| Methods |
Design: three group parallel trial
Purpose: examine the effect of pinaverium bromide (antispasmodic and analgesic drug) in the premedication of endoscopic retrograde cholangio‐pancreaticography (ERCP) and on the motor activity of the sphincter of Oddi |
| Participants |
Patients: with biliary and pancreatic disease and in need of a ERCP
Baseline comparability: NS |
| Interventions |
Placebo: tablet with no pinaverium bromide
Untreated: no tablet
Experimental: tablet with pinaverium bromide
(Co‐intervention: diazepam injection, 10 to 20 mg) |
| Outcomes |
Patient's tolerance of procedure
Time for procedure
Sphincter of Oddi pressure and wave pattern |
| Notes |
Relevant outcome data not accessible |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'A double‐blind study was carried out...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Relevant outcome data not accessible |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 12 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
