Sarrell 2003b.

Methods	Computer‐numbered randomisation Baseline comparability documented Ear drops in identical bottles Double‐blind Not ITT (5 of 90 patients were excluded)
Participants	Israel 85 children in an ambulatory clinic aged 5 to 18 years with ear pain caused by AOM
Interventions	Treatment: anaesthetic ear drops (amethocaine, phenazone, glycerine). Control: naturopathic ear drops (Allium sativum, Verbascum thapsus, calendula flores, Hypericum perforatum, Lavandula officinalis and vitamin E in olive oil) Drops were instilled 3 times daily for 3 days All children were also given oral amoxicillin (80 mg/kg/day divided into 3 doses) Duration: 3 days
Outcomes	Ear pain was assessed using 2 visual analogue scales and an overall ear pain score was determined. The first data point was assessed at the diagnosis of AOM and then pain was assessed during 3 days; before the drops were installed, and at 15 and 30 minutes after instillation Outcome: mean pain score
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"...the children were assigned by computer‐numbered randomization..."
Allocation concealment (selection bias)	Unclear risk	No mention of sequentially numbered, opaque, sealed envelopes or of central randomisation by a third party
Blinding (performance bias and detection bias) All outcomes	Low risk	"A double‐blind design was used, and all ear drops were placed in identical bottles" "The contents of the bottles were unknown by both the subjects and the nurse"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"Nine of the 180 children enrolled in the study (1 in group A, 3 in group B, 3 in group C, and 2 in group D) were excluded from the final analysis because of noncompliance: 5 forgot to take the medicine, and 4 could not be reached for the follow‐up interview."

AOM: acute otitis media 
 ITT: intention‐to‐treat