Liu 2003.
Methods | Two‐arm, blinding not described, parallel‐group RCT, with 2‐week duration of treatment and follow‐up | |
Participants |
Location: China, 1 site Setting of recruitment and treatment: outpatient department, department of Otolaryngology, Wenzhou Second People's Hospital, published in 2003 Sample size: 160
Participant (baseline) characteristics:
Inclusion criteria:
Exclusion criteria:
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Interventions |
Group A (n = 87): rifampicin (0.1%) eye drops, through the ear canal, 3 drops, 3 times a day. Duration of treatment: 2 weeks. Group B (n = 73): chloramphenicol (0.25%) eye drops, through the ear canal, 3 drops, 3 times a day. Duration of treatment: 2 weeks. Concurrent treatment: aural toileting, "wash the ear canal with 3% H2O2 solution and dry the ear" before administration of ear drops |
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Outcomes |
Outcomes of interest in the review: Primary outcomes: Complete resolution of ear discharge measured at 2 weeks: Quote: "Criteria for assessment of outcomes:
The outcome was presented as the number of patients whose treatment was considered curative, significantly effective, or non‐effective, respectively Secondary outcomes:
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Funding sources | No information provided | |
Declarations of interest | No information provided | |
Notes |
Unit of randomisation: person Methods for including patients with bilateral disease: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "We randomly selected 160 patients who were diagnosed with chronic suppurative otitis media in outpatient department (male 92, female 58, age 16 to 65, mean 30). These patients were divided into rifampicin group (group A, 87 patients) and chloramphenicol group (group B, 73 patients). The two group showed no significant difference in terms of gender, age, and course of disease." Comment: it is not clear whether or not the patients were randomised |
Allocation concealment (selection bias) | Unclear risk | Quote: "We randomly selected 160 patients who were diagnosed with chronic suppurative otitis media in outpatient department (male 92, female 58, age 16 to 65, mean 30). These patients were divided into rifampicin group (group A, 87 patients) and chloramphenicol group (group B, 73 patients). The two group showed no significant difference in terms of gender, age, and course of disease." Comment: not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: not mentioned. Given the different colour of the 2 different eye drops, blinding would be difficult to achieve. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: attrition not reported. It seems that no participant was lost to follow‐up. |
Selective reporting (reporting bias) | Unclear risk | Comment: a protocol for this trial is not available |