Graff‐Radford 2000.
Methods | Double blind placebo controlled parallel design, eight weeks Randomisation method not stated Inclusion criteria: duration of pain at least six months |
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Participants | Postherpetic neuralgia of 33.4 (29.5) months. 50 participants (49 final number). Mean age 72.9 (10.1), 27 male and 22 female patients. Pain score VAS 55.22 (16.34) and MPQ 23.22 (13.23). Pain score per group: in amitriptyline VAS 55.9 (19.58) and MPQ 22.54 (13.95), in amitriptyline + fluphenazine VAS 47.6 (13.43) and MPQ 27.25 (17.71), in fluphenazine VAS 65.4 (10.87) and MPQ 21.75 (10.18), and in placebo group VAS 53.92 (17.05) and MPQ 21.46 (10.89) | |
Interventions | Amitriptyline dose escalation from 12.5 mg to 200 mg, or amitriptyline from 12.5 mg to 200 mg + fluphenazine from 1 mg to 3 mg, or fluphenazine from 1 mg to 3 mg, or active placebo (glycopyrrolate or cellulose) daily orally | |
Outcomes | Pain patients reported, VAS and MPQ. Beck Depression Inventory (BDI) Pain by VAS on amitriptyline 26.6 (SD 16.77), on amitriptyline + fluphenazine 35.41 (SD 24.53), on fluphenazine 53.9 (SD 27.79), on placebo 48.53 (SD 24.99) Pain by MPQ on amitriptyline 17.36 (SD 10.92), on amitriptyline + fluphenazine 23.50 (SD 13.52), on fluphenazine 19.83 (SD 8.83), on placebo 17.83 (SD 13.94) Depression by BDI on amitriptyline 11.1 (SD 7.5), on amitriptyline + fluphenazine 7.2 (SD 6.03), on fluphenazine 14.2 (SD 6.5), on placebo 14.0 (SD 14.3). Fluphenazine made no difference either alone or enhancing amitriptyline |
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Notes | Dropouts: 1/12 on amitriptyline (SE), 0/12 on amitriptyline + fluphenazine, 0/13 on fluphenazine, 0/13 on placebo SE: one withdrawn on amitriptyline due to sedation Results of other depression scales also available QS = 4 (R1, DB2, W1) |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 |