Feinmann 1984.
Methods | Double blind placebo controlled parallel design, nine weeks, dothiepin versus dothiepin + nocturnal bite guards vs placebo vs placebo + nocturnal bite guards (analysed in two groups: dothiepin +/‐ bite guards and placebo +/‐ bite guards), 12 months follow‐up. Randomisation method not stated. Inclusion criteria: age 16 to 65 years | |
Participants | Psychogenic facial pain of median 3.4 years (3 months to 30 years), 50 patients with facial arthro myalgia and 43 with atypical facial pain. 93 participants (93 final number). Age range 19 to 65, 20 male and 73 female patients Pain score in dothiepin group 2.2 (0.6), in placebo group 2.2 (0.6). Number of psychiatric cases 26/48 in dothiepin group and 27/45 in placebo group |
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Interventions | Dothiepin dose escalation from 25 mg to 150 mg daily orally +/‐ nocturnal bite guard, mean dose 130 mg; or placebo daily orally +/‐ nocturnal bite guard | |
Outcomes | Pain relief (yes or no), number of patients reduced analgesic use. Number of psychiatric cases Pain relief in 34/48 patients on dothiepin, 21/45 on placebo Reduction in analgesic use 40/48 patients on dothiepin, 19/45 on placebo Number of psychiatric cases 7/48 on dothiepin, 10/45 on placebo |
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Notes | Dropouts: 1/48 on dothiepin (SE), 1/45 on placebo (SE) SE: 1/48 withdrawn on dothiepin (epilepsy), 1/45 on placebo (loss of consciousness). No effect of bite guard QS = 4 (R1, DB2, W1) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |