Davidoff 1987.
Methods | Double blind placebo controlled parallel design, eight weeks (one dose escalation, thereafter stable dose). Randomisation method not stated Inclusion criteria: age at least 18 years, duration of symptoms at least one month |
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Participants | Traumatic myelopathy. 18 participants (18 final number). mean age 39 years, 16 male and 2 female patients Pain score in trazodone group by PRI 33.2 (6.9), by NWC 12.0 (1.7), by PPI 2.9 (0.6), by SPI day 58.2 (9.4), by SPI week 63.8 (7.0), by PAD 55.1 (4.6); in placebo group by PRI 31.2 (6.4), by NWC 12.3 (1.5), by PPI 2.1 (0.3), by SPI day 56.6 (8.7), by SPI week 62.6 (8.8), by PAD 55.8 (4.4) |
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Interventions | Trazodone 150 mg or placebo daily orally | |
Outcomes | Global assessment of efficacy (yes/no), MPQ: pain rating index (PRI), number of words (NWC), present pain intensity (PPI), Sternback pain intensity (0 to 100) day and week (SPI), Zung pain and distress index (PAD) Global improvement on trazodone 4/9 and on placebo 3/9 Pain on trazodone by PRI 33.5 (2.4), by NWC 14.0 (1.0), by PPI 2.6 (0.2), by SPI day 61.7 (6.8), by SPI week 73.9 (4.7), by PAD 67.2 (3.8); in placebo group by PRI 32.1 (3.5), by NWC 13.2 (1.5), by PPI 1.7 (0.2), by SPI day 63.4 (8.4), by SPI week 68.3 (6.9), by PAD 53.0 (3.2) |
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Notes | Dropouts 6/18; 5/9 on trazodone, 1/9 on placebo Reasons for dropouts not stated SE: 4/9 on trazodone and 1/9 on placebo In placebo group there were more patients with sensory complete spinal cord injuries (four patients in placebo group, one in trazodone) QS = 2 (R1, DB1, W0) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | D ‐ Not used |