Methods |
Randomised controlled trial |
Participants |
31 children, mean age 4.6 years. Sex not reported. USA, outpatient clinic |
Interventions |
10% lemon myrtle oil or vehicle (olive oil) for 3 weeks |
Outcomes |
Complete clearance or > 90% reduction in number of lesions after 3 weeks |
Notes |
Funding: Center for Biomedical Research, a commercial institute involved in drug research and sale. Partner of Naturopathix (ZymaDerm for molluscum) |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote: "Children were randomised to active treatment or vehicle (virgin olive oil) by blindly choosing a token numbered from 1 to 100. Odd numbers were assigned to active treatment even numbers to vehicle" |
Allocation concealment (selection bias) |
Low risk |
Quote: "Children were randomised to active treatment or vehicle (virgin olive oil) by blindly choosing a token numbered from 1 to 100." "Parents and physicians were blinded to treatment protocol. A treatment key was held by a participating pharmacist (no patient contact) until study completion" |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Parents and physicians were blinded to treatment protocol. A treatment key was held by a participating pharmacist (no patient contact) until study completion." "A mild synthetic lemon fragrance not containing citral was added to scent the control olive oil preparation. This fragrance by itself had no therapeutic effect." Vehicle controlled. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Parents and physicians were blinded to treatment protocol. A treatment key was held by a participating pharmacist (no patient contact) until study completion." "A mild synthetic lemon fragrance not containing citral was added to scent the control olive oil preparation. This fragrance by itself had no therapeutic effect." Vehicle controlled. |
Incomplete outcome data (attrition bias)
Short‐term outcomes (up to 3 months) |
Low risk |
21 days: 4/31 withdrew: 1/16 in lemon myrtle oil group lost to follow‐up; 3/15 missing in vehicle group, withdrew because of worsening of the molluscum. Withdrawn participants included in analysis as failures. |
Incomplete outcome data (attrition bias)
Medium‐ and long‐term outcomes (3‐6 months and longer) |
Unclear risk |
The study did not address medium‐ and long‐term outcomes. |
Selective reporting (reporting bias) |
Unclear risk |
Unclear |
Other bias |
Unclear risk |
The mean number of lesions at enrolment did not differ between treatment groups. No sex or age comparison between groups. No compliance data |