Elsevier

The Lancet

Volume 366, Issue 9479, 2–8 July 2005, Pages 37-43
The Lancet

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Chloramphenicol treatment for acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial

https://doi.org/10.1016/S0140-6736(05)66709-8Get rights and content

Summary

Background

One in eight schoolchildren have an episode of acute infective conjunctivitis every year. Standard clinical practice is to prescribe a topical antibiotic, although the evidence to support this practice is scarce. We undertook a randomised double-blind trial to compare the effectiveness of chloramphenicol eye drops with placebo in children with infective conjunctivitis in primary care.

Methods

Our study included 326 children aged 6 months to 12 years with a clinical diagnosis of conjunctivitis who were recruited from 12 general medical practices in the UK. We assigned 163 children to receive chloramphenicol eye drops and 163 to receive placebo eye drops. Eye swabs were taken for bacterial and viral analysis. The primary outcome was clinical cure at day 7, which was assessed from diaries completed by parents. All children were followed up for 6 weeks to identify relapse. Survival statistics were used for comparison, and analysis was by intention to treat.

Findings

Nine children were lost to follow-up (one in chloramphenicol group; eight in placebo group). Clinical cure by day 7 occurred in 128 (83%) of 155 children with placebo compared with 140 (86%) of 162 with chloramphenicol (risk difference 3·8%, 95% CI −4·1% to 11·8%). Seven (4%) children with chloramphenicol and five (3%) with placebo had further conjunctivitis episodes within 6 weeks (1·2%, −2·9% to 5·3%). Adverse events were rare and evenly distributed between each group.

Interpretation

Most children presenting with acute infective conjunctivitis in primary care will get better by themselves and do not need treatment with an antibiotic.

Introduction

Acute infective conjunctivitis has a substantial effect on the health-service workload despite its low morbidity. The disease accounts for up to 1% of consultations in primary care.1, 2 One in eight children have an episode of conjunctivitis every year,3 with more than 1 million episodes in the UK and more than 5 million in the USA. Although a diagnosis of acute conjunctivitis is usually straightforward, most family doctors recognise the difficulty of differentiating a viral cause from a bacterial cause. Standard clinical practice is the prescription of topical antibiotics,4 which reinforces the need for consultation, and the scale of ocular antibiotic prescriptions is large—in England, 2·3 million are issued every year in primary care to individuals of all ages.5

Antibiotic resistance is a growing global problem. With research showing little benefit from antibiotics in children with sore throat and otitis media,6, 7 there has been a reduction in antibiotic prescribing in the UK for common childhood respiratory viral infections. Acute conjunctivitis often has a bacterial cause and therefore prescription of antibiotics seems rational. Moreover, social factors and public-health policy often dictate that children receive treatment before returning to nursery or school (Rose PW, Ziebland S, Harnden A, et al, unpublished). A Cochrane systematic review of treatment showed that topical antibiotics resulted in significantly greater clinical and microbiological remission than placebo, but also showed a high rate of resolution with placebo.8 However, the included trials were all based on secondary-care populations, with exclusively bacterial infection and in which disease severity was probably increased. Most patients present in primary care with mild disease, so extrapolation of the Cochrane results to this setting would be difficult. We designed a randomised trial to investigate the effectiveness of topical chloramphenicol for children presenting with acute infective conjunctivitis presenting in primary care.

Section snippets

Participants

The study was a placebo-controlled, double-blind, randomised controlled trial consisting of 326 children with a clinical diagnosis of conjunctivitis. Children were randomly assigned to receive chloramphenicol (n=163) or placebo eye drops (n=163). Chloramphenicol was chosen because it is the most common preparation used by family doctors4 and has a low rate of resistance in common organisms.9, 10 Previous fears about the drug's safety11 have not been proven.12 The study was approved by the

Results

Figure 2 shows the trial profile. From the audit, an estimated 29% of all children presenting in the study period were recruited. No clinical differences were seen between the baseline characteristics of the children in both the chloramphenicol and placebo groups (table 1). More children complained of pain or soreness in the non-randomised group (n=30, p=0·01), but no other difference was recorded between the baseline characteristics of the randomised and non-randomised groups.

(Table 2) shows

Discussion

We have shown that symptoms resolve without antibiotics in most children with acute infective conjunctivitis. In our intention-to-treat analysis, we recorded a modest improvement in symptom resolution at day 7 in the group receiving chloramphenicol. This improvement was further reduced if children lost to follow-up were excluded. We have no reason to believe that these excluded children would behave differently to those completing the trial. About half a day was gained in time to resolution

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