| Methods |
RCT
Method of randomisation ‐ computer generated random numbers
Retreated if no response at 1 month (35 mm PD balloon)
Exclusion criteria: previous treatment, < 18 yrs, neuromuscular disorder, NYHA grade III or IV
Remission ‐ > 50% improvement in symptoms |
| Participants |
47 treatment naive participants
Baseline characteristics of both treatment groups were similar
5 participants were excluded from the analysis ‐ 2 BTX group and 3 PD group |
| Interventions |
BTX 100 U
Rigiflex 30 mm ‐ 9 to 15 psi x 1 minute |
| Outcomes |
Median symptom score (0 to 15)
Symptoms assessed at 1, 3, 6, 9, 12 months
Median LOS pressure at 1 month
Barium retention ‐ height and width 1, 6, 12 months |
| Notes |
1 perforation in PD group ‐ excluded from analysis
4 lost to follow up ‐ excluded from analysis |
| 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) |
Unclear 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 |
Unclear risk |
5 patients not included in analysis, 4 in the PD group |
