| Methods |
Double blind RCT
Method of randomisation was not stated
Crossover to other treatment if failed treatment at any time
Exclusion criteria: previous treatment, < 18 yrs, poor surgical candidates
Remission ‐ decrease in symptom grade ≥ 1 |
| Participants |
34 treatment naive adults
Baseline characteristics of both treatment groups were similar |
| Interventions |
BTX 80 U 4 quadrants
Witzel 40 mm balloon ‐ 180 to 300 mm Hg x 3 min
Sham injection or dilatation |
| Outcomes |
Mean symptom score ‐ dysphagia, chest pain, regurgitation (0 to 9)
Dysphagia score (0 to 21)
Dysphagia severity (0 to 10)
Pain severity (0 to 10)
Global assessment (0 to 10, graded 0, 1, 2, 3)
Weight gain (%)
Mean LOS pressure (mm Hg)at 3 weeks, 3 months, and 12 months |
| Notes |
2 perforations in PD group
2 lost to follow up
Low bias |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not stated |
| Allocation concealment (selection bias) |
Low risk |
Allocation concealment and sham procedures |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double blinding to initial therapy |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Double blinding to initial therapy |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Assessors blinded to therapy |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Two lost to follow up |
