| Methods |
Design: four group parallel trial
Purpose: examine the effect of two homoeopathic preparations on postoperative ileus |
| Participants |
Patients: postoperative in‐patients (after abdominal surgery)
Baseline comparability: yes (sex, age, type and duration of operation) |
| Interventions |
Placebo: granule with no homoeopathic content
Untreated: no granule
Experimental: homoeopathic preparations 'opium' or 'raphanus'
(Co‐intervention: use of laxatives higher in placebo than untreated) |
| Outcomes |
Time from abdominal closure to first stool and first flatus (hours) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'random numbers' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'... in a controlled, double‐blind therapeutic trial...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
Low risk |
N = 300 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop out > 15% or NS |
