Shen 2006.
| Methods | A randomised, parallel group, prospective study | |
| Participants |
Intervention: peripheral adriamycin Diagnostic criteria of patients included in the trial Paroxysmal facial pain, affecting one or more divisions of trigeminal nerve, unilateral, may be evoked pain. There is no clinically evident neurological deficit, pain not attributed to another disorder Age mean (SD) 65 (10) Gender 20 male, 15 female Severity Not available Duration of condition mean (SD) years 10.8 (12.4) Number 35 Intervention: peripheral gentamicin Diagnostic criteria of patients included in the trial Paroxysmal facial pain, affecting one or more division of trigeminal nerve, unilateral, may be evoked pain. There is no clinically evident neurological deficit, pain not attributed to another disorder Age mean (SD) 60 (9) Gender 22 male, 13 female Severity Not available Duration of condition mean (SD) years 5.7 (3.8) years Number 35 |
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| Interventions |
Intervention: adriamycin Type of intervention Adriamycin 5 g/l into all trigeminal nerve exit foramina Once and then 1 or 2 weeks later Length of follow‐up mean month 30 months Intervention: gentamicin Type of intervention Gentamicin 8 x 104 U into all foramina once and then 1 or 2 weeks later Length of follow‐up mean month 30 months |
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| Outcomes |
Primary outcome Relief VAS 0 to 10 Time of measurement: 6 months, 1 year and then at yearly intervals (Kaplan‐Meier) Adverse events |
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| Notes | This is a poor quality randomised controlled trial to determine the effect of peripheral injections of gentamicin or adriamycin on pain relief at two and a half years. Although both treatments were initially effective, long term they were effective in only 23% of patients who received adriamycin and 6% of those who received gentamicin. The adriamycin group was more likely to have facial anaesthesia, which was permanent in up to 14% of patients. Not stated whether pain migrated to other branches and whether medication was reduced or stopped as a result of interventions | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomly, no description of how sequence was generated |
| Allocation concealment (selection bias) | Unclear risk | No description |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | The first, second, third author designed the study, the first author performed all the intervention and assessed the result |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No description |
| Selective reporting (reporting bias) | Unclear risk | No description |
| Other bias | Unclear risk | No description |