| Methods |
RCT
Method of randomisation was not stated
Initially BTX versus placebo saline injection. All placebos relapsed and treated by PD
BTX relapsers were retreated
Remission ‐ symptom score ≤ 2
Exclusion criteria: < 18 yrs, previous PD or myotomy, sigmoid shaped oesophagus |
| Participants |
16 treatment naive adult participants
Baseline characteristics of both treatment groups were similar |
| Interventions |
8 participants received 100 U BTX and 8 participants underwent PD
PD: day 1 ‐ Rigiflex 30 mm, day 2 and 3 ‐ 35 mm balloon |
| Outcomes |
Clinical assessment using mean symptom score ‐ dysphagia, chest pain and regurgitation; each scored 0 to 3
Mean LOS pressure (mm Hg)
Barium retention studies (mean % retained at 10 min)
Outcomes assessed at 1, 6, 12 months
Remission defined as a symptom score ≤ 2 |
| Notes |
No complications reported
All patients were assessed at 6 months; 6 participants were lost to follow up at 12 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not stated |
| Allocation concealment (selection bias) |
High risk |
Initial randomisation and therapy was double blind ‐ BTX or placebo saline injection. The placebo group then had three PD sessions as they all failed to respond. This aspect of the study was not blinded |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Initial randomisation and therapy was double blind ‐ BTX or placebo saline injection. The placebo group then had three PD sessions as they all failed to respond. This aspect of the study was not blinded |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Initial randomisation and therapy was double blind ‐ BTX or placebo saline injection. The placebo group then had three PD sessions as they all failed to respond. This aspect of the study was not blinded |
| 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 |
Low attrition bias at 1 and 6 months but high at 12 months |
