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Evid Based Nurs 9:12 doi:10.1136/ebn.9.1.12
  • Treatment

Topical chloramphenicol was not effective for acute infective conjunctivitis in children


 
 Q In children with acute infective conjunctivitis, is topical chloramphenicol effective for inducing clinical cure?

METHODS

GraphicDesign:

randomised controlled trial.

GraphicAllocation:

concealed.

GraphicBlinding:

blinded (patients, healthcare providers, data collectors, outcome assessors, and data analysts).

GraphicFollow up period:

7 days for the primary outcome plus an extra 5 weeks to assess relapse.

GraphicSetting:

12 primary practices in Oxfordshire, UK.

GraphicPatients:

326 children 6 months to 12 years of age (mean age 3 y, 53% boys) who had acute infective conjunctivitis. Exclusion criteria included allergy to chloramphenicol, use of antibiotics (current or within the previous 48 h), evidence of severe infection, and children who were immunocompromised.

GraphicIntervention:

0.5% chloramphenicol (preservation-free eye drops BP)(n = 163) or placebo (distilled water with the excipients boric acid, 1.5%, and borax, 0.3%)(n = 163). Parents were instructed to put 1 drop in each affected eye every 2 hours for the first 24 hours when their child was awake and then 4 times daily until 48 hours after the infection had resolved.

GraphicOutcomes:

clinical cure at 7 days (based on parent report). Secondary outcomes included time to clinical cure, clinical cure at 3 days, microbiological cure or improvement at 7 days, relapse rate within 6 weeks, and adverse effects.

GraphicPatient follow up:

97% at 7 days (intention to treat analysis) and 94% at 6 weeks.

MAIN RESULTS

The groups did not differ for rates of clinical cure at 7 days (table), time to clinical cure (mean difference −0.33 d, 95% CI −0.75 to 0.09), rates of clinical cure at 3 days (relative benefit increase [RBI] 19%, CI −11 to 59), microbiological cure or improvement (RBI 17%, CI −4 to 45), adverse effects at 7 days (risk difference 0%, CI −2.9 to 2.9), or relapse rate at ⩽6 weeks (risk difference 1.2%, CI −2.9 to 5.3).

Chloramphenical eye drops v placebo in children with acute infective conjunctivitis*

CONCLUSION

In children with acute infective conjunctivitis, topical chloramphenicol was not effective for inducing clinical cure.

A modified version of this abstract also appears in Evidence Based Medicine.

Commentary

  1. Gene Elizabeth Harkless, RN, DNSc, ARNP
  1. University of New Hampshire Department of Nursing
 Durham, New Hampshire, USA

      Although chloramphenicol has been thought to be the “gold standard” of care in the UK,1 the study by Rose et al calls this belief into question. Time or the simple act of providing frequent buffered saline drops along with good lid hygiene may heal mild to moderate conjunctivitis as effectively as chloramphenicol. However, other newer antibiotics may be more effective than placebo.2 The community based sample of patients with conjunctivitis in the study by Rose et al had more confirmed bacterial infections than anticipated. Thus, more research is needed to provide clinicians with better predictive information about the recovery time and transmission rates across different presentations of infective conjunctivitis in children as a basis for determining which children should be treated with antibiotics. The US guidelines for out-of-home child care state that children must be excluded from child care until after treatment for conjunctivitis has been initiated,3 thereby effectively requiring all presentations of this condition to be treated with antibiotics. However, current public health advice in the UK is that children with conjunctivitis do not need to be excluded from school.4 As of June 2005, chloramphenicol eye drops, but not ointment, became available as an over-the-counter medication in the UK. Both are seldom used in the US. UK pharmacists will now be involved in diagnosing and treating “pink eye.” This over-the-counter availability of chloramphenicol eye drops will definitely have an effect on the patient presentations of conjunctivitis that primary care providers see in their offices.

      References

      Footnotes

      • For correspondence: Dr P W Rose, Department of Primary Health Care, University of Oxford, Oxford, UK. peter.rose{at}dphpc.ox.ac.uk

      • Source of funding: Medical Research Council.

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