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. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3

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