| Methods |
RCT
Method of randomisation ‐ computer generated random numbers
Repeat treatment for non‐response and relapse (same BTX dose or 35 mm PD)
Remission ‐ > 50% improvement in symptom score
Exclusion criteria: < 40 yrs |
| Participants |
40 treatment naive participants (> 40 yr old)
BTX group older |
| Interventions |
BTX 200 (80) U 4 quadrants
Rigiflex 30 mm ‐ 10 psi x 30 sec |
| Outcomes |
Mean symptom (0 to 15) 1, 6, 12 months
Mean LOS pressure at 1 month |
| Notes |
No complication
1 lost to follow up
High risk of bias as not double blind |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
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 |
Unclear risk |
Patients were unblinded. Nature of therapies administered did not allow blinding of endoscopists |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Clinical assessor was aware of the treatment received by the patient |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
One participant lost to follow up |
