| Methods |
RCT
Method of randomisation ‐ computer generated random numbers
Non‐responders and relapsers retreated with PD
Remission ‐ dysphagia score 0 or 1 |
| Participants |
17 participants
2 BTX group had previous PD
Baseline characteristics of both treatment groups were similar |
| Interventions |
BTX 60 to 80 units
Rigiflex 30 mm ‐ 1 min 10 to 15 psi |
| Outcomes |
Dysphagia (0 to 3), chest pain (Yes or No), regurgitation (Yes or No)
Symptoms assessed at 1 week, 3 to 6 monthly
Mean LOS pressure at 1 week |
| Notes |
No complications |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Method of randomisation ‐ computer generated random numbers |
| Allocation concealment (selection bias) |
High risk |
Patients were unblinded |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Patients were unblinded. Nature of therapies administered did not allow blinding of endoscopists |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Patients were unblinded. Nature of therapies administered did not allow blinding of endoscopists |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
It is unclear whether the assessors were blinded to the therapies |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
