Lechin 1989.
Methods | Double‐blind placebo‐controlled cross‐over trial Four‐centre study | |
Participants | 68 patients joined the study, final number 48 outpatients, 24 men and 24 women, duration of illness 8 to 17 years Inclusion criteria: severe facial pain for at least 2 years, clinical diagnosis of trigeminal neuralgia Exclusion criteria: placebo responder (improvement of more than 20% during placebo washout period), severe physical illness, history of psychotic episodes, alcohol or drug addiction, epilepsy or any other convulsive disorder | |
Interventions | 4 weeks of placebo washout, 8 weeks of treatment following random assignment to carbamazepine (final dose of 1200 mg with a 14‐day titration period) or pimozide (final dose of 12 mg with a 14‐day titration period), 4 weeks with abrupt withdrawal and placebo substitution, 8 weeks of cross‐over treatment | |
Outcomes | Pain intensity using 6‐point registration cards (0 = no pain, 6 = pain present, cannot be ignored, prompt medical advice sought), duration, frequency, basal pain, sensitivity of trigger zones, number of relief tablets Total trigeminal neuralgia score reduction of 78.1 % (pimozide group) compared to 49.7% (carbamazepine group), statistically significant (P<0.001) at week 10 Adverse effects (hand tremors, involuntary movements during sleep, slight Parkinson's symptoms) observed in 40 of 48 patients |
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Notes | Type of pain: trigeminal neuralgia; 9 patients were not admitted to the treatment phase, 6 patients were excluded. 11 were not included in the statistical analysis. All patients refused interruption of pimozide treatment. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as "identical dark capsules" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as "identical dark capsules" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Imputation method not described |
Size | High risk | Fewer than 50 patients/treatment arm |