Figure 1
Figure 2
Mean scores for each domain of the SF-36 QoL in patients with fibromyalgia syndrome in each group at visits 1, 4, 5, and 6 compared with baseline
| Quality of life domains (scales 0–100) | Placebo Mean ± SEM (n = 13) | Mirtazapine 15 mg Mean ± SEM (n = 13) | Mirtazapine 30 mg Mean ± SEM (n = 14) |
|---|---|---|---|
| Bodily pain | |||
| Visit 1 | 34 ± 15.5 | 40 ± 14.6 | 28 ± 8.8 |
| Visit 4 | 48 ± 11.2 P<0.05 | 48 ± 19.1 | 48 ± 17.4 P<0.05 |
| Visit 5 | 46 ± 10.4 P<0.05 | 54 ± 22.9 | 52 ± 22.1 P<0.05 |
| Visit 6 | 49 ± 18.4 | 58 ± 18.2 P<0.05 | 57 ± 19.0 P<0.05 |
| General health | |||
| Visit 1 | 38 ± 20.4 | 37 ± 21.2 | 36 ± 16.5 |
| Visit 4 | 48 ± 15.5 | 47 ± 19.4 | 48 ± 20.4 |
| Visit 5 | 48 ± 18.78 | 54 ± 21.3 P<0.05 | 50 ± 23.2 |
| Visit 6 | 47 ± 17.2 | 59 ± 18.2 P<0.05 | 53 ± 23.4 P<0.05 |
| Mental health | |||
| Visit 1 | 57 ± 13.8 | 71 ± 14.7 | 63 ± 16.9 |
| Visit 4 | 67 ± 13.2 | 80 ± 12.2 | 78 ± 11.1 P<0.05 |
| Visit 5 | 74 ± 12.1 P<0.05 | 86 ± 11.7 P<0.05 | 85 ± 11.3 P<0.0001 |
| Visit 6 | 72 ± 11.5 P<0.05 | 81 ± 14.4 | 83 ± 12.4 P<0.05 |
| Physical functioning | |||
| Visit 1 | 55 ± 4.1 | 71 ± 5.9 | 60.7 ± 3.8 |
| Visit 4 | 61 ± 5.4 | 75 ± 6.8 | 72.9 ± 4.9 P<0.0001 |
| Visit 5 | 58 ± 5.4 | 78 ± 5.2 | 72.1 ± 6.0 P<0.05 |
| Visit 6 | 58 ± 7.2 | 80 ± 5.1 | 76.7 ± 6.0 P<0.05 |
| Role limitation because of emotional problems | |||
| Visit 1 | 28 ± 30.0 | 59.0 ± 38.9 | 33.3 ± 39.2 |
| Visit 4 | 67 ± 36.5 P<0.05 | 77.8 ± 38.5 | 75.0 ± 40.5 P<0.05 |
| Visit 5 | 73 ± 29.1 P<0.05 | 86.1 ± 22.3 | 69.4 ± 46.0 P<0.05 |
| Visit 6 | 64 ± 40.7 | 88.9 ± 16.4 P<0.05 | 75.0 ± 38.0 P<0.05 |
| Role limitation because of physical problems | |||
| Visit 1 | 23 ± 29.7 | 44 ± 43.5 | 20 ± 26.3 |
| Visit 4 | 46 ± 31.3 | 58 ± 44.4 | 57 ± 44.1 P<0.05 |
| Visit 5 | 57 ± 42.0 P<0.05 | 67 ± 41.7 P<0.05 | 65 ± 41.9 P<0.05 |
| Visit 6 | 57 ± 46.2 | 63 ± 37.7 | 65 ± 45.8 P<0.05 |
| Social functioning | |||
| Visit 1 | 49 ± 14.8 | 53 ± 5.5 | 51.8 ± 9.6 |
| Visit 4 | 56 ± 6.5 P<0.05 | 50 ± 13.1 | 56.3 ± 6.5 |
| Visit 5 | 52 ± 9.4 | 50 ± 9.2 | 47.9 ± 14.9 |
| Visit 6 | 53 ± 9.8 | 48 ± 9.0 | 52.1 ± 4.9 |
| Vitality | |||
| Visit 1 | 43 ± 15.6 | 59 ± 21.9 | 49 ± 15.7 |
| Visit 4 | 52 ± 10.6 | 65 ± 22.6 | 61 ± 14.0 P<0.05 |
| Visit 5 | 58 ± 10.8 P<0.05 | 70 ± 23.8 | 65 ± 17.8 P<0.05 |
| Visit 6 | 59 ± 11.2 P<0.05 | 64 ± 17.2 | 66 ± 17.9 P<0.05 |
Precoded and recoded values for question Nos_ 7 and 8 of the SF-36 QoL questionnaire
