Table 1.
Sixteen Randomized, Placebo-Controlled Trials of Antidepressants in Fibromyalgia
| Study, Year, Country | Inclusion Criteria | N | Treatment Groups | Design Duration | Mean Age (SD or range) % Women |
|---|---|---|---|---|---|
| Carrette, 1986 Canada | Smythe* | 27 | Amitriptyline (50mg q hs) | Parallel | 40.9 (±10.4) |
| 32 | Placebo | 9 weeks | 92 | ||
| Goldenberg, 1986 USA | ≥3 mos widespread pain | 16 | Amitriptyline (25 mg q hs) | Parallel | 43.8 (21–69) |
| 6 tender points and 3 minor criteria‡ | 16 | Placebo | 6 weeks | 95 | |
| Bibolotti, 1986 Italy | Extra-articular pain | 37 | Amitriptyline (50 mg) | Crossover | 38.5 (27–54) |
| Variability in pain, intensity, and duration | Chlorimipramine | 3 weeks each with no washout | 100 | ||
| Modulated by weather Trigger points Muscle hypertone | Placebo | ||||
| Trigger points | |||||
| Muscle hypertone | |||||
| Tavoni, 1987 Italy | ≥3 mos widespread pain | 17 | S-adenosylmethionine (200 mg) | Crossover | 44.5 (33–55) |
| 3 tender pts + 5 minor criteria or 5 tender pts + 3 minor ciriteria‡ | Placebo | 3 weeks with 2-week washout | |||
| Scudds, 1989 Canada | Smythe | 36 | Amitriptyline (50 mg ) | Crossover | 39.9 (24–59) |
| Placebo | 4 weeks with 2-week washout | 89 | |||
| Jaeschke, 1991 Canada | “Conventional criteria” | 23 | Amitriptyline (5–50 mg) | N-of-1 | 55 (43–75) |
| Smythe, predominantly | Placebo | 2 weeks with no washout | Gender not given | ||
| Jacobsen, 1991 Denmark | Smythe | 22 | S-adenosylmethionine (800 mg qd) | Parallel | 49.4 (41–57) |
| 22 | Placebo | 6 weeks | 86 | ||
| Carrette, 1994 Canada | ACR† | 84 | Amitriptyline (50 mg qhs) | Parallel | 45 (±10) |
| 82 | Cyclobenzaprine (20 mg pm, 10 mg am) | 24 weeks | 94 | ||
| 42 | Placebo | ||||
| Wolfe, 1994 USA | ACR | 21 | Fluoxetine (20 mg) | Parallel | 50.5 (±10.7) |
| 21 | Placebo | 6 weeks | 100 | ||
| Carrette, 1995 Canada | ACR | 22 | Amitriptyline (25 mg qhs) | Crossover | 43.8 (±8.0) |
| Placebo | 8 weeks each with no washout | 96 | |||
| Norregaard, 1995 Denmark | ACR | 22 | Citalopram (20 mg) | Parallel | 49 (±9) |
| 21 | Placebo | 8 weeks | Gender not reported | ||
| Ginsberg, 1996 Belgium | ACR | 24 | Amitriptyline (25 mg qhs) | Parallel | 46 (±12) |
| 22 | Placebo | 8 weeks | 83 | ||
| Goldenberg, 1996 USA | ACR | 31 | Amitriptyline (25 mg) | Crossover | 43.2 (±9.1) |
| Fluoxetine (20 mg) | 6 weeks each with 2-week washouts | 90 | |||
| Amitriptyline + Fluoxetine | |||||
| Placebo | |||||
| Kempenaers, 1994 Brussels | ACR | 9 | Anti-diencephalon antibody | Parallel | 38 (7) |
| 6 | Amitriptyline | 8 weeks | 100 | ||
| 8 | Placebo | ||||
| Hannonen, 1998Finland | ACR | 30 | Moclobemide | Parallel | 49.7 (8.2) |
| 32 | Amitriptyline | 100 | |||
| 30 | Placebo | 12 weeks | |||
| Olin, 1998 | ACR | 24 | Ritanserin | Parallel | 44 (24–59) |
| 27 | Placebo | 16 weeks | 100 |
*
Smythe criteria: ≥3 months of widespread pain; 12 of 14 specific tender points; and sleep disturbance.
†
American College of Rheumatology criteria: ≥3 months of widespread pain; and 11 of 18 specific tender points.
‡
Minor criteria for Goldenberg and Tavoni study: modulation of symptoms with activity, weather, anxiety, or stress; sleep disturbance; tiredness; chronic headaches; irritable bowel syndrome; subjective swelling; and numbness.
All studies excluded patients with repetitive trauma or a systemic condition.