Vanlierde 1991.
Methods | Double‐blind, 2‐arm, parallel‐group, randomised controlled trial, with active comparator (no placebo) and 5 days duration of treatment | |
Participants |
Setting: multicentre, 7 continuing care wards Sample size:
Participant baseline characteristics:
Inclusion criteria: stable population of geriatric patients, must have grade 3 or 4 on a wax occlusion scale of 0 to 4 (0 being no wax) Exclusion criteria: none mentioned |
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Interventions |
Intervention group 1 (n = unclear participants; 34 ears): almond oil, 5 drops, twice daily, for 5 days Control group 2 (n = unclear participants; 35 ears): chlorobutanol, arachis oil and dichlorobenzene (Cerumol), 5 drops, twice daily, for 5 days Use of additional interventions: unstated |
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Outcomes |
Primary outcomes:
Secondary outcomes:
Timing of measurements:
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Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes | One patient developed otitis externa after using chlorobutanol, arachis oil and dichlorobenzene (Cerumol) and was withdrawn from the study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "in a randomised observer‐blind fashion" Comment: insufficient information regarding methods used |
Allocation concealment (selection bias) | High risk | Comment: not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "intraobserver variability was negligible due to prior self standardisation" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "in a randomised observer‐blind fashion" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all participants were accounted for |
Selective reporting (reporting bias) | Unclear risk | Comment: unclear distinction between planned methods and results reported |
Other bias | Low risk | Comment: no further sources of bias identified |