Skip to main content
. 2020 Jan 2;2020(1):CD013051. doi: 10.1002/14651858.CD013051.pub2

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
  • Number randomised: 87 in rifampicin, 73 in chloramphenicol

  • Number completed: 87 in rifampicin, 73 in chloramphenicol


Participant (baseline) characteristics:
  • Age: mean 30 years (range: 12 to 65 years)

  • Gender (F/M): 58 (38.7%)/92 (61.3%). Note: only 150 of 160 recruited patients are accounted for

  • Main diagnosis: "patients who were diagnosed with chronic suppurative otitis media in the out‐patient department." No definition was provided.

  • High‐risk population: unclear

    • Cleft palate (or other craniofacial malformation): not reported

    • Down syndrome: not reported

    • Indigenous groups (Australian Aboriginals/Greenland natives): not reported

    • Immunocompromised: not reported

  • Diagnosis method: unclear

    • Confirmation of perforated tympanic membrane: not reported

    • Presence of mucopurulent discharge: not reported

    • Duration of symptoms (discharge): not reported

  • Other important effect modifiers:

    • Alternative diagnosis of ear discharge: not reported

    • Number who have previously had grommets inserted: not reported

    • Number who have had previous ear surgery: not reported

    • Number who had previous antibiotic treatment for CSOM: not reported


Inclusion criteria:
  • Not reported


Exclusion criteria:
  • Not reported

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
Outcomes Outcomes of interest in the review:
Primary outcomes:
Complete resolution of ear discharge measured at 2 weeks:
Quote: "Criteria for assessment of outcomes:
  • Cured: otorrhea disappeared, mucosal hyperemia of the tympanic membrane and tympanic cavity disappeared

  • Significantly effective: no complaints of otorrhea, no visible purulence in the ear canal and tympanic cavity, and nonvisible or slight hyperemia of the tympanic membrane and the tympanic canal

  • Non‐effective: otorrhea persisted after 2 weeks of treatment, purulence in the external ear and tympanic cavity, and hyperemia of the tympanic membrane"


The outcome was presented as the number of patients whose treatment was considered curative, significantly effective, or non‐effective, respectively
Secondary outcomes:
  • Not reported

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
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