| Precoded and recoded values for question No. 7 | ||
|---|---|---|
| Response choices | Precoded value | Recoded value |
| None | 1 | 6 |
| Very mild | 2 | 5.4 |
| Mild | 3 | 4.2 |
| Moderate | 4 | 3.1 |
| Severe | 5 | 2.2 |
| Very severe | 6 | 1 |
Baseline QoL of Thai patients with FMS compared with Thai HVs
| Characteristic | HVs (n = 80) | FMS (n = 76) |
|---|---|---|
| Mean (SD) | Mean (SD) | |
| Bodily pain (0–100) | 87 (14.7) | 33 (15. 9) |
| How much bodily pain have you had during | 5.5 (0.7) | 2.5 (0.7) |
| the past 4 weeks? (1–6) | ||
| During the past 4 weeks, how much did pain | 5.3 (1.0) | 2.8 (1.0) |
| interfere with your normal work? (1–6) | ||
| General health (0–100) | 84 (16.0) | 36 (19.7) |
| In general, would you say your health is? (1–6) | 3.7 (0.8) | 2.0 (1.0) |
| How true or false is each of the following | ||
| statements for you? (1–6) | ||
| I seem to get sick a little easier than other people | 4.6 (0.9) | 2.7 (1.4) |
| (definitely true, mostly true, don’t know) | ||
| I am as healthy as anybody I know | 4.6 (0.8) | 2.5 (1.2) |
| I expect my health to get worse | 4.5 (1.0) | 3.0 (1.3) |
| My health is excellent | 4.3 (0.9) | 1.9 (1.0) |
| Mental health (0–100) | 82 (14.5) | 63 (17.1) |
| Have you been a very nervous person? (1–6) | 5.0 (0.8) | 3.8 (1.1) |
| Have you felt so down in the dumps that nothing | 5.8 (0.6) | 5.1 (1.0) |
| could cheer you up? (1–6) | ||
| Have you felt calm and peaceful? (1–6) | 4.6 (1.2) | 3.2 (1.2) |
| Have you felt down hearted and blue? (1–6) | 5.4 (0.9) | 4.7 (1.1) |
| Have you been a happy person? (1–6) | 4.7 (1.2) | 3.8 (1.3) |
| Physical functioning (0–100) | 96 (8.2) | 59 (21.6) |
| Vigorous activities (1–3) | 2.7 (0.5) | 1.5 (0.6) |
| Moderate activities (1–3) | 3.0 (0.2) | 2.0 (0.7) |
| Lifting or carrying groceries (1–3) | 2.9 (0.3) | 1.9 (0.7) |
| Climbing several flights of stairs (1–3) | 2.9 (0.4) | 1.9 (0.7) |
| Climbing one flight of stairs (1–3) | 3.0 (0.1) | 2.7 (0.5) |
| Bending, kneeling, or stooping (1–3) | 2.9 (0.4) | 1.9 (0.7) |
| Walking more than a mile (1–3) | 3.0 (0.2) | 1.9 (0.8) |
| Walking several blocks (1–3) | 3.0 (0.1) | 2.3 (0.7) |
| Walking one block (1–3) | 3.0 (0.0) | 2.7 (0.6) |
| Bathing or dressing yourself (1–3) | 3.0 (0.0) | 2.9 (0.4) |
| Role limitation because of emotional problems (0–100) | 92 (24.9) | 41 (37.9) |
| Cut down the amount of time you spent on work | 1.9 (0.3) | 1.3 (0.5) |
| or other activities (12) | ||
