| Methods |
Design: ten group parallel trial
Purpose: examine the effect of various forms of drugs and placebo on the pain associated with peptic ulcer disease |
| Participants |
Patients: patients with radiologically confirmed gastric ulcers
Baseline comparability: NS |
| Interventions |
Placebo: patches without active substance
Untreated: no patches, capsules or injections
Experimental: patches, capsules, and injections with various drugs, e.g. bismuth
(Co‐intervention: NS) |
| Outcomes |
Pain (number of days in pain) |
| Notes |
Outcome not reported so that meta‐analysis is possible. |
| 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 |
'Nei Gruppi 2 e 10 il placebo veniva presentato sotto forma di compresse aventi il medesimo aspetto ed il medesimo colore di uno dei medicamenti impiegati nei Gruppi 3 e 9' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
High risk |
Outcome not reported so that meta‐analysis is possible. |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
Low risk |
N = 72 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
