.6%) | <0.001 |
Gastrointestinal disease | 97 (20.0%) | 53 (22.2%) | 0.552 |
Cardiovascular disease | 48 (9.9%) | 24 (10.0%) | 0.889 |
Metabolic disease | 25 (5.1%) | 21 (8.8%) | 0.084 |
Genitourinary disease | 26 (5.6%) | 8 (3.4%) | 0.312 |
Others | 86 (17.7%) | 43 (18.0%) | 0.996 |
SSRI distribution by drug, n (%) | |||
Paroxetine | 177 (36.4) | 57 (23.8) | 0.001 |
Escitalopram | 98 (20.2) | 49 (20.5) | 0.994 |
Sertraline | 60 (12.3) | 42 (17.6) | 0.160 |
Mirtazapine | 67 (13.8) | 31 (13.0) | 0.852 |
Citalopram | 52 (10.7) | 21 (8.8) | 0.596 |
Fluoxetine | 39 (8.0) | 39 (16.3) | 0.007 |
Benzodiazepine use | |||
Users, n (%) | 405 (83.3) | 211 (88.3) | 0.177 |
Mean (SD) # drugs | 0.98 (0.58) | 1.06 (0.56) | 0.151 |
Clinical variables, mean (SD) | |||
HAM-A scale score | 27.2 (6.6) | 25.7 (7.2) | 0.015 |
MADRS scale score | 23.6 (6.9) | 21.7 (7.5) | 0.001 |
CGI-I | 4.2 (0.8) | 4.0 (0.8) | 0.001 |