Background
Methods
Participants
Interventions
Objective
Outcome measures
Sample size
Randomization, sequence generation
Allocation concealment and blinding
Statistical methods
Results
Baseline data
Fibromyalgia | Rheumatoid arthritis | Healthy controls | |
---|---|---|---|
(n = 20) | (n = 20) | (n = 20) | |
Age (mean ± SD) | 43.0 ± 15.2 | 45.4 ± 13.1 | 42.1 ± 14.8 |
Gender (F/M) | (18/2) | (18/2) | (18/2) |
Total fibromyalgia points, (mean ± SD) | 16.8 ± 1.9*
| 1.3 ± 1.7 | 0.7 ± 1.5 |
VAS score, (mean ± SD)
| |||
Pain | 6.5 ± 2.5**
| 4.3 ± 2.5 | 0 ± 0 |
Fatigue | 7.2 ± 2.4*
| 2.6 ± 2.5 | 0.5 ± 1.3 |
Sleep disturbances | 5.9 ± 2.6*
| 2.0 ± 2.5 | 0.2 ± 1.1 |
Morning stiffness | 4.8 ± 3.7**
| 2.4 ± 2.6 | 0.2 ± 0.7 |
Disability | 7.1 ± 2.2*
| 3.1 ± 3.2 | 0.2 ± 0.6 |
Symptoms, % of patients (95% confidence interval)
| |||
Anxiety | 90 (68.3–98.8)*
| 45 (23.0–68.5) | 40(19.1–63.9) |
Headache | 90 (68.3–98.8)*
| 35(15.4–59.2) | 25(8.7–49.1) |
Weakness | 90 (68.3–98.8)*
| 45 (23.0–68.5) | 10(1.2–31.7) |
Forgetfulnes | 85(62.1–96.8)*
| 50 (27.2–72.8) | 15 (3.2–37.9) |
Paresthesias | 85(62.1–96.8)*
| 35(15.4–59.2) | 30(11.9–54.3) |
Irritable bowel | 65 (40.8–84.6)*
| 10(1.2–31.7) | 20 (5.7–43.7) |
Sicca syndrome | 53 (28.9–75.5)**
| 45 (23.0–68.5) | 10(1.2–31.7) |
Sore throat | 45 (23.0–68.5)**
| 25(8.7–49.1) | 5(0.1–24.9) |
Acute onset | 40(19.1–63.9)*
| 5 (0.1–24.9) | 0(0–16.8) |
Cold hands | 40(19.1–63.9)**
| 15(3.2–37.9) | 0(0–16.8) |
Low grade fever | 20 (5.7–43.7)**
| 0(0–16.8) | 0(0–16.8) |
Lymph gland enlargement | 5 (0.1–24.9) | 5 (0.1–24.9) | 0(0–16.8) |
VAS = 10 cm visual analog scale | |||
*=p < 0.05 vs both control groups | |||
** = p < 0.05 vs healthy controls only |
Outcomes and estimation
Adverse events
Fibromyalgia | Rheumatoid Arthritis | Healthy Controls | ||||
---|---|---|---|---|---|---|
(n = 20) | (n = 20) | (n = 20) | ||||
placebo | NE | placebo | NE | placebo | NE | |
Spreading of pain
| 0 | 8 | 0 | 0 | 0 | 0 |
Pale halo
| 0 | 3 | 0 | 1 | 0 | 1 |
Paresthesias
| 5 | 2 | 4 | 3 | 5 | 2 |
Palpitations
| 0 | 1 | 0 | 0 | 0 | 0 |
Sweating
| 0 | 1 | 0 | 0 | 0 | 0 |
Distal swelling
| 0 | 1 | 0 | 0 | 0 | 0 |
Discontinued medications
Fibromyalgia | Rheumatoid Arthritis | ||||
---|---|---|---|---|---|
Drug | Number of patients | Plasma half-life (hours) | Drug | Number of patients | Plasma half-life (hours) |
clonazepam | 6 | 20–60 | acetaminophen*
| 4 | 4–6 |
acetaminophen*
| 5 | 4–6 | celecoxib*
| 3 | 10–12 |
mianserin | 2 | 21–61 | diclofenac*
| 3 | 3–7 |
alprazolam | 2 | 12–15 | piroxicam*
| 2 | 34–50 |
bromazepam | 1 | 20 | clonazepam | 1 | 20–60 |
triazolam | 1 | 1.5–5.5 | alprazolam | 1 | 12–15 |
piroxicam*
| 1 | 34–50 | indomethacin*
| 1 | 4–5 |
celecoxib*
| 1 | 10–12 | aspirin*
| 1 | 2–3 |
ketoprofen*
| 1 | 1.5–4 | rofecoxib*
| 1 | 17 |
fluoxetine | 1 | 96–144 | ibuprofen*
| 1 | 2–3 |
gabapentin*
| 1 | 5–9 | gabapentin*
| 1 | 5–9 |