| Accomplished less than you would like (1–2) | 1.9 (0.3) | 1.4 (0.5) |
| Didn’t do work or other activities as carefully as usual (1–2) | 1.9 (0.3) | 1.5 (0.5) |
| Role limitation because of physical problems (0–100) | 96 (19.4) | 30 (37.0) |
| Cut down the amount of time you spent on work | 1.9 (0.2) | 1.2 (0.4) |
| or other activities (1–2) | ||
| Accomplished less than you would like (1–2) | 2.0 (0.2) | 1.3 (0.5) |
| Were limited in the kind of work or other activities (1–2) | 2.0 (0.2) | 1.4 (0.5) |
| Had difficulty performing the work or other activity (1–2) | 2.0 (0.2) | 1.3 (0.5) |
| Social functioning (0–100) | 93 (14.8) | 53 (12.3) |
| During the past 4 weeks, to what extent has your | 4.8 (0.5) | 3.8 (1.0) |
| physical health or emotional problem interfered | ||
| with your normal social activities with family, | ||
| friends, neighbors, or groups? (1–5) | ||
| During the past 4 weeks, how much of the time | 4.6 (0.9) | 3.5 (1.0) |
| has your physical health or emotional problem | ||
| interfered with your social activities? (1–5) | ||
| Vitality (0–100) | 75 (17.6) | 48 (19.1) |
| Did you feel full of pep (glad, joyful, pleasant)? (1–6) | 4.5 (1.2) | 3.1 (1.3) |
| Did you have a lot of energy? (1–6) | 4.5 (1.3) | 2.9(1.5) |
| Did you feel worn out? (1–6) | 5.3 (0.8) | 4.0 (1.2) |
| Did you feel tired? (1–6) | 4.7 (1.0) | 3.6(1.1) |
Between-group comparisons of mean characteristics and bodily pain of patient with FMS at baseline
| Baseline characteristics | Placebo (n = 13) | Mir 15 mg (n = 13) | Mir 30 mg (n = 14) | Mir 15 + 30 mg (n = 27) |
|---|---|---|---|---|
| Mean (SD) or n (%) | ||||
| Age (y) | 47.4 (37.9) | 42.7 (45.4) | 43.9 (35.2) | 43.3 (56.6) |
| Female, n (%) | 13 (100) | 13 (100) | 14 (100) | 27 (100) |
| Body mass index (kg/m2) | 22.6 (12.3) | 22.0 (9.0) | 22.1 (12.0) | 22.0 (14.5) |
| Duration of widespread pain (y) | 4.0 (11.5) | 3.3 (8.3) | 3.1(10.1) | 3.2 (13.0) |
| Bodily pain (0–100) | 34 (55.9) | 40 (52.6) | 28 (32.9) | 35 (15.1) |
Baseline characteristics of Thai patients with FMS compared with Thai HVs
| Characteristic | HV (n = 80) | FMS (n= 76) | P |
|---|---|---|---|
| Mean (SD) | Mean (SD) | ||
| Age (y) | 43.9 (8.5) | 45.2 (10.5) | NS |
| Female, n (%) | 77 (96.3) | 75 (98.7) | NS |
| Bodily pain (0-100) | 87 (14.7) | 33 (15.9) | <0.001 |
| Body mass index (kg/m2) | 23.1(3.1) | 21.8 (3.2) | 0.012 |
| Duration of widespread pain (y) | 0 (0) | 3.8 (3.5) | – |