Brisinda 2007.
Methods | RCT n=100 | |
Participants | CAF (adults) | |
Interventions | Botox (either Botox 30u or Botox dysport 90u) vs Nitroglycerine 0.2% tid 8 weeks | |
Outcomes | healing incontinence headache anal burning |
|
Notes | ROK AS ok, AC (single blinded), SS not done, 0 dropouts reported F/U 2 months ITT+ |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | computer generated list in sealed envelopes |
Allocation concealment (selection bias) | Unclear risk | single blinding |
Blinding (performance bias and detection bias) All outcomes | Low risk | Patients were aware of the treatment but the two clinical assessors were blinded |
Selective reporting (reporting bias) | Low risk | appropriate outcomes/side effects reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | |
Duration of Follow‐up 6 months or more | High risk | follow up only 2 months |