| Methods |
Design: four group parallel trial
Purpose: examine the effect of homeopathy for upper respiratory infections (URTI) in children |
| Participants |
Patients: children with upper respiratory infection
Baseline comparability: yes (age, gender) |
| Interventions |
Placebo: lactose pill
Untreated: no pill
Experimental:
‐Self‐selected ultramolecular homeopathic pill
‐treatment by homeopath
(Co‐intervention: no) |
| Outcomes |
Total URTI score
Days with URTI
Days with antibiotics
Days with analgesic/antipyretic
Visits to medical doctor
Days with other illness, noises from the chest, or work absence due to ill child
(all outcomes also as binary: proportion of children with days of ...) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'computer' |
| Allocation concealment? |
Low risk |
'central' |
| Blinding?
Treatment provider |
Low risk |
'This trial was of double‐blind, randomized parallel group placebo controlled design' |
| 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? |
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 = 176 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
