Zhu 2009.
| Methods | RCT | |
| Participants | 90 participants divided into three groups. Adults > 40 yrs. Treatment naive Three treatment groups ‐ A) 100 U BTX, B) PD with 30 mm Rigifex balloon, C) PD followed by BTX injection 15 days later Baseline characteristics similar in the two relevant groups Outcomes based on single treatment |
|
| Interventions | Three treatment groups ‐ A) 100 U BTX, B) PD with 30 mm Rigifex balloon, C) PD followed by BTX injection 15 days later | |
| Outcomes | Clinical assessment (mean symptoms score based on dysphagia for solids and liquids, active and passive regurgitation. and chest pain; each scored 0 to 3) and mean lower oesophageal sphincter pressure were assessed after therapy at 1 month, 6 months, 12 months, 18 months, and 24 months | |
| Notes | No major complications reported ‐ significant bleeding requiring hospitalisation, oesophageal perforation, and aspiration 3 lost to follow up (one from BTX and 2 from PD group) ‐ excluded from analysis |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated random numbers |
| Allocation concealment (selection bias) | Low risk | Allocation concealed, randomisation occurred after enrolment. Patients blinded to therapy |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Patients and assessors blinded to therapy |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients and assessors blinded to therapy |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Patients and assessors blinded to therapy |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 lost to follow up |